(13 days)
The Raichem LIPID Calibrator is intended to be used for the calibration of the Raichem LDL and HDL Cholesterol Direct assay.
Not Found
The provided text is related to an FDA 510(k) premarket notification for a medical device called "RAICHEM® LIPID Calibrator." This document is a clearance letter and does not contain the detailed study information, acceptance criteria, or performance data that would be used to prove the device meets acceptance criteria.
The information you've requested (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is typically found in the 510(k) submission itself, or in supporting validation studies referenced within the submission, not in the FDA's clearance letter.
The clearance letter primarily states that the FDA has reviewed the submission (K022767) and determined the device is substantially equivalent to a legally marketed predicate device for the stated indications for use (calibration of Raichem LDL and HDL Cholesterol Direct assay).
Therefore, based solely on the provided text, I cannot fulfill your request for details on acceptance criteria and study data.
§ 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.