(106 days)
The STC AUTO-LYTE® Cocaine Metabolite EIA is intended for use in the qualitative determination of benzoylecgonine in urine using a 300 ng/mL cutoff. This test is intended for in vitro diagnostic use.
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This document is a 510(k) clearance letter from the FDA for a device called "AUTO-LYTE® Cocaine Metabolite EIA." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain the acceptance criteria, details of a study that proves the device meets acceptance criteria, or any of the specific information requested in your prompt (e.g., sample sizes, expert qualifications, ground truth methods, MRMC studies, standalone performance).
The document only states the "Indications For Use" for the device, which is: "The STC AUTO-LYTE® Cocaine Metabolite EIA is intended for use in the qualitative determination of benzoylecgonine in urine using a 300 ng/mL cutoff. This test is intended for in vitro diagnostic use."
To provide the information you requested, I would need access to the actual 510(k) submission document (K982759) or supporting clinical/technical documentation, which is not available in these provided pages.
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).