(93 days)
The STC AUTO-LYTE® Benzodiazepines EIA is intended for use in the Indications I of OSC. The DFC TOTO Cepines in urine. This test is intended for in vitro diagnostic use.
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I apologize, but the provided text from the FDA 510(k) summary (K982831/S2 for the AUTO-LYTE® Benzodiazepine EIA) does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria in the format requested.
The document is an FDA clearance letter and an "Indications For Use" statement. It confirms the device's substantial equivalence to a predicate device and its intended use for the qualitative detection of benzodiazepines in urine. However, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test and training sets, or data provenance.
- Details about experts, ground truth establishment, or adjudication methods.
- Information about MRMC studies or standalone algorithm performance.
To obtain this information, one would typically need to refer to the full 510(k) submission document or a detailed performance study report, which are not included in the provided text.
§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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).