(199 days)
The First Check® Home Drug Test Panel 3 is an educational screening test for the rapid detection of marijuana, cocaine, methamphetamine and/or their metabolites in human urine at cut-off levels of 50ng/mL, 300ng/mL and 1,000 ng/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 three 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 3, like many commercially available drug screening tests, qualitatively measures the presence or absence of marijuana, cocaine, methamphetamine and/or their metabolites in urine, using a one stee, rapid chromatographic immunoassay which operates under the principle of recognition and formation of specific antibody/target drog/anibody complexes. The cut-off concentration for THC is 50ng/mL. The out-off concentration for COC is 300ng/mL. The cut-off concentration four MET is 1,000ng/mL.
This document is a 510(k) summary for a home drug test panel. It claims substantial equivalence to previously marketed devices and focuses on the intended use, technological characteristics, safety, and effectiveness in comparison to those predicates. It does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the way requested for a medical AI/software device.
The provided text describes a qualitative immunoassay device, not an AI/software device. Therefore, many of the requested elements (sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, etc.) are not applicable to this type of device.
For completeness, I can extract the relevant information that is present:
Device: First Check® Home Drug Test Panel 3
Intended Use: An educational screening test for the rapid, qualitative detection of marijuana, cocaine, and methamphetamine and/or their metabolites in human urine at specified cut-off levels (50ng/mL for THC, 300ng/mL for COC, and 1,000ng/mL for MET). It's intended for consumer use as the first step in a two-step process, with information provided for confirmatory testing.
Acceptance Criteria and Device Performance:
The document implies acceptance criteria by claiming substantial equivalence to predicate devices and stating that its performance characteristics are identical to one predicate (Applied Biotech SureStep™ Drug Screen Multi Test). However, it does not explicitly state numerical acceptance criteria (e.g., minimum sensitivity or specificity values) with corresponding reported device performance metrics.
Instead, the argument for safety and effectiveness is based on:
- Identicality to a legally marketed predicate: "Because the First Check® Home Drug Test Panel 3 is identical to the Applied Biotech SureStep™ Drug Screen Multi Test that is legally marketed under K972425..."
- Lack of special skills for use: "...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..."
- Substantial equivalence of labeling and consumer use history: "Because the labeling of the First Check® Home Drug Test Panel 3 is substantially equivalent to a variety of rapid screening tests currently in commercial distribution, including the Phamatecchi QuickScreen™ At Home Drug Test, and there have been no reports of consumer inability to follow instructions or interpret results during the twenty-four months in which the product line has been purchased by the general public and used in quantities exceeding 200,000 tests, it is concluded that the product can be used effectively by the lay user."
Therefore, a table of acceptance criteria and reported device performance cannot be generated from the provided text. The document relies on proving substantial equivalence to existing devices rather than presenting new performance data against pre-defined acceptance metrics for this specific device.
Regarding the other requested points (which are generally for AI/Software devices):
- Sample size used for the test set and the data provenance: Not applicable. This is not a study reporting on a test set for an AI/software device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone immunoassay. Its performance is inherent to its design, not a separate algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this type of test would be confirmed analytical methods, often Gas Chromatography coupled with Mass Spectrometry (GC/MS) or Liquid Chromatography coupled with Mass Spectrometry (LC/MS), which are the gold standards for drug confirmation in urine. However, this document does not detail any such validation study for this specific device, instead relying on equivalence to a predicate.
- The sample size for the training set: Not applicable. This is not a machine learning device.
- How the ground truth for the training set was established: Not applicable.
§ 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).