(71 days)
The Diazyme Lipoprotein (a) Assay is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum or Clinical Chemistry Systems. The measurement of Lipoprotein (a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation. For in vitro diagnostic use only.
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This document is a 510(k) premarket notification acceptance letter from the FDA for a device called "Diazyme Lipoprotein (a) Assay." It is an in vitro diagnostic device, not an AI/ML medical device. Therefore, the information required to answer your specific questions about acceptance criteria, study design (sample size, data provenance, expert adjudication, MRMC, standalone performance), and ground truth establishment, which are typical for AI/ML device submissions, is not present in this document.
The document focuses on:
- The FDA's determination of substantial equivalence to a predicate device.
- Regulatory classifications and general controls (e.g., annual registration, GMP, labeling).
- Indications for Use for the Diazyme Lipoprotein (a) Assay, which is for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum.
To answer your questions, I would need a different type of document, such as a clinical study report or a detailed premarket submission summary (e.g., from the FDA's 510(k) database if it provided more detail than this letter).
Therefore, I cannot populate the table or answer the specific questions about the study design, ground truth, and expert involvement based on the provided text.
§ 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).