(55 days)
The Emit® II Plus Cannabinoid Assay is a homogeneous drugs-of-abuse enzyme immunoassay with a 20 ng/mL, 50 ng/mL (SAMHSA initial test cutoff level), or 100 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of cannabinoids in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.
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The Syva Emit® II Plus Cannabinoid Assay is a homogeneous enzyme immunoassay intended for qualitative and semiquantitative analyses of cannabinoids in human urine, with three different cutoff protocols: 20 ng/mL, 50 ng/mL, and 100 ng/mL. The studies provided demonstrate the device's performance against established predicate methods.
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents performance data for three protocols (20 ng/mL, 50 ng/mL, and 100 ng/mL). The acceptance criteria are implicitly defined by the reported performance relative to the predicate devices and the internal precision and sensitivity targets.
Protocol: 20 ng/mL
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Comparative Analysis | High correlation and agreement with predicate method | 100% agreement with Emit® II Cannabinoid 20 ng Assay (predicate method) in finding samples negative and positive. |
| Spiked Sample Recovery | Correct identification of spiked specimens around cutoff. | Correctly identified spiked specimens: = +25% of cutoff as positive. |
| Semiquantitative Recovery | Recovery within an acceptable range of nominal concentrations for spiked analytes. | 79%-106% recovery of nominal concentrations for THC levels 15-55 ng/mL. |
| Precision (Qualitative) | Acceptable within-run and total precision (%CV). | Within-run %CV: 0.5-0.8%; Total %CV: 1.4-2.6%. |
| Precision (Semiquantitative) | Acceptable within-run and total precision (%CV). | Within-run %CV: 1.8-2.3%; Total %CV: 4.9-6.7%. |
| Sensitivity | Lowest concentration distinguishable from 0 ng/mL with 95% confidence. | = +25% of cutoff as positive. |
| Semiquantitative Recovery | Recovery within an acceptable range of nominal concentrations for spiked analytes. | 86%-118% recovery of nominal concentrations for Cannabinoids levels 25-180 ng/mL. |
| Precision (Qualitative) | Acceptable within-run and total precision (%CV). | Within-run %CV: 0.6-0.7%; Total %CV: 1.4-2.1%. |
| Precision (Semiquantitative) | Acceptable within-run and total precision (%CV). | Within-run %CV: 1.3-1.5%; Total %CV: 2.8-5.4%. |
| Sensitivity | Lowest concentration distinguishable from 0 ng/mL with 95% confidence. | = +25% of cutoff as positive. |
| Semiquantitative Recovery | Recovery within an acceptable range of nominal concentrations for spiked analytes. | 80%-106% recovery of nominal concentrations for Cannabinoids levels 15-180 ng/mL. |
| Precision (Qualitative) | Acceptable within-run and total precision (%CV). | Within-run %CV: 0.6-0.7%; Total %CV: 1.4-2.0%. |
| Precision (Semiquantitative) | Acceptable within-run and total precision (%CV). | Within-run %CV: 2.1-2.7%; Total %CV: 6.0-7.4%. |
| Sensitivity | Lowest concentration distinguishable from 0 ng/mL with 95% confidence. |
§ 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).