(133 days)
The Ameditech ImmuTest™ Drug Screen COC is an In Vitro screen test for the qualitative detection of benzoylecgonine (cocaine metabolite) in human urine at cut-off concentration of 300 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use.
Not Found
This document is the FDA's acceptance of Ameditech, Inc.'s 510(k) premarket notification for their ImmuTest™ Drug Screen COC. It does not contain information about the study or acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document is an approval letter, not a study report or technical specification.
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).