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OnTrak TesTcup® 5 M2K is an in vitro diagnostic test intended for professional use for the qualitative detection of drug or drug metabolite in urine. OnTrak TesTcup 5 M2K simultaneously tests for the presence of multiple drugs or drug metabolites. The OnTrak TesTcup-5 M2K cutoff levels are based on the Federal Mandatory Guidelines.

The OnTrak TesTcup 5 M2K profile (cutoff) consists of amphetamines (1000 ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (2000 ng/mL) and PCP (25 ng/mL).

OnTrak TesTcup 5 M2K provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.

The OnTrak TesTcup-5 M2K is an in vitro diagnostic test intended for professional use in the qualitative detection of amphetamines (1000ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (2000 ng/mL) and PCP (25 ng/mL). The TesTcup 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. Urine is collected directly in the OnTrak TesTcup-5 M2K. After closing the cap and moving it to the "TEST" position, the sample reservoir is filled by tilting the cup. Urine then flows through a membrane by capillary action and reacts with antibody-coated microparticles and drug conjugate present on the membrane. In the absence of drug, the antibody is free to interact with the drug conjugate, causing the formation of a blue band ("negative" sign). When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the drug conjugate, and no blue band is formed. A positive sample causes the membrane to remain white ("positive" sign). An additional antibody/antigen reaction occurs at the "TEST VALID" area for all assays. The "TEST VALID" blue band forms when antibodies, which are imbedded in the membrane, interact with, and bind to, the antigen on the blue-dyed microparticles.

The provided text describes the OnTrak TesTcup-5 M2K device, an in vitro diagnostic test for the qualitative detection of amphetamines, cocaine metabolite, THC, morphine, and PCP in urine. The key focus here is on the Morphine 2000 component of the device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for OnTrak TesTcup-5 M2K (Morphine 2000)

Note: The acceptance criteria are largely implied by the performance of the predicate device. The new device demonstrates comparable performance despite a significantly higher morphine cutoff.

Study Details:

1. Sample Size used for the test set and the data provenance:

   • Positive Samples: 50 urine samples.
   • Negative Samples: 100 urine samples.
   • Agreement Comparison Samples: 150 total samples (comprising the above positive and negative samples, as they were also compared to the reference assay).
   • Data Provenance: The text states, "specimens screened by an automated immunoassay and confirmed positive by GC/MS" and "urine samples, obtained from a clinical laboratory and screened negative by an automated immunoassay." This indicates the data is retrospective and originates from a clinical laboratory, likely in the United States (given the FDA 510(k) submission).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The text does not explicitly state the number of experts or their qualifications for establishing ground truth.
   • However, the ground truth for positive samples was established by GC/MS confirmation (Gas Chromatography/Mass Spectrometry), which is a definitive analytical method, generally considered the gold standard for drug confirmation. For negative samples, the ground truth was established by "screened negative by an automated immunoassay relative to a 2000 ng/mL cutoff for morphine." While an immunoassay is a screening method, its negativity at the specified cutoff served as the ground truth in this context, coupled with confirmation for positive results.

3. Adjudication method for the test set:

   • The text does not describe an adjudication method involving multiple human readers for interpreting test results. The device produces a "blue band" for negative and "remains white" for positive, suggesting a direct visual read without complex interpretation requiring adjudication. Performance was measured directly against the ground truth (GC/MS for positive, immunoassay for negative).

4. 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, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) test, not an AI-powered image analysis system that assists human readers. Its output is a direct qualitative result (positive/negative), not an interpretation for human readers to act upon.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • This is a standalone test in the sense that the device itself generates the result without human interpretive input beyond reading the presence or absence of a blue band. There isn't an "algorithm-only" performance that would be separate from the "human-in-the-loop" as there's no complex human interpretation involved with this type of rapid diagnostic test for which an AI would assist.

6. The type of ground truth used:

   • For positive samples, the ground truth was GC/MS confirmation.
   • For negative samples, the ground truth was "screened negative by an automated immunoassay relative to a 2000 ng/mL cutoff." This serves as a chemical/analytical truth based on established laboratory methods. It is not expert consensus, pathology, or outcomes data.

7. The sample size for the training set:

   • The provided text does not mention or describe a training set for the device. This type of device (rapid immunoassay) typically does not involve a "training phase" in the same way machine learning or AI models do. Its reagents and test mechanisms are developed and validated, rather than "trained" on data.

8. How the ground truth for the training set was established:

   • As no training set is described, this information is not applicable.

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