(54 days)
The MATRIX PLUS Multi-calibrator Kit 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.
MATRIX PLUS MULTI-CALIBRATOR KIT
The provided document is a 510(k) premarket notification letter from the FDA for a device called "MATRIX PLUS™ Multi-Calibrator Kit." This document is a regulatory approval letter and an "Indications for Use" statement. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot provide the requested information based on the given text. The letter only confirms that the FDA has reviewed the notification and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
§ 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.