(43 days)
Abbott Liquid RF Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the value sheet.
Abbott Liquid RF Control
This is an FDA Premarket Notification (510(k)) letter for the Abbott Liquid RF Control, a quality control serum. The letter itself does not contain the detailed study information you are requesting. It primarily states that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed.
To answer your specific questions about acceptance criteria and study details, I would need to review the actual 510(k) submission document or a summary of its contents, which typically includes performance data. The provided text is only the FDA's regulatory response letter.
Therefore, I cannot provide the requested information based solely on the text provided. The document you've shared discusses the regulatory approval of a device, not the technical details of the studies performed to achieve that approval.
§ 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).