DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T

K020156 · Axis-Shield Diagnostics, Ltd. · MID · Mar 6, 2002 · Immunology

Device Facts

• Record ID: K020156
• Device Name: DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T
• Applicant: Axis-Shield Diagnostics, Ltd.
• Product Code: MID · Immunology
• Decision Date: Mar 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The test is for the semi-quantitative combined detection of IgG, IgM and IgA autoantibodies specific for the Phospholipid Cardiolipin in huma serum or plasma (EDTA, citrate, heparin) The kit is intended to assess total anti-Cardiolipin autoantibody levels in patients where this information is useful in diagnosis, particularly as an aid in the assessment of thrombotic risk in patients with systemic lupus erythematosus or other lupus like disorders. Total anti-Cardiolipin levels represent one parameter in a multi-criterion diagnostic process.

Device Story

Axis-Shield DIASTAT Total Anti-Cardiolipin is an ELISA-based in vitro diagnostic test. It utilizes human serum or plasma samples to detect IgG, IgM, and IgA autoantibodies against cardiolipin. The assay functions via an enzyme-linked immunosorbent assay principle; patient samples are incubated in wells coated with cardiolipin; bound antibodies are detected using enzyme-labeled conjugates and a colorimetric substrate. The resulting optical density is measured to provide a semi-quantitative assessment of antibody levels. The device is intended for use in clinical laboratory settings by trained laboratory personnel. Results are interpreted by clinicians as one parameter within a multi-criterion diagnostic process to evaluate thrombotic risk in patients with SLE or related disorders.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

ELISA-based immunological test system. Analyte: IgG, IgM, and IgA anti-cardiolipin autoantibodies. Sample matrix: human serum or plasma (EDTA, citrate, heparin). Detection method: colorimetric enzyme-linked immunosorbent assay.

Indications for Use

Indicated for semi-quantitative detection of IgG, IgM, and IgA anti-cardiolipin autoantibodies in human serum or plasma. Used as an aid in assessing thrombotic risk in patients with systemic lupus erythematosus (SLE) 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

6 2002 MAR

Ms. Eileen McCafferty Regulatory Affairs Manager Axis-Shield Diagnostics Limited Luna Place The Technology Park Dundee DD2 1XA Scotland

Re: k020156

Trade/Device Name: Axis-Shield DIASTAT™ Total Anti-Cardiolipin Regulation Number: 21 CFR § 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: II Product Code: MID Dated: January 15, 2002 Received: January 17, 2002

Dear Ms. McCafferty:

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 for associated in the 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 11 your device to such additional controls. Existing major regulations affecting your device can may or subject to outsil are and Regulations, Title 21, Parts 800 to 898. 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 r rease of actived a determination that your device complies with other requirements of the Act that I Dr Has intatutes and regulations administered by other Federal agencies. You must or any I 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

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This letter will allow you to begin marketing your device as described in your 510(k) premarket I his lotter will and hype a ding 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

## MAR 6 2002

510(k) number if known. K. ما كامي 2015 6

Axis-Shield Total anti-Cardiolipin Elisa Device Name ...

Indications for Use The test is for the semi-quantitative combined detection of IgG, IgM and IgA autoantibodies specific for the Phospholipid Cardiolipin in huma serum or plasma (EDTA, citrate, heparin)

> The kit is intended to assess total anti-Cardiolipin autoantibody levels in patients where this information is useful in diagnosis, particularly as an aid in the assessment of thrombotic risk in patients with systemic lupus erythematosus or other lupus like disorders.

Total anti-Cardiolipin levels represent one parameter in a multi-criterion diagnostic process.

Sonsun S. Altaie

Division Sian-Off Division of Clinical Laboratory Devices

K020156 510(k) Number-

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Prescription Use ... ... ... ... ... ...... Per 21 CFR 801. 109

Over - the - Counter Use ... ... ......................