(174 days)
The Benzodiazepines assay is used for the qualitative analysis of benzodiazepines in human urine with a cutoff of 200 ng/mL. For use in clinical laboratories. Measurements obtained by this device are used in the diagnosis of benzodiazepines use or overdose. The Benzodiazepines assay is calibrated with lormetazepam and will detect a variety of benzodiazepines and their metabolites. The Benzodiazepines assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GCMS) 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 Benzodiazepines assay is an in vitro diagnostic assay for the qualitative analysis of benzodiazepines in human urine. The assay is a homogeneous enzyme immunoassay with a 200 ng/mL cutoff. The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity can be measured in terms of enzyme activity. Active enzyme concentration in the specimen can be measured in decreases upon binding to the antibody, so the drug converted D to NADH, resulting in an absorbance change that can be measured spectrophotometrically.
This document describes the Abbott Laboratories Benzodiazepines assay, an in vitro diagnostic assay for the qualitative analysis of benzodiazepines in human urine. The summary provides information on its substantial equivalence to a predicate device and performance characteristics.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Agreement with predicate device (Emit II Benzodiazepine assay) | 99% agreement |
| Agreement with GC/MS (reference method) | 87% agreement |
| Sensitivity (Limit of Detection) | 15 ng/mL |
| Precision (Within-run %CV) | Verifier I: 1.36% |
| Cutoff Calibrator: 1.48% (total %CV) | |
| Verifier II: 1.10% | |
| -25% Control of Cutoff Calibrator: 1.92% | |
| +25% Control of Cutoff Calibrator: 1.60% | |
| Cutoff | 200 ng/mL |
Study Details
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the total number of clinical specimens used in the comparative performance studies. However, it mentions that the clinical specimens tested ranged from 57.5 to 13,174.0 ng/mL, suggesting a variety of concentrations were included.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for this type of in vitro diagnostic device study. The ground truth (or reference method) was established using another immunoassay (Emit II Benzodiazepine assay) and Gas Chromatography/Mass Spectrometry (GC/MS), which is an analytical chemical method and does not typically involve human expert interpretation for establishing ground truth in this context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as the ground truth was established by analytical methods (another immunoassay and GC/MS) rather than human adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that would involve human readers interpreting results.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance characteristics describe the standalone performance of the Abbott Benzodiazepines assay. The "99% agreement" with the predicate device and "87% agreement" with GC/MS reflect the algorithm's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established by:
- Predicate Device: Emit II Benzodiazepine assay on the SYVA-30R Analyzer (for "substantial equivalence" comparison).
- Reference Method: Gas Chromatography/Mass Spectrometry (GC/MS) (for analytical correlation).
8. The sample size for the training set:
- The document does not provide information on a specific "training set" as this is not a machine learning or AI algorithm in the contemporary sense requiring a distinct training phase. This is an immunoassay, and its development would typically involve optimization and validation rather than training on a separate dataset in the way an AI model is trained.
9. How the ground truth for the training set was established:
- Not applicable (see point 8).
§ 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).