REAADS IGM ANTI-B2GP1 TEST KIT

K982433 · Corgenix, Inc. · MSV · Dec 7, 1998 · Immunology

Device Facts

• Record ID: K982433
• Device Name: REAADS IGM ANTI-B2GP1 TEST KIT
• Applicant: Corgenix, Inc.
• Product Code: MSV · Immunology
• Decision Date: Dec 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The REAADS IgM anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgM anti-B2GPI antibodies in human serum as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (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 ELISA-based in vitro diagnostic assay. Input: human serum samples. Process: samples incubated in microwells coated with purified human Beta-2 Glycoprotein I; anti-B2GPI antibodies bind to antigen; unbound proteins washed away; HRP-labeled anti-human IgM conjugate added; TMB/hydrogen peroxide chromogenic substrate added. Output: color intensity proportional to anti-B2GPI concentration, measured via spectrophotometry at 450nm. Used in clinical/hospital laboratories by trained personnel. Results aid clinicians in assessing thrombosis risk in SLE/antiphospholipid syndrome patients. Benefit: provides specific marker for thrombosis risk assessment.

Clinical Evidence

Clinical performance evaluated in unselected SLE patients. Results showed 93% clinical specificity and 20% clinical sensitivity for IgM anti-B2GPI antibodies. Correlation with predicate device was 0.886 (p=0.764 by single factor ANOVA), demonstrating statistical similarity.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) in 96-microwell plate format. Antigen: purified human Beta-2 Glycoprotein I. Detection: HRP-labeled anti-human IgM conjugate. Substrate: TMB and hydrogen peroxide. Readout: spectrophotometric at 450nm. Manual/automated laboratory assay.

Indications for Use

Indicated for detection and semi-quantitation of IgM anti-B2GPI antibodies in human serum to assess thrombosis risk in patients with systemic lupus erythematosus (SLE) or 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).

Predicate Devices

• QUANTA Lite IgM anti B2GPI ELISA (K973014)

Submission Summary (Full Text)

{0}------------------------------------------------

DEC 7 1998

K982433

Image /page/0/Picture/2 description: The image shows the word "corgenix" in a stylized font. The "c" is lowercase and is followed by a sphere with a tail-like shape extending from it. The rest of the letters are also lowercase and are in a simple, sans-serif font. The overall design is clean and modern.

## SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS REAADS IgM anti-B2GPI Test Kit July 13, 1998

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The REAADS IgM anti-B2GPI Test Kit is compared to a legally marketed predicate device and a substantial equivalence claim made. The predicate device is QUANTA Lite IgM anti B2GPI ELISA (K973014) currently manufactured and marketed by INOVA Diagnostics, Inc., San Diego, California.

The REAADS IgM anti-B2GPI Test Kit is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96-microwell plate format, similar to the predicate device. Diluted serum samples, calibrator sera, and controls are incubated in microwells coated with purified human Beta-2 Glycoprotein I. Incubation allows the anti-B2GPI antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human IgM, labeled with horseradish peroxidase (HRP), are added forming complexes with the B2GPI bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethlybenzidine (TMB) and hydrogen peroxide (H2O.) as the chromogenic substrate. The intensity of the color generated is proportional to the serum concentration of anti-B2GPI antibodies. Ontical density is read spectrophotometrically at 450nm. The total incubation time (at room temperature) of the assay is 40 minutes. The assay makes use of a single point calibrator to measure the amount of IgM anti-B2GPI antibodies in patient samples.

The intended use of the device is for the detection and semi-quantitation of Ig.M anti-B2GPI antibodies in human serum as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). Most autoimmune antiphospholipid antibodies require a serum cofactor (B2GPI) for optimal binding. It has been shown that many anti-phospholipid antibodies may react to a neoepitope formed on the B2GPI molecule by the interaction between the phospholipid and B2GPI. In addition, it has been reported that anti-B2GPI antibodies are more specific for thrombosis than antibodies detected by classic antiphospholipid ELISAs. Testing for anti-B2GPI antibodies in the clinical laboratory by ELISA is becoming increasingly valuable and provides additional clinically relevant results to assess patients for the antiphospholipid syndrome and/or the risk of thrombosis.

Performance indicates that REAADS anti-Beta-2 Glycoprotein I and the QUANTA Lite IgM anti B2GPI ELISA are equivalent, In-house studies indicate a clinical specificity of 93% for IgM anti-B2GPI antibodies and a clinical sensitivity of 20% for unselected SLE patients. The coefficient of correlation for individual values in unselected SLE patients showed a good correlation of 0.886 with a P-value of 0.764 (by single factor ANOVA), indicating the results by the two methods are statistically similar. Although differences between the assays are observed, in general, the performance characteristics are comparable. These results are also in compliance with those in published literature for antiphospholipid syndrome detection. The clinical studies performed demonstrate that the REAADS IgM anti-B2GPI Test Kit is safe and effective.

Marci Defter

Nanci Dexter Director, Quality Assurance and Regulatory Affairs

07/13/98

Date

{1}------------------------------------------------

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC Nanci Dexter Director, Quality and Regulatory Affairs CORGENIX, INC. 12061 Tejon Street Westminster, CO 80234

Re: K982433 Trade Name: REAADS IgM Anti-B2GPI Test Kit Regulatory Class: II Product Code: MSV November 16, 1998 Dated: Received: November 18, 1998

Dear Ms. Dexter:

7 1998

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{2}------------------------------------------------

## 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

{3}------------------------------------------------

## Indications for Use Statement

**510(k) Number:** K982433

REAADS IgM anti-B2GPI Test Kit Device Name:

Indications for Use:

The REAADS IgM anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgM anti-B2GPI antibodies in human serum as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (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)

Prescription Use

Peter E. Mahler