DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT

K060510 · Drew Scientific , Ltd. · JJX · Jun 19, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060510
• Device Name: DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT
• Applicant: Drew Scientific , Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jun 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

For in vitro diagnostic use only. The Drew Scientific Glycated Hemoglobin Five Level Linearity Kit is intended to verify the linearity of HbA1c assays across the patient reportable range (4 to 18%, NGSP aligned) using protocols established in individual laboratories.

Device Story

The Drew Scientific Glycated Hemoglobin Five Level Linearity Kit is an in vitro diagnostic quality control product. It consists of five levels of assayed material used by laboratory personnel to verify the linearity of HbA1c assays. By testing these five levels, the user confirms that the assay performs accurately across the patient reportable range (4 to 18%, NGSP aligned). This verification process ensures the reliability of patient HbA1c results, which are critical for monitoring long-term glycemic control in diabetic patients. The kit is intended for professional use within clinical laboratories following established laboratory protocols.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Five-level linearity kit; matrix: stabilized freeze-dried human whole blood; additives: cryopreservatives, antibiotic, stabilizers, 0.09% sodium azide. Evaluated per CLSI EP6-A standard. Designed for use with low-pressure ion-exchange chromatography systems (e.g., DS5 analyzer).

Indications for Use

Indicated for in vitro diagnostic use to verify linearity of HbA1c assays in clinical laboratories.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

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

JUN 19 2006

Miss. Diane Hill R&D Biochemist Drew Scientific Sowerby Woods Industrial Estate, Park Road Barrow-in-Furness, Cumbria LA14 4QR United Kingdom

Re: k060510

Trade/Device Name: Drew Scientific, Glycated Hemoglobin Five Level Linearity Kit Regulation Number: 21 CFR§862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: May 30, 2006 Received: June 2, 2006

Dear Miss. Hill:

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 iddications 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, Trug, 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 1.0 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 drivire, can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition. EDA 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 aft 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 Party 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 logally marketed predicate device results in a classification for your device and thus, recruits 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 tollefree mober [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto G. A.

Alberto Gutierrez, Ph.D. 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: | k060510 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Drew Scientific,<br>Glycated Hemoglobin Five Level Linearity Kit. |
| Indications For Use: | For in vitro diagnostic use only. The Drew Scientific<br>Glycated Hemoglobin Five Level Linearity Kit is intended to<br>verify the linearity of HbA1c assays across the patient<br>reportable range (4 to 18%, NGSP aligned) using protocols<br>established in individual laboratories. |

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)

Caul C. Boun
Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

K060510