(169 days)
The STC Methamphetamine Micro-Plate EIA is intended for use in the qualitative determination of methamphetamine in oral fluid collected with the EpiScreen™ Oral Specimen Collection Device. For In Vitro Diagnostic Use.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA to STC Technologies, Inc. for their Methamphetamine Micro-Plate EIA device. This type of document confirms that the FDA has determined the device is substantially equivalent to a legally marketed predicate device.
However, the letter itself does not contain the detailed study results, acceptance criteria, or performance data that would be used to answer your specific questions. It primarily addresses the regulatory status and marketing approval of the device.
To answer your questions, I would need to review the actual 510(k) submission document or a summary of its contents, which would include the study design, acceptance criteria, and performance data. This information is not present in the provided FDA clearance letter.
§ 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).