(190 days)
Acro Rapid Benzoylecgonine (Cocaine) Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Benzoylecgonine in hyman wipe at a cutoff of 300 ng/mL The test is used to obtain a visual qualitative result and is intended for laboratory use only.
This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) anchiate is preferred.
Acro Rapid Benzoylecgonine (Cocaine) Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Benzoylecgonine in hyman wipe at a cutoff of 300 ng/mL
The provided text is related to the FDA 510(k) premarket notification for the "Acro Rapid Benzoylecgonine (Cocaine) Urine Test." It describes the regulatory approval of the device and its intended use. However, it does not contain any information about acceptance criteria, detailed study results, sample sizes, ground truth establishment, or expert involvement as requested.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the specific questions regarding the study design and results based on the provided text. The document is a regulatory approval letter and a statement of indications for use, not a detailed study report.
§ 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).