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The ONTRAK TESTCUP -er is an in vitro diagnostic test intended for professional use for the qualitative detection of drug or drug metabolite in urine. ONTRAK TESTCUP-er simultaneously tests for the presence of multiple drugs or drug metabolites. The ONTRAK TESTCUP - er profile consists of amphetamines (1000 ng/mL cutoff), cocaine metabolite (300 ng/mL cutoff), barbiturates (200 ng/mL cutoff), benzodiazepines (200 ng/mL), and morphine (300 ng/mL cutoff).

Measurements obtained by this device are used in the diagnosis and treatment of amphetamine, cocaine, barbiturate, benzodiazepine, and morphine use or overdose.

The ONTRAK TESTCUP-er is an in vitro diagnostic test intended for professional use for the qualitative detection of drug or drug metabolite in urine. ONTRAK TESTCUP-er simultaneously tests for the presence of multiple drugs or drug metabolites. The ONTRAK TESTCUP-er profile consists of amphetamines (1000 ng/mL cutoff), cocaine metabolite (300 ng/mL cutoff), barbiturates (200 ng/mL cutoff), benzodiazepines (200 ng/mL), and morphine (300 ng/mL cutoff).

The ONTRAK TESTCUP-er is a modified version of the currently marketed ONTRAK TESTCUP. The ONTRAK TESTCUP-er test profile consists of amphetamines, cocaine metabolite, barbiturates, benzodiazepines, and morphine whereas the test profile for the ONTRAK TESTCUP consists of amphetamines, cannabinoids, cocaine metabolite, morphine and phencyclidine. Essentially, cannabinoids and phencyclidine have been replaced with barbiturate and benzodiazepine test strips to create what we now refer to as the ONTRAK TESTCUP-er.

ONTRAK TESTCUP®-er Acceptance Criteria and Study Details

1. Acceptance Criteria and Reported Device Performance

This document primarily focuses on the Barbiturates Assay and Benzodiazepines Assay components of the ONTRAK TESTCUP®-er.

¹ Note: The document presents the performance characteristics of the predicate devices as a point of comparison, implying these are the established benchmarks for substantial equivalence. Actual specific acceptance criteria for the new device as distinct from predicate are not explicitly stated, but are demonstrated through the "significant performance characteristics relied upon" for substantial equivalence.

2. Sample Size and Data Provenance for Test Set

• Barbiturates Assay:
  • Sample Size: N = 50 positives for accuracy testing.
  • Data Provenance: Not specified, but generally in vitro diagnostic studies using patient samples are usually prospective laboratory studies. The document does not indicate a specific country of origin or whether it was retrospective.
• Benzodiazepines Assay:
  • Sample Size: N = 50 positives for accuracy testing.
  • Data Provenance: Not specified, same considerations as for Barbiturates Assay.

3. Number and Qualifications of Experts for Ground Truth

• The document does not mention the use of experts to establish ground truth for the test sets.
• The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is an analytical method rather than expert interpretation.

4. Adjudication Method

• No adjudication method is mentioned, as the ground truth was established using an objective analytical method (GC/MS).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. This device is an in vitro diagnostic device for qualitative detection of substances in urine, not an imaging or interpretive device that would typically involve human readers.

6. Standalone Performance Study

• Yes, a standalone (algorithm only without human-in-the-loop performance) study was performed. The reported precision and accuracy indicate the inherent performance of the device itself against objective analytical standards.

7. Type of Ground Truth Used

• The type of ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS), which is an accepted gold standard analytical method for drug confirmation in urine.

8. Sample Size for Training Set

• The document does not specify a separate training set or its sample size. For in vitro diagnostic devices like this, the development and verification process often involves iterative testing and refinement, but a distinct "training set" in the machine learning sense is not explicitly detailed. The reported performance is likely from a validation or test set after development.

9. How Ground Truth for Training Set Was Established

• As no specific training set is identified, the method for establishing its ground truth is not described. However, it is reasonable to infer that any samples used in the development or initial validation phases would also have utilized methods like GC/MS to establish their true content.

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