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(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) |
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