REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001

K022992 · Corgenix, Inc. · MID · Sep 25, 2002 · Immunology

Device Facts

• Record ID: K022992
• Device Name: REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001
• Applicant: Corgenix, Inc.
• Product Code: MID · Immunology
• Decision Date: Sep 25, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

An enzyme-linked immunosorbent assay (ELISA) for the determination of IgG and IgM anti-cardiolipin antibodies in human serum or plasma. For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).

Device Story

REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit is an ELISA-based in vitro diagnostic device. It utilizes human serum or plasma samples to detect and semi-quantify anti-cardiolipin antibodies. The assay employs standard enzyme-linked immunosorbent assay principles to measure antibody levels, providing results that assist clinicians in the diagnosis and management of systemic lupus erythematosus (SLE) and anti-phospholipid syndrome. The test is intended for professional use in clinical laboratory settings. Results are interpreted by healthcare providers to aid in clinical decision-making regarding autoimmune disease status.

Clinical Evidence

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

Technological Characteristics

ELISA-based immunoassay; semi-quantitative detection of IgG and IgM anti-cardiolipin antibodies; in vitro diagnostic test kit; professional use.

Indications for Use

Indicated for detection and semi-quantitation of IgG and IgM anti-cardiolipin antibodies in human serum or plasma for individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).

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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Image /page/0/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the symbol.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

SFP 2 5 2002

8 Gaither Road ckville MD 20850

Ms. Nanci Dexter Director of Quality and Regulatory Affairs Corgenix 12061 Tejon Street Westminister. CO 80234

k022992 Re:

> Trade/Device Name: REAADS Anti-Cardiolipin IgG/IgM Semi-Ouantitative Test Kit Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MID Dated: September 5, 2002 Received: September 9, 2002

Dear Ms. Dexter:

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 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.

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.

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This letter will allow you to begin marketing your device as described in your 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 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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 Statement

510(k) Number: K023192

Device Name: REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit Indications for Use:

An enzyme-linked immunosorbent assay (ELISA) for the determination of IgG and IgM anti-cardiolipin antibodies in human serum or plasma.

For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Deborah M. Moore

of Clinical Laboratory Devices 510(k) Number _

Prescription Use

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)