(107 days)
The Viramed Biotech Borrelia B31 IgG ViraBlot® 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 Western blot assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyme disease. The Viramed Biotech Borrelia B31 IgG Virablot® 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 Western blot, 2) IgG antibodies were found by Western blot but were not considered significant by the CDC criteria for a positive IgG Western blot, 3) previously tested seronegative individuals are shown to develop antibodies by an EIA or IFA test.
Not Found
The user is asking for information about the acceptance criteria and study details for the "Borrelia B31 IgG Virablot®" device as outlined in the provided FDA 510(k) submission document. However, the provided text does not contain any information about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.
The document is an FDA clearance letter for a 510(k) submission, confirming that the device, Borrelia B31 IgG Virablot®, is substantially equivalent to legally marketed predicate devices. It also includes the "Indication for Use" statement.
Therefore, I cannot fulfill the request using only the provided text.
To provide the requested information, I would need access to the actual 510(k) submission document, specifically the sections detailing the clinical and analytical studies, performance data, and validation methods.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 1 2005
Viramed Biotech AG c/o Barry E. Menefee, Ph.D. Chief of Operations Viralab, Inc. 1730 South Ditmar Street Oceanside, CA 92054
Re: K051071
Trade/Device Name: Borrelia B31 IgG Virablot® Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema Pallidum Treponemal Test Reagents Regulatory Class: Class II Product Code: LSR Dated: June 28, 2005 Received: June 29, 2005
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 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).
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter whil anow you to oegin manitoting of substantial equivalence of your device to a legally premarked 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, If you destic specific information access in of your device, please contact the Office of In or questions on the promotion and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sales, a Hong
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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Viramed Biotech: Est. #3004181478 / Borrelia B31 IgG Virablot® 510 (k) Submission/Page 10
Appendix C. Indication of Use Statement
510(k) Number: K051071
Device Name: Borrelia B31 IgG Virablot®
Indication for Use:
The Viramed Biotech Borrelia B31 IgG ViraBlot® 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 Western blot assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyme disease. The Viramed Biotech Borrelia B31 IgG Virablot® 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 Western blot, 2) IgG antibodies were found by Western blot but were not considered significant by the CDC criteria for a positive IgG Western blot, 3) previously tested seronegative individuals are shown to develop antibodies by an EIA or IFA test.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
510k)_
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Division Sign-Off | |
|---|---|
| Concurrence of CDRH, Office of Device Evaluation (ODE) | fole a |
| Office of In Vitro Diagnosi Devi | |
| Evaluation and Safety | |
| Manufactured by Viramed Biotech AG, Behringstrasse, 11, Planegg/Steinkerchen, Germany D-82152 | |
| 760 594-7285 |
§ 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).