(33 days)
The ABM Rapid Drug Screen™ is for the determination of Cocaine, Triavelier, Opiates, Marijuana, PCF, Barontales, Donzoulasspance, Barry, Tricyclics, Methampletamine and Ecstasy in human urine. The device provides only qualitative results and is intended for professional use only.
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The provided document is a 510(k) premarket notification letter from the FDA to American Bio Medica Corporation regarding their Rapid Drug Screen™ device. It confirms the device's substantial equivalence to other legally marketed devices and permits marketing.
Unfortunately, the document does not contain the detailed information necessary to answer the specific questions about the acceptance criteria and the study proving the device meets those criteria. The provided text is a regulatory approval letter, not a scientific study report or a summary of performance data.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size.
- If a standalone performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
To obtain this information, one would typically need to consult the full 510(k) submission, including the detailed performance studies, which are usually much more extensive than the approval letter itself.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).