(120 days)
OnTrak TesTstik 3 for Cocaine/Morphine/THC is an in vitro diagnostic test intended for professional use for the qualitative detection of cocaine metabolite, morphine, and cannabinoids in uripe. The OnTrak TesTstik 3 for Cocaine/Morphine/THC cutoff levels (300 ng/ml for cocaine and morphine and 50 ng/ml for THC) are based on the Federal Mandatory Guidelines. OnTrak TesTstik 3 for Cocaine/Morphine/THC is not intended for over-the-counter sale.
OnTrak TesTstik 3 for Cocaine/Morphine/THC provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytices I rosult. Tras chromatography/mass spectrometry (GC/MS) is the preferred confirmation method.) Cluireal consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The OnTrak TesTstik 3 for Cocaine/Morphine/THC is an in vitro diagnostic test intended for professional use in the qualitative detection of cocainc metabolite, morphine and cannabinoids in urine at or above a cutoff of 300 ng/ml (cocaine and morphine) and 50 ng/ml (THC).
Like the predicate TesTstik devices, the OnTrak TesTstik 3 is also based on the principles of microparticle capture inhibition. The test relies on the competition between drugs, which may be present in the urine being tested, and drug conjugates immobilized on the membrane.
Here's an analysis of the provided text, outlining the acceptance criteria and the study details for the OnTrak TesTstik 3 for Cocaine/Morphine/THC device:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance (OnTrak TesTstik 3) |
|---|---|
| Precision: >95% confidence at 150% cutoff | >95% confidence at 150% cutoff (Same as predicate) |
| Cocaine Accuracy: Clinical correlation between device and GC/MS / automated immunoassay | 94% agreement for all positive (including near cutoff) and negative specimens |
| Morphine Accuracy: Clinical correlation between device and GC/MS / automated immunoassay | 94% agreement for all positive (including near cutoff) and negative specimens |
| THC Accuracy: Clinical correlation between device and GC/MS / automated immunoassay | 95% agreement for all positive (including near cutoff) and negative specimens |
Study Details
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Sample size used for the test set and the data provenance:
- Cocaine:
- 70 specimens (positive, including near cutoff)
- 100 urine specimens (negative)
- Data Provenance: Clinical laboratory, likely retrospective as specimens were "obtained." Country of origin is not specified but is general clinical laboratory practice.
- Morphine:
- 70 specimens (positive, including near cutoff)
- 100 urine specimens (negative)
- Data Provenance: Clinical laboratory, likely retrospective. Country of origin is not specified.
- THC:
- 70 specimens (positive, including near cutoff)
- 100 urine specimens (negative)
- Data Provenance: Clinical laboratory, likely retrospective. Country of origin is not specified.
- Cocaine:
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts or their qualifications. The ground truth was established by automated immunoassays and confirmed by GC/MS (Gas Chromatography/Mass Spectrometry), which are laboratory methods rather than direct human expert assessment. This implies that the 'experts' in this context are the laboratory personnel performing and interpreting these analytical tests, but their specific qualifications are not detailed.
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Adjudication method for the test set:
- Not applicable in the traditional sense of human review. The ground truth was established by a two-step laboratory process: initial screening by automated immunoassay, followed by confirmation with GC/MS. This acts as the "adjudication" against which the device performance is measured, but it's not a panel of human experts.
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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. This device is an in vitro diagnostic test, and its performance is evaluated directly against laboratory reference methods, not in comparison to human reader improvement with or without AI assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, performance evaluation was done in a standalone manner. The device, OnTrak TesTstik 3, is a qualitative diagnostic test that provides a visual "color" endpoint read. Its accuracy was tested against established laboratory methods (automated immunoassay and GC/MS) without direct human intervention as part of its reading mechanism; the human interprets the color change produced by the device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used was laboratory confirmation: initial screening by automated immunoassay and definitive confirmation by Gas Chromatography/Mass Spectrometry (GC/MS). For negative specimens, a portion (15%) were also confirmed negative by GC/MS.
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The sample size for the training set:
- The document describes performance evaluation using clinical specimens. It does not explicitly state details about a separate "training set" or its size, common in machine learning contexts. This suggests the study is a performance validation utilizing a test set, without detailing an explicit training phase in the context of an AI/ML algorithm. For traditional IVDs, the development process might involve internal validation, but this summary focuses on the final performance study.
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How the ground truth for the training set was established:
- As a distinct training set is not explicitly mentioned or detailed in the provided summary, the method for establishing its ground truth is also not provided. For the performance evaluation (test set), the ground truth was established via automated immunoassay and GC/MS confirmation as described in point 6.
§ 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).