(84 days)
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.
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This document is a 510(k) premarket notification FDA approval letter for the Borrelia B31 IgG ViraStripe device. It does not contain the detailed study results, acceptance criteria, or performance data that would allow a complete answer to your request. The letter confirms substantial equivalence but does not provide the underlying data.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details on sample sizes, ground truth establishment, or multi-reader multi-case studies based solely on the provided text.
To answer your questions thoroughly, I would need access to the actual 510(k) summary document (K092693) which typically contains the study design, results, and acceptance criteria for in vitro diagnostic devices.
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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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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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Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) _
§ 866.3830
Treponema pallidum treponemal test reagents.(a)
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), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).