(238 days)
The First Check Home Drug Test (THC) is an educational screening test for the rapid detection of THC (and its metabolites) in human urine at a cut off for the rapid dececeion of the (antended for consumer use as the first step in a two step process to provide consumers, including but not limited to concerned a two seep process to provious concerning the presence of THC (and its parents, with information obliozing is beneficial to consumer metabolices) in a arine baspeable laws and/or societal expectations. Information regarding second step confirmatory testing is provided.
The First Check® Home Drug Test (THC), like many commercially available drug screening tests, qualitatively measures the presence or absence of THC and its 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 cut-off concentration for THC is 50ng/mL.
This 510(k) summary does not contain the detailed criteria or study information typically found in a standalone performance study report. Instead, it relies on substantial equivalence to legally marketed predicate devices.
As such, I cannot provide a table of acceptance criteria and reported device performance from the provided text, nor detailed information on sample sizes, ground truth establishment methods, or multi-reader multi-case studies.
However, I can extract the following relevant information:
1. Acceptance Criteria and Reported Device Performance:
The document states that the "First Check® Home Drug Test (THC) is identical to the Applied Biotech SureStep™ Drug Screen THC Test in terms of intended use, product design, performance characteristics, materials of construction, and manufacturing process." It also claims substantial equivalence to "other commercially available drug screening tests which qualitatively measure the presence of target drugs or metabolites by visual color one step immunoassay technology."
The core performance characteristic mentioned is the cut-off concentration for THC, which is 50ng/mL. The device is intended for the qualitative detection of THC and its metabolites.
Since the submission relies on substantial equivalence rather than a new performance study demonstrating specific sensitivity/specificity metrics, a table of novel acceptance criteria and reported device performance for this specific device would not be present in this type of submission. The performance is assumed to be equivalent to the predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the given 510(k) summary for the "First Check® Home Drug Test (THC)". The submission instead refers to the predicate device K960744 (Applied Biotech SureStep™ Drug Screen THC test) as being "legally marketed". It likely means that the performance data for K960744 was previously established. The current submission focuses on demonstrating equivalence.
The text does mention: "there have been no reports of consumer inability to follow instructions or interpret results during the twenty-four months the product has been purchased by the general public and used in quantities exceeding 87,000 tests". This refers to real-world usage of a similar product (the Phamatech QuickScreen™ At Home Drug Test), not a formal test set for the device in question.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the given 510(k) summary. The nature of the device (a home drug test) and its reliance on substantial equivalence to a predicate device suggests that a complex expert-adjudicated ground truth for a new test set was likely not established for this specific 510(k) submission. For drug tests, ground truth is typically established by confirmatory laboratory methods (e.g., GC/MS).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the given 510(k) summary.
5. 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:
This device is a rapid screening immunoassay for drug detection, not an AI-assisted diagnostic device for human readers. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study of human readers with vs. without AI assistance would be not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This device is a standalone rapid screening test that provides a visual result. It is not an algorithm, but a physical immunoassay device. Its performance is inherent to the device itself. The product is intended for lay users "to follow instructions or interpret results," implying a human-in-the-loop, but the "standalone performance" of the device itself (its ability to detect the analyte at the specified cut-off) is fundamental to its design. However, a formal "standalone (algorithm only)" study as typically understood in AI/software medical devices is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
While not explicitly stated for a new study in this document, for drug screening tests like this, the ground truth is typically established by confirmatory laboratory methods, such as Gas Chromatography/Mass Spectrometry (GC/MS). This is implied by the mention of "confirmatory testing" as the "second step" to follow the home test.
8. The sample size for the training set:
This information is not provided in the 510(k) summary. As this is an immunoassay device, not a machine learning algorithm, the concept of a "training set" as used in AI development is not applicable in the same way. The device is manufactured based on established chemical and biological principles.
9. How the ground truth for the training set was established:
As mentioned above, the concept of a "training set" for this type of immunoassay device is not applicable. The performance characteristics are based on the chemical and biological design of the test, and validation would involve testing against known positive and negative samples, with ground truth established by confirmatory lab methods.
§ 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).