(49 days)
A semiquantitative enzyme linked immunoassay for use in screening n Beaugust for IgM rheumatoid factor (RF) antibodies. Detection of pacitires IgM antibodies is an aid in the diagnosis of rheumatoid arthritis (RA).
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This appears to be a 510(k) clearance letter from the FDA for a diagnostic test kit, not a study report for an AI-powered device. Therefore, the requested information regarding acceptance criteria, study design, and AI-specific metrics cannot be extracted from the provided text.
The document discusses:
- Device Name: QUANTA Lite™ RF IgM Test Kit
- Regulatory Class: II
- Product Code: DHR
- Indications For Use: A semiquantitative enzyme-linked immunoassay for use in screening for IgM rheumatoid factor (RF) antibodies. Detection of specific IgM antibodies is an aid in the diagnosis of rheumatoid arthritis (RA).
- Substantial Equivalence: The FDA's determination that the device is substantially equivalent to legally marketed predicate devices.
The text does not contain any details about clinical studies, acceptance criteria for performance metrics (like sensitivity, specificity, or accuracy), sample sizes for test sets, ground truth establishment, expert involvement, or any information related to AI or machine learning performance.
To answer your questions, a separate study report or clinical trial summary for the QUANTA Lite™ RF IgM Test Kit would be needed.
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).