(22 days)
Photometric clinical chemistry analyzer for clinical laboratory use. Applications include colorimtric, turbidimetric, latex agglutination and homogenous enzyme immunoassay.
Photometric clinical chemistry analyzer
This document is a 510(k) clearance letter from the FDA for the Olympus AU400 Clinical Chemistry Analyzer in 1998. It does not contain the acceptance criteria or a study proving the device meets acceptance criteria.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to devices already on the market. The FDA determines substantial equivalence based on information provided by the manufacturer, but the 510(k) process typically doesn't involve the FDA conducting or requiring detailed studies with specific acceptance criteria in the same way a Premarket Approval (PMA) would.
Therefore, I cannot extract the requested information about acceptance criteria and a study to prove device performance from this document. The document's purpose is to grant clearance for the device to be marketed, not to provide a detailed performance study report.
§ 862.1020 Acid phosphatase (total or prostatic) test system.
(a)
Identification. An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.