Certificate of Traceability A better A1C Test moans bettor diabetes care _ Manufacturer Certification This certifies that_ Shenzhen Microprofit Biotech Co., Itd._, using Immunofluorescence chromatogra hon MF-T1000— bas participated in and successfully completed the NGSP certification for manufacturers and is traceable to the Diabetes Control and Complications Trial Reference method. The comparison was performed with: Zhongshan Hospital ASRL#2 ‘The system evaluated was: Instrument: Calibrator Lot: MF-T1000 Dry-Type Immunofluorescence Analyzer _| 20210501 20210502, 20210503 Reagent Lot: Calibrator Assigned Values: 20210501, 20210502, 20210503; 20210501101, 6.53%, 9.51% 6.50%, 9.52%; 6.51%, 9.49% 202110501102, 20210501103 Date of Certification: August 1, 2021 Certification Expires: August 1, 2022 St Sg Cl RSAte ADs to NGSP Stcering Committee Chair NGSP Network Coordinator SRL director/ supervisorDATE: — July 20,2021 > TO: Dr. Pan Baishen, Shao Wengi FROM: Randie Little RE: Certificates a omens Enclosed is a packet containing a certificate, letter, and method data for Shenzhen Mieroprofit. lease sign and send the packet by overnight Fed. Ex. to: Emily Deng Shenzhen Microprofit Biotech Co,Ltd. Rm, 405, 406, Zone B /4F, Rm. 205, 206-1, 207, West Side of Zone B/ 2F, Haowei Building, No. 8 Langshan 2nd Road, Songpingshan, Songpingshan Community, Xili Street, ‘Nanshan District, Shenzhen, P.R. China +86-755-61688835, +86-755-61688111 emily.deng@microprofit,comNGSP Administrative Core University of Missouri School of Medicine 11 Hospital Drive M766 « Columbia, MO 65212 « (573) 882-1257 » Fax (673) 864-4748 Esmail: ngsp@missourLedu Web site: htp:/iaww.ngsp.crg July 20, 2021 Emily Deng Shenzhen Microprofit Biotech Co.,Ltd Rm. 405, 406, Zone B /4F, Rm 205, 206-1, 207, West Side of Zone B/ 2F, Haowei Building, No. 8 Langshan 2nd Road, Songpingshan, Songpingshan Community, Xili Street, Nanshan District, Shenzhen, P.R. China Dear Dr. Deng, Congratulations! We are pleased to inform you that Shenzhen Microprofit Biotech Co.,Ltd has successfully ‘completed the NGSP Manufacturer certification for the following method: Instrument Calibrator Lot MF-11000 Dry-Type Immunofluorescence Analyzer 20210501, 20210502, 20210503 Reagent Lot: Calibrator Assigned Values 20210501, 20210502, 20210503; 20210501101, 6.53%, 9.51%} 6.50%, 952% 202110501102, 20210501103 6.51%, 9.49% | ‘The above method is now considered traceable to the Diabetes Control and Complications Trial (OCCT) Reference Method. Enclosed is a certificate of traceability for this method. Following is a summary of the method comparison results. Detailed method comparison evaluation reports are also enclosed for your information, Method # within Pass 36/40 YIN Tnumunofluorscenee chromatograph on MF-TTOOO 40, 40, 40 Y Criteria for NGSP Manufacturer certification: 36/40 HbA le results (single results) must be within =5% of the NGSP SRL mean (mean of duplicate results): Your method’s results were within the NGSP criteria for Manufacturer Certification. ‘This certification is effective for one year and will expire on August 1, 2022 All data for next year’s certification should be received by June 1, 2022. Ifyou have any questions about any of the data, please feel free to call. Ifyou or your customers would like updated information about the NGSP (including a list of certified methods and laboratories) they can visit our web site at www.ngsp.org Randie R. Little, Ph.D., NGSP Network CoordinatorMethod Comparison Evaluation Report Location: Shenzhen, China Manufacturer: Shanchen Microprofit Biotech Co, Ltd rest Method (¥); Immunoflouescence chromatograph lot220210S01 -# Within 5% 40 |Comparative Method (X) AASRL#2 Variant Turbo 20 Pass36 ‘Yes Units of Measurement: ss Hate cerieation Type: Manufacturer Blas Estimation Data Test Methor 0 Comparati . Sample] Analysis [Vr xt 1D | Date SRL Mew [VY [ so bi Wines Seas eae a 320] a30-] Ta v coaa_[wesenetetg|_—— 0.10 [8:10 sa ex | am | oom ¥ 26. aesernee| 6 00 | 500 560 ses | ao | 2san ¥ Gseea | aeoenntses| 570 —[ 570 570 sn | 5m | 000% ¥ oe Co 3.00 aos | on | sex ¥ Gaase__ | weeetese| 610 | 520 a0 oa | 610 | term Y cazer | weeeessee| 030 | — 0 ma sao | oo | ton Y Cazse_—[eneeneae| 0.70 | 200 370 ars | am | asim Y ease —[pereataee| 760 | 720 70 v0 | roo | aa Y aero [pereetre| 720 [720 720 zo | 720 | nox + Cazrt _[nereetare| —s60 | —a70 370 so | 300 | 70% ¥ Ceara _[atessesss| ea —[ 00 6 eo | sao | oom Y carr —[aeesetste| 700 [170 70 zs | 100 | 210% y cazra [peteeeete| —o70 | a0 0 eo | ev | arm Y caz7s [ereeeeese| 5.00 | a0 590 530 | sao | 1406 . ears | rvererets| a0 | 20 320 ea | ei | -serm y caer? _[severeesse| eco | —a70 370 am | seo | 5m y eara__[severeerse| 8.00 | san 370 e7 | a0 | osm ¥ aera [sevensesse| 7.50 [70 7.0 veo | 750 | tem ¥ Gaze —[serestese| 3.00 [10 70 710 | 680 | 420% Y Cezet —[setertese| 590 | —s0 7 sa | 500 | 78 Y Cazae | aeatasess| 570 —[ sa $5 sso | 57 | 3000 Y ceaes _[petsaeste| 600 | —az0 7a ex | sao | 320% Y Gaze —[peteetsne| 290 | a0 7 ara | sso | tame ‘ ezas__|veteseeve| ——ee0 —[ — 60 50 exo | cso | coon . Goze —[sersaeste]| 50 | a0 a0 ess | 650 | oon ‘ eae —[seneaeate| 300 —[ a0 30 cas | 800 | 200% ‘ a a 77 ras | 180 | “azo Y eZ 720 zav | 720 | 00% ¥ oe a TO 330 ess | 800 | 48mm y a 30 eas | 800 | oro ¥ eT 50 ras | 700 | cos ¥ cazes _[sareneees| 70 | —se0 560 sss | 57 | 210% ¥ cease _[saneerers| 600 | ean 670 ass | oa | 370% ¥ re ae 560 sss | 550 | oom ’ eo 610 a1s | si | oarm ¥ craze? | eter 2.60 | a0 0 ass | 00 | ose Y zs | seeeeeees| 710 | 700 70 ro | rio | a0 ‘ zee | eteetsee| 7.90 [17 7 ms | 790 | atom Y aca —[eeaeaasee| 3.70 —[ —e00 | —a70 s7__| sx | osm v[ASRLI2 Variant II Turbo 2.0 (%¢HbALC) Immunoflourescence chromatograph loti20210501 - Method Comparison Evaluation Report Bias Plot: Immunoflourescence chromatograph r lot#20210501 vs. ASRL#2 Variant II Turbo 2.0 SRL %HbAIc 5% |Method Comparison Evaluation Between Method Outlier Report to (For Investigational Use Only) Manufacturer: Shanzen Microprofit Biotech Co Certification Type Manufacturer Test Method (¥} Immunaflourescenceehromaoaraph loi!20210801 Comparative Method ASRL#2 Variant I Tuc Report Date: 0 Between Method] Between Differences: ‘Method Y-Mean X Outliers per ne | mean 3a Limit_| Limit | outiers| Between Method | ad | 0.024 oa 0.426) 0405 | oas2 [0 Explanation Batoen method outlers exceed the mean +/- 38d ofthe differences between methods,uolsseiBey--~- Awun— | (0% Oqany || JUBA Z#TYSY) OLVGH % oz oOL og o9 2S vt 9ETO=X48 OF=U £6601 P9TO+X6S6 OK souassoinoyountmury “py] “09 ys2}01g 31y01dos9T A UoyzZUEYS Old 499 e9S x = co > & ov & z 3 = x8 ge oo8e No Bs 33 8 os F 3 a 2 a 3 3 oorMethod Comparison Evaluation Report [Location: [Shenzhen, China [Manufacture |Shanzhen Microprofit Biotech Co., Lid ITest Method (¥): |immunoflourescence chromatograph lot#20210502 #Within 6% 40 |Comparative Method (X): JASRL#2 Variant If Turbo 2.0 Pass 36 Yes [Units of Measurement: los HbA le Manufacturer ‘Sample | Analysis Vi XI x2 wD. Date SRE Meam [| ¥ Mbit | Within 5% Cs26i | peerenvese| 6.20 a0 620 620 620 0.00% Y C2262 | semremeeze| 0.10 20 20 B10 a0 0.00% y (62203 | seeveneeae| 6.00 5.90 520 585 6.00 2.50% ¥ ca2c4 | seeseneeae| 5.70 570 570 570 570 0.00% y e226 | seeseneeae| 0.00 20 9.00) 0s 9.00 155% Y (03206 | aeesansese| 6.10 620 620 620 6.10 181% y (03267 | seesesesse| 6.30 40 640 640 630, 1.50% y (e326 | reseneese| 0.70 9.80 (9.70 975 970 051% y (03260 | eenreneese| 7.60 750) 750) 750 760 139% y (03270 | ensaseese| 7.20 720 720 720 720 0.00% y cari | eeeseneeae| 5.70 570) 570) 570 570 0.00% Y crore | eeeseseeae| 6.40 6.40 6.40 640 8.40 0.00% ¥ 227 | seeweneeae| 7.00 720 720) 745 7.00 210% y cxa74 | seeveneeae| 6.70 3.80 620 680 670 447% Y (03275 | aeesansese| 6.40 530 530) 530 5.40 1.30% y (oa276 | sensansese| 6.20 620 620 620 620 0.00% y (os277 | eesessese| 0.60 370 370 870 360 1.18% y (c3276 | seeseneese| 0.20 a0 370 875 3.20 osr% Y (03270 | seesesseae| 7.60 760 760) 750 780 0.00% y (03280 | eesenseae| 6.00 7.310 710 710 6.00 420% Y (o3281 | seenessess| 5.90 a0 5.80) 580 5.90 17% R (03282 | seesexseae| 6.70 5.50 550 550 570 34% Y cae | eeerenneae| 6.40 6.20 (6.20 620 6.40 3.29% y (os204 | eesewseee| 6.30 3.10 820 815 20 124% y 5285 | aeeseeseae| 6.80 6.80 3.30 680 6.20 0.00% y (03286 | weesawseae| 6.50 360 6.50 655 6.80 0.76% Y (3287 | eoesaeseae| 6.60 3.80 ‘s.a0 5 360 282% Y 2288 | wonvanseae| 7-60 720 770 178 750 323% y (2280 | eeevaaseae| 7-20 720 720 720 720 0.00% y (03200 | #eesaesees| 0.00 9.40 930 9.38 9.00 374% y (csa0i | eeevaeneas| 6.00 6.80 3.90 6.85 6.00 0.79% y (cs202 | weremerees| 6.00 720. 8.00 7.95 8.00 0.89% Y (os205__[seesaseas| 6.70 5.50 5.60 555 570 2.70% y Caza | eeseeneae| —6-<0 660 ‘670 665 640 3.76% Y (03205 _[aseseseas| 6.60 3.0 3.60 5.58 5.50 0.90% i (03296 | eesawseae| 6.00 620 6.10 615 8.00 244% y (os207_|eesesseas| 6.60 360 3.80 358 880 0.58% % (03206 | #ersansea#| 7.10 7.00 7.00) 7.00 740 149% y re oo 720 7301 745 730 2.10% Y (62300 | eens] 6.70 3.80 370 875 370 osr% ¥nese, Method Comparison Evaluation Report Immuneflourescence chromatograph lot¥20210502 - [ASRL#2 Variant Il Turbo 2.0 (%SHbAC) Bias Plot: Immunoflourescence chromatograph lot#20210502 vs. ASRL#2 Variant II Turbo 2.0 0 SRL %HbAIC 15%Manufactur Test Method (¥): Comparative Method CY Method Comparison Evaluation Between Method Outlier Report (For Investigational Uso Only) ‘Shanahen Micoprofc Biotech Co Cerifcation Type Manufacturer Immunallourescence chromatograph loz#20210802 o 21 Between Method Outliers Ieper) Lower m= | Mean sa 380 Limit | Limit | Outliers Between memod | 40 | 0.019 134 0.403) ose _| 0422 [0 Explanation: Between-metnod outers exceed the mean +/- Sed of the ferences between methods.(o°% oquny 1] JUeLEA Z#TYSV) OLVGH % = im od: ooL os 09 ov = or & z 3 — x8 ss gh 09 8 5 a8 gs3 B38 $ | uoissesBey---- og g a Awna— B a 3 Zs oor > 8ZL0=XKS Op=U 660-1 ¥ST'0+X796'0=4 oz ee aauaasainoyounwuny “py “oD ysajorg Wyosdoso1y UoyZHEYS }O}q 189e9S “GSON®‘Method Comparison Evaluation Report [Location: [Shenzhen, China Manufacturer: [Shanzhen Microprofit Biotech Co., Ltd [Test Method (¥): Immunoflourescence chromatograph lot#20210503, #within5% 40 |Comparative Method (X): JASRL#2 Variant II Turbo 2.0 Pass 36 Yes its of Measurement: loo HALE [Certification Type: Manufacturer Bias Estimation Data ‘Test Meth 0 ‘Comparative Method. ‘Sample | Analysis | YI XI XZ 1D Date SRE Mean [| _¥ We Diet| Within 5% a Cc 320 azo 6.20 330 ory Y (03262 |aeseanesse| 0.10 3.10 3:10 310 810 0.00% y (63263 | aeeeasesse| 6.00 5.90 5.80) 588 6.00 2.50% y re cd ‘570 570 570 570 0.00% y ‘Cazes | weseawesse| 0.10 910 9.0) 9.08 910 0.55% y ‘C2200 | weveavesee| 6.10 620 620 620 810 a6t% y ‘ca207 | weseaseses| 6.30 640 6.40 640 8.30 1.56% y ‘ca26e | wevenvenee| 0.70 9.30 970 975 970 051% y a rr 7.501 750 750 770 267% y ‘cazi0_|wesesesses| 720 720) 720 120 720 0.00% y aor [wevesweens| 6:70 570 370 570 570 0.00% y (cara | weveeerers| 6.40 640 6.40 540 6.40 2.00% y ‘Gaara | eeveserers| 7.00 720 7.10 745 7.00 210% y (C2274 | eovewnseas| 6.60 6.20. 6.20 680 660 294% y Cavs | seveanse3| 5.40 330 530 530 540 1.59% y os276 | aseeveveae| 6.10 6.20, 20 620 610 181% y cx27T | sasswssess| 8.60 370 870 870 860 118% y ‘e327 | senewneese| 0.00 3.20 870 375 20 osrs y (cs279 | weneeneese| 7-50 7.80 780) 780 70 1.32% y (63200 | sevewneese| 6.80 7.10 7.10 740 620 423% y (2201 | sevsenoese| 5.00 3.20 580) 580 580 0.00% y C1282 | sesaasaese| 5.70 3.50 3.50 550 570 368% y ©3263 | sesawsasee| 6.40 6.20, 20 620 640 320% y a 3.10 520 818: 330 134% y a ET 6.00 6.00 6.20 620 00% ¥ rae a 6.60 3.50 e28 650 70% y ‘c3287_| aessazessa| 3.70 3.90 3.80. Bas: 370 169% y cszea_[esessseees| 7.60 780. 770. 175 760 1.96% y cszs0_[eeessenees| 7.10, 720 720) 720 7.10 1.39% Y (3200 | eeevenvses| 0.00 340 9.0) 935 2.00 a74t% Y cszot_[aseesenses| 6.80 5.80 6.00 685. 6.80 073% Y ‘cxo02 | esevenveae| 7.00 7.90 8.00 795 790 063% Y (os203[asessenese| 6.70 5.50 5.80 555 570 270% y cacos| eewrenvese| 6.60 6.80 6.70 66s. 6x0 228% y (03205 |aseseesese| 5.00 3.50 5.60 555 560 0.90% y (03206 | seesesreee| 6.10 6.20 6.10 6.15 610 081% y (C2207 | seevesvese| 0.70 2.80 3.50 358 870 178% y (cs208 | aeesesseze| 7.20 7.00 7.00 700 729 206% ¥ (c3200 | aassazeeze| 7.30 7.20 7.10 748 730 210% y (c3300 | essasesze| 0.70 3.60 370 875 370 ost yMethod Comparison Evaluation Between Method Outlier Report — (For Investigational Use Only) Manufacturer: ‘Shanzhen Microprolt Biotech Co Certiffation Type Manufacturer Test Method (V Immunoflourescence chromatograph loti20210503 142 Variant Tuc Re 07121 Between Method] Between Differences. Mothod YeMean X. outliers O10 00 015, 00 0.05 90.10 010 0.05 020 0.09 0.00 0.09 0.18 0.20 010 -o10 0.10 05 0110 0.00 020 020 015 00 005 0.15 08 010 035 005 005 018 015 0.05 008 0.18 020 08 0.05 3d Limit _| Limit | owe Borweonemnod—} 40 | oir 0138 0.405 0394 | 017, Explanation: Betweenmethod outlers exceed the mean +/- Sed ofthe diferenoes between methods,x (0'2 Oquny |] |UELEA Z#TYSW) OLWIH % =x s Oc oO 08 09 or = or 2 3 3 = =2 ge 2 gh e 09 8 3 a8 83 3 oe £ | | uorssesBoy---~ Og g | Aun — S | a a Zz oor > TeT0=x4$ Ob=4 | 466°0=! | LIT0+X896'°0=" ocL pee oom aouaasarnoyounmmny “pry “03 ypaorg 1yosdosoy uayzuEYS }O]d 149}9e9S “GSON®