HEMOGLOBIN A1C REAGENT SET

K051200 · Teco Diagnostics · LCP · Aug 8, 2005 · Hematology

Device Facts

• Record ID: K051200
• Device Name: HEMOGLOBIN A1C REAGENT SET
• Applicant: Teco Diagnostics
• Product Code: LCP · Hematology
• Decision Date: Aug 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The Hemoglobin A1c Reagent Set is for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. The Hemoglobin A1c Calibrator Set is for the purpose of calibrating results in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. The Hemoglobin A1c Control Set is for the purpose of monitoring accuracy and precision in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only.

Device Story

Teco Hemoglobin A1c Reagent Set, Calibrators, and Controls are in vitro diagnostic reagents used for the quantitative measurement of HbA1c in human blood samples. The system is intended for use by healthcare professionals in clinical laboratory settings to assess glycemic control in diabetic patients. The reagents facilitate the measurement of HbA1c, which reflects average blood glucose levels over the previous 4-8 weeks. Calibrators are used to establish the assay's quantitative baseline, while controls are used to monitor the accuracy and precision of the testing process. The output provides a numerical HbA1c value, which clinicians use to monitor diabetes management and adjust treatment plans accordingly.

Clinical Evidence

No clinical data. Bench testing only. Precision evaluated per NCCLS EP5-A (CV 2.7-4.1%). Linearity evaluated per NCCLS EP6-P (2-17% range, r=0.996). Method comparison with predicate (n=40) per NCCLS EP9-A yielded y=0.95x+0.28, r=0.978. Interference testing per NCCLS EP7 showed no significant interference from ascorbic acid, bilirubin, triglyceride, acetylated Hb, or carbamylated Hb.

Technological Characteristics

Latex agglutination immunoassay. Reagents: latex particles, glycine buffer, mouse anti-human HbA1c monoclonal antibody, goat anti-mouse IgG polyclonal antibody. Calibrators/controls: lyophilized human erythrocyte hemolysate. Automated operation on clinical chemistry analyzers. Performance validated on Hitachi 717.

Indications for Use

Indicated for quantitative determination of HbA1c in human blood to evaluate glycemic control in patients with diabetes mellitus. Provides indication of glucose levels over preceding 4-8 weeks.

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

AUG 8 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jian Vaeches Teco Diagnostics 1268 N. Lakeview Avenue Anaheim, CA 92807

Re: k051200

Trade/Device Name: Hemoglobin A1c Reagent Set, Calibrators, and Controls Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, JIS, JJX Dated: July 15, 2005 Received: July 15, 2005

Dear Mr. Vaeches:

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/industry/support/index.html.

Sincerely yours,

Carol C. Benem

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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## TECO DIAGNOSTICS

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1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: [phone] Toll Free: 1-800-222-9880 Fax: [phone] www.tecodiag.com Email:[e-mail]

## Indications for Use

## 05/200 510(k) Number (if known): Unknown at this time

Device Name: Hemoglobin A1c Reagent Set ; Calibrators and Controls

Indications For Use: Teco Hemoglobin A1c Calibrators are for calibrating results in the quantitative determination of human hemoglobin A1c (HbArt) and Teco Hemoglobin Controls are for the purpose of monitoring accuracy and precision in the quantitative determination of human hemogiobin A1c (HbAn). Teco Hemogiobin A1c Reagent set is for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only.

Prescription Use_ ____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801.109) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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