AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA

K030741 · Hycor Biomedical , Ltd. · MID · May 1, 2003 · Immunology

Device Facts

• Record ID: K030741
• Device Name: AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA
• Applicant: Hycor Biomedical , Ltd.
• Product Code: MID · Immunology
• Decision Date: May 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA autoantibodies to cardiolipin in human serum. Uses: The results of the anti-cardiolipin assay can be used as an aid in the diagnosis of autoimmune diseases associated with elevated levels of anti-cardiolipin antibodies including anti-phospholipid syndrome. Levels of these autoantibodies are one indicator in a multifactorial diagnostic regime. This device can be used with the HYCOR HY•TEC automated EIA instrument. For in vitro diagnostic use only. Prescription use

Device Story

Autostat™ II Anti-Cardiolipin IgA ELISA is an in vitro diagnostic assay for detecting IgA autoantibodies to cardiolipin in human serum. The device utilizes an enzyme-linked immunosorbent assay (ELISA) method. It is designed for use with the HYCOR HY•TEC automated EIA instrument. Clinicians use the semi-quantitative results as one indicator within a multifactorial diagnostic regime for autoimmune diseases, specifically anti-phospholipid syndrome. The assay provides laboratory data to assist in clinical decision-making regarding autoimmune disease diagnosis.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) for semi-quantitative detection of IgA autoantibodies. Designed for use with the HYCOR HY•TEC automated EIA instrument. In vitro diagnostic device.

Indications for Use

Indicated for semi-quantitative determination of IgA autoantibodies to cardiolipin in human serum as an aid in diagnosing autoimmune diseases, including anti-phospholipid syndrome. For prescription use in clinical laboratory settings.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY = 1 2003

Ms. Danielle M. Knight Quality Manager Hycor Biomedical Limited Pentlands Science Park Bush Loan Penicuik EH26 OPL United Kingdom

> k030741 Trade/Device Name: Autostat™ II Anti-Cardiolipin IgA ELISA Regulation Number: 21 CFR § 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: II Product Code: MID Dated: March 5, 2003 Received: March 10, 2003

Dear Ms. Knight:

Re:

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). 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

{1}------------------------------------------------

Page 2 -

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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

K030741

## Indications for Use.

## Autostat™II Anti-Cardiolipin IgA ELISA

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA autoantibodies to cardiolipin in human serum.

Uses:

The results of the anti-cardiolipin assay can be used as an aid in the diagnosis of autoimmune diseases associated with elevated levels of anti-cardiolipin antibodies including anti-phospholipid syndrome. Levels of these autoantibodies are one indicator in a multifactorial diagnostic regime.

This device can be used with the HYCOR HY•TEC automated EIA instrument.

For in vitro diagnostic use only.

Prescription use \$\checkmark\$

J.P. Leves for J. Bautista
Division Sign Off

vision of Clinical Laboratory De

510(k) Number R-070674