REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001

K031208 · Corgenix, Inc. · MSV · Jul 7, 2003 · Immunology

Device Facts

• Record ID: K031208
• Device Name: REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001
• Applicant: Corgenix, Inc.
• Product Code: MSV · Immunology
• Decision Date: Jul 7, 2003
• Decision: SESE
• Submission Type: Special
• 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 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 IgM anti-B2GPI Test Kit is intended to be used by clinical (hospital and reference) laboratories. The REAADS IgA anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation 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. The REAADS IgG Anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgG 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 IgG Anti-B2GPI Test Kit is intended to be used by clinical (hospital and reference) laboratories. The REAADS IgG Anti-Prothrombin Semi-Quantitative Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgG anti-prothrombin (aPT) antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). The REAADS IgG Anti-Prothrombin Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories. The REAADS IgM Anti-Prothrombin Semi-Quantitative Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgM anti-prothrombin (aPT) antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). The REAADS IgM Anti-Prothrombin Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

Device Story

REAADS test kits are in vitro diagnostic assays for detecting and semi-quantifying specific autoantibodies (anti-B2GPI or anti-prothrombin) in human serum or plasma. Used by clinical laboratory professionals to aid in assessing thrombosis risk in patients with SLE or antiphospholipid syndrome. Operation involves standard immunoassay procedures where patient samples are analyzed to identify antibody presence and concentration. Results are provided to healthcare providers to support clinical decision-making regarding patient risk profiles. The device benefits patients by providing diagnostic information relevant to managing autoimmune-related clotting risks.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic immunoassay kits for detection of autoantibodies. Designed for use in clinical laboratory settings. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for detection and semi-quantitation of IgM, IgA, or IgG anti-B2GPI antibodies or IgG/IgM anti-prothrombin antibodies in human serum/plasma to assess thrombosis risk in patients with systemic lupus erythematosus (SLE) or lupus-like disorders (antiphospholipid syndrome). For prescription 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circumference of the circle. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

JUL 0 7 2003

Re: k031208

Trade/Device Name: REAADS IgM anti-B2GPI Test Kit REAADS IgA anti-B2GPI Test Kit REAADS IgG anti-B2GPI Test Kit REAADS IgG Anti-Prothrombin Semi-Quantitative Test Kit REAADS IgM Anti-Prothrombin Semi-Quantitative Test Kit Regulation Number: 21 CFR § 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: II Product Code: MSV, DHC Dated: June 20, 2003 Received: June 25, 2003

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 (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket

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Page 2 - Ms. Nanci Dexter

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). You may obtain other general information on your responsibilities under the Act 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 Butman

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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510(k) Number: KO31208

Device Name: REAADS IgM anti-B2GPI Test Kit 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 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 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)

J.P. Reeves for J. Bautista
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_K031208

Prescription Use \$\checkmark\$

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

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510(k) Number: K031208

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 semi-quantitation 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

H. Reeves for S. Bautista
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_K031208

Prescription Use ✓

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# 510(k) Number:_ K 031208

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

The REAADS IgG Anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgG 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 IgG 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)

J.P. Reeves for J. Bautista
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_K031208

Prescription Use ✓

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

{5}------------------------------------------------

510(k) Number: K031208

Device Name: REAADS IgG Anti-Prothrombin Semi-Quantitative Test Kit

Indications for Use:

The REAADS IgG Anti-Prothrombin Semi-Quantitative Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgG anti-prothrombin (aPT) antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

The REAADS IgG Anti-Prothrombin 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)

JPRaves for J. Bautista
Division Sign-Off

Division Sign-C

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K031208

Prescription Use \$\checkmark\$

Special 510(k): REAADS anti-Prothrombin IgG Semi-Quantitative Test Kit

{6}------------------------------------------------

510(k) Number: K031208

Device Name: REAADS IgM Anti-Prothrombin Semi-Quantitative Test Kit

Indications for Use:

The REAADS IgM Anti-Prothrombin Semi-Quantitative Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgM anti-prothrombin (aPT) antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

The REAADS IgM Anti-Prothrombin 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)

J.P. Reeves for J. Bautista

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K031208

Prescription Use ✓

Special 510(k): REAADS anti-Prothrombin IgM Semi-Quantitative Test Kit