(256 days)
The Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay is a single use, unitized immunochromatographic test that uses recombinant B. burgdorferi antigens for the qualitative presumptive (first step) detection of IgG and IgM antibodies to B. burgdorferi in human serum or whole blood. This test should be used only in patients with history, signs and symptoms that are consistent with Lyme disease. The Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay is intended for use in clinical and physicians' office laboratories.
The Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay is a Class II in vitro diagnostic device that utilizes standard immunochromatographic chromophore technology to qualitatively detect, in serum or whole blood, the presence of IgG and IgM antibodies to recombinant Borrelia burgdorferi antigens, as an aid in the diagnosis of Lyme Disease. It consists of a plastic housing, containing an absorbent material that collects the specimen and, with the addition of buffer, delivers it and adjacent adsorbed reagents, onto a chromatographic strip, onto which recombinant test antigen and control antibodies have been adsorbed within their respective test and control detection zones. As the mixture migrates along the strip, gold-conjugated antibodies specific for human IgG and IgM bind to the antibodies in the specimen. Antibodies specific for Borrelia burgdorferi antigens, if present, will bind to the adsorbed recombinant antigens in the test zone, resulting in a visually detectable colored line due to the presence of goldconjugated antibodies, which are bound to the specimen antibodies. If no antibodies to Borrelia burgdorferi are present, no line will appear in the test zone. A line will always appear in the control zone, indicating a valid result, as goat anti-human IgG antibodies adsorbed in the control zone bind excess IgG in the specimen, which have been bound to the gold-conjugate.
The provided text describes a medical device, the Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay, but does not contain the detailed acceptance criteria or the study data that proves the device meets specific performance criteria. The document is a 510(k) summary for regulatory submission, focusing on device description, intended use, and substantial equivalence to a predicate device, rather than a full study report with detailed results.
Therefore, I cannot populate the requested table with acceptance criteria and reported device performance, nor can I provide information on sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, or details about the training set.
The document mainly focuses on establishing the device's functionality and its substantial equivalence to another device (Wampole Borrelia burgdorferi IgG/IgM ELISA) for regulatory approval.
What information is available in the provided text:
- Device Name: Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay
- Intended Use: Qualitative presumptive (first step) detection of IgG and IgM antibodies to B. burgdorferi in human serum or whole blood using recombinant B. burgdorferi antigens. It's intended for patients with a history, signs, and symptoms consistent with Lyme disease, and for use in clinical and physicians' office laboratories.
- Predicate Device: Wampole Borrelia burgdorferi IgG/IgM ELISA (510(k) Document Control Number: K965131)
- Technology: Immunochromatographic in vitro diagnostic device, utilizing recombinant Borrelia burgdorferi antigens.
- Claimed Advantages of Recombinant Antigens: Improved specificity and a continued supply of high-quality, uniform antigen.
§ 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).