THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR

K092757 · Thera-Test Laboratories, Inc. · MSV · Oct 9, 2009 · Immunology

Device Facts

• Record ID: K092757
• Device Name: THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR
• Applicant: Thera-Test Laboratories, Inc.
• Product Code: MSV · Immunology
• Decision Date: Oct 9, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The TheraTest EL-β2GPITM (IgM-IgG-IgA) is a set of in vitro diagnostic tests for the measurement of IgM, IgG and IgA autoantibodies in human serum directed against serum beta 2-glycoprotein I (β2GPI). This measurement aids in the diagnosis of antiphospholipid antibody syndrome (APS) or certain autoimmune thrombotic disorders such as those secondary to systemic lupus erythematosus. The TheraTest EL-32GPI TM Scr is an in vitro diagnostic test for the screening for autoantibodies in human serum directed against the serum glycoprotein beta 2glycoprotein I (B2GPI). This measurcment aids in the diagnosis of antiphospholipid antibody syndrome (APS) or certain autoimmune thrombotic disorders such as those secondary to systemic lupus erythematosus.

Device Story

TheraTest EL-β2GPI assays are in vitro diagnostic tests for human serum; measure IgM, IgG, and IgA autoantibodies against beta 2-glycoprotein I (β2GPI). Used in clinical laboratories to aid diagnosis of antiphospholipid antibody syndrome (APS) or autoimmune thrombotic disorders (e.g., secondary to systemic lupus erythematosus). Tests provide quantitative or screening results to clinicians; results interpreted alongside clinical symptoms and other laboratory findings to support diagnostic decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by design control activities, including risk analysis (Fault Tree Analysis and FMEA) and verification/validation testing confirming that modifications meet predetermined acceptance criteria.

Technological Characteristics

In vitro diagnostic immunoassay for detection of autoantibodies against β2GPI in human serum. Class II device (21 CFR 866.5100, Product Code MSV).

Indications for Use

Indicated for patients suspected of having antiphospholipid antibody syndrome (APS) or autoimmune thrombotic disorders (e.g., secondary to systemic lupus erythematosus). Used for measurement of IgM, IgG, and IgA autoantibodies against β2GPI or screening for such autoantibodies in human serum.

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/0 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 symbol resembling three stylized human profiles facing to the right, stacked on top of each other.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

### OCT - 9 2009

Thera-Test Laboratories Inc. c/o Dr. Marius Teodorescu President and CEO 1111 N. Main St Lombard, IL 60148

Re: k092757

Trade/Device Name: TheraTest EL-β2GPI™ (IgM-IgG-IgA) & TheraTest EL-β2GPI™ Scr. Regulation Number: 21 CFR \$866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: MSV Dated: September 8, 2009 Received: September 9, 2009

Dear Dr. Teodorescu:

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 class II (Special Controls), 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.

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Page 2 – Dr. Marius Teodorescu

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

ie m chan

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

| 510(k)Number | K092757 |
|--------------|------------------------------------|
| Device Name: | TheraTest EL-β2GPITM (IgM-IgG-IgA) |

Indications for Use. The TheraTest EL-β2GPITM (IgM-IgG-IgA) is a set of in vitro diagnostic
tests for the measurement of IgM, IgG and IgA autoantibodies in human serum directed against
serum beta 2-glycoprotein I (β2GPI). This measurement aids in the diagnosis of
antiphospholipid antibody syndrome (APS) or certain autoimmune thrombotic disorders such as
those secondary to systemic lupus erythematosus.

Prescription use X

AND/OR ----------- Over-the-counter use -----

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of in vitro Diagnostic devices (OIVD)

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Page 4 - Dr. Marius Teodorescu

## Indications for Use

K092757 510(k)Number

Device Name: TheraTest EL-B2GPITM Scr

Indications for Use. The TheraTest EL-32GPI TM Scr is an in vitro diagnostic test for the screening for autoantibodies in human serum directed against the serum glycoprotein beta 2glycoprotein I (B2GPI). This measurcment aids in the diagnosis of antiphospholipid antibody syndrome (APS) or certain autoimmune thrombotic disorders such as those secondary to systemic lupus erythematosus.

Prescription use X

AND/OR

Over-the-counter use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of in vitro Diagnostic devices (OIVD)

. 1974

Reena Philip

Office of In Vitro Diagnosilo ഗ്വന്തര മേശ്വരിക്കു മുറിച്ച് ടിമ്പിക്