(141 days)
The QUANTA Lite™ Lyme B. burgdorferi IgM ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for the initial (first-step) qualitative detection of IgM antibodies to B. burgdorferi, the agent of Lyme disease (Lyme borreliosis), in human serum. This ELISA is intended to provide presumptive evidence of the presence of antibodies to B. burodorferi. Equivocal or positive results should be followed by a standardized second-step supplemental procedure such as Western blot assays. Positive results on a second-step assay can support a clinical diagnosis of Lyme disease. Diagnosis of Lyme disease should be based on history, physical findings, and other laboratory data in addition to anti-B. burgdorferi results. The QUANTA Lite™ Lyme B. burgdorferi IgM ELISA can be used alone during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After the acute phase, infected individuals usually develop anti-B. burgdorferi IgG antibodies and a positive IgM result alone is not recommended for supporting a diagnosis of active Lyme disease in persons with illness of greater than 1 month duration. Negative results should not be the sole basis for exclusion of B. burgdorferi infection.
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The provided text is a 510(k) clearance letter from the FDA for an in vitro diagnostic device, the QUANTA Lite™ Lyme B. burgdorferi IgM ELISA. This document outlines the regulatory approval process and the intended use of the device but does not contain information on the acceptance criteria or the specific study details that demonstrate the device meets those criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance: This information is not present in the provided text.
- Sample sizes used for the test set and data provenance: These details are not included. The letter mentions it's an in vitro diagnostic for human serum, but no specifics on test population characteristics or study design are given.
- Number of experts used to establish ground truth and their qualifications: Not applicable/not provided for this type of submission.
- Adjudication method: Not applicable/not provided.
- MRMC comparative effectiveness study details: Not applicable. This letter is for an ELISA kit, not an AI-assisted diagnostic.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: While the device measures IgM antibodies to B. burgdorferi with subsequent Western blot as a supplemental procedure, the specific method for establishing the ground truth for the FDA submission study is not described.
- Sample size for the training set: Not applicable (this is an ELISA kit, not an AI algorithm requiring a training set in the conventional sense).
- How ground truth for the training set was established: Not applicable.
Summary of what the document does provide:
- Device Name: QUANTA Lite™ Lyme B. burgdorferi IgM ELISA
- Regulatory Class: II
- Product Code: LSR
- Indications for Use: Initial (first-step) qualitative detection of IgM antibodies to B. burgdorferi in human serum, providing presumptive evidence of antibodies. Equivocal or positive results should be followed by a standardized second-step supplemental procedure (e.g., Western blot). Can be used alone during the acute phase (0-4 weeks of symptom onset). Not recommended for diagnosis of active Lyme disease after 1 month if only IgM is positive. Negative results do not exclude infection.
To answer your request, one would need access to the actual 510(k) submission document or a summary of safety and effectiveness, which would contain the clinical study data, statistical analysis, and performance claims. The provided FDA clearance letter is a regulatory approval notice, not the scientific study report itself.
§ 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).