LIQUI-HEME GLYCO A1C ASSAY

K031296 · Biodiagnostic Intl · LCP · Oct 15, 2004 · Hematology

Device Facts

• Record ID: K031296
• Device Name: LIQUI-HEME GLYCO A1C ASSAY
• Applicant: Biodiagnostic Intl
• Product Code: LCP · Hematology
• Decision Date: Oct 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The BioDiagnostic Intl LIQUI-HEME Glycohemoglobin A1c Test kit is an In Vitro Diagnostic reagent for the quantitative determination of Glycohemoglobin A1c (HbA1c) in human whole blood. The method is an immunological assay. Both the HbA1c and the total hemoglobin are measured. Concentration of HbA1c is calculated as a percentage of the total hemoglobin concentration. Measurements of percentage HbA1c are effective in monitoring long term glucose control in individuals with diabetes mellitus. This application has been validated for the Hitachi instrument of clinical chemistry and is intended for use by suitably qualified personnel under appropriate clinical laboratory conditions. Further, this test kit also includes a set of six calibrators and bilevel (Human) Low and High controls, which are optional.

Device Story

LIQUI-HEME Glycohemoglobin A1c Assay is an in vitro diagnostic reagent kit; utilizes immunological assay principle to measure HbA1c and total hemoglobin in human whole blood; calculates HbA1c as percentage of total hemoglobin. Used in clinical laboratory settings on Hitachi clinical chemistry instruments; operated by qualified laboratory personnel. Provides quantitative HbA1c percentage to healthcare providers for monitoring long-term glucose control in diabetic patients. Includes optional calibrators and bilevel human-derived controls.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Immunoturbidimetric assay. Reagents: porcine pepsin, alkaline detergents, polyclonal goat anti-HbA1c antibodies on latex particles, HbA1c agglutination reagent. Energy source: optical absorbance measurement at 600nm. Platform: Hitachi 911 clinical chemistry analyzer. Includes human-derived calibrators and controls.

Indications for Use

Indicated for the quantitative determination of HbA1c in human whole blood to monitor long-term glucose control in individuals with diabetes mellitus. For use by qualified personnel in clinical laboratory settings.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 5 2004

Paul Anand, Ph.D. Director BioDiagnostic International 615 North Berry St. # E Brea, CA 92821

k031296 Re: Trade/Device Name: LIQUI-HEME Glycohemoglobin A1c Assay LIQUI-HEME Hemoglobin Alc Control Set LIQUI-HEME Hemoglobin Alc Calibrators Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, KRZ, JJX Dated: October 1, 2004 Received: October 4, 2004

Dear Dr. Anand:

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 http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, U.S. DVM.

Jean M. Cooper, MS, 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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## Indications for Use

510(k) Number (if known): k031296

Device Name: LIQUI-HEME Glycohemoglobin A1c Assay

Indications For Use:

The BioDiagnostic Intl LIQUI-HEME Glycohemoglobin A1c Test kit is an In Vitro The DioDiagnostic reagent for the Styconomission of Glycohemoglobin A1c (HbA1c)
Diagnostic reagent for the quantitative determination of Glycohemoglobin A1c (HbA1c) Diagnostic reagent for the quarklained is an immunological assay. Both the in the numan whole blood. The momentration of the total hemoglobin are measured. Concentration of The and the culated as a percentage of the total hemoglobin concentration.

concentration.
Measurements of percentage HbA1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.

Control in Individuals with diaboted for the Hitachi instrument of clinical This application onoot has been by suitably qualified personnel under appropriate clinical laboratory conditions.

Cillifical laboratory conditions:
Further ,this test kit also includes a set of six calibrators and bilevel(Human) Low and High controls, which are optional.

Prescription Use __ V (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)

Albert S
Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) _k031296