(28 days)
The SPIFE Lipoprotein-12 System is intended for the separation and quantitation of serum or plasma lipoproteins used in the diagnosis and treatment of lipid disorders, atherosclerosis, and various liver and renal diseases.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "SPIFE Lipoprotein-12 System." This document does not contain the detailed information required to describe the acceptance criteria, study design, or performance metrics in the format requested.
Specifically, it lacks:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or expert details for ground truth.
- Information on adjudication methods, MRMC studies, or standalone algorithm performance.
- Details on the type of ground truth used or the training set sample size and its ground truth establishment.
The letter primarily confirms that the device is substantially equivalent to a predicate device and can be marketed, and it outlines the indications for use. It does not delve into the specifics of validation studies.
§ 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.