ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM

K102425 · Zeus Scientific, Inc. · MID · Dec 12, 2011 · Immunology

Device Facts

• Record ID: K102425
• Device Name: ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM
• Applicant: Zeus Scientific, Inc.
• Product Code: MID · Immunology
• Decision Date: Dec 12, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The ZEUS ELISA Cardiolipin IgG/IgM/IgA Test System is intended for the in vitro, qualitative measurement of IgG, IgM and/or IgA antibodies directed to cardiolipin in human serum to aid in the diagnosis of primary antiphospholipid syndrome (PAPS) and secondary antiphospholipid syndrome (SAPS) in conjunction with other laboratory and clinical findings.

Device Story

The ZEUS ELISA Cardiolipin IgG/IgM/IgA Test System is an in vitro diagnostic assay used in clinical laboratories. It detects IgG, IgM, and IgA antibodies against cardiolipin in human serum samples. The device utilizes an enzyme-linked immunosorbent assay (ELISA) principle; patient serum is incubated in microtiter wells coated with cardiolipin antigen. If specific antibodies are present, they bind to the antigen. After washing, an enzyme-labeled conjugate is added, followed by a substrate to produce a colorimetric signal proportional to the amount of bound antibody. Results are interpreted by laboratory personnel to assist clinicians in diagnosing primary or secondary antiphospholipid syndrome. The test provides qualitative data that, when combined with other clinical findings, supports the diagnostic process for patients suspected of having these syndromes.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and performance comparisons to the predicate device.

Technological Characteristics

ELISA-based immunoassay; microtiter plate format; colorimetric detection; qualitative measurement of IgG, IgM, and IgA antibodies. Standard laboratory equipment required for incubation and spectrophotometric reading.

Indications for Use

Indicated for qualitative detection of IgG, IgM, and/or IgA anti-cardiolipin antibodies in human serum to aid in diagnosis of primary and secondary antiphospholipid syndrome (PAPS/SAPS). For prescription use only.

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

• ZEUS Scientific Cardiolipin IgA ELISA Reagents (k973196)
• ZEUS Scientific Anti-Cardiolipin IgG ELISA Test System (k981014)
• ZEUS Scientific Anti-Cardiolipin IgM ELISA Test System (k981021)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Zeus Scientific, Inc c/o Ewa K. Nadolczak Manager, Clinical Affairs 200 Evans Way Branchburg, NJ 08876

DEC 1 2 2011

Re: k102425

Trade/Device Name: ZEUS ELISA Cardiolipin IgG/IgM/IgA Test System Regulation Number: 21 CFR §866.5660 Regulation Name: Multiple autoantibodies immunological test-system Regulatory Class: Class II Product Code: MID Dated: December 1, 2011 Received: December 2, 2011

Dear Ms. Nadolczak:

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice

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Page 2 - Ewa K. Nadolczak

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 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 Parts 801 and 809), 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" (21 CFR 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/cdrh/industry/support/index.html.

Sincerely yours,

Reena Philip

02

Maria 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: K102425

Device Name: ZEUS ELISA Cardiolipin IgG/IgM/IgA Test System Indications for Use:

The ZEUS ELISA Cardiolipin IgG/IgM/IgA Test System is intended for the in vitro, qualitative measurement of IgG, IgM and/or IgA antibodies directed to cardiolipin in human serum to aid in the diagnosis of primary antiphospholipid syndrome (PAPS) and secondary antiphospholipid syndrome (SAPS) in conjunction with other laboratory and clinical findings.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Division Sign-Of

Office of In Vitro Diagn Device Evaluation and

510K < 102425

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