(383 days)
The First Check® Home Drug Fest Panel 4 is an educational sereening test for the rapid detection of marijuana, cocaine, morphine/opiates, methamphetamine and for their metabolites in human urine at cut-off levels of 50ng/mL, 300ng/mL, 300ng/mL and 1,000ng/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 four drugs concorned parchib, was not information is beneficial to consumer offorts to comply with applicable laws and/or societal expectations. Information regarding second step confirmatory testing is provided.
The First Check® Home Drug Test Panel 4, like many commercially available drug screening tests, qualitatively measures the presence or absence of marijuana, cocaine, morphine/opiates, methamphetamine 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 provided text is a 510(k) summary for a home drug test panel and a subsequent FDA clearance letter. It describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through a rigorous scientific study with ground truth established by experts.
The document states:
- "Because the First Check® Home Drug Test Panel 4 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" (Page 1, Section IX).
- "Because the labeling of the First Check® Home Drug Test Panel 4 is substantially equivalent to a variety of rapid screening tests currently in commercial distribution... 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." (Page 1, Section IX).
This indicates that the clearance was based on substantial equivalence to a predicate device and anecdotal evidence of effective consumer use, rather than a specific performance study with acceptance criteria.
Therefore, I cannot extract the requested information as it is not present in the provided text.
To directly answer your numbered points based on the absence of this information:
- A table of acceptance criteria and the reported device performance: Not provided.
- Sample size used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.
- 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, as this is a qualitative drug screening test, not an AI-assisted diagnostic device for human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a qualitative drug screening test, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided. The basis for effectiveness claims is substantial equivalence to a predicate device and widespread consumer use without reported issues.
- The sample size for the training set: Not applicable, as this device functions via immunoassay, not machine learning.
- How the ground truth for the training set was established: Not applicable.
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).