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OnTrak TesTcup® 5 is an in vitro diagnostic test intended for professional use for the qualitative detection of drug or drug metabolite in urine. OnTrak TesTcup 5 simultaneously tests for the presence of multiple drugs or drug metabolites.

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

OnTrak TesTcup 5 provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/mass spectrometry (GC/MS) is the preferred confirmation method. Clinical consideration and professional judgment should be applied to any drug abuse result, particularly when preliminary positive results are used.

The OnTrak TesTcup-5 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 (300 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 . 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 document describes the acceptance criteria and study results for the OnTrak TesTcup-5 device, specifically focusing on its performance for Phencyclidine (PCP) detection.

Here's the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Sizes:
  • PCP Positive Samples: 90 urine samples (for evaluating positive accuracy).
  • PCP Negative Samples: 307 urine samples (for evaluating negative accuracy).
  • Overall Agreement/Comparison to Abuscreen OnLine: 397 samples.
• Data Provenance: The urine samples for the accuracy testing were "obtained from a clinical laboratory". The document does not specify the country of origin. The study is retrospective, using existing urine samples that have already been screened and confirmed.

3. 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 or qualifications of experts used to establish the ground truth. However, the ground truth for positive PCP samples was established by GC/MS (Gas Chromatography/Mass Spectrometry) at the 25 ng/mL cutoff. This is a laboratory-based instrumental method, not typically relying on expert human interpretation for primary ground truth determination in this context. Negative samples were screened by "an automated immunoassay" and then confirmed as negative, implying GC/MS confirmation was likely also used for discordant results or for a subset of negatives.

4. Adjudication method for the test set

The document does not describe any human adjudication method (e.g., 2+1, 3+1). The ground truth was established instrumentally (GC/MS) for positive samples and by automated immunoassay screening for negative samples.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic test for drug detection, and its output (color change indicating positive or negative) is interpreted directly, not through complex image analysis or reader interpretation that would necessitate an MRMC study. There is no AI component mentioned in the document.

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

Yes, a standalone performance evaluation was done. The device itself (OnTrak TesTcup-5) is the "algorithm" in this context, providing a direct visual result. The accuracy metrics (100% for positive and negative samples) directly reflect the device's standalone performance compared to the established ground truth.

7. The type of ground truth used

The primary ground truth used for PCP positive samples was GC/MS (Gas Chromatography/Mass Spectrometry). For negative samples, the ground truth was established by screening with an automated immunoassay relative to the 25 ng/mL cutoff for PCP. "Abuscreen OnLine for PCP" was also used for comparative purposes and showed 100% agreement. GC/MS is a highly specific and sensitive analytical method considered the gold standard for drug confirmation in urine.

8. The sample size for the training set

The document does not specify a separate training set or its sample size. This type of in vitro diagnostic device typically undergoes extensive R&D and validation during its development, but the premarket notification focuses on the final validation study results rather than detailing internal development and training data. The study described focuses on the performance testing of the finalized device.

9. How the ground truth for the training set was established

As no specific training set is mentioned or detailed, the method for establishing its ground truth is not provided in this document.

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