(27 days)
The Triage® TOX Drug Screen Controls are assayed materials to be used with the Triage® TOX Drug Screen and Triage® Meter to assist the laboratory in monitoring test performance.
The Triage® TOX Drug Screen Controls are assayed materials to be used with the Triage® TOX Drug Screen and Triage® Meter to assist the laboratory in monitoring test performance.
This 510(k) submission is for the Triage® TOX Drug Screen Controls, which are assayed materials used to monitor the performance of drug screen tests. This device is not an AI-powered diagnostic tool, but rather a quality control material for laboratory use. Therefore, many of the requested categories related to AI performance, such as human reader improvement with AI, standalone AI performance, and AI training data, are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific acceptance criteria or performance metrics for the Triage® TOX Drug Screen Controls. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. The "Summary of Comparison Data" section compares the characteristics of the new device to two predicate devices.
| Characteristic | Triage® TOX Drug Screen Controls | Reported Device Performance (as compared to predicates) |
|---|---|---|
| Intended Use | Assayed control for monitoring urine-based drugs of abuse assays | Matches predicate devices |
| Matrix | Human Urine | Matches predicate devices |
| Form | Liquid | Matches predicate devices |
| Analytes | Commonly abused drugs | Matches predicate devices |
| Storage | -20 °C or colder | Differs from predicate devices (2-8 °C) |
The difference in storage temperature is noted but not presented as a failure to meet an acceptance criterion. The overall conclusion is that the device is substantially equivalent, implying that its performance as a quality control material is deemed acceptable for its intended use, similar to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the submission. As a quality control material, the "test set" would typically refer to internal validation data, which is not detailed here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/provided. For a quality control material, the "ground truth" would likely be established through chemical analytical methods or certified reference materials, rather than expert consensus on diagnostic images or clinical cases.
4. Adjudication Method for the Test Set
This information is not applicable/provided.
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
This information is not applicable. This device is a quality control material, not an AI-powered diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a quality control material, not an AI-powered diagnostic algorithm.
7. The Type of Ground Truth Used
For a quality control material like this, the "ground truth" for its contained analytes would typically be established through analytical testing methods traceable to reference standards, rather than expert consensus, pathology, or outcomes data in the context of diagnostic interpretation. The document does not explicitly state how the "ground truth" (i.e., the certified values of the control material) was established.
8. The Sample Size for the Training Set
This information is not applicable. This device is a quality control material, not an AI-powered diagnostic device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. This device is a quality control material, not an AI-powered diagnostic device.
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.