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510(k) Data Aggregation
(121 days)
The Abuscreen OnLine II for Opiates 300/2000 Reagent is an in vitro diagnostic test for the qualitative (at 300 and 2000 ng/mL cutoff) and semi-quantitative (at 2000 ng/mL cutoff) detection of morphine and its metabolites in human urine.
The Abuscreen ONLINE Opiates Calibration Pack is an in vitro diagnostic device designed for the calibration of the Roche reagent assays for opiates.
The Roche Abuscreen ONLINE Opiates Control Pack is an assayed quality control sample for use with the Roche assays for opiates.
The Abuscreen OnLine II for Opiates 300/2000 Reagent is an in vitro diagnostic test for the qualitative (at 300 and 2000 ug/mL cutoff) and serni-quantitative (at 2000 ng/mL cutoff) detection of morphine and its metabolites in human urine.
The Abuscreen OnLine Opiates Calibration Pack is an in vitro diagnostic device designed for the calibration of the Roche reagent assays for opiates.
The Roche Abuscreen ONLINE Opiates Control Pack is an assayed quality control sample for use with the Roche assays for opiates.
The Abuscreen OnLine II for Opiates 300/2000 Reagent is an in vitro diagnostic test designed for the qualitative and semi-quantitative detection of morphine and its metabolites in human urine. The following describes its acceptance criteria and the study that demonstrates its performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (Abuscreen OnLine II Opiates Reagent) |
|---|---|---|
| 300 ng/mL Qualitative Application | ||
| Assay Range | Up to 600 ng/mL | Up to 2000 ng/mL |
| Precision (Negative Reading) | >95% confidence at 80% cutoff | >95% confidence at 80% cutoff |
| Precision (Positive Reading) | >95% confidence at 120% cutoff | >95% confidence at 120% cutoff |
| Accuracy (% Agreement vs. GC/MS) | 100% (N=49) | 100% (N=40) |
| Sensitivity (Analytical) | < 5.0 ng/mL | < 12 ng/mL |
| 2000 ng/mL Quantitative Application | ||
| Assay Range | Up to 4000 ng/mL | Up to 8000 ng/mL |
| Precision (Within-run) | 1.7% at 246 ng/mL, 1.7% at 297 ng/mL, 0.7% at 359 ng/mL | 2.2% at 1000 ng/mL, 3.3% at 1600 ng/mL, 2.8% at 2000 ng/mL, 3.8% at 2400 ng/mL, 4.2% at 4000 ng/mL |
| Accuracy (% Agreement vs. GC/MS) | 100% (N=49) | 100% (N=42) |
| Sensitivity (Analytical) | < 5.0 ng/mL | < 12 ng/mL |
2. Sample Sizes Used for the Test Set and Data Provenance
- Accuracy (300 ng/mL qualitative application): N = 40 samples
- Accuracy (2000 ng/mL quantitative application): N = 42 samples
- Data Provenance: Not explicitly stated, but the submission is from Roche Diagnostic Systems, Inc. in the USA. Given the context of a 510(k) submission for an in vitro diagnostic device, the data is likely from retrospective or prospective studies conducted by the manufacturer, but this is not specified.
3. Number of Experts and their Qualifications for Ground Truth
Not applicable. The study utilized Gas Chromatography/Mass Spectrometry (GC/MS) as the reference method for establishing ground truth, not human experts.
4. Adjudication Method for the Test Set
Not applicable, as human expert adjudication was not used. GC/MS served as the objective reference method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is an in vitro diagnostic device, and its performance is evaluated against a reference method (GC/MS) rather than through comparison of human reader performance with and without AI assistance.
6. Standalone Performance
Yes, a standalone performance study was conducted. The tables provided (Table 3) detail the performance characteristics of the Abuscreen OnLine II for Opiates 300/2000 Reagent independently, comparing its results directly with GC/MS. This evaluates the algorithm's performance without a human-in-the-loop component for result interpretation.
7. Type of Ground Truth Used
The ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS). For in vitro diagnostic tests, especially for drug detection, GC/MS is considered the gold standard for analytical accuracy.
8. Sample Size for the Training Set
The document does not specify the sample size for the training set. This information is typically not included in these types of summary documents for in vitro diagnostic devices, as the focus is on validation performance against a reference method.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly state how the ground truth for any training set was established. However, given that GC/MS was used for test set validation, it is highly probable that similar laboratory methods, likely GC/MS, would have been used to establish ground truth for any internal training or development datasets.
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