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510(k) Data Aggregation
(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.
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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.
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