(75 days)
The TCPI One Step™ Urine Drug of Abuse Amphetamine Test is a rapid, qualitative, competitive binding immunoassay for the determination of Amphetamine in urine. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The TCPI One Step™ Urine Drug of Abuse Amphetamine assay is not intended to monitor drug levels, but only to screen urines for the presence of amphetamine and its metabolites.
TCPI's One Step™ Urine Drug of Abuse Amphetamine Test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 500 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.
Here's the information about the acceptance criteria and study for the "One Step™ Urine Drug of Abuse Amphetamine Test":
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in numerical terms (e.g., "accuracy must be >95%"). However, based on the provided text, the implicit acceptance criteria is a high level of accuracy when compared to a gold standard (GC/MS) and other screening tests. The device performance demonstrates that these implicit criteria were met.
| Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Accuracy (Laboratory Study) | High accuracy vs. GC/MS | 99.62% (on 260 samples) |
| Accuracy (Clinical Trials) | High accuracy vs. other methods | 96.00% (on 300 patient samples) |
| Accuracy (Combined Data) | High accuracy | 97.68% (on 560 total comparisons) |
| Accuracy (Excluding Ephedrine) | High accuracy without interference | 99.82% (after dropping 12 ephedrine positive samples) |
| Comparison to Other Screening Tests | No significant difference | "clearly demonstrated no difference" |
2. Sample Sizes Used for the Test Set and Data Provenance
- Laboratory Study: 260 samples
- Clinical Trials: 300 patient samples
- Combined Total: 560 comparisons
The text does not specify the country of origin for the data or whether it was retrospective or prospective. It refers to "laboratory studies" and "clinical trials," which typically involve prospective collection, but this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The text does not mention the use of experts to establish ground truth.
4. Adjudication Method for the Test Set
The text does not mention any adjudication method for the test set.
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
A Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a rapid, qualitative immunoassay for screening, not an image-based or interpretation-based device suitable for an MRMC study with human readers assisted by AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The device itself (the "One Step™ Urine Drug of Abuse Amphetamine Test") is the standalone "algorithm" in this context, providing a qualitative result without human interpretation of complex data. Its performance was tested directly against GC/MS and in clinical trials.
7. The Type of Ground Truth Used
The primary ground truth used was Gas Chromatography/Mass Spectrophotometry (GC/MS), widely considered the gold standard for drug confirmation testing. For the clinical trials, the comparison was implicitly against "other screening tests," but the overall and most robust ground truth mentioned is GC/MS.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" or its size. In the context of a qualitative immunoassay, the development and optimization of the test (which could be analogous to "training") would typically involve numerous iterations and tests with various known positive and negative samples, but these are not explicitly detailed as a distinct "training set" in the submission's summary of safety and effectiveness. The reported sample sizes (260 lab, 300 clinical) are for the performance evaluation, which serves as the "test set."
9. How the Ground Truth for the Training Set Was Established
Since a distinct training set with established ground truth is not explicitly mentioned, this information cannot be provided from the given text. However, for the general development of such a test, the ground truth for samples used in the chemical design and optimization would also be established by reference methods like GC/MS.
§ 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).