(20 days)
Immunoassay for the qualitative detection of barbiturates, benzodiazepine and/or their metabolites in human urine to assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drugs.
AccuSign® DOA2 (BAR/BZO)
The provided document is a 510(k) clearance letter from the FDA for the AccuSign® DOA2 (BAR/BZO) device. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed study information required to answer your questions about acceptance criteria, performance, sample sizes, ground truth establishment, or expert qualifications.
The letter acknowledges the submission and clearance but does not include the specifics of the performance studies or the data generated from them. To answer your questions, one would need to refer to the original 510(k) submission (K991082) itself, which would contain the study reports and data.
Therefore, I cannot provide the requested information based on the text provided.
§ 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).