AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA by HYCOR BIOMEDICAL LTD.

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 Description

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

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the Autostat™ II Anti-Cardiolipin IgA ELISA device.

Unfortunately, this document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.

The letter explicitly states: "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..."

This indicates that the FDA's decision is based on substantial equivalence to a predicate device, rather than a detailed presentation and review of a specific clinical performance study with acceptance criteria and ground truth validation for this particular device. The document primarily focuses on regulatory approval based on this equivalence and general controls, not on specific performance data from a new clinical study.

Therefore, I cannot provide the requested information based solely on the text provided. To answer your questions, I would need to review the actual 510(k) submission and its supporting documentation, which would contain the performance data and study details.

Summary

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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

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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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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

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K030741

Indications for Use.