REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT

K024196 · Corgenix, Inc. · MID · Jan 3, 2003 · Immunology

Device Facts

• Record ID: K024196
• Device Name: REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
• Applicant: Corgenix, Inc.
• Product Code: MID · Immunology
• Decision Date: Jan 3, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The REAADS Anti-Phosphatidylserine Semi-Quantitative Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgG and IgM anti-phosphatidyIserine antibodies in human serum or plasma in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). The REAADS Anti-Phosphatidylserine Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

Device Story

REAADS Anti-Phosphatidylserine IgG/IgM Semi-Quantitative Test Kit is an in vitro diagnostic assay; detects and semi-quantitates IgG and IgM anti-phosphatidylserine antibodies in human serum or plasma. Used in clinical, hospital, and reference laboratories by trained laboratory personnel. Provides semi-quantitative results to assist clinicians in the diagnosis and management of patients with systemic lupus erythematosus (SLE) and antiphospholipid syndrome. Operates as an immunological test system.

Clinical Evidence

No clinical data provided in the document; regulatory clearance based on substantial equivalence to legally marketed predicate devices.

Technological Characteristics

In vitro diagnostic immunological test system; enzyme-linked immunosorbent assay (ELISA) format for detection of IgG and IgM antibodies; utilizes human serum or plasma samples.

Indications for Use

Indicated for detection and semi-quantitation of IgG and IgM anti-phosphatidylserine antibodies in human serum or plasma for individuals with systemic lupus erythematosus (SLE) or lupus-like disorders (antiphospholipid 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# JAN 9 3 2003

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

k024196 Re:

> Trade/Device Name: REAADS Anti-Phosphatidy|serine IgG/IgM Semi-Quantitative Test Kit Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test sysstem Regulatory Class: Class II Product Code: MID Dated: December 19, 2002 Received: December 20, 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 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 (OS) regulation (21 CFR Part 820).

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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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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). 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

## Enclosure

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### Indications for Use Statement

510(k) Number: K024196

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

The REAADS Anti-Phosphatidylserine Semi-Quantitative Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgG and IgM anti-phosphatidyIserine antibodies in human serum or plasma in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

The REAADS Anti-Phosphatidylserine Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

#### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sinita Y. Michine M.D.
FOR T. BAUTISTA

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_ KO24 196

Prescription Use (Per 21 CFR 801.109) Over-The-CounterUse

(Optional Format 1-2-96)

Special 510(k): REAADS anti-PhosphatidyIserine IgG/M Semi-Quantitative Test Kit

OR

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