The DRI® Hemoglobin A1c Assay is an in vitro reagent system for the quantitative determination of Hemoglobin A1c in human whole blood using automated clinical chemistry analyzers. It is intended to aid in monitoring long-term blood glucose control in individuals with diabetes mellitus.

The DRI® Hemoglobin A1c Calibrators are intended for use in the calibration of the DRI® Hemoglobin A1c Assay in human whole blood.

Device Description

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DRI Hemoglobin A1c Assay kit contains reagent 1, 2a, 2b and a hemolysis buffer. All are in liquid format.

DRI Hemoglobin A1c Calibrator kit contains four lyophilized positive calibrators with different hemoglobin Dr. Hemogrobin ATC Galibrator int colution that serves as negative hemoglobin calibrator.

AI/ML Overview

This document describes the DRI® Hemoglobin A1c Assay, a diagnostic device for measuring HbA1c levels in human whole blood. The submission focuses on demonstrating substantial equivalence to a predicate device, the Tosoh G7 Automated High Performance Liquid Chromatography (HPLC) Analyzer.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a separate table. However, the "Performance" table summarizes the results of the study, which can be interpreted as demonstrating the device meets the expected performance for an HbA1c assay. The implicit acceptance criterion for this 510(k) submission is substantial equivalence to the predicate device, implying that the performance metrics of the new device are comparable or statistically equivalent within acceptable ranges to the predicate.

Performance Metric	Reported Device Performance (DRI HbA1c Assay)	Implicit Acceptance Criteria (based on predicate equivalence)
Limit of Detection	0.2%	Comparable to predicate device's LOD (not explicitly stated for predicate)
Precision (n=80)		Within clinically acceptable variability and comparable to predicate
- Within run (Normal HbA1c)	0.67%CV
- Within run (Elevated HbA1c)	0.62% CV
- Total run (Normal HbA1c)	2.03% CV
- Total run (Elevated HbA1c)	2.36%CV
Assay Linearity	5.2% to 16% HbA1c concentration	Within range of clinical relevance and comparable to predicate
Interference		No significant interference observed at specified concentrations
- Billirubin	No interference observed with 50 mg/dL
- Ascorbic Acid	No interference observed with 50 mg/dL
- Triglycerides	No interference observed with 1000 mg/dL
- EDTA	No interference observed with 6 mg/mL
- Heparin	No interference observed with 75 units/mL
- Citrate	No interference observed with 9 mg/mL
- Oxalate	No interference observed with 15 mg/mL
Method Comparison		Shows substantial agreement (slope near 1, intercept near 0, high correlation) to the predicate device
- DRI HbA1c vs Tosoh (n=80)
- Slope (Deming 95% CI)	0.999 (0.969 to 1.028)
- Intercept (Deming 95% CI)	0.176 (-0.067 to 0.419)
- Std Err Est	0.254
- Correlation	0.9915

The "acceptance criteria" are implicitly met if the reported performance supports the claim of substantial equivalence to the Tosoh G7 HPLC Analyzer, which is NGSP certified.

2. Sample size used for the test set and the data provenance:

Precision Test Set Sample Size: n=80 (for both normal and elevated HbA1c samples).
Method Comparison Test Set Sample Size: n=80.
Data Provenance: Not explicitly stated regarding country of origin or specific demographics, but the study follows current guidance (NGSP and NCCLS), implying standard clinical laboratory practices. The study is implicitly retrospective in the sense that samples would have been collected and then tested with both devices, rather than a prospective cohort study for device evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. For a diagnostic assay, "ground truth" is typically established by a reference method with known accuracy. Here, the predicate device (Tosoh G7 Automated HPLC Analyzer) is presented as the reference method, especially given its NGSP certification and use for establishing traceable results to the DCCT. The document doesn't mention expert interpretation of results, but rather direct comparison to the predicate's quantitative output.

4. Adjudication method for the test set:

This information is not applicable as there is no mention of human adjudication for the test results. The comparison is quantitative, machine-to-machine, against the predicate device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device is an in vitro diagnostic assay, not an AI-assisted imaging or diagnostic tool requiring human reader interpretation. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, the study primarily demonstrates the standalone performance of the DRI® Hemoglobin A1c Assay system. It evaluates the assay's performance characteristics (limit of detection, precision, linearity, interference) and its agreement with a predicate reference method. There is no "human-in-the-loop" aspect to the analytical performance itself; the device provides a direct quantitative measurement.

7. The type of ground truth used:

The ground truth for the method comparison study is established by the predicate device, the Tosoh G7 Automated HPLC Analyzer, which is certified by the National Glycohemoglobin Standardization Program (NGSP) and is used as a reference method for establishing traceable results to the Diabetes Control and Complications Trial (DCCT). This represents a well-established, standardized reference measurement within the field of HbA1c testing.

8. The sample size for the training set:

This information is not provided. As an in vitro diagnostic assay (specifically an immunoassay), the development process typically involves reagent formulation, optimization, and extensive analytical validation. There isn't a "training set" in the sense of machine learning algorithms. The performance data presented are for the validated product.

9. How the ground truth for the training set was established:

This is not applicable as there is no explicit mention of a "training set" for an algorithm. The development of an immunoassay involves optimizing reagents and protocols to achieve desired performance, which is then validated against reference methods like the Tosoh G7. Any "ground truth" used during development would similarly refer to reference values from established methods or certified materials.

Summary

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FER 3 2006

Section II

510(k) SUMMARY

General Information Required for Premarket Notification per 21 CFR 807.87

510k Number:	K053411
Submitter:	Microgenics Corporation46360 Fremont BlvdFremont, CA 94538Telephone: (510)-979-5000Facsimile: (510) 979-5255
Contact Person:	Tony C. LamTelephone: (510)-979-5055Facsimile: (510) 979-5255tlam@microgenics.com
Device's Trade Name:	DRI® Hemoglobin A1c Assay
Device's Classification Name:	Glycosylated Hemoglobin Assay
Registration Number:	2937369 (Microgenics Corp. Fremont, CA, US)
Regulation Number:	21 CFR 864.7470
Classification:	Class II
Product Code:	LCP

Predicate Device(s):

Tosoh G7 Automated High Performance Liquid Chromatography (HPLC) Analyzer: HbA1c Variant Analysis Mode.

Device Description:

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DRI Hemoglobin A1c Assay kit contains reagent 1, 2a, 2b and a hemolysis buffer. All are in liquid format.

DRI Hemoglobin A1c Calibrator kit contains four lyophilized positive calibrators with different hemoglobin Dr. Hemogrobin ATC Galibrator int colution that serves as negative hemoglobin calibrator.

Intended Use:

The DRI® Hemoglobin A1c Assay is an in vitro reagent system for the quantitative determination of Hemoglobin A1c in human whole blood using automated clinical chemistry analyzers. It is intended to richlogiobili / (1) in human wood glucose control in individuals with diabetes mellitus.

The DRI® Hemoglobin A1c Calibrators are intended for use in the calibration of the DRI® Hemoglobin A1c Assav in human whole blood.

DRI® Hemoglobin A1c Assay comparison to Predicate Device(s):

The DRI® Hemoglobin A1c Assay, including calibrators, is substantially equivalent to Tosoh G7 HPLC The DNY "Tichlogines" ATO ASSULT In and in the quantitative determination of HbA1c concentration in whole blood sample.

DeviceCharacteristics	Subject Device(DRI HbA1C Assay)	Predicate Device(Tosoh G7 Automated HPLC Analyzer:HbA1c Variant Analysis Mode)
Intended Use	The DRI® Hemoglobin A1c Assay is an invitro reagent system for the quantitativedetermination of Hemoglobin A1c in humanwhole blood using automated clinicalchemistry analyzers. It is intended to aid inmonitoring long-term blood glucose controland compliance in individuals with diabetesmellitus.The DRI® Hemoglobin A1c Calibrators areintended for use in the calibration of theDRI® Hemoglobin A1c Assay in humanwhole blood.	The Tosoh G7 automated HPLC Analyzer-HbA1c Variant Analysis mode is intendedfor in vitro diagnostic use for themeasurement of hemoglobin A1c (HbA1c) inwhole blood specimens. Hemoglobin A1cmeasurements are used in the clinicalmanagement of diabetes to assess the long-term efficacy of diabetic control.
Analyte	Hemoglobin A1c	Hemoglobin A1c and total Hemoglobin A
Matrix	Whole blood	Whole blood
Calibrator Level	5 levels calibrators including a negative	2 points

Summary:

The information provided in this pre-market notification demonstrates that the DRI® Hemoglobin A1c Assay including calibrators is substantially equivalent to Tosoh G7 Automated HPLC Analyzer. Tosoh G7 Automated HPLC Analyzer is certified by the National Glycohemoglobin Standardization Program (NGSP). It is used as a reference method for establishing traceable results of other methods to the Diabetes Control and Complications Trial (DCCT). Data and results provided in this premarket notification were collected and prepared, respectively, in accordance with the NGSP and NCCLS quidance. The performance of the DRI Hemoglobin A1c Assay including calibrators is substantially equivalent to Tosoh G7 Automated HPLC Analyzer for the quantitative determination of HbA1c, as approved by NGSP manufacturer certification (see attached NGSP certification).

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The performance of the assay were conducted using DRI Hemoglobin A1c Assay kit and calibrator kit are summarized below:

Performance	Results
Limit of Detection	0.2%
Precision (n=80)	Normal HbA1c Sample	Elevated HbA1c Sample
Within run	0.67%CV	0.62% CV
Total run	2.03% CV	2.36%CV
Assay Linearity	5.2% to 16% HbA1c concentration
Interference	No interference observed with
	Billirubin	50 mg/dL
	Ascorbic Acid	50 mg/dL
	Triglycerides	1000 mg/dL
	EDTA	6 mg/mL
	Heparin	75 units/mL
	Citrate	9 mg/mL
	Oxalate	15 mg/mL
Method Comparison
DRI HbA1c vs Tosoh (n=80)	Deming (95% CI)	Regular (95%CI)
Slope	0.999 (0.969 to 1.028)	0.995 (0.965 to 1.024)
Intercept	0.176 (-0.067 to 0.419)	0.210 (-0.033 to 0.453)
Std Err Est	0.254	0.254
Correlation	0.9915

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

Tony C. Lam, MS Vice President, Regulatory, Quality & Compliance Microgenics Corporation 46360 Fremont Blvd. Fremont, CA 94538

FEB 3 2006

K053411 Re: Trade/Device Name: DRI® Hemoglobin A1c Assay DRI® Hemoglobin A1c Calibrators Regulation Number: 21 CFR § 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, KRZ Dated: November 30, 2005 Received: December 7, 2005

Dear Mr. Lam:

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 (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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Guts

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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SECTION III

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K053411

DRI® Hemoglobin A1c Assay Device name: DRI® Hemoglobin A1c Calibrators

Indications for Use:

The DRI® Hemoglobin A1c Calibrators are intended for use in the calibration of the DRI® Hemoglobin A1c Assay in human whole blood.

Prescription Use X (Part 21 CFR §801 Subpart D) AND/OR

Over-the Counter Use (21 CFR §807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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14 US3411

Regulation Number and Section

§ 864.7470 Glycosylated hemoglobin assay.

(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).