(41 days)
The Bionike One Step Cocaine Test is a rapid immunochromatographic competitive assay used to screen human urine for the presence of benzoylecgonine at a cutoff concentration of 300ng/mL. The test is qualitative and provides only a preliminary analytical result which must be confirmed using GC/MS. The test is for use by health care professionals only.
Not Found
This FDA premarket notification (510k) provides marketing authorization for a device and therefore does not contain acceptance criteria or study data.
To clarify, 510(k)s demonstrate substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. This typically involves performance data compared to the predicate, but not necessarily a formal study with acceptance criteria in the same way a de novo or PMA submission would require.
Therefore, I am unable to provide the requested information based on the provided document.
§ 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).