(107 days)
Not Found
Not Found
No
The 510(k) summary describes a qualitative in vitro diagnostic assay (Western blot) for detecting antibodies. There is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of such technologies. The description focuses on the biological assay itself.
No
The device is an in vitro diagnostic assay used for detecting antibodies, not for treating or preventing disease.
Yes
The device is described as an "in vitro qualitative assay for the detection of IgG antibodies to Borrelia burgdorferi in human serum" and its results are "supportive evidence of infection with B. burgdorferi, the causative agent for Lyme disease." This indicates its use in identifying a disease, which is the definition of a diagnostic device.
No
The device is an in vitro diagnostic assay, which is a laboratory test involving reagents and physical samples, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement explicitly states that it is an "in vitro qualitative assay for the detection of IgG antibodies to Borrelia burgdorferi in human serum." This clearly indicates that the device is used to test samples taken from the human body (in vitro) to provide diagnostic information.
N/A
Intended Use / Indications 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.
Product codes
LSR
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles three overlapping human profiles or figures, with flowing lines suggesting movement or connection.
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).
1
Page 2 -
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
2
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 |