(22 days)
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.
A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.
Olympus HDL Cholesterol Reagent & Calibrator
The provided document is a 510(k) clearance letter from the FDA for the Olympus HDL Cholesterol Reagent & Calibrator. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain specific acceptance criteria or details of a study demonstrating the device meets those criteria.
Therefore, I cannot provide the requested information based on the given text. A 510(k) clearance typically relies on demonstrating substantial equivalence to a predicate device, which may involve analytical performance data, but the specific acceptance criteria and study design are not included in this document.
To answer your request, I would need a different type of document, such as a summary of safety and effectiveness, a detailed study report, or a submission dossier that outlines the specific performance studies conducted for the device.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.