(62 days)
The Preciset DAT Plus II calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. The Cfas DAT Qualitative Plus calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.
Roche Preciset DAT Plus II calibrators contain a mixture of 2 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are benzodiazepines and opiates. The calibrator set contains up to six levels for each drug contained in bottles 1-6. Bottle 1 is negative (drug free) human urine, followed by bottles 2-6 containing increasing amounts of each drug in a multi-analyte mixture. Drug or drug metabolite and their respective levels included are as follows: Benzodiazepines: 0, 50, 100, 200, 400 ng/ml (no 6th level) Opiates: 0, 150, 300, 600, 1000, 2000 ng/ml. Roche Cfas DAT Qualitative Plus calibrator contains a mixture of 7 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, and propoxyphene. The calibrator set contains a single level for each drug mixture. Drugs or drug metabolites and their respective levels included are as follows: Barbiturates: 200 ng/ml Benzodiazepines: 300 ng/ml Cocaine: 150 ng/ml Methadone: 300 ng/ml Opiates: 2000 ng/ml Phencyclidine: 25 ng/ml Propoxyphene: 300 ng/ml
The provided text describes a 510(k) summary for Roche Preciset DAT Plus II and Cfas DAT Qualitative Plus Calibrators, which are devices used for calibrating drug of abuse assays in human urine on automated clinical chemistry analyzers. As such, the information does not contain acceptance criteria or study results in the typical sense of measuring device performance against a predefined clinical or technical threshold.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device. This regulatory pathway does not require new efficacy studies if the new device is sufficiently similar to a previously cleared one.
Therefore, many of the requested elements for describing acceptance criteria and study results are not applicable to this type of regulatory submission and the provided documentation.
Here's an assessment based on the available information:
1. Table of acceptance criteria and the reported device performance:
- Not applicable. The document does not describe specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for its own performance. Instead, it aims to show substantial equivalence to a predicate device.
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 document does not describe a performance study with a test set in the way you might expect for a diagnostic device measuring patient outcomes. The "data" here refers to the quantitative addition of drug or drug metabolite to drug-free human urine for calibrator preparation.
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 in this context would relate to the precise concentration of drugs in the calibrators, which is established by the manufacturer through quantitative addition, not by expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method is described as this is not a study assessing diagnostic performance against a clinical ground truth.
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:
- Definitely Not applicable. This device is a calibrator for laboratory assays, not an AI-powered diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm, but a physical calibrator product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the calibrators is the known, quantitatively added concentration of drug or drug metabolite in drug-free human urine. This is an engineered "truth" rather than a discovery-based one (like pathology).
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of this device. The calibrators are manufactured to precise specifications.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for this product. The "ground truth" for the calibrators themselves is established by the quantitative addition process during manufacturing.
Summary of what the document DOES provide regarding comparison:
The core of the submission is to establish substantial equivalence to the predicate device: "Abuscreen OnLine Preciset DAT I Calibrators" (K951595).
The comparison focuses on:
- Intended Use: Both the new device and the predicate are designed for the calibration of Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.
- Device Description (Composition):
- Preciset DAT Plus II: Contains Benzodiazepines (0, 50, 100, 200, 400 ng/ml) and Opiates (0, 150, 300, 600, 1000, 2000 ng/ml). Up to six levels.
- Cfas DAT Qualitative Plus: Contains Barbiturates (200 ng/ml), Benzodiazepines (300 ng/ml), Cocaine (150 ng/ml), Methadone (300 ng/ml), Opiates (2000 ng/ml), Phencyclidine (25 ng/ml), Propoxyphene (300 ng/ml). Single level.
- Predicate Device (Abuscreen OnLine Preciset DAT I): Contains a mixture of 9 different drugs (amphetamines, barbiturates, benzodiazepines, cocaine, methadone, methaqualone, opiates, phencyclidine, and propoxyphene). Four levels for each drug.
- All calibrators are prepared by the quantitative addition of drug or drug metabolite to drug-free human urine.
The primary argument for substantial equivalence rests on the similar intended use and the fact that both the new and predicate devices are calibrators for drug of abuse assays, even though the specific drug mixtures and number of levels differ. The regulatory approval letter confirms that the FDA determined the device to be substantially equivalent to legally marketed predicate devices.
§ 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.