(71 days)
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the calibration of Pointe Scientific's autoHDL™ Cholesterol assay in serum or plasma. It is intended for in vitro diagnostic use only.
autoHDL™ Cholesterol Calibrator
The provided text is a 510(k) clearance letter from the FDA for the autoHDL™ Cholesterol Calibrator. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications.
The letter is a regulatory document confirming that the device is substantially equivalent to a predicate device and can be marketed. It does not include the detailed technical study results typically found in a clinical or performance validation report. Therefore, I cannot extract the requested information from this document.
§ 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.