(18 days)
The Roche Diagnostics Corporation OnTrak TesTcup M2K/OnTrak TesTstik Controls are quality control samples for use with the OnTrak TesTcup M2K and OnTrak TesTstik systems for amphetamine, barbiturates, benzodiazepines, cocaine, morphine 2000 (M2K), phencyclidine (PCP) and THC.
The OnTrak TesTcup M2K/OnTrak TesTstik Controls are quality control samples for use with the OnTrak TesTcup M2K and OnTrak TesTstik systems for amphetamine, barbiturates, benzodiazepines, cocaine, morphine 2000 (M2K), phencyclidine (PCP) and THC. The OnTrak TesTcup M2K/OnTrak TesTstik Controls are prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Preservatives and stabilizers are added to maintain product integrity.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the OnTrak TesTcup M2K/OnTrak TesTstik Controls:
1. Acceptance Criteria and Reported Device Performance
The device under review is a quality control material, not a diagnostic device with performance metrics like sensitivity or specificity. Its "performance" is primarily defined by the concentration of drug or drug metabolites it contains. The acceptance criteria are implicitly that the control material contains the specified concentrations of the substances. The "study" described is a comparison of the new control material's formulation (specifically, the morphine level and the addition of oxazepam) to predicate devices.
| Analyte | Acceptance Criteria (Target Concentration in Positive Control) | Reported Device Performance (Concentration in Modified OnTrak TesTcup M2K and TesTstik Controls - Positive) |
|---|---|---|
| Amphetamines | 2500 ng/mL | 2500 ng/mL |
| Cannabinoids | 125 ng/mL | 125 ng/mL |
| Cocaine | 750 ng/mL | 750 ng/mL |
| Morphine | 5000 ng/mL | 5000 ng/mL |
| Phencyclidine | 62.5 ng/mL | 62.5 ng/mL |
| Secobarbital | 500 ng/mL | 500 ng/mL |
| Oxazepam | 500 ng/mL | 500 ng/mL |
Note: The negative controls are consistently reported as 0 ng/mL for all drugs, which is implicitly the acceptance criteria for negative controls to be drug-free.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size of a "test set" in the traditional sense for diagnostic performance. This is a quality control product, and the "testing" involves ensuring the prepared control materials contain the intended drug concentrations. The data provenance is implied to be from internal laboratory preparation and testing by Roche Diagnostics Corporation in Indianapolis, IN, USA. The study design is focused on demonstrating the composition of the control materials rather than their diagnostic performance against patient samples. It's a characterization of the control product itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for a quality control material is its precisely prepared composition (i.e., known-added concentrations of analytes), not an expert interpretation of a diagnostic output.
4. Adjudication Method for the Test Set
Not applicable. There is no expert adjudication because the "ground truth" is the known chemical composition of the control material.
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
Not applicable. This device is a quality control material, not an AI-powered diagnostic tool, and therefore, an MRMC study and AI assistance are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The ground truth used is the known, quantitative addition of drug or drug metabolite to drug-free human urine during the manufacturing process of the control material. This is a highly controlled, synthetic "ground truth" established by the product's formulation.
8. The Sample Size for the Training Set
Not applicable. This is a quality control material, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is involved. The "ground truth" for the control material itself is established by its precise manufacturing formulation and verified through analytical chemistry methods.
§ 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.