(123 days)
Pacific Hemostasis Reference Emulsion is intended to be used on Instrumentation Laboratories ACL system.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding the "Pacific Hemostasis Reference Emulsion" device. This document primarily focuses on regulatory approval and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in the prompt regarding a study proving device meets acceptance criteria.
The letter states that the FDA has reviewed the 510(k) and determined the device is "substantially equivalent" to legally marketed predicate devices. This indicates that the device has met regulatory requirements for market approval based on comparison to existing devices, but it does not detail the specific performance metrics or studies used to demonstrate that equivalence.
Therefore, I cannot provide the requested information based on the content of the 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.