—% Laboratories MICROKIT He ) tA IPasiGn por la creatividad! Apartado de Correcs / P.O. Box 4 28240:¥aldemorillo (Madrid, spain) @ (a4) sus) 4036 Fan(s) 987 4641 PLAGUISS | ORITPROSS E-mall: mlcrokit Pmierokits z SELAGUAD Wab: pret aborsteriogmlere bie coh ‘senwemleralities GALERIAS DE IDENTIFICACION CRYSTAL BBL PARA GRAM POSITIVOS (Bacillus, Enterococcus, Lactococcus, Leuconostoc, Listeria, Micrococcus, Pediococcus, Staphylococcus, Streptococcus...) Gram-Positive Identification Color Chart ©000995000 oe ec eee Yee Ye = O9OO03900008 FGC FGS FAR FGN|LAC MNT GLR PCE PAM ESC Of Ye eee Ye =O8O00055000 FVA FPY FGA FIS | MAB MTT FRU PLN PGO ARG oon A ee Be ee Goel Pea eet Pee ee ene CAJAS DE SOLO 10 TEST. REFERENCIA 245140 Distribuida por MICROKIT desde 07-2012 rorya8809911(0404) .qxd 07/19/2004 3:18 PM on i @BD BBL Crystal™ Identification Systems Gram-Positive ID Kit 18809911184 2004/08 uig.comPLEATTY: HIGH CDC IDENTIFIER CODES [ANALYTE 0412 ‘est SYSten 7919, See symbol glossary at end of insert. INTENDED USE ‘The BBL Crystal™ Gram-Positive (GP) Identification (D) system is @ miniaturized identification method employing modified conventional, fluorogenic and chromogenic substrates. Its intended for the identification of aerobic ‘gram positive bacteria. 21316 SUMMARY AND EXPLANATION Mieromethods fr the biochemical identifiation of microorganisms ware reported as erly as 19182 Several pubixations reported on te uve of the reagentsmpregrated paper dis and muctortube methods for Sifferentiating enteric bacteria 37.179 The interest in miniaturized identification systems led to the introduction ‘ot several commercial systems inthe ite 1960s, ana they provided advantages n requiring Iie orage space, fxtended shelf fe, standardized quality contol and eae of use In general, many ofthe tests used inthe BBLCrystal IO Systems are mexifications of classical methods. These inchae tests for fermentation, oxidation, degradation and hysalyt of various substrates. In addon, tere are hromogen and fvorogen ine substrate n the BBLCrystal GP iD pare, to detect enzymes that microbes ote metabolize various subsratessa5i 12 “he BBL Crystal GP 1D its comprised of () BBLCrystal GP 10 pane! lids, i BBL Crystal bases and (i) BBL Crystal AN, GP RGP, Nib inoculum Futd GF ues. The hd contain 29 detyeratedsubrrates and a {iorence carr on rot pati prongs. he ave ha 20 recon wl, Test ncaum prepared th he inoculum fiuid and is used tof ilall Sd wels in he base When thei aligned with the bese and snapped i lace, the test inoculum reydrates the arid substrates and inate tex reactions. incubation period, the walls are examined for color changes or presence of fluorescence that reutt Setuites ef tne microorganisms, The resulting pater of the 28 rections i converted Into a ‘crcaig profile number thet ued st te bass for dentition. Biochemical and ensymatic reaction patterns {or the 28 BoLCrystal GP Id substrates for awide variety of microorganisms are stored tre BBLCrystal @ > dita base. ens ation i erie fom a comparstive trai of te reaction pasten ofthe tes lat 9 those ire inthe database compet st of taxothat compres te cent database bproviced in Tablet ee pg. 7. PRINCIPLES OF THE PROCEDURE “The BBLCrystal GP 1D panes contain 29 dried biochemical and enzymatic substrates. A bacterial suspension inthe inoculum fluid used for rehydration of the substrates The test used nthe sytem ae based on microbitutlzstion and degradation of specicubstates detected by various indicator systems: Enzymatic Iyrobsis af fvoragenic substrates contaning coumarin deratives of 4metnylumbelferane aM) or ‘Pamnod-mathycuarin (AMO), reals i increased fluorescence that seal Setected visual th a UV ight source" "8¥ chromogenic substrates upon hydrolysis produce color change’ that can be detected ‘Buniy tn elton there are ats that detect te ably ofan organo to hyolpee degrade, teduce ar ‘thertiseutlize @ substrate inthe BBLCrystal ID Systems cl by vorbis tulsrates andl sie nlite prices enpload in the seta cepa. Bh Parl locaton in refered tables indicates tne fw and column where the well ‘retest Row tin column) REAGENTS ‘The BBL Crystal GP 1D panel contains 29 enzymatic and biochemical substrates, Refer to Table 3 (see pg. 9) for a list of active ingredients Warnings and Precautions: For in vitro Diagnostic Use.8809911(0404) .qxd 07/19/2004 ge 2 ‘After review by the U.S. Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) under CLIA aa, this product has been identified as high complexity. The COC Analyte identifier Code is 0412; the CDC Test System Identifier Code fs 07919, ‘After use, all infectious materials including plates, cotton swabs, inoculum fluid tubes, and panels must be ‘autoclaved prior to disposal or Incineration, STORAGE AND HANDLING/SHELF LIFE Lids: BBL Crystal GP lids are individually packaged and must be stored unopened in 2 refrigerator at 2-8°C (BO NOT FREEZE. Visually inspect the package for holes or cracks In the Toll package. Do not use Ifthe packaging ‘appears to be damaged. Lids in the original packaging, if stored as recommended, will retain expected reactivity Until the date of expiration. ‘Bases: Bases are packayed in two sets of ten, in BBL Crystal incubation trays. The bases are stacked facing down to minimize alr contamination. Store in a dusttree environment at 2-30°C, untl ready to use. Store unused Dares in the tray, in plastic bag. Empty trays should be used to incubate inoculated panels. Inoculum Fluid: BBLCrystal ANA, GP, RGP, NIH ID Inoculum Fluid (IF Is packaged in two sets of ten tubes. Visually inspect the tubes for cracks, leaks, etc, Bo not use if there appears to be a leak, tube or cap damage or visual evidence of contamination {ie., haziness, turbidity). Store tubes at 2-25°C. Expiration dating is shown om the ‘tube label, Only ANR, GP, RGP, NIH Inoculum Fluid should be used with BBL Crystal GP ID panels (On receipt store the BBL Crystal GP ID kit at 2-8°C. Once opened, only the lids need to be stored at 2-8°C. The remaining ‘components of the kit may be stored at 2-25°C, Ifthe kit or any of the components ae stored refrigerated, each should be brought to room temperature prior to use. ‘SPECIMEN COLLECTION AND PROCESSING BBL Crystal ID Systems are not for use directly with clinical specimens. Use isolates from media such as Teyptiease™ Soy Agar with 5% Sheep Blood {TSA I) oF Columbia Agar with 5% sheep Blood (Columbia Blood ‘Agat). Use of selective media such as Phenylethy Alcohol Agar with 5% Sheep Blood (PEA) or Columbia CNA. ‘Agar with 5% Sheep Blood (CNA) is also acceptable, Media containing esculin should not be used, The test isolate ‘mist be 2 pure culture, no more than 18-24 h old for most genera; for some slow growing organisms up to 48h ‘may be acceptable. When swabs are utilized, only cotton-tipped applicators should be used to prepare the inoculum suspensions. Some polyester swabs may cause problems with Inoculation of the panels. (See Limitations of the Procedure") The incubator used should be humidified to prevent evaporation of fluid from the wells during incub recommended humidity level is 40-60%. The usefulness of BBL Crystal ID Systems or any other diagnostic procedlure performed on clinical specimens is direct influenced by the quality of the specimens themselves, Itis Strongly recommended that laboratories employ methads discussed in the Manual of Clinical Microbiology for Specimen collection, tranaport and inceulation anta primary isolation media.) TEST PROCEDURE ‘Materials Provided: BBL Crystal GP IO Kit. 20 BBL Crystal GP ID Pane! Lids, 20 BBL Crystal Bases, 20 BBLCrystal ANR, GP, RGP, NH ID IF Tubes. Each tube has approximately 2.3 + 0.15 mL of inoculum Fiuid Containing: KCI 7.5'g, CaCl 05 g, Tricine N{2-Hydroxy-1, Tis (hydroxymethy)methyll glycine 0.895 a, purified ‘water to 1000 ml, 2 incubation trays, 1 BBLCrystal GP ID Color Reaction Chart and Results Pad. Materials Required But Not Provided: Sterile cotton swabs (do not use polyester swabs), incubator (35 ~ 37°C) ‘non-CO; (40-60% humidity), McFarland No. 0.5 standard, BBL Crystal Panel Viewer, BBLCrystal ID Systern Electronic Codebook or BBL Crystal Gram-Positive Manual Codebook, and appropriate culture medi Akio cequired are the necestary equipment and labware used for preparation, storage and handling of clinigal specimens. 9. The Test Procedure: BBL Crystal GP ID System requires a Gram stain 45. Remove lids from pouch, Discard desiccant. Once removed from the pouch, covered lids should be used within 1h. Do nat use ‘the panel if there is no desiccant in the pouch, 2. Take an inoculum fluid tube and label with patient's specimen hhumber. Using aseptic technique, pick cofonies of the same morphology with the tip of a sterile cotton swab (do not use a polyester swab) or a wooden applicator stick from one of the Fecommended media (see section under "Specimen Collection nd Processing"). 3. Suspend colonies in a tube of BBLCrystal ANR, GP, RGP, NIH ID inoculum Fluid 4. Recap tube and vortex for approximately 10-15 s. The turbidity should be equivalent to a McFarland No. 0.5 standard, f the inoculum suspension concentration is in excess of the recommended McFarland standard, one (of the following steps is recommended: 3. Use afresh tube of inoculum fu to prepare anew inocukum suspension equivalent to a MeFatland No. 05 standard. b, If additional colonies are unavailable for preparation of a new inoculum suspension, using aseptic techniques, dilute the inoculum by adding the minimum required volume (not to exceed 1.0 mU). of 0.8586 sterile saline or inoculum fluid to bring down the turbidity equivalent to a McFarland No. 0 Standard, Remove the excess amount added to the tube with a sterile pipet s0 that the final volume of inoculum fluid Is approximately equivalent to that of the original volume in the tube (2.3 + 0.15 mL). Failure to make this adjustment in volume will result in spiling of the Inoculum suspension over the black portion of the base rendering the panel unusable 2 Se809921 (0408) .qxd 07/19/2004 ge 3 5. Take a base, and mark the patient's specimen number an the side wall 66. Pour-entie contents of the inaculum fluid tube into target area of the base 7. Hold base in both hands andl roll inoculum gently along the tracks untl all of the wells are filled. Roll back any excess fluid {0 the target area and place the base on a bench top. 8. Align the lid so thatthe labeled end of the lid is on top of the: target area of the base, 9. Push down until a slight resistance is felt. Place thumb on edge Of lid towards middle of panel an each side and push Raneously until the lid snaps into place (ster Purity Plate: Using a sterile loop, recover a small drop from the ineeulun fluid tube either before or after inoculating the base and inoculate an agar slant or plate (any appropriate medium) for purity cheek, Discard inoculum fluid tube and ¢ap in a biohazard disposal Container. Incubate the slant or plate for 24-48 h at 35-37°C under ‘appropriate conditions. The purity plate or slant may also be used ‘or any supplementary tests or serology, if required. Incubation: Place inoculated panels in incubation trays. Ten panels can fit in one tray (5 rows of 2 panels). All panels should be incubated face down (larger windows facing up: label facing down) ina non-CO3 incubator with 40-60% humidity. Trays should not be ‘stacked more than twa high during incubation. The incubation tiene for panels \s 18-24 h at 35-37°C. If panels are incubated for 24h, ‘they should be read within 30 min after removing from incubator. Reading: After the recommended period of incubation, remove the panels from the Incubator. All panels should be read face down larger windows up; label facing dow) using the BBL Crystal Panel Viewer Refer to the color reaction chart and/or Table 3 (Gee pg. 9 for an interpretation of the reactions, Use the results pad {to record reactions. Aitemnatively, the BBL Crystal AutoReader may be used to read the panels ‘a. Read columns thru fist, using the regular (white) light source. b. Read columns A thru D (fluorescent substrates) using the UV light source in the panel viewer. fluorescent substrate well is considered positive only i the intensity of the fluorescence fbserved in the well is greater than the Negative Control well CA), Caleulation of 881 Crystal Profle Number: Each test result (except 4A, which is used asa fluorescenee negative contral) scored positive «given a value of 4,2, or I, corresponding to the row where the test islocated. 4 value 3 —o—809911 (0804) .qxd 07/19/2004 3:18 EM be 4 0f 0 (zero) is given to any negative result. The values resulting fram each positive reaction in each column are then added together. A 10digit number s generated: this isthe profile number. Eample: [aA [® [© ]® .® ]* |e]. z 4 * [+ - [+ [+ [+ + 2 = | |e : se 1 + * | = )* L= + [+ Profile 6 3 [7 +(4A) = fluorescent negative control The resulting profile number and cell morphology, if known, should be entered on a PC in which the BBL crystal Mind Software has been installed to obtain the Identification. I using the BBL Crystal AutoReader, organisms are automaticaly identified by the PC. A manual codebook i also available, fa PC is not available eomtact BD Technieal Services for asstance with the identification, User Quality Control: Quality control testing is recommended for each lat of panels as follows ~ 1, noculate a panel with Streptococcus pyogenes ATCC™ 19615 per recommended procedure (refer to "Test Procedure”) 2. Incubate panel for 18-20 h at 35-37°C 3. Read panet with the panel viewer and color reaction chart; record reactions using the results pad Alternatively, read the panel on the BBLCrystal AutoReader. 4, Compare recorded reactions with those liste in Table 4 (see pg. 10). If cliscrepant results are obtained, confirm purity of quality control strain before contacting 8D ‘Technical Services, Expected test results for additional quality control test strains are listed in Table $ (see pg. 10k. Quality control requirements must be performed in accordance with applicable local, state andlor Federal regulations or accreditation requirements and your laboratory’s standard Quality Control procedures. Itis recommended that the user refer to pertinent NCCLS guidance and CLLA regulations for appropriate Quality Control practices, LIMITATIONS OF THE PROCEDURE The BBL Crystal GPID System is designed for the taxa provided. Taxa other than those listed in Table are not intended for use in this system, ‘The BBL Crystal GP 1D System database includes some species that are rarely isolated from human clinical specimens ond were not encountered in the clinical studies of this product. It abo includes some species that Were encountered les than 10 times inthe clinical studies: Refer to Table 1 (see pg. 7) for a breakdown of the ‘humber of strains per species tested in clinical trial, The laboratorian should determine If additional testing Is Fequired to confirm identity of those species for which performance has not been established (he. those species (where less than 10 isolates were evaluted inthe clinica trials for this product). ‘The BBLCrystal GP ID database was developed with BBL" brand media. Reactivity of some substrates in miniaturized identification systems may be dependent upom the source media used in inoculum preparations. We fecommend the use of the following media for use with the BBLErystal GP ID System TSA ll and Columbia Blood ‘Agar. Use of selective media, such 9 PEA or CNA is also acceptable: Media containing esculin should not be Used BBL Crystal Identiication Systems use a modified microenvironment; therefore, expected valves for its individual tests may difer from information previously established with conventionel test reactions. The accuracy of the BBL Crystal GP 10 System is based on statistical Use of specially desighed tests and an exclusive databese While BBL Crystal GP ID System aids in microbial differentiation, i should be recognized that minor variations may exist in strains within species. Use of panels end interpretation of results require a competent microbiologist ‘The final identification of the isolate should take into consideration the source of the specmen, aerotolerance, call morphology, colonial characteristics on various media as well ax metabolic end products as determined by {gas-liquid chromatography, when warranted Only cotton-tipped applicator swabs should be used to prepare the inoculum suspension as some polyester swabs may couse the inoculum fluid to become viscous. This may result in insufficient inoculum flud to fil the wel, Cavered lids once removed from the sealed pouches must be used within 1 to ensure adequate performance. ‘The incubator where panels are placed should be humidified to prevent evaporation of inoculum fluid from the wells during incubation, The recemmended hum ity level i 40-60%. ‘The panels, after inoculation, should only be incubated! face down (larger windows facing up: label facing down) to maximize the effectiveness of substrates, ifthe BBL Crystal test profile yields a "No identification” result and culture purity has been confirmed, then itis Ukely that (the test Golate & procicing saypica!8BL Crystal reactions (which may also be caused by procedural ‘errors, (i) the test spaces is rot part ofthe intended taxa or (il the system is unable to identity the test wolate si the required eve! of conisence, Conventional test methods ae recommended when ter eror hat been Tuled out, EXPECTED VALUES The expected substrate reactions for the species of organisins most frequently encountered in the clinical study of 88 Crystal GP 10 Sytem are shown in Table 6 Gee\pg.17), The ravided percentages were generated from ‘eactions given by the organisms used in generating the database. Table 1 ee pg.) shows all the tava tested during database generation —p—8809921(0804) .qxd 07/19/2004 PERFORMANCE CHARACTERISTICS Reproducibility: In an external study involving four clinical laboratories (otal of four evaluations), the: reproducibility of BBL Crystal GP ID substrates’ (29) reactions was studied by replicate testing. The reproduelbilty Of the individual substrate reactions ranged from 79.2%-100%, The overall reproducibility of BBL Crystal GP ID ‘panel was determined to be 96.7% 22 ‘Accuracy of Identification: The performance of BBL Crystal GP ID System was compared to currently available commercial systems using lina isolates and stock cultures. A total of four studies were conducted in four independent laboratories Fresh, routine lates arriving in the clinieal laboratory, as well a previously identified isolates ofthe clinical tril sites’ choice, were utilzed to establish performance characteristics (Out of 735 total isolates tested from the four studies using BBL Crystal GP Identification System, 623 (84.8%) were correctly identified without the use af sunplement tess, and 668 (90.9%) were correctly identified when Supplemental tests were included. A total of 56 (7.6%) isolates were incorrectly identified, and a message of "No Identification” was obtained for 11 (1.5%) solates*9 Table 7 (see pg. 12} shows the acccuracy of Identification for the species most frequently encountered (je, 10 of more isolates) in the clinical tral as well as forthe remaining group of species where les than 10 frolates wore tested AVALABIITY Cat.Ne. Deserintion Cat No. Description 285240 BBLCrystal™ Gram Poste D Kit 265200 BBLCrysal™® AutoReader containing 20 each: BBLCrystal GP ID 221165 BBL™™ Columbia Agar with 5% Shee Panel Lids, BBL(rystal Bases and Blood, pkg, of 20.7 ee BBL Crystal AN, GP, AGP, NH 12 221263 gat Cakumbia Agar with 5% Sheep 245038, sLCrystal™ AINR, GP, RGP, NIH ID Bibsey eet eam 221352 BBLI™ Columbia CNA Agar with Inoculum Fluig, in. of 10 Bey eee iA fons 245031 BBLCrystal™ Panel Viewer, Domestic 285052 BBL Crystal Panel Viewer, European 221179 aL Phenyl Alcano! Agar with 245023 ‘BBL Crystal™ Panel Viewer, Japanese ica aaabarte ps ater rr SE mer menneoaiceaserem 245036, IL Crystal™ Panel Wiewer, White Light SF Sheep Blood (154 W.-pya. of 20. zc 221261 BBL™ Trypticase” Soy Agar with 55. sheep Blowd (TSA), cin of 100 245037 BALCostar™ tdensiicsin syste 212589 BBL Gram stain Kit, py of 4 250 mb 441010 sL Crystal™ Mind Software fees 1, Balows, Ay Wad, Hauslen Jr, Kil, Herrmann, H.O. Isenberg, and HJ. Shadamy (ed. 1991. Manual of clinical microbiology, Sth ed. American Society for Microbiology, Washington, D.C. Baron, £4, LR, Peterson, and S.M, Finegold, 1984, Bailey and Scotts diagnostic microbiology, Sth ed. Mosby= Year Book, Inc, St. Lou's 3. Bronfenbrennet, J, and MJ. Schlesinger. 1918. A rapid method for the identification of bacteria fermenting carbohydrates. Am. | Public Health, :922-923, 4. Cowan, S7., and K.J. Steel. 1974, Manual for the identification of medical bacteria. nd ed, Cambridge University Press, Cambridge 5. 6 Edberg, S.C, and CM. Kentniek. 1986. Comparison of 8-glucuranidase-based substrate systems for Identification of Escherichia cof, Clin, Microbiol 24:366-371 Ferguson, W.W, and A £, Hook. 1983. Urease activity of Proteus and Salmonella organisms. J. Lab, Clin, Med. 217151720. Hartman, P.A. 1968. Miniaturized microbiological methods. Academic Press, Naw York, z 8. Kampfer, P, 0. Rauhoff, and W. Dott. 1991. Glycosidase profiles of members of the family Enterobacteriaceae, J. Clin. Microbiol, 28-2877-2878, ©. Killian, M,, and P. Bulow. 1976. Rapid diagnosis of Enterobacteriaceae 1: detection of bacterial glycosidases ‘Acta Pathol, Microbiol, Seand, Sect. 8. 84245-251, 10, MacFaddin,-F. 1980, Biochemical tests for identitication of medical bacteria, 2nd ed. Wiliams & Wilkins, Baktimore, 11, Maddocks,L, and M. Greenan. 1875. Rapid method for identifying bacterial enzymes. J. Clin. Pathol. 28686587, 12, Manafi, M, W. Koeifel, and 5. Bascomb. 1991. Fluorogenic and chromogenic substrates used in bacterial diagnostis. Microbiol. Rev. 55:335:348, 13, Mandell, G.L,, RG. Douglas, Jr. and J.6. Bennett, 1990, Principles and practice of infectious diseases, 3rd ed. ‘Churchill Livingstone Ine, New York 14, Mangels, J, Edvalson, and M. Cox. 1993. Rapid Identification of Bacteroides fragilis group organisms with the use of 4-methylumbelliferone derivative substrates, Clin. Infect. Dis. 16(54):5319-5321 ico899911 (0808) .qxd 07/15/2004 3:18 EM be 6 15. Mondla, 8, P. Braham, LK. Rabe, and SL Hiller. 1991, Rapid presumptive identification of black pigmented ‘gram-negative anaerobic bacteria by using 4-methylumbeliferone derivatnes. J lin. Microbial 22:1955-1958, 16. Murray, PR, EJ. Baron, M.A. Pfaller, F.C. Tenover, and RH. Yoken (ed). 1995, Manual of clinical microbiology, 6th ed. American Society for Microbiology, Washington, D.C. 17, Sanders, AC, JE. Faber, and TM. Cook. 1957. rapid method for the characterization of enteric pathogen Using paper discs. Appl. Microbiol}. 5:36-40. 18, Sneath, P.H.A, 1957, The application of computers to taxonomy. J. Gen. Microbiol, 17:201-221 19, Soto, 0.8. 1949. Fermentation reactions with dried paper discs containing carbohydrate andi indicator. Puerto Rican J. Public Health. Trop. Med. 25:96-100. 20, Data on file at 8D Diagnostics. Key: Table + KEY: = These taxa have fewer than 10 unique BBLCrystal profiles in the current database. ox Number of isolates ("x") encountered in the elnical tal. Ifo number in parenthesis shown after an organism name or group description, these species were nt encountered in the clinica tial Note #1: There were 14 additional isolates encountered in the clinical trial that are not shown above. Five (5) (Le, 4 Staphylococcus spacies and 1 Enterococcus were identified only to the genus level by the Feference system against which BBL Crystal GP was compared, although BBL Crystal GP identified these organisms to the species level. Nine (9) were identifed by the reference system, but were ot included in the BBLCrystal GP database taxa, Note #2: The organisms shown in bald face type were encountered 10 ar more times in the clinical study for this product. Note #3: The organisms not shown in bold face type are either species which are rarely isolated from human linizal specimens or species that were infrequently (less than 10) encountered in the clinical study. {for this product. The laboratorian should determine if additional testing is required to confirm their identity. —p—ge09921 (0804) .gxd 07/19/2008 ge 7 [Tablet [Taxa In BBL Crystal™ GP 1D System Acinomyces pyogenes | Aerococus species cues A urnge and A irda) Aerococis uinge Aevocoeus widens Asiccoccur ott * /Anarobacterism semobticun) acts ves) Bacis cereus) Bact culos Beats coagulas acts Kenitor’s (0) acts megaterium acs purus Bits speces (icades cis soherius cits sabes (1 oyebacteiam aquatioun Coyrebscterium bos conmebacteriarm aiphcherse induces C dpharense subsp | coyrebacteriam pscudelphhertcum 2) coryrebocternr pscusegentalum nyebacteria pseudotaberuls’ 2) onyrebecteriam rene grou Corynebacterium Enterococeas ours) Enterococcus Faecal (78) Enterococcus faecium (33) Enteroccxus irae Erterococasrofrosas 8) Ererococtuewotare Egspebthricrhusgpathioe Gorenerls vaginas Gemelo hemotsans ‘Gemell martitorum ‘Geel species (nclces tracrosans and {& morailorun) Gobistel oncuis (3) coco kur Lactococcus gorviewe Lactococcus Laetocoeeut ets Dorcnive Lactococcus lactic acrococesraffinocti Lactocccusspeces eles Cloaissubypcemons Loc subsp hore, lactissubsp lbetisandtrathinoloces) Leuconostoc clean Leuconostoc lat (I) Leuconostoc mesenteraises ‘sep mesentorer Leuconostoc pesudomecentacises Levcanastoe species ndudes oteum,L fects L mesentevoidessubsp ‘mesenteroides and pseudomesenteroies) usteragray* {storia hanoul subsp Nanow Litera monoxytogenes (3) storia murray Mirococus kristine Mirococs tous Mirococus ve Merococus seus ‘Mlerococussedentars (includes Mt kristin, S cohni subsp ureahicum) (N) Saphyococes cob bsp coh Sraphyococes obi esp realm Staphylococcus ‘permis (88) Saphyocoecs equorum Saphyocoas tes Saphyococus galinaram Staphylococass haemolyticus (23) ‘Staphylococas bhominis (17) Saphyocoecus intermedius Staphylococcus kos (2) Ssaphyococuslrtus Ssaphyococa Iugaunerss Saphyococes pasteur*0) Saphycoms actors Sropbyocoies sprophyias. Staphyococas sheer linus shlefen sap coagulansand shee subsp sche Saphylocoacs scr Staphylococeus simulans 8) Saphyococes tls Sraphyocoes warmer (6) Staphyococus sos) Stamatoceceus muclaginoass ‘Sreptococas acdominimas apes opiate Sroprocors angina (1) Streptococas bovis (includes 5 bovis and 55 bovis 1) (10) ‘Sroptococsconsteats (1) Seeptococascrcetus* Sireprococas rita Streptococes equi Grades Sequisubsp equ and S equi subsp zooepiemi (1) Siroprococes ql subspequ 2) Streptococasequisubs ‘acepieonces ‘srepracocast equinus Ssreptococas gordon ‘Streptococass Group 1G a Streptococs intermedius Streptocoxas ni) Streptococars mits group Gineludes 5 mits and Sora) 20) Steptococas mutans Stoprococes mutans gfoup ince §cicees SSmutars and 5 sobs) (2) Streptococcus ras Sreprococest parasangus (0) Streptococass [pneumoniae (58) Sreptococus pacnus Streptococass pyogenes 6a) Streprocoras saris 8) Sreptocomae sala group Giclaes § saris and ‘Svesbesars () Sreprococessangute@) Stroptococessarguis group Andes § cists gordon, Spansangus and © sanous) Streprococssbris Sreptocoreus uberis ‘Sreprococas vestibule Turia onic *809911 (0804) .qxd 07/19/2004 3:18 EM $ Table 2 Principles of Tests Employed in the BBLCrystal™ GP ID System wwaation restore Code (Reteranee TR Horeca negate anol FCT Conv te andar Noreen what TaD gC ica TA Lralin MC BVA 48 phenjalonine ANC fa 28 AMUa-b-gucoide fs 18 Lpyrogltamic ai ANRE FPY Enzymatic aol of the amide or alyoniie &_-yptophan-aMtc re Ee see feorenr [22 Carsinineae Fa 1C__aMUAtaceiyihS-lucorminige FEA 40 aMu-phosphate 40 20 aMu-$-0-aluaonide FGN 1D Lioteucine AME ma 4€__Vehalose TE 2E_tacose ac HE Methyiu efile MAS af sucrose suc 2F Mennitol MNT Uilation of catty eis inter os ETT Change in indicator Phenol ei). 2247 16 Arabinose APA 26 Giyerot Gtk ie Frucose au @H_prnitophenyhO-gucosde GL aya hydro of the colores ay Substituted ghcoie releases yellow prtrophenel8 ZH prnivophenyipo-clobioide PCE TH Proline &Levce-pnitreaniide PIN Enamatic yar of he ceatau amie ubnratereeares yellow p-nvosnie 3 H__priroghenyiphosphate PHO 21 prnitophenyla-D-maltosde PAM Eneymati yey of the coeres ay Submitted ghcosie releases yellow prntrophenolss W ‘o-nitrophenyl-{-D-galactoside (ONPG) PGO S pitropnenyiecb galactose Ure URE Wysrotis of urea and the resting ammonia Stange the ph nseator color fromsymal buoys a fain TSE Heros of exain res Tao Back precptate inthe presence offre ion 7 wonine TRG Uilizaton of ginine results np ond thange nthe calor ofthe nestor (romeresol purple)" 8899911 (0808) .qxd 07/15/2004 3:18 EM be ° Clivacma maze aan sew Got a ae] “A__ Fluorescent negative control FCT va ls Fluorescent coumarin dervative <1 ZA AMUs+O-glucoside: FGC blue fluorescence bive fluorescence 4MU-frD-glucoside a | Sema o—aee See | ones ——S=———K———— aml —_ Saar he ais — ae 5 Somme Shermans ie raat tet Te ne mec ES | 4D aMiU-phosphate FHO blue fluorescence blue fluorescence 4taU-phosphate st | 2D 4MU4-D-glucuronide FGN blue fluorescence blue fluorescence 4MU+-glucuronide | Sea et = aa wee ee oa a se See fe es — 36. Wai APIS SAA Sonik iOrancanad Nethntacd pool a] ae oe eee gene ee =| | 2F Mannitol MINT GoldiVellow _Orange/Red ‘Mannitol 300 a Sey ee ee # oie 222 ee ee “ a pep PO gE GL Yell Colores pap O-gienae =] | TH Proline & Leucine-p- PIN Yellow Colorless Proline & Leucine-p- 0) | apace Balin avon pepo a] 1 (ONPG& GO Yellow: Colorless ‘ONPG & 10 | BE el ee Te THE _Aguatine ——YelowSreen Urea =| seta ESC BrownttsroonCleayffan Esl as] = a 7ge 10 om e09911 (0404) .qxd 07/19/2008 = be 220y pooja equunjoy woug paisa vol ajqeuen= « MOREA 5 wlAI9 1 {2354S 35 wle549 FEUD janNuOD AEM vane, : —__ = va] | —-oe — + + i t 7 ‘one aoe are : we z — aS = 7 z Taw BoneneW at * 18 ren areod 5; & aN ue mz + i) so + + + ons ‘as0n0nS a = ; - = aa 7 OTN z > * 7 + ‘ona meakoutnw ov + = ¥ 7 Wi 3z = 5" va vi ——# ae —S {ane a =a TERY REN PBRY BEE ewes || TERRE ee cmos es smazoveyydeys — smazereua.uz smpeg — smraro\Ayders: ansoso1dans ee aebiy pooig equinioy TeBy poog e1quInjo) 404] ¥5] Woy UOHEGnIN] NOH OZ-BL PHY3:18 PM gge 11 07/19/2008 8809912 (0404) .qxd nied ol =~‘9NUsod ¥eSz-41 = (> ONRISOd gopL-$2 = A /2MYsOd %68-S0 = (4) ‘SMOG HOG = + “431 Oo” oles ~ save ofas A= eniowNaUE's Gl) = S095 = senseyene's = ‘qoreq Ss === rowers | less vasa} al lal A aa efile alolals aaa ere prs Se saide's a ie snaine's 7S ‘wapeey 3 8 Wo a eS WT asa un 054 Wives OW a4 198 ‘nus ID VWY LWW ININ 3S BY VT 3UL SIF NDS OH VO! WV ULE aad 594 Had YAY 394 D3 UsIUeBI0 SIRPL THD ONEKS QT AD wal OITE —$— paisjunesg Ayusnbaly Wow Sopedg 16} SvOREDY POpEAT seg u899911 (0808) .qxd 07/15/2004 3:18 EM be 12 Table? ‘Accuracy of Kdentifiction for Species Most Frequently Encountered in BBL Crystal™ GP 1D System Clinical Trial Organism Number BBLCrystal —BBLCiystal Correct Total Tested CorrectD__WiSupplemental Tests Correct Connebacterium species Enterococcus cassaliffavuslgallinarum Enterococcus faecalis Enterococcus faecium Micrococcus species “Staphylococeus aureus Staphylococcus capitis ‘Staphylococcus epidermidis Staphylococcus haemalyticus ‘Staphylococcus hominis Streptococcus agalactige Streptococcus bovis Streptococcus mitter! group ‘Streptococcus mitis group? Streptococcus pneumoniae ‘Streptococcus pyogenes Grand Total This category comprises all Kolates where less than 10 were encountered in clinical tla Colony pigmentation isthe sols supplemental test required to obtain correct identification, ‘As followup to this group's accuracy results, remedial actions were subsequently implemented to improve performancege09921 (0404) .qxd 07/19/2008 WD 9 DM eee 13 Manufacturer / Vprobee / Producent Fatrikant / Toot / Valmistaa / Fabricant / Heetelae/ Reraowevacrs! Gyars /Dtta praduttice/Gamrntojas/Producent J Fabricante/ Vyrobea Tiverkare Use by /Spotfebujte de / Anvendes for / Houdbasr tat /Kasutada enne / Viimeinkayttopsiva A utiliser avant) Verwendoar Bie /suepoqiia MENG Felrasanainatorag détuma /Usare ero / Naucokite ki /Brukes fr! Storowae do! 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Kataldgusszim/ Numere di catalog / Kateloge numaris/ Numer katalogowy /Namero do catslogo /Ketalégove chic Mimero de catloge ‘Authorized Representative inthe European Community / Auttizovany zastupce pro Evtopskou url! Aaorvert ropresentant | EU /Erkend vertegenwonediger th de Europese Unie /Voltatud esindaja Europa Noukogus / Valtuutetty edustaja Euroopan yhtelois Représentant agree pour la CEE, /Autoriserte EG-Vertretung / EEquotoSomeveg avamecoures omy Evpuralen Kaverna / Hivatalos kepuislet 32 Europol Unioban /Rappresentante autorlazato nella Comunita europe /Igaltass alsiovas Europos Bendijoje/ Autorisertrepresentant iEU / Autonzowane przedstamiielstwo w Uni Europeskie/Representante autorizado na Unio Europela / ‘Atrizovany z8sbupcav Eurépskom spolocenstve/Representante autorzado ef Ia CComunided Europea /Auktorserad represertant | EU In Vit Diagnostic Medical Device Leka ake zafizen’ uréen¢ pro diagnostixu in vitro /1n vitro dagnostsk medicnsk anordaing / Medich Hulpmiddel vor in vitro diagnose / mn ‘vo diognostice medtsiniaparotuur/ Lsakinnslinen in vito -diagnestiekalate J Dispositif médieal de diagnostic in vitro / Medizinischesin-vito-Diagrestkum /in vito Beason arpich oveNeLr Jn vito dagnosatkal eros es2ka2 / Dispositiva medio Glagnostico in vitro. in vio diagnostkosprietaisas/ In via dlagnostisk medisinsk Utsty J Urzadzenie medyezne do diagnostyk in ultro I Dispositivo médico pare Siagnastico sn vitro Medicinska pamécka na diagnastku invita /Dispostive médica de ‘iagnastico in vitro / Medicnsk anerdning Torin vitro-diagnestik Temperature limitation /Teplotni amezeni/ Temperaturbegeeensning { “Temperatwurlimiet/Ternpera tus pirang / Limpotilaraoit / Temperate limite / Zulassger Temperaturenbereich / Opso Bepuoxpaciog / HGmersékleti hata / “Temperatura limite /Laikymo temperatore/Temperatutbegtensning / Ograniczenie temperatuy /imitacia da temperatura! Ohrani¢eie tepioty/ Liitacion le temperatura! Temperaturbearansning atch Code (Lot) / Kd Kl) larde/ Batch kode (Lot) Chargenummer lot} / Parti kood ? Erakood (LOT) / Code de fot fLat) Chargencode (chargenbezelcnnung) / Kabd rwaptib (Repti) / Teel sz4ma (Lot) / Codie del ito (partta /Fartjos numeri (Lot)/ Batch-KodedSere) / Kos parti (sera) / Codigo Wo lote (Lote) Keéd série Garda) / Codigo de lote (Lote) Satskod (parti), Consult instructions for Use Prostudute pokynyk poutil aes brugsanvsningen / Raadpleeg gebrikssanvijzing/ Ligeda kaastusjuhencit/Tarkistakayttoohjesta/ Contukterla notice demplo/ Gebrauchsarwesung beachten / Zuyfoukeree MG Briyies xpsiong / Obases els hatanslat tasitast/ Contltar le sruzion per uso / ‘Skattycite naudojia intrukeijae/ Se bruksanvisningen / Zobacz inetrukja uzytkowania CConsulte a: instragBes de utiiasie /Pozr Pokyry na pouBhanie/ Consulta ls instrucciones de uso Se bruksanvsningen