(20 days)
Immunoassay for the qualitative detection of barbiturates 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 drug.
Not Found
I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA, which confirms that the identified device, AccuSign® BAR, is substantially equivalent to a legally marketed predicate device.
The letter mentions the indications for use of the device: "Immunoassay for the qualitative detection of barbiturates 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 drug."
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Information on MRMC comparative effectiveness studies or specific effect sizes.
- Information on standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set or how its ground truth was established.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study based on this document.
§ 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).