AU-448-468

TM EN UC-3500:
UC-CONTROL 1) Open the bottle. Remove any foam on the surface of liquid with a dropper or other tool
before measurements.
Identification of the IVD reagent 2) The UC-CONTROL can be placed in a sample rack directly. Refer to the detailed description
UC-CONTROLTM
of the quality control analysis procedure in the analyzer’s Instructions for Use, and measure
Intended use UC-CONTROL after changing the mode to the control analysis series (C. Series).
For in vitro diagnostic use only UC-1000:
UC-CONTROL is used for quality controlling the Sysmex urine chemistry analyzer (UC-3500 and 1) Open the bottle. Refer to the package insert of the urinalysis test strip and immerse the test
UC-1000). strip in UC-CONTROL or suction the required amount of liquid with a dropper or other tool,
and quickly drop it in order from the tip pad of the test strip. Do not reuse the dropper after
Principles of the examination method use but immediately dispose of it.
1. UC-CONTROL is a liquid control composed of UC-CONTROL -L and UC-CONTROL -H. 2) Refer to the detailed description of the quality control analysis procedure in the analyzer’s
2. The UC-CONTROL covers the following analysis parameters. UC-CONTROL contains the Instructions for Use, and measure UC-CONTROL after changing the mode to the control
ingredients corresponding to the analysis parameters. For details about the measurement analysis series (C. Series).
principles of the analysis parameters, refer to the analyzer’s Instructions for Use and the
package insert of the urinalysis test strip. Storage and shelf life of unopened product
1. Store unopened UC-CONTROL at 2-8 ºC and avoid exposure to sunlight.
Analysis parameters: Urobilinogen (URO), Blood (Hemoglobin) (BLD), Bilirubin (BIL), Ketones 2. The expiration date of the unopened product is printed on the box and labels.
(KET), Glucose (GLU), Protein (PRO), pH, Nitrite (NIT), Leukocytes (LEU), Creatinine (CRE),
Albumin (ALB), Specific gravity (S.G). Storage and shelf life after first opening
When measured on the Fully Automated Urine Chemistry Analyzer (UC-3500), UC-CONTROL can
Components be used for 30 days after opening. When measured on the Semi-Automated Urine Chemistry
Human urine 10-60 %; Reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one and Analyzer (UC-1000), UC-CONTROL can be used either for 7 days after opening or 5 immersions of
2-methyl-2H -isothiazol-3-one (3:1) <0.01 %; Acetone <5 % test strip, whichever comes first. When suctioning the required amount of liquid with a dropper
NOTE: The UC-CONTROL is prepared from human urine. Chemical and biochemical substances without immersing the test strip, UC-CONTROL can be used for 30 days after opening. After
as well as other constituents derived from human origin are also contained within this control opening UC-CONTROL, store at 2-8 ºC in the package box to avoid exposure to sunlight.
material.
Interpretation of results
Warnings and precautions 1. UC-CONTROL measures hemoglobin as the quality control for blood. Though in rare cases,
1. All human source material used to manufacture UC-CONTROL was non-reactive for antigens the result of blood could be assessed as red blood cell (RBC) indicating the RBC count, and
to Hepatitis B (HBsAg) and HIV-1 Ag, negative by tests for antibodies to HIV (HIV-1/HIV-2) needs to re-measured.
and Hepatitis C (HCV), when tested on single donor basis by the U.S. Food and Drug 2. The bilirubin parameter of UC-CONTROL -H presents as a different color than that of an
Administration accepted methods. Because no known test method can assure complete analyzed human urine sample, therefore the abnormal color signs flag will present with the
absence of human pathogens, UC-CONTROL should be handled with appropriate analysis result.
precautions.
2. Always wear protective coat, gloves and goggles when carrying out work on or with the Performance characteristics
UC-CONTROL. When calibrated correctly, measurements in the control analysis series (C. Series) of the analyzer
3. Adhere the warnings and precautions for handling described on the product container, should fall within the ranges specified on the table of UC-CONTROL Expected Values printed in
package box, package insert, the analyzer’s Instructions for Use and use the product this insert.
correctly. The reliability of the analysis values cannot be guaranteed if the product is used Limitations of the examination procedure
outside the prescribed intended use. 1. UC-CONTROL is for use to monitor the analysis paramaters indicated on the table of
4. The product must not be used after its expiration date. The product that is not properly Expected Values and for use with the dedicated instrument only. Do not use it for control of
stored may fail to maintain adequate performance even though the product has not reached other instruments or other test strips.
the expiration date. 2. When the UC-CONTROL is measured in any mode other than the control analysis series
5. Do not use the UC-CONTROL if bacterial contamination is observed. (C. Series) of the instrument or in the case of the instrument settings are changed, the
6. Do not dilute the UC-CONTROL or do not add foreign materials to the product. This may measurement results may differ from the expected values.
affect the measurement results. 3. The UC-CONTROL should not be used as the standard urine.
7. Do not freeze the UC-CONTROL. Do not use a product that is suspected to have been
frozen. Disposal procedures
8. Do not replenish the UC-CONTROL or mix the residual liquid after use with new product. Disposal procedures should meet requirements of applicable local regulations.
9. Do not transfer or store the product in other containers (such as test tubes), otherwise
Manufacturer
stability is not guaranteed.
10. When a strong shock or force is applied to the container of the product, the container may
1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan
be damaged.
11. Do not reuse the container after use but immediately dispose of it.
Producer on OEM-Basis:
12. Do not leave UC-CONTROL with the cap removed. This may affect the measurement results.
Cliniqa Corporation
13. Once test strip is immersed, UC-CONTROL may not be used for quality control of the Fully
495 Enterprise Street San Marcos, CA 92078 USA
Automated Urine Chemistry Analyzer (UC-3500) any more.
14. For measurements of UC-CONTROL, use the dedicated analyzer, reagents, and test strips. For Authorized representatives
details of the required reagents and test strips, refer to the analyzer’s Instructions for Use. Europe, Middle East and Africa:
15. Before use, please read the Safety Data Sheet carefully.
Warning Bornbarch 1, 22848 Norderstedt, Germany
H317 May cause an allergic skin reaction. Asia-Pacific:
P261 Avoid breathing spray. 9 Tampines Grande #06-18, Singapore 528735
P280 Wear protective gloves/protective clothing/eye protection/
face protection. Product information
P333+P313 If skin irritation or rash occurs: Get medical advice/attention. UC-CONTROL (UCC-900A):
P362+P364 Take off contaminated clothing and wash it before reuse. UC-CONTROL -H 10 mL × 3
P501 Dispose of contents/container in accordance with local and national regulations. UC-CONTROL -L 10 mL × 3
Examination procedure Date of issue or revision
1. Remove the UC-CONTROL from the refrigerator and allow it to return to room temperature 04/2019
before use.
2. Mix it by gentle inversion to prevent the liquid from bubbling up.
3. The following steps depend on each type of analyzer. Carry out measurements according to
the applicable instructions. Immediately after measurements, place the cap on to the bottle
and tighten, then put the bottle of UC-CONTROL into the package box and return to the
refrigerator.

UC-CONTROL Expected Values *1 as lithium acetoacetate *2 c/μL=cells/μL

Analysis parameters UC-CONTROL -L UC-CONTROL -H
Urobilinogen (URO) normal 1+ - 4+ (2.0 - 12.0 mg/dL) (34 - 202 μmol/L)
Blood (Hemoglobin) (BLD) - 1+ - 3+ (0.06 - 0.75 mg/dL)
UC-3500 - 1+ - 3+ (0.5 - 2.0 mg/dL) (8.6 - 34 μmol/L)
Bilirubin (BIL)
UC-1000 - - 1+ ( - 0.5 mg/dL) ( - 8.6 μmol/L) - - 3+ ( - 2.0 mg/dL) ( - 34 μmol/L)
Ketones*1 (KET) - 1+ - 3+ (10 - 80 mg/dL) (0.93 - 7.4 mmol/L)
Glucose (GLU) - 1+ - 3+ (100 - 500 mg/dL) (5.6 - 28 mmol/L)
Protein (PRO) - 1+ - 4+ (30 - 1000 mg/dL) (0.3 - 10 g/L)
pH (pH) 5.0 - 6.0 7.0 - 9.0
Nitrite (NIT) - +
Leukocytes (LEU) - 2+ - 3+ (75 - 500 c/μL*2)
Creatinine (CRE) 10 - 50 mg/dL (0.1 - 0.5 g/L) 100 - 300 mg/dL (1.0 - 3.0 g/L)
Albumin (ALB) 10 mg/L (0.01 g/L) 150 - over mg/L (0.15 - over g/L)
UC-3500 1.003 - 1.017 1.018 - 1.032
Specific gravity (S.G)
UC-1000 1.000 - 1.025 1.010 - 1.030

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