(88 days)
The Advantage Multiple Drugs of Abuse Test is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of one to five of the following Drugs of Abuse at the indicated cut off: THC 50ng/mL, Phencyclidine (PCP) 25ng/mL, Opiates 2000 ng/mL, Cocaine 300ng/mL, Amphetamine 1,000ng/mL and Methamphetamine 1,000ng/mL. The tests are formatted in multiple plastic test cards, which hold up to 5 drug test strips, and single plastic test cards which hold one drug test strip. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS. The test is for professional use.
The Advantage Multiple Drugs of Abuse Test is an immunochromatographic based one step in vitro test. The tests are formatted in a multiple plastic card, which holds up to 5 drug test strips, and a single plastic test card, which holds a single drug test strip.
Here's a breakdown of the acceptance criteria and study information for the Advantage Multiple Drugs of Abuse Test, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Drug Tested | Cut-off Concentration (ng/mL) | Acceptance Criteria (Correlation) | Reported Device Performance (Correlation) |
|---|---|---|---|
| THC | 50 | Not explicitly stated as a number, but implied by "substantially equivalent" | 90-96% (vs. GC/MS), >99% (vs. EMIT in drug-free urine) |
| Benzoylecgonine/Cocaine | 300 | Not explicitly stated as a number, but implied by "substantially equivalent" | 90-96% (vs. GC/MS), >99% (vs. EMIT in drug-free urine) |
| Opiates | 2,000 | Not explicitly stated as a number, but implied by "substantially equivalent" | 90-96% (vs. GC/MS), >99% (vs. EMIT in drug-free urine) |
| Methamphetamine | 1,000 | Not explicitly stated as a number, but implied by "substantially equivalent" | 90-96% (vs. GC/MS), >99% (vs. EMIT in drug-free urine) |
| Amphetamine | 1,000 | Not explicitly stated as a number, but implied by "substantially equivalent" | 90-96% (vs. GC/MS), >99% (vs. EMIT in drug-free urine) |
| PCP | 25 | Not explicitly stated as a number, but implied by "substantially equivalent" | 90-96% (vs. GC/MS), >99% (vs. EMIT in drug-free urine) |
Note: The acceptance criteria are not explicitly numerical targets in the summary but are represented by the claim of "substantial equivalence" to GC/MS and EMIT testing, with the provided correlation percentages demonstrating this equivalence.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the provided document. The summary only mentions "individual Advantage drug tests" were evaluated.
- Data Provenance: Not specified. It's likely the testing was conducted in a laboratory setting, but the country of origin or whether the samples were retrospective or prospective is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not applicable and not provided. The ground truth was established by laboratory reference methods (GC/MS and EMIT), not by human expert opinion.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods are typically used when subjective human interpretation is involved. For a diagnostic test compared to objective lab measurements like GC/MS and EMIT, adjudication is not relevant.
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:
- Not applicable. This device is an in-vitro diagnostic test for drugs of abuse; it is not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The performance data (correlations) are for the device itself as a standalone diagnostic tool, comparing its results directly against reference methods (GC/MS and EMIT). There is no "human-in-the-loop" component described for interpreting the primary device result. Although a human reads the test result, the performance metrics are for the device's accuracy in producing that result.
7. The type of ground truth used:
- Laboratory Reference Standards:
- GC/MS (Gas Chromatography/Mass Spectrometry): Considered a "gold standard" for drug testing, providing definitive identification and quantification of substances.
- EMIT (Enzyme Multiplied Immunoassay Technique): Another immunoassay method for screening drugs, specifically used for comparison in "drug-free urine."
8. The sample size for the training set:
- Not applicable and not provided. This device is an immunochromatographic test, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The test's design is based on chemical and biological principles rather than data-driven learning.
9. How the ground truth for the training set was established:
- Not applicable. As noted above, there is no "training set" for this type of device. The accuracy of the device is assessed against established laboratory reference methods using test samples.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).