(108 days)
The Randox Laboratories Limited Direct HDL - C Test Kit is an in vitro diagnostic reagent for the quantitative determination of HDL - C in serum or plasma. This method measures HDL - C directly without the need for a separate precipitation step. An inverse relationship has been found to exist between HDL - C levels and the incidence of coronary heart disease (CHD). The importance of HDL - C as a risk factor for CHD is now recognised.
Not Found
The provided document is an FDA 510(k) clearance letter for the "Boehringer Mannheim Direct HDL-Cholesterol" device (K970735). It establishes substantial equivalence to a predicate device, allowing it to be marketed. However, this document does not contain the specific details of acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information. The letter only indicates regulatory clearance, not the underlying performance study details.
To answer your request, I would need a different type of document, such as:
- A summary of safety and effectiveness (SSE) from the 510(k) submission.
- The actual study report submitted to the FDA.
- Published literature detailing the validation of the device.
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.