(66 days)
The alcohol reagent set is for the quantitative determination of ethyl alcohol in serum or whole blood. Alcohol analysis is most frequently requested for emergency room patients to aid in the differential diagnosis of central nervous system depression, which can be due to alcohol intoxication. It is also requested for forensic medicine purposes.
Alcohol Reagent Set
This document is a 510(k) clearance letter from the FDA for an "Alcohol Reagent Set." It does not contain information about acceptance criteria or a study proving device performance in the way typically seen for AI/ML-driven medical devices.
The letter indicates that the device is substantially equivalent to a pre-amendment device, which means it likely passed based on performance characteristics similar to those already on the market, rather than a new clinical study with detailed acceptance criteria and performance metrics.
Therefore, I cannot provide the requested information from the provided text. The document is a regulatory approval notice, not a scientific report detailing a device's performance study.
§ 862.3040 Alcohol test system.
(a)
Identification. An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.(b)
Classification. Class II.