QAB2A IGG ELISA KIT

K020695 · Cheshire Diagnostics , Ltd. · MSV · Apr 19, 2002 · Immunology

Device Facts

• Record ID: K020695
• Device Name: QAB2A IGG ELISA KIT
• Applicant: Cheshire Diagnostics , Ltd.
• Product Code: MSV · Immunology
• Decision Date: Apr 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The Cheshire Diagnostics Limited QAß2A IgG Elisa Kit is a semi quantitative enzyme linked immunoassay for the detection of the IgG isotype autoantibody to ß2-Glycoprotein-I in human serum. The presence of ß2-GPI antibodies can be used in conjunction with other serological tests and clinical findings to aid in the assessment of the risk from thrombosis in patients with Systemic Lupus Erythematosus or other Lupus like disorders.

Device Story

Device is semi-quantitative enzyme-linked immunoassay (ELISA) for detection of IgG autoantibodies to ß2-Glycoprotein-I in human serum. Used in clinical laboratory settings by trained personnel. Input: human serum sample. Process: enzyme-linked immunoassay reaction. Output: semi-quantitative measurement of IgG isotype autoantibody. Results used by clinicians alongside other serological tests and clinical findings to assess thrombosis risk in patients with Systemic Lupus Erythematosus or lupus-like disorders.

Technological Characteristics

Semi-quantitative enzyme-linked immunoassay (ELISA) for detection of IgG autoantibodies. Class II device, product code MSV (Multiple autoantibodies immunological test system).

Indications for Use

Indicated for the detection of IgG isotype autoantibody to ß2-Glycoprotein-I in human serum to aid in assessing thrombosis risk in patients with Systemic Lupus Erythematosus or lupus-like disorders.

Regulatory Classification

Identification

A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 2 1 2005

Mr. Neil B. Stringer Managing Director Cheshire Diagnostics Ltd. Management Centre, Inward Way Ellesmere Port Cheshire United Kingdom CH 65 3EN

Re: k020695

Trade/Device Name: QAB2A IgG Elisa Kit AP Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MSV Dated: March 1,2002 Received: March 4, 2002

Dear Mr. Stringer:

This letter corrects our substantially equivalent letter of April 19, 2002 regarding the OAB2A IgG Elisa Kit AP in which the wrong product code was used.

We have reviewed your Section 510(k) premarket notitication 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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue 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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulationentitled, "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.qov/cdrh/dsrna/dsrnarnain.htrnl

Sincerely yours,

Robert Becker Jr.

Robert L. Becker, Jr., M.D., Ph& Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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QAß2A IgG Elisa Kit 510(k)

## Indications for Use Statement

KO20695 510(k) Number:____

QAß2A IgG Elisa Kit AP Device Name:

Indications for Use: The Cheshire Diagnostics Limited QAß2A IgG Elisa Kit is a semi quantitative enzyme linked immunoassay for the detection of the IgG isotype autoantibody to ß2-Glycoprotein-I in human serum. The presence of ß2-GPI antibodies can be used in conjunction with other serological tests and clinical findings to aid in the

assessment of the risk from thrombosis in patients with Systemic Lupus Erythematosus or other Lupus like disorders.

(Please do not write below this line - Continue on another page if needed)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Sausan S. Alta.e

510(k) Number*K020645*

Prescription Use
(Per 21 CFR 801.109)
✓

OR

Over-the-counter Use

(Optional Format 1-2-96)

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