(76 days)
The C.f.a.s. DAT Qualitative Plus Clinical calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. The Control Set DAT Clinical is for use as an assayed control in the Roche test system for qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers.
C.f.a.s. DAT Qualitative Plus Clinical calibrators contain a mixture of 10 different drugs, prepared by quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, barbituates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine, and propoxyphene. The calibrator set contains a single level for each drug in a drug mixture. Drug concentrations are verified by gas chromatography/mass spectrometry (GC/MS). Control Set DAT Clinical controls contain a mixture of 10 different drugs, prepared by quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, barbituates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine, and propoxyphene. Drug concentrations are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ±25% of the assay cutoff.
The provided text is a 510(k) summary for the C.f.a.s. DAT Qualitative Plus Clinical and Control Set DAT Clinical devices. It establishes substantial equivalence to previously marketed predicate devices rather than proving a device meets specific acceptance criteria through a study with performance metrics.
Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, training set details) are not applicable or not provided in this type of submission.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
This document describes calibrators and controls for drug-of-abuse testing, not a diagnostic device with performance metrics like sensitivity and specificity against a clinical condition. Therefore, there are no specific "acceptance criteria" for clinical performance in the sense of a diagnostic test, nor reported device performance in terms of clinical accuracy (e.g., sensitivity, specificity, accuracy).
Instead, the acceptance criteria for these calibrators and controls revolve around their composition, their traceability to GC/MS verification, and their intended use for calibrating and controlling Roche assays. The "performance" is implicitly that they function as intended for these purposes when used with the specified assays.
The table below summarizes the device characteristics rather than performance against acceptance criteria in a clinical study:
| Characteristic | C.f.a.s. DAT Qualitative Plus Clinical | Control Set DAT Clinical |
|---|---|---|
| Composition | Mixture of 10 drugs in drug-free human urine | Mixture of 10 drugs in drug-free human urine |
| Drugs Included | Amphetamines, Barbituates, Benzodiazepines, Cannabinoids, Cocaine, Methadone, Methaqualone, Opiates, Phencyclidine, Propoxyphene | Amphetamines, Barbituates, Benzodiazepines, Cannabinoids, Cocaine, Methadone, Methaqualone, Opiates, Phencyclidine, Propoxyphene |
| Verification Method | Gas Chromatography/Mass Spectrometry (GC/MS) | Gas Chromatography/Mass Spectrometry (GC/MS) |
| Calibrator Levels | Single level for each drug in drug mixture | N/A (controls have target concentrations) |
| Control Target Conc. | N/A | Established at ±25% of the assay cutoff |
| Intended Use | Qualitative calibration of Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers | Assayed control in Roche test system for qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) for calibrators and controls based on substantial equivalence, not a clinical study on a device's performance against a test set of patient samples. The verification of drug concentrations is done via GC/MS of the manufactured calibrator/control product itself, not on patient samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. Ground truth for the drug concentrations within the calibrators and controls is established by Gas Chromatography/Mass Spectrometry (GC/MS), which is an analytical method, not by human experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no human adjudication of results is involved in establishing the ground truth for these calibrators and controls. The drug concentrations are verified by GC/MS.
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 not an AI-assisted diagnostic tool, and no MRMC study or AI-related performance evaluation is relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a calibrator/control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the drug concentrations within the calibrators and controls is established by Gas Chromatography/Mass Spectrometry (GC/MS). This is a highly accurate analytical technique used to verify the precise amount of each drug or drug metabolite added to the drug-free human urine matrix.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this 510(k) submission. These are manufactured chemical reference materials, not machine learning algorithms that require training data.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth establishment for one.
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special 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.