(64 days)
The SPIFE 2000/3000 Lipoprotein System is useful in the prevention of coronary heart disease. Increased dietary fats and cholesterol are associated with atherosclerosis which leads to cardiovascular disease and strokes.
Not Found
These two pages contain a Food and Drug Administration (FDA) Substantial Equivalence Determination letter for the "Spife 2000/3000 Lipoprotein System" and an "Indications for Use" statement.
Unfortunately, this document does not contain the information requested regarding acceptance criteria, device performance tables, study details (sample sizes, provenance, ground truth, experts, adjudication, MRMC, standalone performance), or training set information.
This letter is a regulatory approval document stating that the device is substantially equivalent to a previously marketed predicate device and can be marketed. It summarizes the regulatory classification and general controls but does not delve into the specific technical studies or performance data that led to that determination.
§ 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.