(182 days)
Immunoassay for the qualitative detection of THC metabolite, 11-nor-A-THC-9carboxylic acid, at the cut-off of 50 ng/mL and cocaine metabolite, benzoylecgonine, at the cut-off of 300 ng/mL in human urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use.
LifeSign® Home Drug Test (THC/COC) is simple one step immunochromatographic test for the rapid, qualitative detection of THC and cocaine.
Here's a breakdown of the acceptance criteria and study information for the "LifeSign® Home Drug Test, Marijuana & Cocaine (THC/COC)" and related devices, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Qualitative detection of THC metabolite (11-nor-A-THC-9-carboxylic acid) at a cutoff of 50 ng/mL | 100% correlation with predicate device (K990786) |
| Qualitative detection of cocaine metabolite (benzoylecgonine) at a cutoff of 300 ng/mL | 100% correlation with predicate device (K990786) |
| Overall accuracy (for consumer study) | Over 96% overall accuracy |
Study Information
The provided document describes a study primarily for demonstrating substantial equivalence to a predicate device, rather than a de novo clinical trial with extensive acceptance criteria and detailed performance metrics.
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Sample size used for the test set and the data provenance:
- Sample Size: 100 specimens for each drug (THC and cocaine), consisting of 50 negative and 50 positive samples.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be retrospective as it compares the device's performance to an already established predicate device's results using collected specimens.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The ground truth seems to be implicitly established by the results from the predicate device (K990786) or a reference method used to classify the 100 specimens as positive or negative. No explicit mention of expert readers or their qualifications is provided.
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Adjudication method for the test set:
- Not applicable/Not specified. The study design described is a direct comparison to a predicate device on pre-classified samples, not one involving multiple human readers needing adjudication.
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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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The device is an immunochromatographic test, not an AI-powered diagnostic tool requiring human reader assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance described (100% correlation and >96% overall accuracy) refers to the standalone performance of the immunochromatographic test device itself. It operates without human-in-the-loop for its direct result interpretation. The "consumer study" indicates its ease of use and accuracy in a home setting, which implies standalone performance by a lay user.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the comparison study appears to be established by the results obtained from the legally marketed predicate device (K990786) or a reference method used to classify the 100 specimens as positive or negative for THC and cocaine. The statement "The tests demonstrate 100 % correlation when 100 specimens (50 negative and 50 positive) for each drug were compared respectively" implies that these 100 specimens had a known status (positive/negative) determined by a reliable method.
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The sample size for the training set:
- Not applicable/Not specified. This is a rapid immunochromatographic test, not an algorithm that requires a separate training set in the machine learning sense. The device's components (antibodies, reagents) are developed through research and manufacturing processes, but there isn't a "training set" like one would describe for an AI model.
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How the ground truth for the training set was established:
- Not applicable. (See point 8).
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).