(91 days)
BNZG reagent, when used in conjunction with SYNCHRON® System(s) and SYNCHRON® Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of Benzodiazepine (BNZG) in human urine at a cutoff value of 200 ng/mL (oxazepam).
The BNZG assay provides a rapid screening procedure for determining the presence of the analyte in urine. This test provides only a preliminary analytical result, a positive result by these assays 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.
Here's an analysis of the acceptance criteria and supporting study for the SYNCHRON® Systems BNZG Reagent, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state 'acceptance criteria' in a formal table with predefined targets. However, the study aims to demonstrate substantial equivalence to a predicate device, and the concordance summary provides the key performance metrics. Based on common practice for this type of device, acceptable performance would typically involve high sensitivity, specificity, and overall agreement with a confirmatory method, as well as good imprecision.
Here's a table based on the provided results, with implied acceptance based on the successful clearance of the device:
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (SYNCHRON® Systems BNZG Reagent) |
|---|---|---|
| Concordance Study | ||
| Sensitivity | High agreement with GC/MS (e.g., >90%) | 98% (for both SYNCHRON CX and LX systems) |
| Specificity | High agreement with GC/MS (e.g., >80%) | 84% (for both SYNCHRON CX and LX systems) |
| Overall Agreement | High agreement with GC/MS (e.g., >90%) | 92% (for both SYNCHRON CX and LX systems) |
| Imprecision Study | (Representative values shown) | |
| Within-Run %CV | Low variability (e.g., |
§ 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).