HBA1C ENZYMATIC ASSAY

K050178 · General Atomics · LCP · Jun 28, 2005 · Hematology

Device Facts

• Record ID: K050178
• Device Name: HBA1C ENZYMATIC ASSAY
• Applicant: General Atomics
• Product Code: LCP · Hematology
• Decision Date: Jun 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The Diazyme HbA1c Enzymatic Assay is intended for the quantitative determination of stable HbA1c (glycated hemoglobin A1c) in human whole blood samples. Measurement of HbA1c is a valuable indicator for long term diabetic control.

Device Story

The HbA1C Enzymatic Assay is a clinical test kit for quantitative determination of stable HbA1C in human whole blood. The assay uses a two-reagent kinetic system. Samples undergo protease digestion to release glycated N-terminal valines, which serve as a substrate for fructosyl valine oxidase (FVO). This reaction produces hydrogen peroxide, which is measured via a peroxidase-catalyzed reaction. Total hemoglobin is determined separately by converting hemoglobin derivatives into hematin using an alkaline method. The final result is calculated as a concentration ratio of glycated hemoglobin to total hemoglobin. The assay is intended for use in clinical settings to monitor long-term diabetic control. Healthcare providers use the resulting HbA1C percentage to assess patient glycemic management over time.

Clinical Evidence

No clinical studies performed. Evidence based on analytical performance testing: intra-assay precision (CV 1.6-3.5%), inter-assay precision (CV 5.0-7.2%), and linearity (4.0-16.0% HbA1c). Method comparison against predicate (n=74) showed r=0.92. Interference testing confirmed <10% interference for triglycerides, bilirubin, ascorbic acid, uric acid, and glucose.

Technological Characteristics

Two-reagent kinetic assay system. Reagents include protease, fructosyl valine oxidase (FVO), and peroxidase. Total hemoglobin measured via alkaline conversion to hematin. Quantitative determination based on ratio of glycated hemoglobin to total hemoglobin. Standalone in vitro diagnostic kit.

Indications for Use

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

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 Medics G7 Automated Hemoglobin A1c Assay (k011434)

Submission Summary (Full Text)

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Diazyme Laboratories Division, General Atomics

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JUN 2 8 2005

K050178

# Summary

Submitter's name:

Submitter's address:

Phone: Fax:

Name of Contact Person:

Huan Tran Diazyme Laboratories Division General Atomics 3550 General Atomics Court San Diego, CA 92121 Phone: [phone] Fax: [phone]

3550 General Atomics Court

San Diego, CA 92121

858-455-4754

858-455-4750

Date the summary was prepared:

December 25, 2004

HbA1C Enzymatic Assay Name of the device: HbA1C Enzymatic Assay Trade Name: Enzymatic Assay, HbA1C Common/Usual Name: Glycosylated Hemoglobin Assay (Per 21CFR section 864.7470) Classification Name: Device Class: II

#### Predicate Device:

The legally marketed device to which we are claiming equivalence [807.92(4)(3)]: G7 I he regally marketed device to willon we are canning of I
Automated HPLC Analyzer: HbA1c Variant Analysis Mode (K011434) manufactured by Tosoh Medics, Inc., San Francisco, CA, 94080.

## Description of the device

The Diazyme's HbA1C assay kit is a clinical test kit, intended for quantitative determination of The Diazynie's TibATC assay ar is a chailed to monitor long-term glucose control in individuals with diabetes mellitus.

The Diazyme's HbA1C assay kit is comprised of a Reagent 1, Reagent 2, Lysis Buffer, THb Reagent, and calibrators.

Measurement of hemoglobin A1C is determined enzymaticly by subjecting lyseted samples to extensive protease digestion. This process releases amino acids including glycated samples to extensive process digestion: This process sines then serve as a substrate for fructosyl valines from the nemogrom octa enainer - Ery - Leaves N-terminal valines and produces valife oxidase (1' V O) chiz milen special is measured using a peroxidase catalyzed reaction nydrogen peroxiac. The fryarogen personalism is determined separately by conversion of all

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hemoglobin derivatives of the samples into hematin using an alkaline method as of scribed in nemogram delivatives of the samples mosterialism sed as a concentration ratio of glycated hemoglobin to total hemoglobin.

# Intended Use of the Device:

HbA1C Enzymatic Assay is intended for the in vitro quantitative determination of stable HbA1C (glycated hemoglobin A1c; A1c) in human whole blood samples. Measurement of hemoglobin A1C is a valuable indicator for long-term diabetic control.

HbAIC Enzymatic Assay Kit contains an A1C calibrator and a THb calibrator. The calibrators HDATC Entzymanc Assay for the quantitative determination of HbA1C in blood.

HbAIC Enzymatic Assay has controls design to be used with the assay for the quantitative determination of HbA1C in blood.

## Performance Characteristics

Diazyme's HbA1C Enzymatic Assay is a two reagents based kinetic assay system. The assay offers excellent precision as shown in the table below:

| | 5.3% Alc | 12% Alc |
|-----------------------|-----------|-----------|
| Intra-Assay Precision | CV%= 3.5% | CV%= 1.6% |
| Inter-Assay Precision | CV%= 5.0% | CV%= 7.2% |

Diazyme's HbA1C Enzymatic Assay has a good correlation with Tosoh's with arthershap Diazyine S TIOATC Litzynatic Tissay has a good - See a good by spiking the substances correlation coefinelen of 0.22. We have connected at the indicated concentrations:

| Interference | Concentration |
|---------------|---------------|
| Triglyceride | 2000 mg/dl |
| Bilirubin | 10 mg/dl |
| Ascorbic Acid | 4 mg/dl |
| Uric Acid | 5 mg/dl |
| Glucose | 2400 mg/dl |

Conclusion: Comparison analysis presented in the 510K submission for this device in the comparison section, together with linearity, precision and interference study presented demonstrated that the Diazyme's HBAIC Enzymatic Assay has excellent accuray and is safe and effective. There is no significant deviation between the results obtained by Diazyme's and enective. There is no significant actively come testing clinical patient samples.

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Therefore, Diazyme's HbA1C Enzymatic Assay is substantially similar to the commercially Therefore, Diazyme's HDATC Entzymane Assay is Sabstannally Ships of Same Shole blood samples.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

JUN 2 8 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Huan Tran Quality Assurance Manager Diazyme Laboratories Division General Atomics 3550 General Atomics Court San Diego, CA 92121

k050178 Re:

Trade/Device Name: HbA1C Enzymatic Assay Kit Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, JIS; JJX Dated: June 1, 2005 Received: June 3, 2005

Dear Mr. Tran:

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,

Carol C. Benam

Carol C. Benson, M.A. Acting 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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# Indications for Use

510(k) Number (if known): K050178

Device Name: HbA1C Enzymatic Assay Kit

Indications for Use:

HbA1C Enzymatic Assay is intended for the in vitro quantitative determination of stable HbA1C Enzymatic Assay is intented for the in human whole blood samples. Measurement
HbA1c (glycated hemoglobin A1c; A1c) in human whole blootis control HDATC (glycated nemogrobin ATC, ATC) in management diabetic control.
of hemoglobin A1C is a valuable indicator for long-term diabetic control.

Prescription Use (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)

Keeleff
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Office of In Vitro Diagnostic Device Evaluation and Safety

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