(237 days)
The Viramed Biotech AG Borrelia B31 Viro qualitative protein nicroaray assay for the detection of IgM antibodies to Borreia burgdorfer in human serum. It is intended for use in the testing of human serum samples which have been found positive or equivocal using an EA or FFA test procedure for B. burgdorferi antibodies. Positive essay are supportive evidence of infection with B. burgdorfer, the causative agent for Lyme disease.
The Viramed Biotech AG Borrelia B31 ViraChip® IgM Test must be used with a ViraChip® Reader and the ViraChip® Software.
Not Found
I am sorry, but the provided text does not contain the information necessary to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter for a medical device (Borrelia B31 ViraChip IgM Test Kit), which confirms that the FDA has determined the device is substantially equivalent to a legally marketed predicate device.
However, it does not contain the following specific details required to answer your request:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number and qualifications of experts for ground truth establishment.
- Adjudication method.
- Information on Multi-Reader Multi-Case (MRMC) studies or effect sizes.
- Information on standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
This document is an administrative clearance letter, not a clinical study report or a summary of performance data. To get the requested information, you would typically need to review the device's 510(k) submission summary or a separate clinical study publication.
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August 22, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Viramed Biotech AG Barry Menefee Operations Manager 105 Copperwood Way Suite H Oceanside, California 92058
Re: K163695
Trade/Device Name: Borrelia B31 ViraChip IgM Test Kit Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: Class II Product Code: LSR Dated: July 21, 2017 Received: July 25, 2017
Dear 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801 and Part 809); medical device reporting of
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medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Steven R. Gitterman -S for
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163695
Device Name Borrelia B31 ViraChip IgM Test Kit
Indications for Use (Describe)
The Viramed Biotech AG Borrelia B31 Viro qualitative protein nicroaray assay for the detection of IgM antibodies to Borreia burgdorfer in human serum. It is intended for use in the testing of human serum samples which have been found positive or equivocal using an EA or FFA test procedure for B. burgdorferi antibodies. Positive essay are supportive evidence of infection with B. burgdorfer, the causative agent for Lyme disease.
The Viramed Biotech AG Borrelia B31 ViraChip® IgM Test must be used with a ViraChip® Reader and the ViraChip® Software.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 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).