(110 days)
The SYNCHRON Systems Cannabinoid 20 ng Reagent, in conjunction with the SYNCHRON Systems THC Urine Calibrators, is intended for use in the qualitative determination of cannabinoids in human urine samples. This assay is designed for use with the family of SYNCHRON Systems, which include analyzers such as the SYNCHRON® CX4, CX@4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.
The SYNCHRON Cannabinoid 20 ng Reagent is an enzyme immunoassay reagent test kit for the SYNCHRON Systems and provides a rapid screening procedure for determining the presence of cannabinoids and it's metabolites in urine. It is designed to complement the current panel of CX Drugs of Abuse Assays, previously cleared by FDA. The kit consists of reagent and calibrators.
Acceptance Criteria and Device Performance for BECKMAN SYNCHRON® Systems Cannabinoid 20 ng Reagent
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. Instead, it describes "equivalence" to a predicate device through various performance studies. Therefore, the "acceptance criteria" are inferred from the demonstrated performance that supports substantial equivalence.
| Performance Metric | Inferred Acceptance Criteria (based on predicate equivalence) | Reported Device Performance (SYNCHRON Cannabinoid 20 ng Reagent) |
|---|---|---|
| Overall Agreement | High agreement with predicate (Emit II Cannabinoid Reagent) | 99% |
| Relative Sensitivity | High sensitivity relative to predicate | 99% |
| Relative Specificity | High specificity relative to predicate | 100% |
| Number of Discordant with Emit II | Low number of discordant results (indicating strong agreement) | 1 |
| Shelf-life (unopened) | At least 12 months (matching or exceeding predicate) | 12 months |
| On-Instrument Stability | At least 60 days (matching or exceeding predicate) | 60 days |
| Calibration Frequency | 7 days | 7 days |
| Within-Run Imprecision (%CV) | Low variability (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).