(41 days)
The Ethyl Alcohol Clinical Standard Solutions are intended for use in the calibration and standardization of instruments and methods for the determination of Ethyl alcohol in whole blood or serum. The Standard Solutions may also be used for validation of the standardization of instruments and/or control materials.
Not Found
The provided text is a 510(k) clearance letter from the FDA for an "Ethyl Alcohol Calibrator" product. It states that the device is substantially equivalent to a predicate device and can be marketed.
However, the document does not contain specific information about:
- Acceptance criteria for device performance.
- The study that proves the device meets acceptance criteria (e.g., performance metrics, statistical analyses).
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- Multi-reader multi-case (MRMC) studies or effect sizes.
- Standalone algorithm performance.
- Types of ground truth used or how it was established.
The document is a regulatory approval letter, not a performance study report. Therefore, I cannot extract the requested information from the given text.
§ 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.