(29 days)
CAPTIA™ Syphilis (T. pallidum )-G is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the agent of syphilis)
CAPTIA™ Syphilis (T. pallidum )-G is also intended for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis.
Warning: A positive result is not useful for establishing a diagnosis of syphilis. In most situations, such a result may reflect a prior treated infection; a negative result can exclude a diagnosis of syphilis except for incubating or early primary disease.
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This document is a 510(k) clearance letter from the FDA for the CAPTIA™ Syphilis-G device. While it states that the device is substantially equivalent to legally marketed predicate devices and is subject to general and special controls, it does not contain the detailed study information required to answer your request. Specifically, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number and qualifications of experts, adjudication methods for the test set.
- Information on MRMC comparative effectiveness studies or standalone performance studies.
- Type of ground truth used.
- Sample size for the training set or how its ground truth was established.
To obtain this information, you would typically need to refer to the original 510(k) submission document itself, which contains the detailed premarket data and studies conducted by the manufacturer, Trinity Biotech, plc. The clearance letter only summarizes the FDA's decision based on that submission.
§ 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).