(20 days)
Immunoassay for the qualitative detection of barbiturates, benzodiazepine, phencyclidine, and/or their metabolites in human urine.
Not Found
The provided document is limited to a 510(k) clearance letter for the AccuSign® DOA3 (BZO/BAR/PCP) device, which is an immunoassay for the qualitative detection of certain drugs in human urine. A 510(k) clearance determines substantial equivalence to a legally marketed predicate device, but it does not typically include detailed information about the acceptance criteria and the specific study data that demonstrates the device meets those criteria.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available within the provided document.
The document primarily states that the FDA reviewed the 510(k) notification and determined the device is substantially equivalent for the stated indications for use (qualitative detection of barbiturates, benzodiazepine, phencyclidine, and/or their metabolites in human urine).
To obtain the detailed study information you're asking for, one would typically need to refer to:
- The original 510(k) submission itself, which contains the test data and performance validation.
- The device's Instructions for Use (IFU) or package insert, which often includes performance characteristics.
- Scientific publications or clinical study reports if the manufacturer chose to publish the validation data.
Without these additional documents, I cannot fulfill your request for the specific study details.
§ 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).