ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM

K113397 · Zeus Scientific, Inc. · LSR · Jul 26, 2012 · Microbiology

Device Facts

• Record ID: K113397
• Device Name: ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM
• Applicant: Zeus Scientific, Inc.
• Product Code: LSR · Microbiology
• Decision Date: Jul 26, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3830
• Device Class: Class 2

Intended Use

The ZEUS ELISA Borrelia VlsE1/PepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive evidence of infection with Borrelia burgdorferi. Diagnosis of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data. Negative first or second tier results should not be used to exclude Borreliosis. This kit is for in vitro diagnostic use.

Device Story

ZEUS ELISA Borrelia VlsE1/PepC10 IgG/IgM Test System is an in vitro diagnostic assay for detecting antibodies to Borrelia burgdorferi. Input: human serum samples. Principle: ELISA (Enzyme-Linked Immunosorbent Assay) using VlsE1 and pepC10 antigens. Output: qualitative detection of IgG and IgM antibodies. Used in clinical laboratory settings by trained laboratory personnel. Results are interpreted by healthcare providers in conjunction with patient history, clinical symptoms, and other laboratory data to support the diagnosis of Lyme Borreliosis. Positive or equivocal results require confirmation via second-tier testing (e.g., Western Blot).

Technological Characteristics

ELISA-based immunoassay utilizing VlsE1 and pepC10 antigens for the detection of IgG and IgM antibodies to Borrelia burgdorferi in human serum. In vitro diagnostic test system.

Indications for Use

Indicated for qualitative detection of IgG and IgM antibodies to VlsE1 and pepC10 antigens of Borrelia burgdorferi in human serum. Intended for symptomatic patients or those with history of Lyme Borreliosis. Positive/equivocal results require second-tier testing (e.g., Western Blot). Negative results do not exclude infection.

Regulatory Classification

Identification

Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), the Treponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies to Treponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genus Treponema and provides epidemiological information on syphilis.

Submission Summary (Full Text)

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## Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

JUL 26 2012

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

Re: k113397

Trade/Device Name: ZEUS ELISA Borrelia V1sE-1/pepC10 IgG/IgM Test System Regulation Number: 21 CFR §866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: II Product Code: LSR Dated: June 25, 2012 Received: June 26, 2012

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 - Ms. Ewa 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,

Salazar

Sally A. Hojvat, M.Sc., Ph.D. Director . Division of Microbiology 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: K113397 Device Name: ZEUS ELISA Borrelia VLSe-1/pepC10 IgG/IgM Test System

Indications for Use:

The ZEUS ELISA Borrelia VlsE1/PepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive evidence of infection with Borrelia burgdorferi. Diagnosis of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data. Negative first or second tier results should not be used to exclude Borreliosis. This kit is for in vitro diagnostic use.

Prescription Use × (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)

Sereva

**Division Sign-Off**

Office of In Vitro Diagnos vice Evaluation an

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Device Evaluation and Saf