(16 days)
The diaDexus PLAC™ test is an enzyme immunoassay for the quantitative determination of Lp-PLA2 (lipoprotein - associated phospholipase A2) in human plasma, to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk for coronary heart disease.
Not Found
This is a 510(k) premarket notification for an in vitro diagnostic device, the diaDexus PLAC™ test, which is an enzyme immunoassay. The information provided in the document focuses on the regulatory aspects of the device's clearance and does not contain the details requested about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement for a clinical study proving device performance.
The document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This determination typically relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or if there are differences, that those differences do not raise new questions of safety and effectiveness.
Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory clearance letter, not a clinical study report.
§ 866.5600 Low-density lipoprotein immunological test system.
(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).