OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032)

K031380 · Olympus America, Inc. · LCP · Nov 14, 2003 · Hematology

Device Facts

• Record ID: K031380
• Device Name: OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032)
• Applicant: Olympus America, Inc.
• Product Code: LCP · Hematology
• Decision Date: Nov 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The Olympus Hemoglobin A1c Test is for the quantitative measurement of Hemoglobin A1c in human whole blood on the Olympus system analyzers.

Device Story

The Olympus Hemoglobin A1c Test is an in vitro diagnostic reagent kit for measuring glycated hemoglobin (HbA1c) and total hemoglobin in human whole blood. The device is used on Olympus system analyzers (AU600, AU400, AU640, AU2700, AU5400) in clinical laboratory settings. The process involves pre-treating whole blood with a denaturant to lyse red cells and hydrolyze hemoglobin chains. Total hemoglobin is measured via conversion to alkaline haematin (absorbance at 600nm). HbA1c is measured using a latex agglutination inhibition assay; HbA1c in the sample competes with a synthetic agglutinator for binding to HbA1c-specific monoclonal antibody-coated latex particles, resulting in an absorbance increase at 700nm. The system calculates the %HbA1c as the ratio of HbA1c to total hemoglobin. Results assist clinicians in monitoring glycemic control in patients.

Clinical Evidence

No clinical studies were performed. Evidence is based on analytical bench testing, including precision (within-run CV ≤3%, total CV ≤4%), linearity (±10% deviation), and method comparison studies against the predicate device (n=97 per analyzer, r=0.995-0.996). Interference testing confirmed <10% interference for bilirubin, lipemia, and triglycerides.

Technological Characteristics

Reagent-based latex agglutination inhibition assay. Measures total hemoglobin via alkaline haematin conversion (600nm) and HbA1c via latex agglutination inhibition (700nm). Calibrators are traceable to IFCC standard reference material. Designed for use on Olympus AU-series automated chemistry analyzers. Sterilization method not specified.

Indications for Use

Indicated for the quantitative measurement of Hemoglobin A1c in human whole blood for monitoring long-term glycemic control in patients with diabetes.

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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Image /page/0/Picture/1 description: The image shows a circular seal or logo. The text around the top half of the circle reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is a stylized graphic that resembles a bird in flight or a person reaching upwards. The image is in black and white and appears to be a scan or photocopy.

#### Public Health Service

# NOV 1 4 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Michael Campbell Senior Manager, Regulatory Affairs/Quality Assurance Olympus America, Inc. 3131 West Royal Lane Irving, TX 75063-3104

k031380 Re:

> Trade/Device Name: Olympus HbA1c Reagent Test System (Reagent, Calibrator & Control, Hemoglobin Denaturant) Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated Hemoglobin Assays Regulatory Class: Class II Product Code: LCP, JIS, JJX Dated: August 4, 2003 Received: September 9, 2003

Dear Mr. Campbell:

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). 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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## Indications for Use Statement

#### Ko31380 510(k) Number (if known):

Device Name:

Olympus HbA1c Reagent Test System (Reagent, Calibrator & Control, Hemoglobin Denaturant)

Indications for Use:

In vitro diagnostic method for the quantitative measurement of Hemoglobin A1c in human whole blood on the Olympus system analyzers.

Measurements obtained through this method can be used for monitoring the long-term care of people with diabetes.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
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510(k) K031380### PAGE NUMBER 97