(104 days)
The STC AUTO-LYTE® Barbiturates EIA is intended for use in the qualitative determination of barbiturates in urine. This test is intended for in vitro diagnostic use.
Not Found
This looks like a 510(k) clearance letter for the STC AUTO-LYTE® Barbiturates EIA device, dated November 18, 1998. It confirms the device's substantial equivalence to a predicate device and lists its intended use. However, this document does not contain the detailed study information, acceptance criteria, or performance data that you've requested.
The letter itself is the result of the FDA's review process, which would have involved the manufacturer submitting such studies and data. To answer your questions, I would need access to the actual 510(k) submission document (K982745) that STC Technologies, Inc. sent to the FDA, which is typically not publicly available in this level of detail for older submissions like this one, or the device's labeling which might summarize performance.
Therefore, based solely on the provided text, I cannot answer your questions.
§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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).