REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT

K013077 · Corgenix, Inc. · MSV · Sep 28, 2001 · Immunology

Device Facts

• Record ID: K013077
• Device Name: REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT
• Applicant: Corgenix, Inc.
• Product Code: MSV · Immunology
• Decision Date: Sep 28, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The REAADS Anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation THE KEADS AM-D2GFI antibodies in human serum or plasma as an aid for assessing the risk of the risk of the make in 01 TEM and DEOTT annovetes in hemantosus (SLE) and lupus-like disorders (antiphospholipid syndrome). The REAADS IgM anti-B2GPI Test Kit is intended to be used by clinical (hospital and reference) laboratories.

Device Story

REAADS IgM anti-B2GPI Test Kit is an in vitro diagnostic assay; detects and semi-quantitates IgM anti-B2GPI antibodies in human serum or plasma samples. Used in clinical, hospital, and reference laboratories by trained laboratory personnel. Assists clinicians in assessing risk for systemic lupus erythematosus (SLE) and antiphospholipid syndrome. Provides semi-quantitative results to support clinical decision-making regarding autoimmune disease diagnosis and management.

Clinical Evidence

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

Technological Characteristics

In vitro diagnostic test kit; enzyme-linked immunosorbent assay (ELISA) format for detection of IgM antibodies; utilizes human serum or plasma samples; manual or automated laboratory processing; no specific materials or software algorithms described.

Indications for Use

Indicated for detection and semi-quantitation of IgM anti-B2GPI antibodies in human serum or plasma to aid in assessing risk of SLE and lupus-like disorders (antiphospholipid syndrome). For use in clinical/hospital/reference laboratories.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Nanci Dexter Director, Quality Assurance and Regulatory Affairs Corgenix, Inc. 12061 Tejon Street Westminster, Colorado 80234

SEP 2 8 2001

Re: K013077

Trade/Device Name: REAADS IgM anti-B2GPI Test Kit Regulation Number: 21 CFR § 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: II Product Code: MSV Dated: September 11, 2001 Received: September 14, 2001

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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## Page 2

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/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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:** K013077

Device Name: REAADS IgM anti-B2GPI Test Kit Indications for Use:

The REAADS Anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation THE KEADS AM-D2GFI antibodies in human serum or plasma as an aid for assessing the risk of the risk of the make in 01 TEM and DEOTT annovetes in hemantosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

The REAADS IgM anti-B2GPI 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)

Donald S. Bell

(Division Sign-Off

510(k) Number_Ko13077

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