(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) |
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).