D-10 HEMOGLOBIN A1C

K031043 · Bio-Rad Laboratories, Inc. · LCP · Aug 27, 2003 · Hematology

Device Facts

• Record ID: K031043
• Device Name: D-10 HEMOGLOBIN A1C
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: LCP · Hematology
• Decision Date: Aug 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The Bio-Rad D-10 Hemoglobin A1c Program is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high performance liquid chromatography (HPLC). The D-10 Hemoglobin A1c is intended for use only with the Bio-Rad D-10 Hemoglobin Testing System. For In Vitro Diagnostic Use.

Device Story

D-10 Hemoglobin A1c Program utilizes ion-exchange high performance liquid chromatography (HPLC) to measure hemoglobin A1c levels in human anticoagulated whole blood (EDTA). System operates via cation exchange cartridge; detects hemoglobin components at 415 nm. Designed for use with Bio-Rad D-10 Hemoglobin Testing System. Provides quantitative %A1c results; results are traceable to DCCT reference method and IFCC; certified via NGSP. Used in clinical laboratory settings to assist healthcare providers in monitoring glycemic control. Output facilitates clinical decision-making regarding diabetes management.

Clinical Evidence

Bench testing only. Method correlation study performed comparing D-10 Hemoglobin A1c Program to VARIANT II Hemoglobin A1c Program using 40 anticoagulated whole blood samples. Samples ranged from 4.98% to 12.15% HbA1c. Results demonstrated excellent correlation between the two methods.

Technological Characteristics

Cation exchange high performance liquid chromatography (HPLC) system. Analyte: %A1c. Detection: 415 nm. Sample: Human anticoagulated whole blood (EDTA). Standardization: Traceable to DCCT/IFCC and NGSP certified.

Indications for Use

Indicated for the percent determination of hemoglobin A1c in human anticoagulated whole blood (EDTA) for clinical diagnostic use.

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

• VARIANT™ II Hemoglobin A1c Program (K984268)

Submission Summary (Full Text)

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Bio-Rad Laboratories

Diagnostics Group 4000 Alfred Nobel Drive Hercules, California 94547 Telephone: [phone] Fax: [phone]

# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K034043

| Submitter: | Bio-Rad Laboratories, Inc.<br>Clinical Diagnostics Group<br>4000 Alfred Nobel Drive,<br>Hercules, California 94547<br>Phone: [phone]<br>FAX: [phone] |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jackie Buckley<br>Regulatory Affairs Representative |
| Date of Summary Preparation: | March 31, 2003 |
| Device Name: | D-10™ Hemoglobin A1c Program |
| Classification Name: | Assay, Glycosylated Hemoglobin, 81LCP |
| Predicate Device: | VARIANT™ II Hemoglobin A1c Program<br>K984268<br>Bio-Rad Laboratories, Inc. |
| Statement of Intended Use: | The Bio-Rad D-10 Hemoglobin A1c Program is intended for<br>the percent determination of hemoglobin A1c in human whole<br>blood using ion-exchange high performance liquid<br>chromatography (HPLC). The D-10 Hemoglobin A1c is<br>intended for use only with the Bio-Rad D-10 Hemoglobin<br>Testing System.<br>For In Vitro Diagnostic Use. |

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#### Description of Device:

The D-10 Hemoglobin Testing System uses the principles of high performance liquid chromatography The D-10 Hemoglobin A1c Program is based on chromatographic separation of Hemoglobin A1c (HPLC). on a cation exchange cartridge.

#### Technical Characteristics Compared to Predicate:

D-10 and VARIANT II systems have the same technical characteristics that are summarized in the table below:

| Characteristics | D-10 Hemoglobin A1c | VARIANT II Hemoglobin A1c |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyte Measured: Reported | %Alc | %Alc |
| Intended Use | The Bio-Rad D10 Hemoglobin A1c<br>Program is intended for the percent<br>determination of hemoglobin A1c in<br>human whole blood using ion-<br>exchange high performance liquid<br>chromatography (HPLC). | The Bio-Rad VARIANT II<br>Hemoglobin A1c Program is intended<br>for the percent determination of<br>hemoglobin Alc in human whole blood<br>using ion-exchange high performance<br>liquid chromatography (HPLC). |
| Assay Principle | Cation exchange high performance<br>liquid chromatography | Cation exchange high performance<br>liquid chromatography |
| Sample Type | Human anticoagulated whole blood<br>(EDTA) | Human anticoagulated whole blood<br>(EDTA) |
| Visible Detection | 415 nm | 415 nm |
| Standardization | Traceable to the Diabetes Control<br>and Complications Trial (DCCT)<br>reference method and IFCC.<br>Certified via the National<br>Glycohemoglobin Standardization<br>Program (NGSP). | Traceable to the Diabetes Control and<br>Complications Trial (DCCT) reference<br>method and IFCC. Certified via the<br>National Glycohemoglobin<br>Standardization Program (NGSP). |

## Testing To Establish Substantial Equivalence:

Method correlation between D-10 Hemoglobin Are Program and VARIANT II Hemoglobin A1c Program was evaluated with 40 anticoagulated whole blood samples ranging from 4.98% to 12.15% HbAIc. The results are presented in the following table:

| Regression Method | | lone | ntercept |
|-------------------|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| eget<br>Squares | 00/ | 0 07 4 0 7 4 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 | 2070<br>. Ju |

#### Conclusion:

When considering the similarities of the intended use, general characteristics of the use of the same technology and excellent correlation between the two methods, it can be concluded that the D-10 Hemoglobin Atc Program and VARIANT II Hemoglobin Aic Program are substantially equivalent.

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 2 7 2003

Ms. Jackie Buckley Regulatory Affairs Representative Bio-Rad Laboratories, Inc. Diagnostics Group 4000 Alfred Nobel Drive Hercules, CA 94547

Re: k031043

> Trade/Device Name: D-10 Hemoglobin A1c Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: Class II Product Code: LCP Dated: July 25, 2003 Received: July 29, 2003

Dear Ms. Buckley:

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). 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Statement of Indications for Use

510(k) Number:

Device Name:

Indications for Use:

K031043

Bio-Rad D-10™ Hemoglobin Ale Program

The Bio-Rad D-10 Hemoglobin A1c Program is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high performance liquid chromatography (HPLC). The D-10 Hemoglobin A1c Program is intended for use only with the Bio-Rad D-10 Hemoglobin Testing System.

For In Vitro Diagnostic Use.

Adam Cooper

(Division Sign-Off) Division of Clinical Laborato 510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescriptive Use
(Per 21 CFR 801.109)

OR Over-The-counter Use ___