(25 days)
Benzodiazepine (BENZ) Reagent, in conjunction with SYNCHRON® Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of benzodiazepines in human urine at a cutoff value of 200 ng/mL (oxazepam), on SYNCHRON Systems.
The Benzodiazepine assay provides a rapid screening procedure for determining the presence of benzodiazepines in urine. This test provides only a preliminary analytical result; a positive result by this assay should be confirmed by another generally accepted non-immunological method, such as thin layer chromatography (TLC), gas chromatography (GC), or gas chromatography/mass spectrometry (GC/MS). GC/MS is the preferred confirmatory method.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The SYNCHRON Systems Benzodiazepine (BENZ) reagent is designed for optimal performance on the SYNCHRON CX (CX4/4CE/4A/4PRO, CX5/5CE/5Δ/5PRO, CX7/7RTS/7Δ/7PRO, CX9ALX/9PRO, LX20/PRO, and UniCel DxC 600/800 Systems. The reagent kit contains one 250-test cartridge that is packaged separately from the associated calibrators.
The provided text is a 510(k) summary for the SYNCHRON Systems Benzodiazepine Reagent. It mentions a modification to the predicate device and states that "Performance data from validation testing supports equivalency." However, it does not include the detailed performance data or a study report with acceptance criteria.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided document alone. The summary explicitly states "Summary of Performance Data Performance data from validation testing supports equivalency," but does not present that data or the acceptance criteria.
To fulfill your request, I would need access to the actual validation testing report that was submitted with the 510(k).
§ 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).