(210 days)
The Viramed Biotech AG Borrelia B31 ViraChip® IgG Test Kit is an in vitro qualitative protein microarray 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 assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyne disease.
The Borrelia B31 ViraChip® IgG Test Kit must be used with a ViraChip® Reader and the ViraChip® Software.
The Viramed Biotech AG Borrelia B31 ViraChip® IgG Test Kit is an in vitro qualitative protein microarray 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 assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyne disease.
The Borrelia B31 ViraChip® IgG Test Kit must be used with a ViraChip® Reader and the ViraChip® Software.
The provided text is an FDA 510(k) clearance letter for the "Borrelia B31 ViraChip IgG Test Kit." This document does not contain the detailed acceptance criteria and performance study results as it is an approval letter, not the submission itself. The letter states that the FDA has "reviewed your Section 510(k) premarket notification" and "determined the device is substantially equivalent" to a predicate device.
Therefore, I cannot provide the requested information based on the provided text. The information requested, such as specific acceptance criteria for performance metrics (sensitivity, specificity), sample sizes, ground truth establishment methods, or details about comparative effectiveness studies, would typically be found in the manufacturer's 510(k) submission, which is not provided here.
The document does include the "Indications for Use" for the device, which describes its intended purpose.
§ 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).