(85 days)
For in vitro diagnostic use as a calibrator in clinical chemistry assays for UIBC (Unsaturated Iron Binding Capacity) and CO2(Carbon Dioxide). DC-UIBC-CO2 Calibrator may be used to check the linearity over the reportable patient range of UIBC assays.
Clinical Chemistry assays may require a point of reference to determine the values of unknown samples. DC-UIBC-CO2-CAL may be used for this purpose in UIBC and CO2 assays.
For IN VITRO diagnostic use.
DC-UIBC-CO, Calibrator is a human based, tyophilized serum which contains nonreactive stabilizers and additives.
The provided text describes a 510(k) submission for the DC-UIBC-CO2-Cal calibrator. It appears to be a regulatory submission document for a medical device rather than a study report that details acceptance criteria and performance against those criteria. Therefore, much of the requested information regarding specific acceptance criteria, study design, sample sizes, expert qualifications, and detailed performance metrics is not present in the provided text.
Based on the information available:
1. Table of acceptance criteria and the reported device performance:
The document does not explicitly state acceptance criteria or provide a table of performance data against such criteria. The submission is for a calibrator, which typically undergoes validation for stability, accuracy, and homogeneity, but these specific metrics and their acceptance thresholds are not detailed here.
2. Sample sized used for the test set and the data provenance:
Not available in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as this is a calibrator and not a diagnostic device requiring ground truth established by experts for performance evaluation on patient samples.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable.
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, as 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, as this is a calibrator, not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the context of diagnostic performance. For a calibrator, the "truth" would be its assigned target values, established through a rigorous analytical process. The text mentions it's a "human-based, lyophilized serum," implying its composition is designed to mimic human serum for calibration purposes.
8. The sample size for the training set:
Not applicable. Calibrators are not "trained" in the way AI algorithms are.
9. How the ground truth for the training set was established:
Not applicable.
Summary of what is available from the text:
- Device Type: DC-UIBC-CO2-Calibrator, a human-based, lyophilized serum.
- Intended Use: For in vitro diagnostic use as a calibrator in clinical chemistry assays for UIBC (Unsaturated Iron Binding Capacity) and CO2 (Carbon Dioxide). It may also be used to check linearity over the reportable patient range of UIBC assays.
- Predicate Device: DC-UIBC-CAL, Cat. No. SE-090. This implies that the current device's substantial equivalence was established by comparing it to this already marketed device. The performance of the current device would have been demonstrated to be substantially equivalent to the predicate, but the specific details of that comparison are not in this excerpt.
- Safety Information: The product is prepared from blood donors tested and shown to be free from HBsAg and antibodies to HCV and HIV, but standard precautions for handling laboratory reagents are advised.
- Regulatory Decision: The FDA determined the device is substantially equivalent to legally marketed predicate devices.
To provide the requested information, a more detailed study report or validation protocol for the DC-UIBC-CO2-Calibrator would be required, which would typically be part of a larger 510(k) submission but is not included in this summary document.
§ 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.