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The Roche Diagnostics Corporation OnTrak TesTstik™ for Morphine 2000 (M2K) is an in vitro t st intended for professional use for the qualitative detection of morphine in urine at or above a cutoff concentration of 2000 ng/mL

OnTrak TesTstik 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 M2K is an in vitro test intended for professional use in the qualitative detection of d,l-amphetamines (1000ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL) and morphine (2000 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 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.

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

Acceptance Criteria and Device Performance

Study Details

2. Sample Size Used for the Test Set and Data Provenance:

• Precision Test Set: 100 replicates for each urine standard concentration (0, 500, 1000, 1500, 2500, 3000 ng/mL). The provenance of these standards (e.g., synthetic urine, spiked human urine) and their origin (country) is not specified.
• Accuracy Test Set:
  • 50 positive samples: Confirmed by GC/MS at 2000 ng/mL cutoff. Provenance details (e.g., country of origin, retrospective/prospective collection) are not specified beyond being "specimens screened by an automated immunoassay."
  • 100 negative samples: Obtained from a clinical laboratory and screened negative by an automated immunoassay relative to a 2000 ng/mL cutoff. Provenance details are not specified.
  • 150 samples for overall agreement: Tested by both OnTrak TesTcup M2K and Abuscreen OnLine II for Opiates 2000. These likely overlap with the positive and negative accuracy samples, but the exact breakdown and provenance are not detailed.

All samples appear to be retrospective as they were collected and then tested.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

The document does not explicitly state the number of experts or their qualifications for establishing ground truth.

• For positive samples, ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry) at a 2000 ng/mL cutoff. GC/MS is a laboratory analytical method, not typically performed by a "human expert" in the context of adjudication.
• For negative samples, ground truth was established by an automated immunoassay. This is also a laboratory analytical method.

4. Adjudication Method for the Test Set:

Not applicable. The ground truth was established by objective laboratory analytical methods (GC/MS and automated immunoassay), not by human expert review requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. This device is a diagnostic test kit for in-vitro use, not a medical imaging device or a software that assists human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone performance study was conducted. The OnTrak TesTcup M2K is an in-vitro diagnostic device that provides a result independently. Its performance (precision, accuracy, and agreement) was assessed directly against established laboratory methods (GC/MS, automated immunoassay, and a predicate immunoassay) without human interpretation affecting the device's output. The device itself produces the "positive" or "negative" result based on color change.

7. The Type of Ground Truth Used:

• GC/MS (Gas Chromatography/Mass Spectrometry): Used to confirm positive samples for morphine. This is considered a gold standard analytical method for drug confirmation.
• Automated Immunoassay: Used to screen negative samples. This is a common and accepted laboratory method for initial drug screening.
• Comparison to a Predicate Device (Abuscreen OnLine II for Opiates 2000): Used for overall agreement, implying the predicate device's performance serves as an additional reference point for evaluating the new device's concordance.

8. The Sample Size for the Training Set:

The document does not provide any information regarding a training set. This is typical for simple in-vitro diagnostic devices where performance is assessed through analytical and clinical validation, rather than machine learning models requiring training data.

9. How the Ground Truth for the Training Set Was Established:

As no training set is mentioned or applicable given the device type, this information is not provided.

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