DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS

K053411 · Microgenics Corp. · LCP · Feb 3, 2006 · Hematology

Device Facts

• Record ID: K053411
• Device Name: DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS
• Applicant: Microgenics Corp.
• Product Code: LCP · Hematology
• Decision Date: Feb 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

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 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 Story

DRI Hemoglobin A1c Assay is a homogeneous immunoturbidimetric reagent system for automated clinical chemistry analyzers (Hitachi 900 series). Input: human whole blood samples. Principle: hemoglobin and HbA1c bind to microparticles; HbA1c-specific antibody induces agglutination; spectrophotometric measurement of agglutination proportional to HbA1c percentage. Output: quantitative HbA1c concentration. Used in clinical laboratory settings by trained technicians. Results assist clinicians in monitoring long-term blood glucose control and diabetes management.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A (n=80 per sample type) with total-run %CV ranging 1.52-2.36%. Linearity confirmed from 5.2% to 16.0% (r=0.9995). Method comparison against Tosoh G7 HPLC using 40 whole blood samples yielded y = 0.995x + 0.210 (r=0.9915) with bias <±1%. Interference testing showed <1% interference for bilirubin, ascorbic acid, and triglycerides, and <0.3% for various anticoagulants.

Technological Characteristics

Homogeneous immunoturbidimetric assay. Reagents: microparticles, glycine buffer, mouse anti-human HbA1c, polyclonal goat anti-mouse IgG. Calibrators: lyophilized human blood hemolysate. Detection: spectrophotometric. Calibration: five-point. Stability: 24 months unopened at 2–8 °C. Standards: CLSI EP5-A, NGSP Manufacturer Certification Guidelines.

Indications for Use

Indicated for quantitative determination of HbA1c in human whole blood to aid in monitoring long-term blood glucose control in individuals with diabetes mellitus.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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 Corporation<br>46360 Fremont Blvd<br>Fremont, CA 94538<br>Telephone: [phone]<br>Facsimile: [phone] |
| Contact Person: | Tony C. Lam<br>Telephone: [phone]<br>Facsimile: [phone]<br>[e-mail] |
| 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:

DRY® Hemoglobin A1c Assay, including calibrators, is a homogeneous immunoassay that measures the DRY Helliogioun' ATC Assay, Including callbraters, 18 a ministry analyzers. The assay s based on the HDATC In human while blood doing automation of microparticles. Hemoglobin and HbA1c in measurement of light boation non specifically at the same rate. When HbA1c specific Samples bird to micropartioloo by adoelphon to HbA1c on the microparticles resulting in agglutination. The amibody is introduced, the antibody birde to the percent in the Use of HBA to present in the Uit hemoglobin extent or aggiatifically propertically. This technology used in the DRI hemoglobin A1c assay is an established method (ref 1).

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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.

| Device<br>Characteristics | Subject Device<br>(DRI HbA1C Assay) | Predicate Device<br>(Tosoh G7 Automated HPLC Analyzer:<br>HbA1c Variant Analysis Mode) |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The DRI® Hemoglobin A1c Assay is an in<br>vitro reagent system for the quantitative<br>determination of Hemoglobin A1c in human<br>whole blood using automated clinical<br>chemistry analyzers. It is intended to aid in<br>monitoring long-term blood glucose control<br>and compliance in individuals with diabetes<br>mellitus.<br><br>The DRI® Hemoglobin A1c Calibrators are<br>intended for use in the calibration of the<br>DRI® Hemoglobin A1c Assay in human<br>whole blood. | The Tosoh G7 automated HPLC Analyzer-<br>HbA1c Variant Analysis mode is intended<br>for in vitro diagnostic use for the<br>measurement of hemoglobin A1c (HbA1c) in<br>whole blood specimens. Hemoglobin A1c<br>measurements are used in the clinical<br>management of diabetes to assess the long-<br>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 [phone]. 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 [phone] or [phone] 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 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.

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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