MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON

K070734 · Diazyme Laboratories · LCP · Apr 9, 2007 · Hematology

Device Facts

• Record ID: K070734
• Device Name: MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON
• Applicant: Diazyme Laboratories
• Product Code: LCP · Hematology
• Decision Date: Apr 9, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

Diazyme Direct Enzymatic Hemoglobin A1c (glycated hemoglobin A1c; A1c; HbAlc) reagents are intended for use in the quantitative determination of stable HbAlc in human whole blood samples. Measurement of hemoglobin A1c is a valuable indicator for long-term diabetic control. For in-vitro diagnostic use only.

Device Story

The Diazyme Direct Enzymatic HbA1c Assay is an in-vitro diagnostic reagent kit used for the quantitative measurement of stable HbA1c in human whole blood. The assay utilizes an enzymatic method to determine HbA1c levels, which serves as a clinical indicator for long-term glycemic control in diabetic patients. The device is intended for professional use in clinical laboratory settings. By providing accurate HbA1c measurements, the assay assists healthcare providers in assessing a patient's average blood glucose levels over the preceding weeks to months, thereby informing clinical decisions regarding diabetes management and treatment adjustments.

Clinical Evidence

No clinical data provided in the document; the submission relies on the demonstration of substantial equivalence to legally marketed predicate devices for in-vitro diagnostic use.

Technological Characteristics

In vitro diagnostic reagent system. Modifications: reagent count reduced from 4 to 3; component concentration adjusted; calculation algorithm updated to NGSP format. Design controls per 21 CFR 820.30 applied.

Indications for Use

Indicated for quantitative determination of stable HbA1c in human whole blood samples to monitor long-term diabetic control. For in-vitro 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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR - 9 2007

Diazyme Laboratories Division of General Atomics c/o Dr. Abhijit Datta 3550 General Atomics Court San Diego, CA 92121

Re: k070734

Trade/Device Name: Diazyme Direct Enzymatic HbA1c Assay Regulation Number: 21 CFR§ 864.7470 Regulation Name: Glycosylated hemoglobin assay. Regulatory Class: Class II Product Code: LCP Dated: March 15, 2007 Received: March 19, 2007

Dear Dr. Datta:

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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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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. 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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Pre-market Notification-Diazyme Direct Enzymatic HbA1c Assay

## Indications for Use

14070734 510(k) Number (if known):

Device Name: Diazyme Direct Enzymatic HbA1c Assay

Indications for Use: Diazyme Direct Enzymatic Hemoglobin A1c (glycated hemoglobin A1c; A1c; HbAlc) reagents are intended for use in the quantitative determination of stable HbAlc in human whole blood samples. Measurement of hemoglobin A1c is a valuable indicator for long-term diabetic control. For in-vitro diagnostic use only.

Prescription Use

(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 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)

Carol C. Benam
Action Sign-Off

Tice of In Vitro Diagnostic Device valuation and Safety

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K070734