(51 days)
The SYNCHRON® Systems DAT Low and High Urine Calibrators 1, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for the calibrations of Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine enzyme immunoassays.
The SYNCHRON® Systems DAT Low and High Urine Calibrators 1 are used for the calibrations of Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine enzyme immunoassay on Beckman SYNCHRON® Systems.
Here's an analysis of the provided text regarding the SYNCHRON® Systems DAT Low and High Urine Calibrators 1, focusing on acceptance criteria and supporting study details:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state quantitative acceptance criteria for the device performance beyond the general claim of "substantial equivalence to toxicology calibrators already in commercial distribution." However, it does mention a key performance study related to stability.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate toxicology calibrators. | "Supports a finding of substantial equivalence." (Overall) |
| Stability for a specified duration. | "Stress stability studies... support the Beckman stability claim of 18 months." |
| Ability to calibrate Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine enzyme immunoassays. | Intended use statement confirms this function. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the stress stability studies or any other performance evaluation. It also doesn't mention the provenance (e.g., country of origin, retrospective/prospective) of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For calibrators, ground truth would typically be established through highly accurate reference methods or certified reference materials, not explicitly by human experts in the manner of diagnostic image interpretation.
4. Adjudication method for the test set
Not applicable/not mentioned. Adjudication methods are typically used in studies involving human interpretation or classification, not for the performance of a calibrator.
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 for enzyme immunoassays, not an AI-assisted diagnostic tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not directly applicable to a calibrator. The calibrator's performance is standalone in the sense that its values are objectively measured, but its role is to enable the accurate function of an immunoassay system, which is then used by a human. The document describes evaluations of the calibrator itself rather than a standalone diagnostic algorithm.
7. The type of ground truth used
For the stability studies, the ground truth would have been the accepted concentrations of the analytes (Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine) within the calibrator solutions, measured by highly accurate and traceable methods over time. The document doesn't explicitly state the method used to establish this ground truth, but it implies comparison to industry standards for toxicology calibrators.
8. The sample size for the training set
Not applicable. This device is a calibrator, not a machine learning algorithm, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a calibrator.
§ 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.