(61 days)
For the quantitative determination of ethanol in serum. For IN VITRO diagnostic use.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding the "Ethanol-L3K Assay." This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications in the way you've requested for an AI/ML medical device.
The information you are asking for typically comes from the actual 510(k) submission document itself, or from a scientific publication detailing the device's validation. This FDA letter is merely the agency's response granting market clearance.
Therefore, I cannot fulfill your request for the specific details outlined as they are not present in the provided text.
§ 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.