(18 days)
Immunoassay for the qualitative detection of amphetamine or methamphetamine, opiates, evcaine metabolites, THC metabolites, and phencyclidine in human urine to assist in screening of drugs of abuse samples. The detecting cut-off concentrations are as follows:
THC 11-nor-Δ9-9-carboxylic acid 50 ng/mL
OPI Morphine 300 ng/mL
COC Benzoylecgonine 300 ng/mL
AMP Amphetamine 1000 ng/mL
MET D-Methamphetamine 1000 ng/mL
PCP Phencyclidine 25 ng/mL
Not Found
I am sorry, but the provided text does not contain information regarding rejection criteria or studies that prove the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a drug screening device, outlining the device's substantial equivalence to predicate devices and its intended use. It does not include performance data, study design details, or acceptance criteria tables.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide the associated table, sample sizes, expert qualifications, or other study-specific details.
§ 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).