(98 days)
For the quantitative determination of Low-density lipoprotein cholesterol (LDL-C) in human serum or plasma. LDL Cholesterol is recognized as a useful tool in identifying patients who are at a higher risk for coronary heart diseas. High LDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.
Not Found
The provided FDA document is a 510(k) premarket notification for a "Direct LDL Cholesterol Reagent." This is an in vitro diagnostic device, not an AI/ML medical device. Therefore, the concepts of acceptance criteria met by an algorithm, training and test sets, expert ground truth, MRMC studies, or standalone performance do not apply in the context of this document.
The document states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This means its performance is considered comparable to existing, legally marketed devices.
The "Indications for Use" section specifies that the device is "For the quantitative determination of Low-density lipoprotein cholesterol (LDL-C) in human serum or plasma."
To adequately respond to your request for AI/ML device-specific information, I would need a document pertaining to an AI/ML medical 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.