(35 days)
The ARCHITECT C-Peptide Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of C-peptide in human serum, plasma and urine.
The ARCHITECT C-Peptide Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the quantitative determination of C-peptide in human serum, plasma and urine.
For in vitro diagnostic use.
Not Found
The provided document is a 510(k) summary for the ARCHITECT C-Peptide Calibrators and Controls. It describes the intended use and states substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria or a study proving device performance against such criteria.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves the device meets them based on the provided text. The document is a regulatory approval notification, not a performance study report.
§ 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.