(133 days)
The Gold Standard Diagnostics Borrelia burgdorferi VISE-OspC IgG/IgM ELISA Test Kit is intended as a qualitative test for the detection of IgG and IgM class antibodies to VIsE and OspC antigens from Borrelia burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of having Lyme disease. When used as the first-tier screening test, positive and equivocal results must be confirmed through additional testing by one of the following methods:
• Standard two-tier test methodology (STTT) using an IgG and/or IgM blot testing following current interpretation guidelines. OR
• Modified two-tier test methodology (MTTT) using one or more of the following three ELISA based assays:
a. Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test
b. Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test
c. Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test
The assay can also be used as a second-tier confirmation test using the MTTT methodology when used with one or more of the following three ELISA based assays:
a. Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test
b. Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test
c. Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test
Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies. history, symptoms, and other laboratory findings.
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This document is a 510(k) clearance letter for the Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the acceptance criteria for the device, nor does it provide details of a study proving the device meets acceptance criteria, or information regarding sample sizes, ground truth establishment, or expert involvement.
The letter explicitly states: "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..."
Therefore, I cannot extract the requested information from the provided text. To answer your questions, the actual 510(k) summary or the full submission (which is usually publicly available on the FDA website) would be required.
§ 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).