(165 days)
Acro Rapid Benzodiazepine Urine Test is a lateral flow, rapid immunoassay for the qualitative Acro Rapid Oxazepam in human urine at a cutoff of 300 ng/mL. The test is used to obtain a visual, qualitative result and is intended for laboratory use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In mast be applied to a more specific al result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.
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The provided text is related to a 510(k) premarket notification for a medical device called "Acro Rapid Benzodiazepine Urine Test." This seems to be an in-vitro diagnostic device.
Unfortunately, the provided text does not contain any information about acceptance criteria, detailed study designs, sample sizes for training/test sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document is a letter from the FDA confirming the substantial equivalence of the device to legally marketed predicate devices, allowing it to be marketed. It also includes the "Indications for Use" for the device, which states:
Device Name: Acro Rapid Benzodiazepine Urine Test
Indications for Use: Acro Rapid Benzodiazepine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Oxazepam in human urine at a cutoff of 300 ng/mL. The test is used to obtain a visual, qualitative result and is intended for laboratory use only.
The letter explicitly states that this assay provides only a preliminary result and that a more specific alternate chemical method (like Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis) is needed to confirm a preliminary positive result. This implies that the device itself is not providing a definitive diagnostic outcome, but rather a screening result.
Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study proving the device meets them based on the provided text. This information would typically be found in the 510(k) submission summary or detailed study reports, which are not included in this extract.
§ 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).