(56 days)
The Preciset DAT Plus I calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.
Roche Preciset DAT Plus I calibrators contain a mixture of 9 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, phencyclidine, and propoxyphene. 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.
This document is a 510(k) Summary for the Roche Preciset DAT Plus I Calibrators. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving device performance in the way typically expected for a medical device's analytical or clinical performance.
Instead, this submission is for calibrators, which are used to standardize other assays. The "performance" in this context refers to their composition and their equivalence to a legally marketed predicate calibrator.
Therefore, many of the requested categories (acceptance criteria, device performance, sample sizes for test/training, number of experts, adjudication, MRMC studies, standalone studies, ground truth types) are not applicable or not reported in this type of submission for a calibrator device.
Here's a breakdown of the information that can be extracted, and where the requested information is absent:
1. A table of acceptance criteria and the reported device performance:
This document does not explicitly state acceptance criteria or report performance data for the calibrators in terms of accuracy, precision, or other analytical metrics. The claim of performance is based on the contents and the comparison to an existing predicate calibrator.
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (Implied by description) |
|---|---|
| (Not stated) | The calibrators contain a mixture of 9 different drugs at specified concentrations, quantitatively added to drug-free human urine (as described in {1}). The device is substantially equivalent to a predicate calibrator {2}. |
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 describes the calibrator itself, not a study evaluating its performance with test samples. The "test set" in this context would implicitly be the various drug assays that would be calibrated using this device, which are not detailed here.
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. This device is a calibrator, and its "ground truth" is its precisely defined chemical composition. There are no human experts involved in establishing this type of ground truth for a calibrator.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set or adjudication process is described.
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 calibrator, not an AI-powered diagnostic tool, and involves no human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a calibrator and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for these calibrators is their known, quantitative chemical composition. They are prepared by the "quantitative addition of drug or drug metabolite to drug-free human urine" {1}.
8. The sample size for the training set:
Not applicable. This document describes a calibrator, not a machine learning model that would require a training set.
9. How the ground truth for the training set was established:
Not applicable. No training set is involved.
§ 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.