Medconn Glycated Hemoglobin Test System is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood or hemolysate with ion-exchange high performance liquid chromatography (HPLC) using the Medconn HbA1c Assay Kit (HPLC) on the Medconn Glycated Hemoglobin Analyzer, models MQ3000 and MQ3000PT.

Hemoglobin A1c measurements are used as an aid in diagnosis of diabetes, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus.

Device Description

The Medconn Glycated Hemoglobin Test System is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human venous blood or hemolysate using ion-exchange high performance liquid chromatography (HPLC) on the Medconn Glycated Hemoglobin analyzer, models MQ-3000 and MQ-3000PT.

A high-pressure pumping system delivers a buffer solution to an analytical cartridge and detector. Whole blood samples undergo an automatic hemolysis and dilution process before being introduced into the analytical flow path. Manually hemolyzed and prediluted samples loaded in sample cups at designated location are directly introduced for analysis. A programmed buffer gradient of increasing ionic strength delivers the sample to the analytical cartridge where the hemoglobin species are separated based upon their ionic interactions with the cartridge material and the buffer gradient. The separated hemoglobin species then pass through the flow cell where changes in the absorbance are measured at 415nm and recorded as a digital chromatogram. The software performs an analysis of the hemoglobin peaks in the chromatogram, recording information including retention time, peak area, and relative peak area of the detected substance over the total peak area of all substances. Peaks identified as target analytes are calibrated to generate a report and a chromatogram for each sample.

Medconn Glycated Hemoglobin Test system contains the following components:

Medconn Glycated Hemoglobin analyzer
Medconn HbA1c Assay Kit (HPLC)
Medconn Hemoglobin A1c Calibrator
Medconn Hemoglobin A1c Control
Medconn HbA1c Column Kit (HPLC)
Medconn HbA1c Haemolyser

AI/ML Overview

The Medconn Glycated Hemoglobin Test System is an in vitro diagnostic device intended for the quantitative determination of hemoglobin A1c (HbA1c) in human whole blood or hemolysate. It uses ion-exchange high-performance liquid chromatography (HPLC) on the Medconn Glycated Hemoglobin Analyzer (models MQ3000 and MQ3000PT). HbA1c measurements are used as an aid in the diagnosis of diabetes, to identify patients at risk for developing diabetes mellitus, and for monitoring long-term blood glucose control in individuals with diabetes mellitus.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Medconn Glycated Hemoglobin Test System's performance are embedded within the "Summary of Performance Data" section of the 510(k) submission, specifically through demonstrating acceptable precision, linearity, analytical specificity (interference), and method comparison against a standardized reference method. The performance criteria as stipulated by the Special Controls requirements for HbA1c systems that diagnose diabetes have clearly been met.

Here's a table summarizing the acceptance criteria and the reported device performance, derived from the provided text:

Performance Characteristic	Acceptance Criteria (Implied by study design and FDA clearance)	Reported Device Performance (Summary)
Precision/Reproducibility	Based on CLSI EP05-A3. Acceptable CV% across different levels and sources of variation.	Whole Blood Mode: Total Precision (CV%) for 4 samples (5.11% to 12.25% NGSP): 0.86% to 1.59%.Dilution Mode: Total Precision (CV%) for 4 samples (5.20% to 12.15% NGSP): 0.87% to 1.43%. All CV% values are considered acceptable and within expected ranges for this type of test.
Linearity	Based on CLSI EP06-A2. Regression parameters (slope, intercept, R2) demonstrating linearity across the claimed measuring range (3.0% to 15.0% NGSP / 9.3-140.5 mmol/mol IFCC). Maximum Bias (mean) between observed and theoretical values should be minimal.	Whole Blood Mode: Slope 0.9967, Intercept 0.0318, R2 0.9999 (NGSP).Dilution Mode: Slope 0.9971, Intercept 0.0352, R2 0.9999 (NGSP).Maximum Bias (mean) observed: ± 0.1 (NGSP %) and ±1 (IFCC mmol/mol). Results support the claimed measuring range of 3.0% to 15.0% HbA1c.
Analytical Specificity (Interference)	Based on CLSI EP07-A3. Significant interference defined as a ± 6% change in %HbA1c value from the control. No significant interference by common endogenous substances, drugs, or common hemoglobin derivatives/variants at specified concentrations.	Endogenous Interference: No significant interference observed for Unconjugated Bilirubin (21.3 mg/dL), Conjugated Bilirubin (19.2 mg/dL), Lipemia (Triglycerides) (6000 mg/dL), RF (750 IU/mL), TP (21.0 g/dL).Drug Interference: No significant interference observed for a wide range of drugs (e.g., Ascorbic acid 100 mg/dL, Acetaminophen 200 mg/dL, Ibuprofen 500 mg/dL, etc.).Cross Reactivity with Hemoglobin Derivatives: No interference from Acetylated Hb, Carbamylated Hb, or Labile A1c at tested concentrations.Hemoglobin Variant Interference: No significant interference observed for HbC (≤ 40%), HbD (≤ 43%), HbS (≤ 42%), HbE (≤ 30%), HbA2 (≤ 6.2%) and HbF (≤33%) at concentrations tested.
Method Comparison (Accuracy vs. NGSP Reference)	Based on CLSI EP09c 3rd Edition. Acceptable regression analysis (Deming, Passing-Bablok) and Total Error (TE) values near clinical decision points, showing good agreement with a standardized reference method.	Whole Blood Mode:Deming Regression: y-Intercept 0.0004, Slope 1.0074 (95% CI for slope includes 1).Passing-Bablok Regression: y-Intercept 0.0500, Slope 1.0000 (95% CI for slope includes 1).Total Error (TE) at key HbA1c levels for Whole Blood Mode: 2.44% to 4.15% (depending on method and level).Dilution mode data:Deming Regression: y-Intercept 0.1940, Slope 0.9894.Passing-Bablok Regression: y-Intercept 0.1000, Slope 1.0000.Total Error (TE) at key HbA1c levels for Dilution Mode: 2.27% to 5.70% (depending on method and level).Correlates well with current cleared methods and NGSP standardized testing.
Traceability	To international and national standardization programs (IFCC, NGSP, DCCT).	Device standardization is traceable to IFCC reference calibrators and certified via NGSP Program. Results are provided in both NGSP (%) and IFCC (mmol/mol) units using the Master Equation.
Measuring Interval/Reportable Range	The device should accurately measure within its claimed range.	Claimed: 3.0% to 15.0% (NGSP) and 9.3-140.5 mmol/mol (IFCC). Linearity study results support this claimed measuring range.

2. Sample Sizes Used for the Test Set and Data Provenance

Precision/Reproducibility:
- Four K2-EDTA whole blood samples (at concentrations near 5%, 6.5%, 8%, and 12% HbA1c) and two-level quality control products were used.
- For each sample, there were 720 measurements (analyzed in duplicate, twice a day, with three lots of reagents, over 20 non-consecutive days, on three analyzers).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the study design follows laboratory testing standards (CLSI guidelines), suggesting well-controlled, likely prospective, laboratory-based experiments.
Linearity:
- Eleven test samples (high, low, and 9 intermediate levels) were used. These were altered patient samples collected using K2-EDTA.
- Each was run three times with 3 lots of reagents on one instrument.
- Data Provenance: Not explicitly stated. Likely laboratory-prepared and tested.
Analytical Specificity (Interference):
- Endogenous Interference: Two EDTA whole blood sample pools (low (~6.5% HbA1c) and high (~8.0% HbA1c)). Ten replicates of each pool prepared with test and control samples were analyzed.
- Drug Interference: Two EDTA whole blood sample pools (low (~6.5% HbA1c) and high (~8.0% HbA1c)). Ten replicates of each drug prepared with test and control samples were analyzed.
- Hemoglobin Derivatives: Low (~6.5% HbA1c) and high (~8.0% HbA1c) whole blood EDTA samples. Each sample was analyzed using ten replicates.
- Hemoglobin Variant Interference:
  - Study #1: 67 variant samples (HbS=11, HbC=10, HbD=13, HbE=12, HbA2=10, HbF=11).
  - Study #2: 143 variant samples (HbS=25, HbC=25, HbD=25, HbE=25, HbA2=20, HbF=23).
  - Samples were whole blood EDTA patient variant samples.
- Data Provenance: Not explicitly stated for endogenous/drug/derivative interference. For hemoglobin variants, they were "patient variant samples." It is implied these were collected and tested specifically for the study, likely in a controlled laboratory setting.
Method Comparison:
- 124 variant-free whole blood K2-EDTA samples.
- The distribution of samples spanned around clinical decision points (e.g., 25% of samples between 6-6.5%, 24.19% between 6.5-7%).
- Data Provenance: Not explicitly stated. The samples were patient samples. Given the nature of an FDA 510(k) submission, these would typically be from a well-defined cohort, likely retrospective collections or prospectively collected samples in a controlled clinical laboratory or research setting. The comparison was made against a "NGSP Secondary Reference Laboratory," implying adherence to established quality and calibration standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the given text. For an in vitro diagnostic device for HbA1c, the "ground truth" for the test set is established by the reference methods themselves (e.g., NGSP Secondary Reference Laboratory using a previously cleared HPLC HbAlc assay method - BIO-RAD D-100 analyzer, and other reference methods like Trinity Biotech Premier Hb9210, Bio-Rad VARIANT II Hemoglobin Testing System, and Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 for variant studies). The accuracy of these reference methods is inherent in their standardization and certification, rather than requiring expert adjudication of individual results as one might see in imaging studies.

4. Adjudication Method for the Test Set

Since the ground truth is established by well-defined and certified reference laboratory methods (e.g., NGSP Secondary Reference Laboratory using HPLC), there is no human adjudication method described or typically required for this type of quantitative diagnostic device. The comparison is purely analytical, comparing the numerical output of the candidate device to the numerical output of the reference method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. MRMC studies are typically performed for devices where human interpretation is a critical part of the diagnostic process, such as medical imaging AI algorithms (e.g., radiologists reading images with and without AI assistance). This device is a quantitative in vitro diagnostic test, meaning the output is a numerical value directly from the instrument, not an interpretation by a human reader. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This entire submission describes a standalone performance study of the device. The "Medconn Glycated Hemoglobin Test System" is an automated analytical system (analyzer plus reagents) that provides a quantitative result. Its performance evaluation (precision, linearity, interference, method comparison) is based on the result produced by the device itself, without human intervention in the interpretation of the final HbA1c value.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation is established through:

Certified/Standardized Reference Laboratory Methods: For the method comparison study, the samples were compared to results obtained by a "NGSP Secondary Reference Laboratory using a previously cleared HPLC HbAlc assay method (BIO-RAD D-100 analyzer)." For hemoglobin variant interference studies, comparison was made to reference methods "demonstrated to be free from interference with the hemoglobin variant being tested (Trinity Biotech Premier Hb9210, Bio-Rad VARIANT II Hemoglobin Testing System and Tosoh Automated Glycohemoglobin Analyzer HLC-723G8)."
A Priori Known Values/Controlled Samples: For precision, linearity, and interference studies, ground truth is established by the careful preparation of samples with known or targeted concentrations (e.g., spiked samples, diluted samples, or control materials with assigned values).

This is a quantitative analytical ground truth established by established and validated laboratory methodologies, not expert consensus (as in clinical diagnosis from imaging), pathology (as in histopathology), or long-term outcomes data.

8. The Sample Size for the Training Set

The concept of a "training set" is not explicitly applicable in the context of this 510(k) submission for a traditional in vitro diagnostic device like an HbA1c assay. This device is based on a chemical/physical separation principle (HPLC) and established analytical methodologies, not machine learning or artificial intelligence algorithms that inherently require training data sets. The performance data presented (precision, linearity, interference, method comparison) constitutes analytical validation, not the evaluation of a "trained" model.

9. How the Ground Truth for the Training Set Was Established

As noted above, there isn't a "training set" in the machine learning sense for this device. The underlying principles and calibration of the HPLC system and assay kits are established through standard chemical and metrological practices, traceable to international reference materials and methods (IFCC, NGSP, DCCT). This traceability and analytical validation inherently serve the purpose equivalent to ensuring the "accuracy" or "correctness" of the system's measurements.

Summary

FDA 510(k) Clearance Letter - Medconn Glycated Hemoglobin Test System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

June 20, 2025

Shanghai Medconn Medical Technology Co.,Ltd.
℅ Jessie Mu, Project Manager
Guangdong Grzan Group Co., Ltd.
Room 103-108, 1st Floor, Block B, Building 2, Bangkai Science and Technology Park
Guanguang Road, Guangming District
Shenzhen, 518107
China

Re: K242911
Trade/Device Name: Medconn Glycated Hemoglobin Test system
Regulation Number: 21 CFR 862.1373
Regulation Name: Hemoglobin A1c Test System
Regulatory Class: Class II
Product Code: PDJ, LCP
Dated: May 20, 2025
Received: May 20, 2025

Dear Jessie Mu:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Page 2

K242911 - Jessie Mu Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

Page 3

K242911 - Jessie Mu Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Joshua Balsam -S

Joshua M. Balsam, Ph.D.
Branch Chief
Division of Chemistry and
Toxicology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K242911

Please provide the device trade name(s).

Medconn Glycated Hemoglobin Test System

Please provide your Indications for Use below.

Please select the types of uses (select one or both, as applicable):
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

Medconn Glycated Hemoglobin Test System Page 12 of 67

Page 5

042_510k Summary (Summary of Safety and Effectiveness)

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

This 510(k) Summary is being submitted in accordance with requirements of Title 21 CFR 862.1373. The assigned 510(k) Number: K242911
Date of Preparation: 2025-06-18

1. Applicant information:

Submitter Name: Shanghai Medconn Medical Technology Co.,Ltd.
Submitter Address: No.1018 Weichang Road, Shanyang Town Jinshan District 201508 Shanghai, China
Contact Person: Judan Guan (Regulatory Affairs Director)
Telephone Number: +0086 13817317440
Email: guanjudan@medconn.com

2. Correspondent's information:

GRZAN GROUP CO., LTD.
Address: Room 103-108, 1st Floor, Block B,Building 2, Bangkai Science and Technology Park, Guanguang Road, Guangming District, Shenzhen, Guangdong, China
Contact Person: Jessie Mu
E-mail: jessie@grzan.cn

3. Device Name/Trade Name

Trade Name: Medconn Glycated Hemoglobin Test system
Models: MQ3000/MQ300PT
Classification Name: Hemoglobin A1c test system
Common Name: Hemoglobin A1c test system
Product Code: PDJ, LCP
Regulation Number: 21 CFR 862.1373
Regulation Class: 2
Review Panel: Clinical Chemistry
Regulation Medical Specialty: Clinical Chemistry

4. Predicate Device:

Trade Name: D-100™ HbA1c
D-100™ HbA1c Calibrator Pack

Page 6

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

510(k) Submitter/holder: BIO-RAD LABORATORIES, INC.
510(k) Number: K151321

5. Description of the Device:

Medconn Glycated Hemoglobin Test system contains the following components:

Medconn Glycated Hemoglobin analyzer
Medconn HbA1c Assay Kit (HPLC)
Medconn Hemoglobin A1c Calibrator
Medconn Hemoglobin A1c Control
Medconn HbA1c Column Kit (HPLC)
Medconn HbA1c Haemolyser

6. Indications for Use

Page 7

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

chromatography (HPLC) using the Medconn HbA1c Assay Kit (HPLC) on the Medconn Glycated Hemoglobin Analyzer, models MQ3000 and MQ3000PT.

7. Substantial Equivalence Information:

Predicate Device Information:

Predicate Device Name	Predicate Device 510(k) Number
D-100™ HbA1c D-100™ HbA1c Calibrator Pack	K151321

The comparison of the technological characterizes of Medconn Glycated Hemoglobin Test System (candidate assay) utilizes principles of ion-exchange high-performance liquid chromatography (HPLC) similar to the same technology of the predicate device.

Table below provides the similarities and differences between the candidate assay and the predicate assay.

Elements of Comparison	Subject Device	Predicate Device	Remark S/D
510(K) Number	/	K151321	NA
Applicant	Shanghai Medconn Medical Technology Co.,Ltd.	BIO-RAD LABORATORIES, INC.	NA
Device Name	Medconn Glycated Hemoglobin Test System	D-100™ HbA1c D-100™ HbA1c Calibrator Pack	NA
Instrument Platform	Medconn Glycated Hemoglobin Analyzer	D-100™ Hemoglobin Testing System	NA
Regulation number	21 CFR 862.1373	21 CFR 862.1373	SE
Regulatory Class	2	2	SE
Product Code	PDJ, LCP	PDJ, LCP, JIT	SE
Intended Use	Medconn Glycated Hemoglobin Test System is intended for the quantitative determination of	The D-100™ HbA1c test is intended for the quantitative determination of hemoglobin	SE

Page 8

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

	hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood or hemolysate with ion-exchange high performance liquid chromatography (HPLC) using the Medconn HbA1c Assay Kit (HPLC) on the Medconn Glycated Hemoglobin Analyzer, models MQ3000 and MQ3000PT. Hemoglobin A1c measurements are used as an aid in diagnosis of diabetes, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus.	A1c(IFCC mmol/mol and NGSP %) in human whole blood using ion-exchange high performance liquid chromatography (HPLC) on the D-100™ Hemoglobin Testing System. Hemoglobin A1c measurements are used as an aid in diagnosis of diabetes, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. The Bio-Rad D-100™ HbA1c test is intended for Professional Use Only.
Type of Use	Prescription Use	Prescription Use
System Composition	Medconn Glycated Hemoglobin Analyzer Medconn HbA1c Assay Kit (HPLC) Medconn HbA1c Column Kit (HPLC) Medconn HbA1c Haemolyser Medconn Hemoglobin A1c Calibrator Medconn Hemoglobin A1c Control	D-100™ Hemoglobin Testing System Bio-Rad D-100 HbA1c assay D-100 TM HbA1c Analytical Cartridge/Calibrator Pack Lyphochek® Diabetes Control（K070546） Bio-Rad Laboratories LiquichekTM Diabetes Control（K052838）
Test principle	Ion exchange HPLC	Ion exchange HPLC
Sample Types	Human Whole Blood	Human Whole Blood
Matrices	K2-EDTA	K2-EDTA, K3-EDTA Potassium Oxalate/Sodium Fluoride, Sodium Citrate, Sodium Heparin, Lithium Heparin
Measuring	3.0%～15.0% (NGSP)	3.5 to 20% (NSGP)

Page 9

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

interval	9.3-140.5 mmol/mol HbA1c (IFCC)	15 – 195 mmol/mol HbA1c (IFCC)	ce
Standardization	Traceable to the Diabetes Control and Complications Trial (DCCT) reference method and IFCC. Certified via the National Glycohemoglobin Standardization Program (NGSP).	Traceable to the Diabetes Control and Complications Trial (DCCT) reference method and IFCC. Certified via the National Glycohemoglobin Standardization Program (NGSP).	SE

Both the subject device (Medconn Glycated Hemoglobin Test System) and the Predicate device (D-100™ HbA1c, D-100™ HbA1c Calibrator Pack) have the same intended use, principle of operation, intended user, use environment and the similar technological characteristics.

Only the measuring interval is little different (subject device: 3.0%~~15.0%(NGSP) and 9.3~~140.5mmol/mol HbA1c (IFCC); predicate device: 3.5%~~20% (NGSP) and 15~~195 mmol/mol HbA1c (IFCC), and the analytical performance validation demonstrates that the subject device can cover the claimed measuring interval, and it does not raise any new questions of safety or effectiveness. Thus, the subject device is substantially equivalent to the predicate device.

8. Summary of Performance Data:

(1) Analytical performance

a. Precision/Reproducibility:

Precision of the Medconn Glycated Hemoglobin Test System was evaluated based on CLSI EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures, 3rd Edition. Four K2-EDTA whole blood samples at concentrations near 5% (31.1mmol/mol), 6.5%(47.5mmol/mol), 8%(63.9mmol/mol) , 12% (109.8mmol/mol) HbA1c and two-level quality control products were analyzed in duplicate, twice a day, with three lots of reagents, over 20 non-consecutive days, on three MQ-3000 Glycated Hemoglobin Analyzers with two opreation modes(whole blood mode and dilution mode). For each sample there were 720 measurements. Results are shown in the tables below:

Variation Source	Instrument 1 % CV by Sample
	Control 1

Page 10

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

	5.70	11.66	5.10	6.61	8.03	12.27
Repeatability	1.25%	0.94%	1.42%	1.18%	0.99%	0.68%
Between-Run	0.11%	0.12%	0.18%	0.26%	0.69%	0.32%
Between-Day	0.53%	0.02%	0.61%	0.46%	0.14%	0.43%
Between-Lot	0.0*	0.20%	0.15%	0.12%	0.09%	0.06%
Total Precision	1.36%	0.97%	1.56%	1.30%	1.22%	0.87%

Variation Source	Instrument 2 % CV by Sample
	Control 1
	5.71
Repeatability	1.10%
Between-Run	0.49%
Between-Day	0.56%
Between-Lot	0.11%
Total Precision	1.33%

Variation Source	Instrument 3 % CV by Sample
	Control 1
	5.70
Repeatability	1.22%
Between-Run	0.44%
Between-Day	0.49%
Between-Lot	0.0*
Total Precision	1.38%

Page 11

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

	5.70	11.66	5.10	6.61	8.03	12.27
Repeatability	1.25%	0.94%	1.42%	1.18%	0.99%	0.68%
Between-Run	0.11%	0.12%	0.18%	0.26%	0.69%	0.32%
Between-Day	0.53%	0.02%	0.61%	0.46%	0.14%	0.43%
Between-Lot	0.0*	0.20%	0.15%	0.12%	0.09%	0.06%
Total Precision	1.36%	0.97%	1.56%	1.30%	1.22%	0.87%

Instrument 2 % CV by Sample

Variation Source	Control 1	Control 2	Sample 1	Sample 2	Sample 3	Sample 4
	5.71	11.65	5.10	6.59	8.06	12.24
Repeatability	1.10%	0.82%	1.19%	0.99%	1.14%	0.77%
Between-Run	0.49%	0.36%	0.99%	0.34%	0.52%	0.38%
Between-Day	0.56%	0.15%	0.44%	0.11%	0.25%	0.09%
Between-Lot	0.11%	0.05%	0.20%	0.55%	0.33%	0.09%
Total Precision	1.33%	0.91%	1.62%	1.19%	1.32%	0.87%

Instrument 3 % CV by Sample

Variation Source	Control 1	Control 2	Sample 1	Sample 2	Sample 3	Sample 4
	5.70	11.66	5.12	6.61	8.05	12.25
Repeatability	1.22%	0.77%	1.19%	1.25%	1.00%	0.69%
Between-Run	0.44%	0.10%	0.80%	0.17%	0.68%	0.46%
Between-Day	0.49%	0.32%	0.54%	0.16%	0.26%	0.12%
Between-Lot	0.0*	0.09%	0.26%	0.13%	0.18%	0.10%
Total Precision	1.38%	0.85%	1.56%	1.28%	1.25%	0.84%

Page 12

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

Combined % CV by Sample

Variation Source	Control 1	Control 2	Sample 1	Sample 2	Sample 3	Sample 4
	5.71	11.66	5.11	6.60	8.05	12.25
Repeatability	1.19%	0.85%	1.27%	1.15%	1.05%	0.71%
Between-Run	0.39%	0.23%	0.74%	0.26%	0.64%	0.39%
Between-Day	0.54%	0.20%	0.56%	0.21%	0.21%	0.26%
Between-Lot	0.0*	0.13%	0.21%	0.33%	0.22%	0.08%
Between-Instrument	0.11%	0.0*	0.08%	0.02%	0.10%	0.05%
Total Precision	1.36%	0.91%	1.59%	1.24%	1.27%	0.86%

Table 1: Results of Precision Study of whole blood mode (NGSP%)

Instrument 1 % CV by Sample

Variation Source	Control 1	Control 2	Sample 1	Sample 2	Sample 3	Sample 4
	38.85	103.93	32.25	48.76	64.26	110.54
Repeatability	1.84%	1.18%	1.60%	1.77%	1.35%	0.77%
Between-Run	0.27%	0*	0.20%	0.27%	0.78%	0.36%
Between-Day	0.69%	0.13%	0.76%	0.71%	0.33%	0.48%
Between-Lot	0.12%	0.22%	0.13%	0*	0*	0.06%
Total Precision	1.99%	1.19%	1.78%	1.93%	1.59%	0.98%

Instrument 2 % CV by Sample

Variation Source	Control 1	Control 2	Sample 1	Sample 2	Sample 3	Sample 4
	38.94	103.84	32.18	48.46	64.59	110.33

Page 13

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

Repeatability	1.62%	1.08%	1.63%	1.54%	1.48%	0.87%
Between-Run	0.54%	0.43%	1.30%	0.49%	0.70%	0.46%
Between-Day	0.76%	0.08%	0.49%	0.25%	0.35%	0*
Between-Lot	0.18%	0*	0.43%	0.85%	0.40%	0.10%
Total Precision	1.88%	1.17%	2.18%	1.84%	1.72%	0.99%

Instrument 3 % CV by Sample

Variation Source	Control 1	Control 2	Sample 1	Sample 2	Sample 3	Sample 4
	38.76	103.98	32.38	48.71	64.41	110.35
Repeatability	1.81%	0.99%	1.71%	1.82%	1.45%	0.78%
Between-Run	0.36%	0.06%	1.19%	0*	0.83%	0.45%
Between-Day	0.74%	0.44%	0.76%	0.33%	0.30%	0.25%
Between-Lot	0*	0.11%	0.48%	0.21%	0.16%	0.08%
Total Precision	1.97%	1.09%	2.28%	1.84%	1.70%	0.94%

Combined % CV by Sample

Variation Source	Control 1	Control 2	Sample 1	Sample 2	Sample 3	Sample 4
	38.85	103.92	32.27	48.64	64.42	110.41
Repeatability	1.76%	1.09%	1.65%	1.72%	1.42%	0.81%
Between-Run	0.41%	0.23%	1.03%	0.26%	0.77%	0.43%
Between-Day	0.72%	0.24%	0.61%	0.43%	0.31%	0.30%
Between-Lot	0.03%	0.14%	0.39%	0.51%	0.25%	0.09%
Between-Instrument	0.18%	0*	0.14%	0.11%	0.18%	0.05%
Total Precision	1.95%	1.14%	2.08%	1.86%	1.68%	0.97%

Table 2: Results of Precision Study of whole blood mode (IFCC mmol/mol)

Page 14

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

Repeatability	1.62%	1.08%	1.63%	1.54%	1.48%	0.87%
Between-Run	0.54%	0.43%	1.30%	0.49%	0.70%	0.46%
Between-Day	0.76%	0.08%	0.49%	0.25%	0.35%	0*
Between-Lot	0.18%	0*	0.43%	0.85%	0.40%	0.10%
Total Precision	1.88%	1.17%	2.18%	1.84%	1.72%	0.99%

Instrument 3 % CV by Sample

Variation Source	Control 1	Control 2	Sample 1	Sample 2	Sample 3	Sample 4
	38.76	103.98	32.38	48.71	64.41	110.35
Repeatability	1.81%	0.99%	1.71%	1.82%	1.45%	0.78%
Between-Run	0.36%	0.06%	1.19%	0*	0.83%	0.45%
Between-Day	0.74%	0.44%	0.76%	0.33%	0.30%	0.25%
Between-Lot	0*	0.11%	0.48%	0.21%	0.16%	0.08%
Total Precision	1.97%	1.09%	2.28%	1.84%	1.70%	0.94%

Combined % CV by Sample

Variation Source	Control 1	Control 2	Sample 1	Sample 2	Sample 3	Sample 4
	38.85	103.92	32.27	48.64	64.42	110.41
Repeatability	1.76%	1.09%	1.65%	1.72%	1.42%	0.81%
Between-Run	0.41%	0.23%	1.03%	0.26%	0.77%	0.43%
Between-Day	0.72%	0.24%	0.61%	0.43%	0.31%	0.30%
Between-Lot	0.03%	0.14%	0.39%	0.51%	0.25%	0.09%
Between-Instrument	0.18%	0*	0.14%	0.11%	0.18%	0.05%
Total Precision	1.95%	1.14%	2.08%	1.86%	1.68%	0.97%

Table 2: Results of Precision Study of whole blood mode (IFCC mmol/mol)

Page 15

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

Instrument 1 % CV by Sample

Variation Source	Control 1	Control 2	Sample 1	Sample 2	Sample 3	Sample 4
	5.70	11.55	5.20	6.42	7.90	12.17
Repeatability	1.01%	0.83%	1.15%	0.91%	0.90%	0.64%
Between-Run	0.73%	0.34%	0.71%	0.65%	0.39%	0.46%
Between-Day	0.25%	0.29%	0.43%	0.12%	0.24%	0.08%
Between-Lot	0.19%	0.14%	0.18%	0.08%	0.17%	0.24%
Total Precision	1.29%	0.95%	1.43%	1.13%	1.03%	0.83%

Instrument 2 % CV by Sample

Variation Source	Control 1	Control 2	Sample 1	Sample 2	Sample 3	Sample 4
	5.71	11.55	5.20	6.41	7.89	12.13
Repeatability	0.99%	0.86%	1.10%	1.13%	0.74%	0.85%
Between-Run	0.85%	0.31%	0.45%	0.35%	0.55%	0.28%
Between-Day	0.36%	0.06%	0.70%	0.15%	0.24%	0.17%
Between-Lot	0.13%	0.11%	0.20%	0.30%	0.14%	0.14%
Total Precision	1.36%	0.93%	1.39%	1.23%	0.96%	0.92%

Instrument 3 % CV by Sample

Variation Source	Control 1	Control 2	Sample 1	Sample 2	Sample 3	Sample 4
	5.69	11.53	5.19	6.39	7.89	12.15
Repeatability	1.21%	0.82%	1.14%	1.11%	0.88%	0.75%
Between-Run	0.52%	0.14%	0.66%	0.48%	0.48%	0.41%

Page 16

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

Instrument 1 % CV by Sample

Variation Source	Control 1	Control 2	Sample 1	Sample 2	Sample 3	Sample 4
	5.70	11.55	5.20	6.42	7.90	12.17
Repeatability	1.01%	0.83%	1.15%	0.91%	0.90%	0.64%
Between-Run	0.73%	0.34%	0.71%	0.65%	0.39%	0.46%
Between-Day	0.25%	0.29%	0.43%	0.12%	0.24%	0.08%
Between-Lot	0.19%	0.14%	0.18%	0.08%	0.17%	0.24%
Total Precision	1.29%	0.95%	1.43%	1.13%	1.03%	0.83%

Instrument 2 % CV by Sample

Variation Source	Control 1	Control 2	Sample 1	Sample 2	Sample 3	Sample 4
	5.71	11.55	5.20	6.41	7.89	12.13
Repeatability	0.99%	0.86%	1.10%	1.13%	0.74%	0.85%
Between-Run	0.85%	0.31%	0.45%	0.35%	0.55%	0.28%
Between-Day	0.36%	0.06%	0.70%	0.15%	0.24%	0.17%
Between-Lot	0.13%	0.11%	0.20%	0.30%	0.14%	0.14%
Total Precision	1.36%	0.93%	1.39%	1.23%	0.96%	0.92%

Instrument 3 % CV by Sample

Variation Source	Control 1	Control 2	Sample 1	Sample 2	Sample 3	Sample 4
	5.69	11.53	5.19	6.39	7.89	12.15
Repeatability	1.21%	0.82%	1.14%	1.11%	0.88%	0.75%
Between-Run	0.52%	0.14%	0.66%	0.48%	0.48%	0.41%

Page 17

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

Between-Day	0.16%	0.24%	0.27%	0.07%	0.17%	0.16%
Between-Lot	0.18%	0.07%	0.19%	0.10%	0.05%	0.03%
Total Precision	1.34%	0.87%	1.36%	1.22%	1.02%	0.87%

Combined % CV by Sample

Variation Source	Control 1	Control 2	Sample 1	Sample 2	Sample 3	Sample 4
	5.70	11.54	5.20	6.41	7.89	12.15
Repeatability	1.08%	0.84%	1.13%	1.06%	0.85%	0.75%
Between-Run	0.72%	0.28%	0.62%	0.51%	0.48%	0.39%
Between-Day	0.38%	0.22%	0.59%	0.07%	0.22%	0.14%
Between-Lot	0.16%	0.11%	0.18%	0.19%	0.13%	0.16%
Between-Instrument	0.04%	0.02%	0.06%	0.13%	0.05%	0.07%
Total Precision	1.36%	0.92%	1.43%	1.20%	1.01%	0.87%

Table 3: Results of Precision Study of dilution mode (NGSP%)

Instrument 1 % CV by Sample

Variation Source	Control 1	Control 2	Sample 1	Sample 2	Sample 3	Sample 4
	38.81	102.79	33.23	46.62	62.85	109.50
Repeatability	1.64%	1.05%	0.76%	1.32%	1.26%	0.83%
Between-Run	1.05%	0.37%	1.25%	0.86%	0.61%	0.56%
Between-Day	0.41%	0.40%	0.98%	0*	0.37%	0.09%
Between-Lot	0.21%	0.15%	0.26%	0.13%	0.31%	0.26%

Page 18

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

Between-Day	0.47%	0.29%	0.99%	0*	0.26%	0.16%
Between-Lot	0.25%	0.11%	0.22%	0.25%	0.22%	0.18%
Between-Instrument	0.13%	0.06%	0.09%	0.16%	0*	0.10%
Total Precision	2.08%	1.15%	1.80%	1.63%	1.43%	1.08%

Table 4: Results of Precision Study of dilution mode (IFCC mmol/mol)

b.Linearity

A linearity study was performed based on CLSI EP06-A2: Evaluation of the Linearity of Quantitative Measuring Procedures, 2nd Edition; Linearity across the reportable range/measuring range was performed using altered patient samples collected using K2-EDTA.

Dilution mode: Samples were prepared by diluting the high concentration samples and the low concentration samples with the Medconn HbA1C Haemolyser to obtain a low HbA1c of 3.0% (9.3 mmol/mol) and a high HbA1c of 15.1% (141.5 mmol/mol). These high and low samples were mixed together in varying ratios to obtain 9 additional intermediate sample levels. The eleven test samples (high, low and 9 intermediates) were run three times with 3 lots of reagents on one instrument; measured values were compared to theoretical values.

Whole blood mode: A low HbA1c of 3.0% (9.3 mmol/mol) and a high HbA1c of 15.1% (141.5 mmol/mol) were mixed together in varying ratios to obtain 9 additional intermediate sample levels. The eleven test samples (high, low and 9 intermediates) were run three times with 3 lots of reagents on one instrument with two operation modes(dilution mode and whole blood mode); measured values were compared to theoretical values.

The maximum Bias(mean) between observed value and theoretical value were ± 0.1(NGSP %) and ±1(IFCC mmol/mol).

The regression parameters (slope, intercept, and R2) were the following:

Reagent lot	Units/Values	Slope	Intercept	R2
Lot 1	NGSP	0.999	0.0227	0.9998
Lot 2	NGSP	0.998	0.0287	0.9998

Page 19

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

Lot 3	NGSP	0.994	0.0559	0.9999
Lot (mean)	NGSP	0.9971	0.0352	0.9999

Table 5: Results of regression parameters of dilution mode (NGSP %)

Reagent lot	Units/Values	Slope	Intercept	R2
Lot 1	IFCC	0.9985	0.2955	0.9998
Lot 2	IFCC	0.9989	0.2219	0.9998
Lot 3	IFCC	0.9943	0.4784	1.0000
Lot (mean)	IFCC	0.9973	0.333	0.9999

Table 6: Results of regression parameters of dilution mode (IFCC mmol/mol)

Reagent lot	Units/Values	Slope	Intercept	R2
Lot 1	NGSP	0.9922	0.0687	0.9999
Lot 2	NGSP	0.9980	0.0287	0.9998
Lot 3	NGSP	1.0015	-0.0181	0.9999
Lot (mean)	NGSP	0.9967	0.0318	0.9999

Table 7: Results of regression parameters of whole blood mode (NGSP %)

Reagent lot	Units/Values	Slope	Intercept	R2
Lot 1	IFCC	0.9927	0.5509	0.9999
Lot 2	IFCC	0.9983	0.2132	0.9999
Lot 3	IFCC	1.0019	-0.2590	0.9999
Lot (mean)	IFCC	0.9976	0.1679	0.9999

Table 8: Results of regression parameters of whole blood mode (IFCC mmol/mol)

The linearity study was reviewed and found acceptable. Results of the linearity study support the claimed measuring range of the device of 3.0% to 15.0% HbA1c (9.3-140.5 mmol/mol).

Page 20

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Traceability:
Medconn Glycated Hemoglobin Test System standardization is traceable to the International Federation of Clinical Chemistry (IFCC) reference calibrators.

HbA1c results are provided to users in two different units: NGSP equivalent units (%) and IFCC equivalent units (mmol/mol). Results in % HbA1c from the NGSP correlation are calculated from the individual quantitative results for Hemoglobin A1c. The IFCC units of mmol/mol are calculated using the Master Equation: NGSP (%) = 0.09148 x IFCC (mmol/mol) + 2.152.

d. Detection limit:

Not applicable.

e. Analytical specificity:

An Endogenous Interference study was performed per CLSI EP07-A3, Interference Testing in Clinical Chemistry. Two EDTA whole blood sample pools were evaluated using a low level whole blood sample with a concentration ~6.5% HbA1c and a high level whole blood sample with a concentration of HbA1c of ~8.0%.

Unconjugated Bilirubin, Conjugated Bilirubin, glucose and lipemia(Triglycerides), available in pure form, were obtained and stock solutions prepared at 10x the intended test concentration. The 10x stock solution of the test substance was pipetted into a low whole blood sample pool (at ~6.5% HbA1c) and a high whole blood sample pool (~8.0% HbA1c), making the test pool. Ten replicates of each pool prepared with the test and control samples were analyzed using the MQ-3000 Testing System.

Rheumatoid factor, lipemia and total protein were not available as pure standards therefore serum samples with known concentration of these compounds were used. The test pool was prepared by mixing the serum sample known to have a high test substance concentration with a whole blood non-variant sample such that the concentration of test substance in the final mixture would be at the desired level. Ten replicates of each pool prepared with the test and control samples were analyzed using the MQ-3000 Testing System.

Significant interference was defined as a ± 6% change in %HbA1c value from the control. Results in Table 9 showed no significant interference up to the stated concentrations.

Page 21

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

Table 9: Endogenous Interference Study Results

Interfering substance	Concentration with No Interference
Unconjugated bilirubin	21.3 mg/dL
Conjugated bilirubin	19.2 mg/dL
Lipemia (Triglycerides)	6000 mg/dL
RF(rheumatoid factors)	750 IU/mL
TP(total protein)	21.0 g/dL

ii. Drug Interference

A Drug Interference study was performed based per CLSI EP07-A3, Interference Testing in Clinical Chemistry. Two EDTA whole blood sample pools were evaluated using a low level whole blood sample with a concentration ~6.5%HbA1c and a high level whole blood sample with a concentration of ~8.0%HbA1c. Ten replicates of each drug prepared with the test and control samples were analyzed using the MQ-3000 Testing System.

With Hplc, the red cells are lysed and eluted across the column for separation of the hemoglobin fractions. Research of the FDA website and others show no Contraindication of Levodopa, Methyldopa, Acetaminophen and ibuprofen when used by pre-diabetic or diabetic patients, and the drugs do not interfere with the Hplc technology as they might during an antigen antibody reaction, FDA stated that based On the technology of the device, it has been shown that the additional substances do not appear to interfere with this type of device, therefore, the additional interference data on these drugs was not needed.

Significant interference was defined as a more than ± 6% change in %HbA1c value from the control. No significant interference was observed at therapeutic levels up to the stated concentrations in Table 10 on the following page.

Table 10: Drug Interference Study Results

Interfering substance	Concentration with No Interference
Ascorbic acid	100 mg/dL
Acetylcysteine	166 mg/dL
Ampicillin-Na	1,000 mg/dL
Cefoxitin	2,500 mg/dL
Heparin	5,000 U/L
Levodopa	20 mg/dL
Methyldopa	20 mg/dL

Page 22

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

Metronidazole	200 mg/dL
Doxycyclin	50 mg/dL
Rifampicin	64 mg/dL
Cyclosporine	5 mg/dL
Acetaminophen	200 mg/dL
Ibuprofen	500 mg/dL
Theophylline	100 mg/dL
Phenylbutazone	400 mg/dL

iii. Cross Reactivity with Hemoglobin Derivatives

A Hemoglobin Derivatives Interference study was performed based on CLSI EP07-A3, Interference Testing in Clinical Chemistry. Potential interference from Acetylated hemogloblin (Hb), Carbamylated hemoglobin (Hb) and Labile HbA1c were evaluated using a low level whole blood EDTA sample with a concentration ~6.5%HbA1c and a high level whole blood EDTA sample with a concentration of ~8.0% HbA1c. The potentially interfering hemoglobin derivatives were spiked into the low and high level blood samples and each sample was analyzed using ten replicates each in the same analytical run on the MQ-3000 Testing System.

Significant interference was defined as more than a ±6% change in HbA1c value from the control. The test result conclusions are as follows:

• Acetylated Hb (Acetylsalicylic acid up to 500 mg/dL) does not interfere with this assay.
• Carbamylated Hb (Potassium cyanate up to 10 mg/dL ) does not interfere with this assay.
• Labile A1c- ( Glucose up to 2000 mg/dL, Acetaldehyde up to 60 mg/dL) does not interfere with this assay.

Results showed there was no cross reactivity with these substances at physiological levels.

iv. Hemoglobin Variant Interference

Two hemoglobin variant studies were performed using a panel of normal and diabetic whole blood EDTA patent variant samples known to contain hemoglobin variants S, C, E, D, A2 and F. Testing of the samples containing hemoglobin variants S, C, E, D , A2 and F were performed in duplicate using the MQ-3000 Testing System and compared to results obtained by a reference method that has been demonstrated to be free from interference with the hemoglobin variant being tested (Trinity Biotech Premier Hb9210,Bio-Rad VARIANT II Hemoglobin Testing System and Tosoh Automated Glycohemoglobin Analyzer HLC-723G8).

Page 23

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

Tables 11-1 and 11-2 contain the number of samples, range of samples and concentration of samples used in the Hemoglobin Variant Study. Tables 12-1 and 12-2 contain the results for the hemoglobin variant study bias.

Hemoglobin Variant	n	Range in % Abnormal Variant	Range in %HbA1c Concentration
HbS	11	30 – 42	5.1 – 11.4
HbC	10	30 – 40	5.0 – 10.9
HbD	13	23 – 41	5.4 – 10.1
HbE	12	21 – 30	5.5 – 11.6
HbA2	10	4.8 – 6.2	5.1 – 11.7
HbF	11	4.3 – 33	4.6 – 12.6

Table 11-1: Variant samples used in hemoglobin variants study #1

Hemoglobin Variant	n	Range in % Abnormal Variant	Range in %HbA1c Concentration
HbS	25	36 – 42	5.0 – 14.0
HbC	25	30 – 38	5.0 – 10.9
HbD	25	39 – 43	5.3 – 14.7
HbE	25	23 – 27	5.1 – 12.2
HbA2	20	3.5 – 5.6	5.2 – 9.0
HbF	23	3.0 – 27	5.5 – 16.5

Table 11-2: Variant samples used in hemoglobin variants study #2

HemoglobinVariant	Relative % Bias to Comparative Method
	Relative %Bias (Range of %Bias) forHbA1c ~ 6.5%
HbS	-1.34 (-3.54 to 1.98)
HbC	-0.96 (-2.65 to 1.65)
HbD	-0.10 (-1.65 to 1.65)
HbE	-0.86 (-1.83 to 0.88)
HbA2	-0.29 (-1.71 to 1.90)
HbF	-0.23 (-1.98 to 2.20)

Table 12-1: Results of hemoglobin variants study #1

HemoglobinVariant	Relative % Bias to Comparative Method
	Relative %Bias (Range

Page 24

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

	of %Bias) forHbA1c ~ 6.5%	of %Bias)for HbA1c ~ 8.0%
HbS	1.20 (-1.59 to 3.23)	-0.31 (-2.35 to 1.18)
HbC	1.59 (0.00 to 3.23)	0.27 (-1.20 to 1.33)
HbD	0.93 (-1.67 to 3.28)	0.67 (0.00 to 1.33)
HbE	0.14 (-0.98 to 0.93)	-0.02 (-1.16 to 1.38)
HbA2	1.01 (0.00 to 3.03)	-0.66 (-2.53 to 2.41)
HbF	0.59 (-1.67 to 3.08)	0.16 (-2.38 to 2.50)

Table 12-2: Results of hemoglobin variants study #2

No significant interference was observed for HbC (≤ 40%), HbD (≤ 43%), HbS (≤ 42%), HbE (≤ 30%), HbA2 (≤ 6.2%) and HbF (≤33%) at the concentrations tested in this study.

f. Assay cut-off:

Not applicable.

(2) Comparison studies

a. Method comparison with a standardized test method:

A Method comparison study was performed per CLSI EP09c 3rd Edition, Measurement Procedure Comparison and Bias Estimation Using Patient Samples. 124 variant-free whole blood K2-EDTA samples, ranging from 3.0% to 15.0% HbA1c were evaluated using MQ-3000 and MQ-3000PT analyzer on the Medconn Glycated Hemoglobin Test system. 124 samples were tested, and the results were compared to testing performed at by a NGSP Secondary Reference Laboratory using a previously cleared HPLC HbAlc assay method (BIO-RAD D-100 analyzer). To support the diagnostic claim, the distribution of samples spanned around the clinical decision point as follows in the table below.

Sample distribution in the method comparison study

Hemoglobin A1c level	Number of samples	% of Samples
≤ 5%	6	4.84
5 – 6%	15	12.10
6 – 6.5%	31	25.00
6.5 – 7%	30	24.19

Page 25

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

7 – 8%	18	14.52
8 – 9%	10	8.06
> 9%	14	11.29
Total samples	124	100.00

Bias between the Candidate and NGSP method

Deming (weighted) and Passing-Bablok regression analyses were performed for the MQ-3000 analyzer versus the NGSP SRL reference method.

Summary of Method Comparison Results:

1) Dilution mode data:

	y-Intercept	95% CI	Slope	95% CI
Deming	0.1940	0.1139 to 0.2740	0.9894	0.9781 to 1.0007
PassingBablok	0.1000	0.1000to 0.1000	1.0000	1.0000 to 1.0000

The following biases between the MQ-3000 run on Medconn Glycated Hemoglobin Test system versus the NGSP Reference Method ( BIO-RAD D-100 analyzer ) were observed:

%Decision Level (x)	Bias (Deming)	%Bias (Deming)
5.0	0.1410	2.8200
6.5	0.1251	1.9246
8.0	0.1092	1.3650
12.0	0.0668	0.5567

%Decision Level (x)	Bias (PassingBablok)	%Bias (PassingBablok)
5.0	0.1000	2.0000

Page 26

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

6.5	0.1000	1.5385
8.0	0.1000	1.2500
12.0	0.1000	0.8333

Total Error Near the Cutoff:

Using the results of bias estimation (%Bias) in the method comparison study and precision estimates in the precision study, Total Error (TE) at four HbA1c concentrations (5.0%, 6.5% , 8.0% and 12.0%) was calculated as follows: %TE =|%Bias| + 1.96*%CV*(1+%Bias/100).

The results are presented in the tables below.

Total Error(%TE)-Deming：

HbA1c Level	%TE	%Bias	%CVTotal
5.0%	5.70	2.82	1.43
6.5%	4.32	1.92	1.20
8.0%	3.37	1.37	1.01
12.0%	2.27	0.56	0.87

Total Error(%TE)-PassingBablok：

HbA1c Level	%TE	%Bias	%CVTotal
5.0%	4.86	2.00	1.43
6.5%	3.93	1.54	1.2
8.0%	3.25	1.25	1.01
12.0%	2.55	0.83	0.87

2) Whole blood mode data:

Page 27

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

	y-Intercept	95% CI	Slope	95% CI
Deming	0.0004	-0.0609 to 0.0617	1.0074	0.9990 to 1.0158
PassingBablok	0.0500	-0.0677 to 0.0500	1.0000	1.0000 to 1.0154

The following biases between the MQ-3000 run on Medconn Glycated Hemoglobin Test system versus the NGSP Reference Method ( BIO-RAD D-100 analyzer ) were observed:

%Decision Level (x)	Bias (Deming)	%Bias (Deming)
5.0	0.0374	0.7480
6.5	0.0485	0.7462
8.0	0.0596	0.7450
12.0	0.0892	0.7433

%Decision Level (x)	Bias (PassingBablok)	%Bias (PassingBablok)
5.0	0.0500	1.0000
6.5	0.0500	0.7692
8.0	0.0500	0.6250
12.0	0.0500	0.4167

Total Error Near the Cutoff:

The results are presented in the tables below.

Total Error(%TE)-Deming：

Page 28

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

HbA1c Level	%TE	%Bias	%CVTotal
5.0%	3.89	0.75	1.59
6.5%	3.20	0.75	1.24
8.0%	3.26	0.75	1.27
12.0%	2.44	0.74	0.86

Total Error(%TE)-PassingBablok：

HbA1c Level	%TE	%Bias	%CVTotal
5.0%	4.15	1.00	1.59
6.5%	3.22	0.77	1.24
8.0%	3.13	0.63	1.27
12.0%	2.11	0.42	0.86

(3) Expected values/Reference range:

The sponsor provided the following expected values in the labeling:

As the recommendation from the American Diabetes Association:

Non-diabetic level <5.7%
Criteria for diagnosis of prediabetes level 5.7% - 6.4%
Criteria for diagnosis of diabetes level ≥ 6.5% (threshold)
The expected HbA1c range for non-diabetic adults is 4-6%

It is recommended that each laboratory establish its own reference values based on the characteristics of population.

9. Proposed Labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

10. Conclusion

The information and data in this 510(k) document demonstrate that the Medconn Glycated Hemoglobin Test System is an accurate, reliable, precise test that correlates

Page 29

Sponsor: Shanghai Medconn Medical Technology Co.,Ltd.
Subject Device: Medconn Glycated Hemoglobin Test system

well with current cleared methods and NGSP standardized testing for the quantitation of HbA1c. And the performance criteria as stipulated by the Special Controls requirements for HbA1c systems that diagnose diabetes have clearly been met.

The contents of this submission demonstrates that the Medconn Glycated Hemoglobin Test System is substantially equivalent to its predicate device, D-100™ HbA1c and, therefore, safe and effective for its intended use.

Regulation Number and Section

§ 862.1373 Hemoglobin A1c test system.

(a)
Identification. A hemoglobin A1c test system is a device used to measure the percentage concentration of hemoglobin A1c in blood. Measurement of hemoglobin A1c is used as an aid in the diagnosis of diabetes mellitus and as an aid in the identification of patients at risk for developing diabetes mellitus.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must have initial and annual standardization verification by a certifying glycohemoglobin standardization organization deemed acceptable by FDA.
(2) The premarket notification submission must include performance testing to evaluate precision, accuracy, linearity, and interference, including the following:
(i) Performance testing of device precision must, at a minimum, use blood samples with concentrations near 5.0 percent, 6.5 percent, 8.0 percent, and 12 percent hemoglobin A1c. This testing must evaluate precision over a minimum of 20 days using at least three lots of the device and three instruments, as applicable.
(ii) Performance testing of device accuracy must include a minimum of 120 blood samples that span the measuring interval of the device and compare results of the new device to results of a standardized test method. Results must demonstrate little or no bias versus the standardized method.
(iii) Total error of the new device must be evaluated using single measurements by the new device compared to results of the standardized test method, and this evaluation must demonstrate a total error less than or equal to 6 percent.
(iv) Performance testing must demonstrate that there is little to no interference from common hemoglobin variants, including Hemoglobin C, Hemoglobin D, Hemoglobin E, Hemoglobin A2, and Hemoglobin S.
(3) When assay interference from Hemoglobin F or interference with other hemoglobin variants with low frequency in the population is observed, a warning statement must be placed in a black box and must appear in all labeling material for these devices describing the interference and any affected populations.