INFINITY HBA KIT, MODELS 537-A, 537-B

K012410 · Sigma Diagnostics, Inc. · LCP · Oct 26, 2001 · Hematology

Device Facts

• Record ID: K012410
• Device Name: INFINITY HBA KIT, MODELS 537-A, 537-B
• Applicant: Sigma Diagnostics, Inc.
• Product Code: LCP · Hematology
• Decision Date: Oct 26, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Indications for Use

Sigma Diagnostics INFINITY™ HbA1c assay is an in vitro assay for the quantitative determination of hemoglobin A1c (HbA1c) in whole blood for use on automated analyzers.

Device Story

INFINITY HbA1c is a microparticle-enhanced turbidimetric immunoassay for quantitative determination of HbA1c in human anticoagulated whole blood (EDTA or Heparin). Used on automated clinical chemistry analyzers; operated by laboratory personnel. Device measures turbidity changes resulting from antigen-antibody reactions; output is percentage of HbA1c. Results assist clinicians in monitoring long-term glycemic control in diabetic patients.

Clinical Evidence

Clinical performance established via method comparison studies. 45 patient samples tested comparing INFINITY HbA1c against Roche HbA1c II and Bio-Rad VARIANT II on multiple analyzer platforms (Cobas Mira, Hitachi 717, Hitachi 911). Correlation coefficients ranged from 0.976 to 0.990. Regression equations provided for all comparisons, confirming clinical equivalence to predicate methods.

Technological Characteristics

Microparticle-enhanced turbidimetric immunoassay. Sample type: human anticoagulated whole blood (EDTA or Heparin). Designed for use on automated clinical chemistry analyzers. No specific materials, energy sources, or software algorithm classes (e.g., ML/DL) described beyond standard turbidimetric assay principles.

Indications for Use

Indicated for monitoring long-term glucose control in individuals with diabetes mellitus. Measures percent hemoglobin A1c in anticoagulated whole blood.

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

• Roche Diagnostics HbA1c II (K940082)
• Bio-Rad VARIANT™ II (K984268)

Submission Summary (Full Text)

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KOI2Y10

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## Submitter, name, address, contact 1.

Sigma Diaqnostics Inc. 545 South Ewing Ave St. Louis, MO 63103

William R. Gilbert Contact person: [phone]

July 26, 2001 Date Prepared:

## 2. Device name

INFINITY™ HbAic Proprietary name:

Hemoglobin Arc Common name:

Classification name: Assay, Glycosylated Hemoglobin, 81 LCP, 21 CFR 864.7470

#### Predicate device 3.

Roche Diagnostics HbA1c II K940082 Bio-Rad VĂRIANT™ II K984268

#### 4. Device description

The INFINITY HbA1c assay is a microparticle enhanced turbidimetric immunoassay.

## 5. Intended Use

Sigma Diagnostics INFINITY™ HbA1c assay is an in vitro assay for the quantitative determination of hemoglobin Are (HbAyc) in whole blood for use on automated analyzers.

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## 6. Comparison to predicate devices

| Characteristic | INFINITY™ HbA1c<br>(Candidate Device) | Bio-Rad VARIANT™ II<br>(Predicate Device) | Roche Diagnostics<br>HbA1c II<br>(Predicate Device) |
|----------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in the<br>quantitative<br>determination of<br>hemoglobin A1c (HbA1c)<br>in whole blood on<br>automated analyzers. | For use in the<br>quantitative<br>determination of<br>hemoglobin A1c (HbA1c)<br>in whole blood | For use in the<br>quantitative<br>determination of<br>hemoglobin A1c (HbA1c)<br>in whole blood on<br>automated analyzers. |
| Format | Microparticle enhanced<br>turbidimetric<br>immunoassay | Cation exchange<br>chromatography (HPLC) | Immunoturbidimetric |
| Sample Type | Human anticoagulated<br>whole blood (EDTA or<br>Heparin) | Human anticoagulated<br>whole blood (EDTA) | Human anticoagulated<br>whole blood (EDTA or<br>Heparin) |

The substantial equivalency of Sigma Diagnostics INFINITY™ HbAy (537-A, 537-B) to the Roche Diagnostics HbAre II and to the Bio-Rad Variant™ II Hemoglobin A1c, is supported by the following facts:

- 1. %HbA1c was determined in 45 patient samples using the Sigma Diagnostics INFINITY™ HbAz, on the Cobas Mira and the Roche Diagnostics HbAic II on the Hitachi 717. The correlation coefficient was 0.976 and the regression equation was y = 0.9513x + 0.4184.
- 2. %HbA1c was determined in 45 patient samples using the Sigma Diagnostics INFINITY™ HbAg on the Cobas Mira and the Bio-Rad Variant™ II Hemoglobin Ay. The correlation coefficient was 0.981 and the regression equation was y = 1.047x - 0.5462.
- . 3. %HbA1c was determined in 45 patient samples using the Sigma Diagnostics INFINITY™ HbAzon the Hitachi 911 and the Roche Diagnostics HbAic II on the Hitachi 717. The correlation coefficient was 0.990 and the regression equation was y = 0.9639 + 0.5574.
- %HbA1c was determined in 45 patient samples using the Sigma Diagnostics 4. INFINITY™ HbA% on the Hitachi 911 and the Bio-Rad Variant™ II Hemoglobin A%. The correlation coefficient was 0.981 and the regression equation was y = 1.046x - 0.2878.
- ട. %HbA1c was determined in 45 patient samples using the Sigma Diagnostics INFINITY™ HbA1; on the Hitachi 717 and the Roche Diagnostics HbA1; II on the Hitachi 717. The correlation coefficient was 0.985 and the regression equation was y = 0.8988x + 0.9656.
- 6. %HbA1c was determined in 45 patient samples using the Sigma Diagnostics INFINITY™ HbAzon the Hitachi 717 and the Bio-Rad Variant™ II Hemoglobin Ay. The correlation coefficient was 0.988 and the regression equation was y = 0.9877x + 0.0711.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

William R. Gilbert, Ph.D. Manager, Scientific Affairs Sigma Diagnostics, Inc. 545 South Ewing Avenue St. Louis, Missouri 63103

OCT 2 6 2001

Re: K012410

> Trade Name: Sigma Diagnostics INFINITY™ HbA1c Regulation Number: 21 CFR § 864.7470 Regulation Name: Glycosylated Hemoglobin Regulatory Class: II Product Code: LCP Dated: July 27, 2001 Received: July 30, 2001

Dear Dr. Gilbert:

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 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.

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ KOLQH IQ

Device Name: Sigma Diagnostics INFINITY™ HbA1c

## Indications For Use:

Sigma Diagnostics INFINITY™ HbA ¿ is a device to measure the percent hemoglobin A . in anticoagulated whole blood. Hemoglobin A . is indicated for the monitoring of long-term glucose control in individuals with diabetes mellitus.

Sglite Mohine O for J. BAUTISTA

Division of Clinical Laboratory Devices

012410 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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