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OnTrak TesTstik for Morphine 2000 (M2K) is an in vitro test intended for professional use in the qualitative detection of morphine in urine at or above a cutoff concentration of 2000 ng/mL.

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

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

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

The OnTrak TesTstik Morphine 2000 assay contained in this submission is an in vitro test intended for professional use in the qualitative detection of morphine in urine at or above a cutoff concentration of 2000 ng/mL.

The TesTstik 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.

When the TesTstik is immersed in the urine sample, some of the sample is absorbed into the TesTstik sample pad. The absorbed sample travels through a reagent strip 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 conjugate. In the absence of drug in the urine, the antibody-coated microparticles bind to the drug conjugate and a blue band is formed at the result window ("negative" sign).

When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the micro-particles are inhibited from binding the drug conjugate and no blue band is formed at the result window. A positive sample caused the membrane to remain white ("positive" sign).

An additional antibody/antigen reaction occurs at the "TEST VALID" area. The "TEST VALID" blue band forms when antibodies, which are 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 are viable, and the results are ready to interpret.

Here's a breakdown of the acceptance criteria and study information for the OnTrak TesTstik for Morphine 2000 (M2K), based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • Precision: 100 replicates of urine standards for each concentration (0, 500, 1000, 1500, 2500, 3000 ng/mL). The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin specified.
   • Accuracy:
     • 50 samples confirmed positive for morphine by GC/MS.
     • 100 urine samples, screened negative by an automated immunoassay, obtained from a clinical laboratory.
     • An additional 150 samples were tested for comparison between the OnTrak TesTstik M2K and the predicate device.
   • The data provenance for accuracy studies is not explicitly stated as retrospective or prospective, nor is the country of origin specified beyond "obtained from a clinical laboratory."

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

   • The document does not mention the use of human experts to establish ground truth for the test set. Instead, objective laboratory methods were used:
     • For positive samples, ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry).
     • For negative samples, ground truth was established by screening with an automated immunoassay relative to the 2000 ng/mL cutoff for morphine.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • No adjudication method involving multiple readers is mentioned. The ground truth was established by objective laboratory methods (GC/MS and automated immunoassay).

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 MRMC comparative effectiveness study involving human readers or AI assistance was conducted. This device is an in-vitro diagnostic test for qualitative detection of morphine in urine, not an imaging or interpretive AI device that would involve human readers for diagnostic improvement.

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

   • Yes, the performance study is entirely standalone. The device (OnTrak TesTstik for Morphine 2000) is an in-vitro diagnostic test that provides a visual result (blue band for negative, white for positive), and its performance was evaluated against laboratory-established ground truth without human interpretive input for the test results themselves. The "reading" is an objective visual assessment of band presence/absence.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth used was objective laboratory testing:
     • GC/MS (Gas Chromatography/Mass Spectrometry) for confirmed positive samples.
     • Automated immunoassay for confirmed negative samples.
     • The concentrations of drug in the standards for precision studies served as their own ground truth.

7. The sample size for the training set:

   • The document describes performance studies, but it does not provide information about a training set size. This is typical for a device using capture inhibition technology (a chemical assay) rather than a machine learning or AI-based device that would require training data.

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

   • Since no training set is mentioned (as the device is a chemical assay, not an AI/ML model), there is no information on how the ground truth for a training set was established.

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