(135 days)
The STC Cannabinoids Micro-Plate EIA is intended for use in the qualitative determination of cannabinoids in oral fluid collected with the EpiScreen™ Oral Specimen Collection Device. For In Vitro Diagnostic Use.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "STC Cannabinoids Micro-Plate EIA." It acknowledges the device's clearance for marketing based on substantial equivalence to a predicate device. However, this document does not contain the acceptance criteria, reported device performance, or details of any studies as requested.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the device was cleared based on its similarity to existing legal devices, rather than a detailed performance study described in this letter.
Therefore, I cannot provide the requested information from the given text. To answer your questions, I would need a different document, such as the full 510(k) submission, a clinical study report, or a summary of safety and effectiveness data.
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).