(111 days)
evidence® Benzodiazepine Assay: The evidence® Benzodiazepine test has been designed for use on the evidence@analyser for qualitative detection of benzodiazepine compounds. drugs with sedative and hypnotic effects, in urine using a cut-off concentration of 200ng/ml. Qualitative results obtained can be utilized in the diagnosis and treatment of benzodiazepine use or overdose. evidence® performs two Benzodiazeoine based on - oxazepam (Benzodazepine Assay 1) and lorazepam assavs (Benzodiazepine Assay 2). This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography / mass spectrometry (GC/MS) is the preferred method. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The evidence® benzodiazenine class assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
The evidence® Drugs of Abuse Calibrators: The evidence®Drugs of Abuse Calibrators are liquid Calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone, morphine sulphate pentahydrate, Phenobarbital, 11-nor-D9-THC-9 carboxylic acid, oxazepam and lorazepam. There are 9 levels of calibrator. They have been developed for use in calibration of the evidence® system. The evidence® Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
evidence® Benzodiazepine Assay: Qualitative detection of benzodiazepine compounds in urine using a cut-off concentration of 200ng/ml. Performs two assays based on oxazepam and lorazepam.
The evidence® Drugs of Abuse Calibrators: Liquid Calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone, morphine sulphate pentahydrate, Phenobarbital, 11-nor-D9-THC-9 carboxylic acid, oxazepam and lorazepam. 9 levels of calibrator for use in calibration of the evidence® system.
1. Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (from the predicate device) | Reported Device Performance (BENZODIAZEPINE CLASS ASSAY) |
|---|---|---|
| Accuracy against GC/MS | Not explicitly stated in the provided text, but implied as the preferred confirmation method. | 100% agreement with GC/MS for positive and negative samples at the 200 ng/ml cutoff. |
| Cross-reactivity | Not explicitly stated in the provided text, but implied by the need for specificity. | Various benzodiazepine compounds showed reactivity (ranging from 100% to |
§ 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).