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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 <0.01%) at different concentrations. Other drugs and compounds showed no or minimal cross-reactivity. |
| Precision (Within-run) | Not explicitly stated in the provided text, but implied by standard laboratory practice. | For Benzodiazepine 1: %CV ranged from 0.0% to 1.1% for positive samples and 1.9% to 2.8% for negative samples. For Benzodiazepine 2: %CV ranged from 0.0% to 0.5% for positive samples and 1.6% to 2.0% for negative samples. |
| Precision (Between-run) | Not explicitly stated in the provided text, but implied by standard laboratory practice. | For Benzodiazepine 1: %CV ranged from 0.0% to 1.7% for positive samples and 2.1% to 2.7% for negative samples. For Benzodiazepine 2: %CV ranged from 0.0% to 1.2% for positive samples and 1.8% to 2.5% for negative samples. |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- GC/MS Comparison: 288 samples (144 negative, 144 positive) were tested for each assay.
- Cross-reactivity: Varies depending on the compound tested, but numerous compounds were evaluated at different concentrations.
- Precision:
- Within-run: 20 replicates of each sample were tested.
- Between-run: 20 replicates of each sample were tested over 5 days.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective for the clinical samples. The study appears to be an analytical validation conducted internally by Randox Laboratories.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)
- Number of Experts: Not applicable in the context of this device being a chemical assay.
- Qualifications of Experts: Not applicable. The ground truth for the clinical sample comparison was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is an objective chemical method.
4. Adjudication Method for the Test Set
- Not applicable for a chemical assay. The comparison was made against GC/MS as the gold standard, not expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This is a standalone chemical assay, not an imaging device or a diagnostic tool that relies on human interpretation.
6. Standalone Performance Study
- Yes, a standalone study was performed. The described performance data (accuracy against GC/MS, cross-reactivity, and precision) are all measures of the algorithm's (the assay's) performance without human-in-the-loop assistance for interpretation. The assay provides a qualitative result (positive/negative) automatically based on a predefined cutoff.
7. Type of Ground Truth Used
- The primary ground truth used for establishing the accuracy of the BENZODIAZEPINE CLASS ASSAY was Gas Chromatography/Mass Spectrometry (GC/MS). For the precision and cross-reactivity studies, known concentrations of various substances were used.
8. Sample Size for the Training Set
- The document does not explicitly mention a "training set" in the context of machine learning, as this is a chemical assay with established analytical principles, not an AI/ML algorithm. The development of such an assay involves extensive laboratory work to optimize reagents and reaction conditions, which could be considered an analogous "training" phase to achieve desired sensitivity and specificity. However, specific sample sizes for this development are not provided.
9. How the Ground Truth for the Training Set Was Established
- Not applicable as this is not an AI/ML algorithm with a distinct training set. The "ground truth" during the development of the assay would have been established through a combination of:
- Known concentrations of benzodiazepine compounds and their metabolites.
- Known concentrations of potential cross-reactants.
- Reference analytical methods (like GC/MS) used during the assay's development to ensure its chemical specificity and sensitivity.
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