(26 days)
The OnTrak TesTcard menus are various combinations of the different drugs hat are listed below. The TesTcard products are in vitro diagnostic tests for the qualitative detection of drug or drug metabolite in urine. The TesTcard devices simultaneously test for the presence of multiple drugs or drug metabolites. The TesTcard profile (cutoff) consists of the following: Amphetamines (d,l-amphetamine): 1000 ng/mL, Barbiturates (secobarbital): 200 ng/mL, Benzodiazepines (oxazepam): 100 ng/mL, Cocaine metabolite (benzoylecgonine): 300 ng/mL, Methamphetamine (d-methamphetamine): 500 ng/mL, Morphine (morphine): 300 ng/mL, PCP (phencyclidine): 25 ng/mL, Tricyclic Antidepressants (TCA)(Imipramine): 1000 ng/mL, THC (11-nor-delta9-THC-9-carboxylic acid): 50 ng/mL. AND/OR TesTcard products provide only preliminary analytical test result. A more specific alternate test method must be used in order to obtain a confirmed analytical result. Prescription Use V (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
The OnTrak TesTcard assays contained in this submission are in vitro diagnostic tests intended for the qualitative detection of drug or drug metabolite in urine. The TesTcard devices simultaneously test for the presence of multiple drugs or drug metabolites. The TesTcard profile (cutoff) consists of amphetamines (d,l-amphetamine 1000 ng/mL), barbiturates (secobarbital 200 ng/mL), benzodiazepines (oxazepam 100 (benzoylecgonine cocaine metabolite ng/mL). methamphetamine (d-methamphetamine 500 ng/mL), morphine (morphine 300 ng/mL), PCP (phencyclidine 25 ng/mL), tricyclic antidepressants (TCA) (imipramine 1000 ng/mL) and THC (11-nor-A-THC-9-carboxylic acid 50 ng/mL). The TesTcard assays are based on the principle of microparticle capture inhibition. The test relies on the competition between drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane in the test chamber. When the TesTcard contacts the urine sample, the sample is absorbed into the TesTcard sample pad. The absorbed sample travels through the reagent strips contained in the device by capillary action. In the reagent strip, the sample rehydrates and mobilizes antibody-coated blue microparticles. The microparticle-urine suspension continues to migrate through the reagent strip and comes in contact with the immobilized drug conjugates. In the absence of drugs in the urine, the antibody coated microparticles bind to the drug conjugates and blue bands are formed in the result areas. When drugs are present in the specimen, they bind to the respective antibody-coated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the appropriate drug conjugate and no blue band is formed in the result area below the drug name. A positive specimen causes the membrane to remain white. An additional antibody/antigen reaction occurs at the "VALID" area. The "TEST VALID" blue band forms when antibodies imbedded in the reagent membrane bind to the antigen on the blue microparticles. The presence of the "TEST VALID" band indicates that the test has completed, the reagents in the "TEST VALID" area are valid, and the results are ready to interpret.
The provided text describes a 510(k) premarket notification for the OnTrak TesTcard, a device for qualitative detection of drugs or drug metabolites in urine. However, it does not contain any information about a study proving the device meets specific acceptance criteria.
The document outlines the device's intended use, technological characteristics, and claims substantial equivalence to a predicate device, but it lacks detailed performance data, sample sizes for testing, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or answer most of the other questions regarding a study, as this information is not present in the provided text.
Based on the information provided, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
- Not provided in the document. The document lists the cutoff concentrations for various drugs, which are essential for defining "positive" or "negative" results, but it does not present acceptance criteria (e.g., sensitivity, specificity thresholds) or actual performance data against these criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Information not provided in the document | Information not provided in the document |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided in the document.
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)
- Not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided in the document.
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/Not provided. This device is an in-vitro diagnostic test, not an AI-assisted diagnostic tool that would involve human "readers" in the context of radiology or similar fields.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is an IVD device, not an algorithm, so "standalone" performance in the AI sense is not relevant. The device operates as a self-contained test.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated within the provided text. For qualitative drug detection tests like this, the ground truth for a study would typically be established by a reference method (e.g., Gas Chromatography/Mass Spectrometry - GC/MS) performed on the urine samples. The document only mentions that "A more specific alternate test method must be used in order to obtain a confirmed analytical result" which implies that such reference methods are for confirmation but doesn't detail their use in validation.
8. The sample size for the training set
- Not provided in the document. (This type of device does not typically have a "training set" in the machine learning sense.)
9. How the ground truth for the training set was established
- Not provided in the document. (See above, not applicable in the ML sense.)
§ 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).