(199 days)
The First Check® Home Drug Test Panel 2 is an educational screening test for the rapid detection of marijuana and cocaine and/or their metabolites in human urine at cut-off levels of 50ng/mL and 300ng/mL, respectively. The test is intended for consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the two drugs listed above in a human urine sample. Such information is beneficial to consumer efforts to comply with applicable laws and/or societal expectations. Information regarding second step confirmatory testing is provided.
The First Check® Home Drug Test Panel 2, like many commercially available drug screening tests, qualitatively measures the presence or absence of marijuana, and cocaine, and/or their metabolites in urine, using a one step, rapid chromatographic immunoassay which operates under the principle of recognition and formation of specific antibody/target drug/antibody complexes. The cutoff concentration for THC is 50ng/mL. The cut-off concentration for COC is 300ng/mL.
The provided document is a 510(k) summary for the First Check® Home Drug Test Panel 2. It describes the device's intended use, technological characteristics, and claims substantial equivalence to a legally marketed predicate device. However, it does not contain specific acceptance criteria, performance data from a study, or details about the study design, sample sizes, ground truth establishment, or expert involvement that you've requested.
The document states:
- Intended Use: "a preliminary, rapid screening test for the detection of marijuana and cocaine and/or their metabolites in urine." at cut-off levels of 50ng/mL for THC and 300ng/mL for COC.
- Safety and Effectiveness: "Because the First Check® Home Drug Test Panel 2 is identical to the Applied Biotech SureStep™ Drug Screen Multi Test that is legally marketed under K972425, and because no special skills, training, education, or licensure are required to transfer a dropper level of urine sample into the test card well, there is no issue regarding the safety or effectiveness of the product to perform its intended function, i.e., to screen urine for the presence or absence of the listed drugs and their metabolites."
Therefore, I cannot provide the requested information as it is not present in the given text.
To fully answer your questions, details from a specific performance study (clinical or in-vitro) would be required, which are typically found in the full 510(k) submission, not just the summary.
§ 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).