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510(k) Data Aggregation
(237 days)
LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603
The DiaSorin LIAISON® 25 OH Vitamin D TOTAL Calibration Verifiers are assayed quality control materials intended for in vitro diagnostic use in the quantitative verification of calibration and reportable range of the LIAISON® 25 OH Vitamin D TOTAL Assay when performed on the LIAISON® Analyzer.
The LIAISON® 25 OH Vitamin D TOTAL Calibration Verifiers consist of four human serum-based total vitamin D levels with buffer salts and sodium azide. Each vial contains 5,0 mL of ready to use liquid material. The set is provided with targeted total vitamin D concentrations. The individual Calibration Verifier concentrations were chosen to represent values closest to the important decision limits used to determine Vitamin D sufficiency status in individual patients.
The LIAISON® 25 OH Vitamin D TOTAL Calibration Verifiers are assayed quality control materials intended for in vitro diagnostic use in the quantitative verification of calibration and reportable range of the LIAISON® 25 OH Vitamin D TOTAL Assay when performed on the LIAISON® Analyzer.
Here's an analysis of the acceptance criteria and the study performed:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly demonstrated by the "Expected Range" for each Calibration Verifier level. The reported device performance, in terms of precision (SD and %CV for overall results), falls within or is expected to enable the LIAISON® 25 OH Vitamin D TOTAL Assay to operate within these ranges.
| Cal Verifier ID# | Expected Range (ng/mL) | Overall Mean Conc (ng/mL) | Overall SD | Overall %CV |
|---|---|---|---|---|
| A Lot #1 | 7.1 - 13.3 | 10.5 | 1.35 | 12.9 |
| B Lot #1 | 29.9 - 48.9 | 41.9 | 3.71 | 8.9 |
| C Lot #1 | 54.5 - 81.7 | 71.4 | 5.66 | 7.9 |
| D Lot #1 | 92.9 - 139.3 | 122.6 | 9.63 | 7.9 |
| A Lot #2 | 7.1 - 13.3 | 9.7 | 1.42 | 14.6 |
| B Lot #2 | 30.7 - 50.1 | 40.3 | 4.23 | 10.5 |
| C Lot #2 | 56.6 - 85.0 | 72.4 | 5.86 | 8.1 |
| D Lot #2 | 90.5 - 135.7 | 116.3 | 8.01 | 6.9 |
| A Lot #3 | 7.9 - 14.7 | 10.6 | 1.03 | 9.7 |
| B Lot #3 | 32.9 - 53.6 | 40.7 | 3.18 | 7.8 |
| C Lot #3 | 59.0 - 88.5 | 67.9 | 3.76 | 5.5 |
| D Lot #3 | 97.2 - 145.8 | 111.1 | 6.51 | 5.9 |
The acceptance criteria are not explicitly stated for the device's own performance (e.g., maximum allowable %CV for a verifier), but rather the verifiers are designed to confirm the calibration and reportable range of the LIAISON® 25 OH Vitamin D TOTAL Assay. The study demonstrates the reproducibility of the verifiers themselves, indicating their stability and consistency for their intended use.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For each of the four Calibration Verifier levels (A, B, C, D) across three different lots, the sample size (N) for the precision study was 60. This was achieved by testing each verifier in quadruplicate, one run per day for 5 days, across 3 LIAISON® Analyzers (4 measurements/day * 5 days/run * 3 analyzers = 60).
- Data Provenance: The document does not specify the country of origin of the data. It is highly likely to be internal data from DiaSorin Inc., given the direct reference to their established performance and the conduct of the study to verify that performance. The study is prospective as it involves controlled testing under defined conditions specifically to assess the device's reproducibility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the device is an assayed quality control material, not a diagnostic device that requires expert interpretation of results to establish ground truth. The "ground truth" for the Calibration Verifiers are their targeted total vitamin D concentrations, which would have been established by DiaSorin using a reference method or validated internal process during their manufacturing and assaying.
4. Adjudication Method for the Test Set
This section is not applicable. The study involves quantitative measurements by automated analyzers, not subjective assessments requiring adjudication among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a quality control material for an automated assay, not an imaging device or diagnostic tool requiring human interpretation. Therefore, there is no "human readers improve with AI vs without AI assistance" effect size to report.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance study was done in the sense that the performance of the Calibration Verifiers was evaluated independent of human interpretation of results, using automated LIAISON® Analyzers. The focus was on the analytical reproducibility of the verifiers themselves when processed by the LIAISON® system.
7. The Type of Ground Truth Used
The ground truth for the Calibration Verifiers themselves is their "targeted total vitamin D concentrations" (as stated in the device description). These concentrations are established during the manufacturing and assaying of the control materials, likely using highly accurate reference methods or certified reference materials to assign the values.
8. The Sample Size for the Training Set
This section is not applicable. The LIAISON® 25 OH Vitamin D TOTAL Calibration Verifiers are quality control materials, not an artificial intelligence (AI) or machine learning (ML) algorithm that requires a training set. Their "targeted concentrations" are assigned through analytical processes, not learned from data.
9. How the Ground Truth for the Training Set was Established
This section is not applicable for the same reasons as #8.
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