VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE

K082329 · Viramed Biotech AG · LSR · Aug 5, 2009 · Microbiology

Device Facts

• Record ID: K082329
• Device Name: VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE
• Applicant: Viramed Biotech AG
• Product Code: LSR · Microbiology
• Decision Date: Aug 5, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3830
• Device Class: Class 2

Intended Use

The Viramed Biotech AG Borrelia B31 IgM ViraStripe® is an in vitro qualitative assay for the detection of IgM antibodies against 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 ElA 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 IgM ViraStripe® can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. Patients who are positive by IgM but not IgG should have the test repeated a few weeks later if they remain ill. If they are still positive only by IgM and have been ill longer than one month, this is likely a false positive.

Device Story

Line blot assay for qualitative detection of IgM antibodies to B. burgdorferi antigens; utilizes nitrocellulose membrane with purified B. burgdorferi B31 antigens. Patient serum incubated with strip; specific antibodies bind to antigens; alkaline-phosphatase anti-human IgM conjugate added; substrate causes precipitation/color change at specific band locations. Visualized bands compared to Cut-off control band intensity. Used in clinical laboratories; interpreted by technicians. Positive results support Lyme disease diagnosis; negative results do not rule out infection. Aids clinical decision-making during acute phase (0-4 weeks).

Clinical Evidence

No clinical data provided in the document. The document focuses on the regulatory determination of substantial equivalence for an in vitro diagnostic assay.

Technological Characteristics

Line blot assay; B. burgdorferi B31 antigens purified via electrophoretic/chromatographic methods; antigens fixed to nitrocellulose membrane. Manual visual interpretation using a uniform band locator and Cut-off control band. Integrated control system (function and conjugate controls). Complies with CLSI EP5-A2 and M34-A guidelines.

Indications for Use

Indicated for qualitative detection of IgM antibodies against Borrelia burgdorferi in human serum. Intended for patients with positive or equivocal EIA/IFA screening results for B. burgdorferi. Used during acute phase (0-4 weeks post-symptom onset) of Lyme disease. Contraindicated for diagnosis of patients ill longer than one month who remain IgM positive only (likely false positive).

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 U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

## AUG 0 5 2009

Barry E. Menefee, M. Sc., Ph.D. General Manager ViraLab Biotech, AG ViraLab, Inc. 105 Copperwood Way Unit M Oceanside, CA 92504

Re: k082329

> Trade/Device Name: Borrelia B31 IgM ViraStripe® Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: Class II Product Code: LSR Dated: July 29 2009 Received: July 30, 2009

Dear Dr. 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, 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

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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 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). Other general information on your responsibilities under the Act may be obtained 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.

Solly astyr

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 (if known): K082329

Device Name: Borrelia B31 IgM ViraStripe®

Indication for Use: The Viramed Biotech AG Borrelia B31 IgM ViraStripe® is an in vitro qualitative assay for the detection of IgM antibodies against 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 ElA 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 IgM ViraStripe® can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. Patients who are positive by IgM but not IgG should have the test repeated a few weeks later if they remain ill. If they are still positive only by IgM and have been ill longer than one month, this is likely a false positive.

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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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Flad : J. D.Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K081329