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510(k) Data Aggregation
(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 |
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