(28 days)
The Branan Medical Corporation Fastix Drug Screen THC/COC Dipstick Test is an in vitro screen test for the rapid detection of 11-nor-Delta9-Tetrahydrocannabinol-9-carboxylic acid (a metabolite) and Benzoylecgonine in human urine. The cutoff concentrations are as follows: THC 50 ng/ml, COC 300 ng/ml. The test kit is used to obtain a visual, qualitative result and is intended for professional use only. It is not intended for over-the-counter sale to lay persons.
The Branan Medical Corporation Fastix Drug Screen THC/COC/MET Dipstick Test is an in vitro screen test for the rapid detection of 11-nor-Delta9-Tetrahydrocannabinol-9-carboxylic acid, Benzoylecgonine and D-Methamphetamine in human urine. The cutoff concentrations are as follows: THC 50 ng/ml, COC 300 ng/ml, MET 1000 ng/ml. The test kit is used to obtain a visual, qualitative result and is intended for professional use only. It is not intended for over-the-counter sale to lay persons.
The Branan Medical Corporation Fastix Drug Screen OPI/MET/THC/COC Dipstick Test is an in vitro screen test for the rapid detection of Opiate, Methamphetamine, THC, and Cocaine in human urine. The cutoff concentrations are as follows: OPI 2000 ng/ml, MET 1000 ng/ml, THC 50 ng/ml, COC 300 ng/ml. The test kit is used to obtain a visual, qualitative result and is intended for professional use only. It is not intended for over-the-counter sale to lay persons.
The Branan Medical Corporation Fastix Drug Screen OPI/AMP/THC/COC Dipstick Test is an in vitro screen test for the rapid detection of Opiate, Amphetamine, THC and Cocaine in human urine. The cutoff concentrations are as follows: OPI 2000 ng/ml, AMP 1000 ng/ml, THC 50 ng/ml, COC 300 ng/ml. The test kit is used to obtain a visual, qualitative result and is intended for professional use only. It is not intended for over-the-counter sale to lay persons.
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This document outlines the Indications for Use and Cutoff Concentrations for several Fastix™ Drug Screen Dipstick Tests. It does not contain information about the acceptance criteria or a study proving that the device meets those criteria.
Therefore, I cannot provide the requested information from the given text.
The document primarily serves as a 510(k) premarket notification letter and describes the intended use and specific drug cutoffs for various configurations of the Fastix™ Drug Screen Dipstick Test. It indicates that the FDA has reviewed the submission and allows the device to be marketed.
§ 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).