(47 days)
The Ethyl Alcohol Clinical Standard Solutions are intended for use in the calibration and standardization caruments and methods for the determination of ethyl alcohol in whole blood or serum. The Standard tions may also be used for validation of the laboratory's routine standards and/or control materials.
Not Found
This document is a 510(k) clearance letter from the FDA for "Ethyl Alcohol Clinical Standard Solutions." It does not contain information about acceptance criteria or a study proving device performance in the way described in the request. The letter confirms substantial equivalence to a legally marketed predicate device, but it doesn't detail performance metrics or studies.
Therefore, I cannot extract the requested information from the provided text. The document is regulatory approval, not a performance study report.
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology 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. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (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.