VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS

K092693 · Viramed Biotech AG · LSR · Nov 25, 2009 · Microbiology

Device Facts

• Record ID: K092693
• Device Name: VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS
• Applicant: Viramed Biotech AG
• Product Code: LSR · Microbiology
• Decision Date: Nov 25, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3830
• Device Class: Class 2

Intended Use

The Viramed Biotech AG Borrelia B31 IgG ViraStripe® is an in vitro qualitative assay for the detection of IgG antibodies to Borrelia burgdorferi in human serum. It is intended for use in the testing of human serum samples which have been found positive or equivocal using an EIA or IFA test procedure for B. burgdorferi antibodies. Positive results from this line blot assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyme disease. The Viramed Biotech AG Borrelia B31 IgG ViraStripe® can be used anytime after onset provided the EIA or IFA are positive or equivocal. It should also be used for follow-up when: 1) Only IgM antibodies were found positive in a line blot assay or Western blot, 2) IgG antibodies were found by line blot or Western blot but were not considered significant by the CDC criteria for a positive IgG Western blot, 3) previously tested sero-negative individuals are shown to develop antibodies by an EIA or IFA test.

Device Story

Line blot assay for qualitative detection of IgG antibodies to B. burgdorferi antigens in human serum; utilizes B31 strain antigens purified via electrophoresis and chromatography, then line-striped onto nitrocellulose membrane. Procedure involves incubating serum with strip; washing; adding alkaline-phosphatase anti-human IgG conjugate; adding substrate to induce precipitation/color change at specific antigen locations. Visualized bands compared to Cut-off control band intensity. Used in clinical laboratories; results interpreted by healthcare providers to support Lyme disease diagnosis. Benefits include standardized identification of specific B. burgdorferi antibodies compared to traditional Western blot.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Line blot assay using purified B. burgdorferi B31 antigens fixed to nitrocellulose membrane. Qualitative visual readout based on colorimetric precipitation. Integrated control system (function and conjugate controls). Cut-off control band used for intensity comparison. Complies with CLSI EP5-A2 and M34-A guidelines.

Indications for Use

Indicated for qualitative detection of IgG antibodies to Borrelia burgdorferi in human serum. Intended for follow-up testing of samples previously found positive or equivocal by EIA or IFA. Not studied in pediatric or adolescent patients.

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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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Viramed Biotech AG c/o Dr. Barry Menefee Viralab, Inc. 1730 S. Ditmar Street Oceanside, CA 92054

NOV 2 5 2009

Re: k092693

Trade/Device Name: Borrelia B31 IgG ViraStripe Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: Class II Product Code: LSR Dated: August 31, 2009 Received: September 2, 2009

Dear Dr. Barry Menefee:

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. Ilsting 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 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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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

Lavyangma
Heidi M. Szpek, Ph.D.

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 Statement

510(k) Number K092693

Device Name: Borrelia B31 IgG ViraStripe®

The Viramed Biotech AG Borrelia B31 IgG ViraStripe® is an in vitro qualitative assay for the detection of IgG antibodies to Borrelia burgdorferi in human serum. It is intended for use in the testing of human serum samples which have been found positive or equivocal using an EIA or IFA test procedure for B. burgdorferi antibodies. Positive results from this line blot assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyme discasc. The Viramed Biotech AG Borrelia B31 IgG ViraStripe® can be used anytime after onset of symptoms provided the EIA or IFA are positive or equivocal. It should also be used for follow-up when: 1) Only IgM antibodies were found positive in an line blot assay or Western blot, 2) IgG antibodies were found by line blot or Western blot but were not considered significant by the CDC criteria for a positive IgG Western blot, 3) previously tested sero-negative individuals are shown to develop antibodies by an EIA or IFA test. The Viramed Biotech AG Borrelia B31 ViraStripe has not been studied in pediatric or adolescent patients.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 8001 Subpart D)

(21 CFR 801 Subpart C)

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

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