(280 days)
The EUROIMMUN Lyme ELISA (IgG/IgM) test kit is intended for the qualitative determination of IgC and/or IgM class antibodies against Borrelia burgdorferi in human serum and plasma (K++EDTA, Li+-heparin) from symptomatic patients or people suspected of B. burgdorferi infection. It is used as an aid in the disease, in conjunction with other laboratory and clinical findings. All positive and borderline results should be supplemented by a second step testing method such as Western blot.
Not Found
This FDA 510(k) clearance letter for the EUROIMMUN Lyme ELISA (IgG/IgM) device provides an "Indications for Use" statement but does not contain the detailed study information required to answer your questions about acceptance criteria and device performance.
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..." This means the FDA found the device to be similar enough to a pre-existing legally marketed device that it does not require a new Premarket Approval (PMA) application, which would necessitate extensive clinical trial data submission and review.
Therefore, I cannot provide the requested information based on this document. A 510(k) clearance typically relies on demonstrating substantial equivalence, and the detailed performance studies and acceptance criteria are usually summarized in the 510(k) submission itself, not fully articulated in the clearance letter.
To answer your questions, I would need access to the full 510(k) submission document (K142038) or a dedicated performance study report for the EUROIMMUN Lyme ELISA (IgG/IgM).
§ 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).