(40 days)
The Preciset® Serum Proteins calibrator is intended to be used in the calibration of immunoturbidimetric assays on the BM/Hitachi systems.
The Preciset® Serum Proteins consists of multi-level calibrators based on human serum. The concentrations of the components have been adjusted to ensure optimal calibration of the following immunoturbidimetric assays: Tina-quant® IgA, Tina-quant® IgG, Tina-quant® IgM, Tina-quant® C3, and Tina-quant® C4, Transferrin, and C-Reactive Protein (CRP).
The provided text is a 510(k) summary for the Preciset® Serum Proteins calibrator. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria, device performance studies to meet such criteria, sample sizes, expert involvement, or ground truth establishment.
The document focuses on the regulatory submission process for a calibrator, which is a device used to establish calibration curves for quantitative determinations. The "performance" in this context refers to the stated values of constituent analytes in the calibrator, not a diagnostic accuracy performance as might be seen for devices like imaging AI. Therefore, most of the requested information is not applicable or not present in this type of submission.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of performance metrics like sensitivity, specificity, or clinical accuracy. For calibrators, acceptance criteria would typically revolve around the accuracy and stability of the assigned analyte values, and their ability to produce valid calibration curves on specified instruments. This document does not include these specific criteria or the studies that demonstrate compliance.
- Reported Device Performance: The "performance" for a calibrator is presented as the representative constituent analyte levels used in the calibrator, which are listed in the table below. This is not performance as in diagnostic accuracy, but rather the intrinsic property of the calibrator.
| Constituent | Level 1 | Level 2 | Level 3 | Level 4 | Level 5 | Units |
|---|---|---|---|---|---|---|
| IgG | 194 | 408 | 845 | 1622 | 2985 | mg/mL |
| IgA | 50 | 94 | 193 | 400 | 723 | mg/mL |
| IgM | 28 | 51 | 103 | 213 | 388 | mg/mL |
| C3 | 38 | 70 | 147 | 305 | NA | mg/mL |
| C4 | 6.4 | 12.4 | 26.1 | 54.9 | 99.3 | mg/mL |
| Transferrin | 42 | 80 | 159 | 333 | 603 | mg/mL |
| CRP | 0.6 | 1.3 | 2.2 | 11.2 | 29.2 | mg/mL |
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 / Not Provided: This document does not describe performance studies involving "test sets" in the context of diagnostic accuracy. The data provenance is not mentioned.
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 / Not Provided: This information is not relevant for a calibrator's regulatory submission, as there's no "ground truth" to establish through expert consensus as there would be for a diagnostic tool. The values for the calibrator analytes are determined through established analytical methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: This is not relevant for 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 is a calibrator, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This is a calibrator, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided: For a calibrator, the "ground truth" for the analyte concentrations is established through rigorous analytical measurement processes and metrological traceability, not through clinical expert consensus, pathology, or outcomes data. The specific methods used to assign values are not detailed in this summary.
8. The sample size for the training set
- Not Applicable: This device is a calibrator, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable: This device is a calibrator, not an algorithm that requires a training set.
§ 862.1150 Calibrator.
(a)
Identification. A 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. (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.