REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT

K013079 · Corgenix, Inc. · MSV · Sep 28, 2001 · Immunology

Device Facts

• Record ID: K013079
• Device Name: REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA 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 IgA anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semiquantitation of IgA anti-B2GPI antibodies in human serum or plasma as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). The REAADS IgA anti-B2GPI Test Kit is intended to be used by clinical (hospital and reference) laboratories.

Device Story

The REAADS IgA anti-B2GPI Test Kit is an in vitro diagnostic assay used in clinical and reference laboratories to detect and semiquantify IgA anti-beta-2 glycoprotein I (anti-B2GPI) antibodies in human serum or plasma. By identifying these autoantibodies, the test aids clinicians in assessing the risk of thrombosis in patients diagnosed with systemic lupus erythematosus (SLE) or lupus-like disorders (antiphospholipid syndrome). The assay provides laboratory professionals with quantitative data that supports clinical decision-making regarding patient risk stratification for thrombotic events.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on 510(k) regulatory review.

Technological Characteristics

In vitro diagnostic test kit for immunological detection of autoantibodies. Classified under 21 CFR 866.5660 (Multiple Autoantibodies Immunological Test System), Class II, Product Code MSV.

Indications for Use

Indicated for detection and semiquantitation of IgA anti-B2GPI antibodies in human serum or plasma to assess thrombosis risk in patients with systemic lupus erythematosus (SLE) or lupus-like disorders (antiphospholipid 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)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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: K013079

Trade/Device Name: REAADS IgA 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 wo nave reviews of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encreat 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, de nees mat have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Four may , are severy interest 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 may or backed to be 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 r rease of a 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 noutication. The I Drivinating of station 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 IT you desire specific daily of your ostic devices), please contact the Office of Compliance at additionally 607.10 for in in in many of the promotion and advertising of your device, [phone] - 11 - 15 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 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 Information on your responsibilities with er answer Assistance at its toll-free number [phone] or 1901) 443-6597 or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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: K013079

Device Name: REAADS IgA anti-B2GI Test Kit Indications for Use:

The REAADS IgA anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semiquantitation of IgA anti-B2GPI antibodies in human serum or plasma as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

The REAADS IgA anti-B2GPI Test Kit is intended to be used by clinical (hospital and reference) laboratories.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign Off Division of Clinical Laboratory Devices

510(k) Number K013079

Prescription Use √

Special 510(k): REAADS Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit