(99 days)
MAS® DOA Total is intended for use as an assayed control for monitoring assay conditions in semi-quantitative and qualitative analysis of patient urine specimens for drugs and drug metabolites. These controls are human urine based and are composed of d-methamphetamine, secobarbital, nitrazepam, oxazepam, buprenorphine, benzoylecgonine, cotinine, ethyl glucuronide, ethanol, LSD, methadone, EDDP, methaqualone, morphine, oxycodone, phencyclidine, propoxyphene, nortriptyline, and L-2-9-THC-COOH.
MAS® DOA Total provides 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.
DOA TOTAL is prepared from certified drug free human urine pools. Analyte levels are adjusted with purified drugs or drug metabolites. Preservatives and stabilizers are added to maintain product integrity.
DOA TOTAL offers levels of controls, at concentrations 25% below and 25% above the screening cutoff levels used by the United States Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA); for Amphetamines, PCP (Phencyclidine), Opiates, Cocaine and Marijuana (Cannabinoid).
Here's a breakdown of the acceptance criteria and study information for the Thermo Scientific MAS® DOA Total device, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Evaluation Parameter | Acceptance Criteria | Reported Device Performance | Pass/Fail |
|---|---|---|---|
| Target Achievement | Analyte concentrations meet specification | L1: Negative; L2-L6: recovery difference vs. target within +/-10%, except LSD which is within +/-15% | Pass |
| Open Bottle Stability at 5°C | 30 days | L1: Negative; L2-L6: recovery change within +/- 10% | Pass |
| Closed Bottle Stability – Product Shelf Life (5°C) | 24 months (predicted) | L1: Negative; L2-L5: recovery change within +/- 15%; L6: recovery change within +/- 20% | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes control materials (MAS® DOA Total) intended for monitoring assay conditions, not a diagnostic device that processes patient samples to generate a result. Therefore, the concept of a "test set" with patient samples and data provenance (e.g., country of origin, retrospective/prospective) as typically applied to diagnostic algorithms is not directly applicable here.
Instead, the "test set" here refers to the batches of the control material itself that were subjected to various stability and target achievement evaluations. The sample size for these evaluations is not explicitly stated in the provided summary. However, the evaluation parameters imply testing across different levels (L1-L6) and over time for stability studies.
The data provenance is internal to Thermo Fisher Scientific, as they manufactured and tested these control materials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable to this device. MAS® DOA Total is a control material with defined analyte concentrations. The "ground truth" for the control material's composition is established by the manufacturing process and analytical chemistry techniques used to prepare and characterize the material, not by expert interpretation.
4. Adjudication Method for the Test Set
This question is not applicable to this device. As the device is a control material with defined chemical compositions, there is no need for expert adjudication of results. The "truth" is inherent in the manufacturing specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and an AI-powered system might assist or replace them. MAS® DOA Total is a control material, not a diagnostic algorithm or a system that involves human interpretation of patient cases.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable to this device. MAS® DOA Total is a chemical control material, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for MAS® DOA Total is analytical chemistry characterization and manufacturing specifications of the control material itself. The concentrations of the various drugs and metabolites are precisely adjusted and measured during the manufacturing process.
8. The Sample Size for the Training Set
This question is not applicable to this device. MAS® DOA Total is a manufactured control material, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable to this device for the same reason as above (not an AI model). The "ground truth" for the control material's composition is established through analytical chemistry and quality control during its production.
§ 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.