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.

Sigma Diagnostics INFINITY™ HbA1c is a device to measure the percent hemoglobin A1c in anticoagulated whole blood. Hemoglobin A1c is indicated for the monitoring of long-term glucose control in individuals with diabetes mellitus.

Device Description

The INFINITY HbA1c assay is a microparticle enhanced turbidimetric immunoassay.

AI/ML Overview

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

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state formal "acceptance criteria" in terms of predefined performance thresholds (e.g., "correlation coefficient must be ≥ 0.95"). Instead, the substantial equivalence is demonstrated through correlation and regression analysis against two predicate devices. The implicit acceptance criterion is that the correlation coefficients and regression equations should indicate a strong linear relationship and equivalence in measurements.

Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance (Correlation Coefficient)	Reported Device Performance (Regression Equation)	Comparator Device
Correlation to Roche Diagnostics HbA1c II (on Hitachi 717)	Strong linear correlation expected	0.976	y = 0.9513x + 0.4184	Roche Diagnostics HbA1c II (Cobas Mira)
		0.990	y = 0.9639x + 0.5574	Roche Diagnostics HbA1c II (Hitachi 911)
		0.985	y = 0.8988x + 0.9656	Roche Diagnostics HbA1c II (Hitachi 717)
Correlation to Bio-Rad VARIANT™ II HbA1c	Strong linear correlation expected	0.981	y = 1.047x - 0.5462	Bio-Rad VARIANT™ II HbA1c (Cobas Mira)
		0.981	y = 1.046x - 0.2878	Bio-Rad VARIANT™ II HbA1c (Hitachi 911)
		0.988	y = 0.9877x + 0.0711	Bio-Rad VARIANT™ II HbA1c (Hitachi 717)

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

Sample Size: 45 patient samples were used for each comparison study.
Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission from Sigma Diagnostics Inc. (a US company) to the FDA, it is highly probable that the samples were collected in the United States. The data is retrospective, as patient samples were tested using established methods (predicate devices) and the new device.

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

Not applicable. This device is an in vitro diagnostic (IVD) assay that quantitatively measures a biomarker (HbA1c). The "ground truth" for each sample is assumed to be the measurement obtained by the predicate devices, which are also IVD assays. There is no mention of human expert interpretation of results to establish ground truth for individual samples.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth is established by the measurements from the predicate devices. There is no human interpretation or adjudication involved for the individual sample results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human interpretation is a key component of the diagnostic process. The INFINITY™ HbA1c assay is an IVD for quantitative measurement, not an imaging device requiring human reader interpretation. No effect size for human readers with or without AI assistance is reported.

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

Yes, the studies presented are standalone performance studies of the INFINITY™ HbA1c assay. The device directly produces a quantitative result (%HbA1c) without human interpretation steps in the measurement process. Its performance is compared directly against results from predicate devices.

7. The Type of Ground Truth Used

The "ground truth" for the test set was established by the measurements obtained from the predicate devices: the Roche Diagnostics HbA1c II and the Bio-Rad VARIANT™ II Hemoglobin A1c. These are established in vitro diagnostic assays.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the INFINITY™ HbA1c assay. As this is a turbidimetric immunoassay, its development likely involves calibration and optimization rather than a machine learning training phase in the conventional sense. The 45 patient samples per comparison would be considered the validation/test set for demonstrating substantial equivalence.

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

Not applicable, as a distinct "training set" with ground truth in the context of machine learning is not described or likely relevant for this type of immunoassay. The development and calibration of the assay would typically rely on reference methods and calibrators, which are not detailed in this summary.

Summary

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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: (314) 286-6693

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(Candidate Device)	Bio-Rad VARIANT™ II(Predicate Device)	Roche DiagnosticsHbA1c II(Predicate Device)
Intended Use	For use in thequantitativedetermination ofhemoglobin A1c (HbA1c)in whole blood onautomated analyzers.	For use in thequantitativedetermination ofhemoglobin A1c (HbA1c)in whole blood	For use in thequantitativedetermination ofhemoglobin A1c (HbA1c)in whole blood onautomated analyzers.
Format	Microparticle enhancedturbidimetricimmunoassay	Cation exchangechromatography (HPLC)	Immunoturbidimetric
Sample Type	Human anticoagulatedwhole blood (EDTA orHeparin)	Human anticoagulatedwhole blood (EDTA)	Human anticoagulatedwhole blood (EDTA orHeparin)

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.
1. %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.
1. %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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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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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Page 2

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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).