DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT

K043378 · Drew Scientific , Ltd. · JIT · Dec 29, 2004 · Clinical Chemistry

Device Facts

• Record ID: K043378
• Device Name: DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT
• Applicant: Drew Scientific , Ltd.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Dec 29, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The drew Scientific Glycated Haemoglobin Two Level Calibrator Kit is intended for use with instruments for the measurement of HbA1c and is designed to allow calibration to either the American NGSP system or the International IFCC system. For Prescription use only.

Device Story

The Drew Scientific Ltd. Glycated Haemoglobin Two Level Calibrator Kit is an in vitro diagnostic accessory used in clinical laboratory settings. It provides standardized reference values for instruments measuring HbA1c. By using these calibrators, laboratories ensure their HbA1c measurements are traceable to either the NGSP or IFCC systems. This calibration process is essential for accurate monitoring of long-term glycemic control in patients with diabetes. The device is intended for professional use by laboratory technicians to maintain instrument accuracy and consistency in clinical decision-making regarding patient diabetes management.

Clinical Evidence

No clinical data. Bench testing only. Stability established via reconstitution and assaying at 2-8°C; open vial stability confirmed at 24 hours (p > 0.05). Value assignment validated via linear regression across multiple instruments using NGSP and IFCC reference materials.

Technological Characteristics

Two-level calibrator kit for HbA1c measurement. Designed for traceability to NGSP or IFCC systems. Class II device under 21 CFR 862.1150.

Indications for Use

Indicated for use as a calibrator for HbA1c measurement instruments to align results with American NGSP or International IFCC systems.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 9 2004

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

Re: k043378

Trade/Device Name: Drew Scientific Ltd., Glycated Haemoglobin Two Level Calibrator Kit Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: December 03, 2004 Received: December 08, 2004

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 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) rms let 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 Pouring, 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,

ctore

Cornelia B. Rooks, MA 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: | K043378 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Drew Scientific Ltd., Glycated Haemoglobin Two Level Calibrator Kit. |
| Indications For Use: | For <i>in vitro</i> diagnostic use only. These calibrators are intended for use with instruments for the measurement of HbA1c and are designed to allow calibration to either the American NGSP system or the International IFCC system. |

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

petini

Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K043378

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