(173 days)
Orion Diagnostica UniQ™ PINP RIA is a quantitative radioimmunoassay designed for the measurement of intact aminoterminal propeptide of type I procollagen, an indicator of osteoblastic activity, in human serum. The test is intended to be used an aid in the management of postmenopausal osteoporosis. For in vitro diagnostic use.
Not Found
The provided text is related to an FDA 510(k) clearance for a diagnostic device, the Orion Diagnostica UniQ™ PINP RIA. However, it does not contain any information regarding acceptance criteria, device performance, specific study details (sample size, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, or training set details.
The document is a clearance letter and an "Indications for Use" statement. It confirms that the device has been found substantially equivalent to a predicate device but does not present the data from the studies that led to this determination.
Therefore, I cannot provide the requested information based on the given input.
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.