(68 days)
On Trak TesTcard 9 product, is an in vitro diagnostic test intended for use by health care professionals only for the qualitative detection of drug or drug metabolites in urine. On Trak TesTcard 9 simultaneously tests for the presence of multiple drugs or drug metabolites at or above the stated concentrations.
Cutoff Concentrations:
Amphetamines 1000 ng/mL
Barbiturates 200 ng/mL
Benzodiazepines 100 ng/mL
Cocaine metabolite 300 ng/mL
Methamphetamine 500 ng/mL
Morphine 300 ng/mL
Phencyclidine (PCP) 25 ng/mL
Tricyclic Antidepressants (TCA) 1000 ng/mL
Tetrahydrocannabinols (THC) 50 ng/mL
On Trak TesTcard 9 product provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) is the preferred confirmation method. Clinical consideration and professional judgment should be applied to any drug abuse test result, particularly when preliminary positive results are used.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in the provided document beyond the qualitative nature of the test. However, the device is intended for the "qualitative detection of drug or drug metabolites in urine" at or above specific cutoff concentrations. Therefore, the device would be expected to accurately identify the presence or absence of these substances at the given thresholds. The reported performance is not detailed in terms of sensitivity, specificity, or accuracy compared to the gold standard, but the statement about "preliminary analytical test result" and the recommendation for "Gas chromatography/ mass spectrometry (GC/MS) as the preferred confirmation method" implies that the device serves as a screening tool.
| Analyte | Cutoff Concentration (ng/mL) | Device Performance (Implied) |
|---|---|---|
| Amphetamines | 1000 | Qualitative detection at/above cutoff |
| Barbiturates | 200 | Qualitative detection at/above cutoff |
| Benzodiazepines | 100 | Qualitative detection at/above cutoff |
| Cocaine metabolite | 300 | Qualitative detection at/above cutoff |
| Methamphetamine | 500 | Qualitative detection at/above cutoff |
| Morphine | 300 | Qualitative detection at/above cutoff |
| Phencyclidine (PCP) | 25 | Qualitative detection at/above cutoff |
| Tricyclic Antidepressants | 1000 | Qualitative detection at/above cutoff |
| Tetrahydrocannabinols | 50 | Qualitative detection at/above cutoff |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide information on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth.
4. Adjudication Method
The document does not provide information on the adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or the effect size of human reader improvement with AI assistance. This type of study is generally not applicable to a qualitative diagnostic test like the On Trak TesTcard 9, which is designed for standalone analysis rather than human-AI collaboration.
6. Standalone Performance Study
The study described is inherently a standalone performance study. The device, On Trak TesTcard 9, is an "in vitro diagnostic test" intended for "qualitative detection," meaning it produces a result without human interpretation of complex outputs.
7. Type of Ground Truth Used
While not explicitly stated, the implication that "Gas chromatography/ mass spectrometry (GC/MS) is the preferred confirmation method" suggests that GC/MS is intended to be the gold standard or ground truth for confirming the results of the On Trak TesTcard 9.
8. Sample Size for the Training Set
The document does not provide information on the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established. Given the nature of a rapid diagnostic test, the "training set" might refer to well-characterized samples with known concentrations of drug metabolites, likely confirmed by a highly accurate method like GC/MS.
§ 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).