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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.

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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.

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