(51 days)
Abuscreen ONLINE for Cannabinoids is an in vitro diagnostic test for the qualitative and semiquantitative detection of cannabinoids in human urine on automated clinical chemistry analyzers at cutoff concentrations of 20 ng/mL, 50 ng/mL, and 100 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of cannabinoid use or abuse.
Abuscreen ONLINE Cannabinoids is an in vitro diagnostic test for the qualitative and semiquantitative detection of cannabinoids and its metabolites in human urine on automated clinical chemistry analyzers at cutoff concentrations of 20 ng/mL, 50 ng/mL, and 100 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of cannabinoid use or abuse.
The proposed Abuscreen ONLINE Cannabinoids test kit is specifically intended for use on the Hitachi 917 Analyzer and future similar analyzer models. It was adapted from the currently marketed Abuscreen ONLINE Cannabinoids test kit. The labeling and packaging have been changed for use on the Hitachi 917 Analyzer as well as an addition of a surfactant to the diluent. This modified test kit is not a replacement to the currently marketed kit.
The Hitachi 917 Analyzer System is a fully automatic, computer-controlled system for clinical chemistry. It was conceived for both quantitative and qualitative in vitro determination using a large variety of tests for analysis, e.g. in serum and urine. Integrated in the system is an ion-selective unit for determination of electrolytes. The throughout per hour is 800 tests for clinical chemistry (1200 with electrolytes). The system consists of the analyzer which performs all functions required for fully automatic sample and test processing. Beginning with the automatic recording of patient samples - provided that they are supplied in barcode-labeled vessels - up to the photometric measurement and results transmission to the computer unit.
The Abuscreen ONLINE Cannabinoids device meets its acceptance criteria through various performance characteristics, primarily precision (qualitative and quantitative) and accuracy studies across different cutoff concentrations (20 ng/mL, 50 ng/mL, and 100 ng/mL).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by performing "Precision Qualitative" where >95% negative at a concentration below the cutoff and >95% positive at a concentration above the cutoff should be observed. Precision is also assessed by coefficients of variation (CV%) for both within-run and day-to-day measurements of optical density (OD) and concentration (ng/mL). Accuracy is assessed by comparing the device's qualitative results with confirmed positive samples.
| Performance Characteristic | Acceptance Criteria (Implicit from Predicate/Standard Practice) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Precision Qualitative (20 ng/mL Cutoff) | ||
| at 15 ng/mL (Negative) | >95% negative | >95% negative |
| at 25 ng/mL (Positive) | >95% positive | >95% positive |
| Within Run CV% (OD) | Low CV% (e.g., 95% negative | >95% negative |
| at 60 ng/mL (Positive) | >95% positive | >95% positive |
| Within Run CV% (OD) | Low CV% (e.g., 95% negative | >95% negative |
| at 120 ng/mL (Positive) | >95% positive | >95% positive |
| Within Run CV% (OD) | Low CV% (e.g., |
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).