(68 days)
dBest Cocaine Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of cocaine and primarily benzoylecgonine as metabolites in urine with cutoff of 300 ng/ml. The dBest Cocaine Test Kits are for professional and laboratory use only.
dBest Cocaine Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of cocaine and primarily benzoylecgonine as metabolites in urine with cutoff of 300 ng/ml.
This appears to be a 510(k) clearance letter from the FDA for a device called "dBest Cocaine Test Kit." However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
The document primarily focuses on:
- Confirming the substantial equivalence of the "dBest Cocaine Test Kit" to a legally marketed predicate device.
- Outlining the regulatory implications and responsibilities of the manufacturer (AmeriTek, Inc.).
- Providing contact information for various FDA offices.
- Stating the intended use of the device.
To address your request, I would need a different document, likely a 510(k) Summary, 510(k) Premarket Notification submission, or a clinical study report associated with this device. These documents typically contain the detailed performance data, study designs, and acceptance criteria you are asking for.
Since the provided text does not contain the necessary information, I cannot complete the table or answer the specific questions about acceptance criteria and the supporting study.
§ 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).