(66 days)
The Kamiya K-ASSAY® Lp(a) Assay is an in vitro diagnostic reagent for the quantitative determination of human Lp(a) in human serum by immunoturbidimetric assay. The test may provide in conjunction with other lipoprotein tests, the risk assessment of coronary artery disease for specific populations.
The K-ASSAY ® Lp(a) Calibrator Set is an in vitro diagnostic reagent for calibration of the K-ASSAY® Lp(a) Assay.
For in vitro diagnostic use.
Not Found
This document is an FDA 510(k) clearance letter for an in vitro diagnostic device, not a study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria, device performance, study design, or ground truth establishment.
The letter simply states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means it has met the regulatory requirements for clearance, not that a specific performance study with acceptance criteria has been detailed in this document.
To provide the requested information, a separate study report or regulatory submission document detailing the performance evaluation of the K-Assay® Lipoprotein (a) Immunoturbidimetric Assay would be necessary.
§ 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).