(35 days)
The Microprotein Standard 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.
MICROPROTEIN STANDARD KIT
This document is a 510(k) clearance letter from the FDA for a device called "Microprotein Standard Kit." It does not contain information about acceptance criteria, study details, or performance data for the device.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."
This means the device was cleared based on its substantial equivalence to a predicate device, not on a new study demonstrating its performance against specific acceptance criteria.
Therefore, I cannot provide the requested information from this document. The 510(k) process often relies on existing data or equivalence to established devices rather than requiring new clinical trials with detailed performance metrics and acceptance criteria as would be found in a Premarket Approval (PMA) application or a de novo submission.
§ 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.