Search Results
Found 1 results
510(k) Data Aggregation
(107 days)
Elecsys Anti-TPO CalSet is used for calibrating the quantitative Elecsys Anti-TPO assay on the Elecsys and cobas e immunoassay analyzers.
The Elecsys® Anti-TPO CalSet is a lyophilized product consisting of sheep anti-TPO antibodies in a human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
The Elecsys® Anti-TPO CalSet is a calibrator for the Elecsys Anti-TPO assay. The submission (K103171) is for a modified version of the CalSet, changing it from a liquid to a lyophilized (freeze-dried) material. The primary aim of the study is to demonstrate that the performance of the lyophilized Elecsys® Anti-TPO CalSet (candidate device) is substantially equivalent to the previously cleared liquid Elecsys® Anti-TPO CalSet (predicate device, K051890).
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Implicit: Substantial Equivalence to Predicate) | Reported Device Performance (Candidate Device) |
|---|---|---|
| Value Assignment | Must demonstrate comparable and accurate value assignment to the predicate. | Evaluated for value assignment. (Specific data not provided in summary, but conclusion states substantial equivalence). |
| Stability | Must maintain stability (unopened, reconstituted, and on-analyzer) comparable to or improved from the predicate. | Unopened: Store at 2-8°C until expiration date. |
| Reconstituted: | ||
| • At 2-8°C: 7 days | ||
| • At -20°C: 8 weeks (freeze only once) | ||
| • On analyzers at 20-25°C: use only once | ||
| Reconstitution | Must be reliably reconstitutable according to instructions. | Evaluated for reconstitution. (Specific data not provided in summary, but conclusion states substantial equivalence). |
| Intended Use | Must retain the same intended use: calibrating the quantitative Elecsys Anti-TPO assay. | Elecsys Anti-TPO CalSet is used for calibrating the quantitative Elecsys Anti-TPO assay on the Elecsys and cobas e immunoassay analyzers. (Same as predicate's CalSet function). |
| Analyte | Anti-TPO Antibodies (Sheep) (Same as predicate). | Anti-TPO Antibodies (Sheep) (Same). |
| Traceability | NIBSC 66/387 International Standard (Same as predicate). | NIBSC 66/387 International Standard (Same). |
| Matrix | Human serum (Same as predicate). | Human serum (Same). |
| Levels and Corresponding Concentrations | Two levels: Calibrator 1 (approx. 35.0 IU/mL) and Calibrator 2 (approx. 350 IU/mL) (Same as predicate). | Two levels: Calibrator 1 (approx. 35.0 IU/mL) and Calibrator 2 (approx. 350 IU/mL) (Same). |
| Overall Performance | Performance of the candidate device must be substantially equivalent to the predicate device. | The data demonstrate that the performance of the Elecsys® Anti-TPO CalSet is substantially equivalent to that of the predicate device. |
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective).
- The study is a comparison of a modified calibrator to a predicate calibrator. In such studies, the "test set" would typically refer to the samples used to evaluate the performance characteristics like value assignment and stability. While general areas of evaluation (value assignment, stability, reconstitution) are mentioned, specific sample sizes (e.g., number of batches, number of stability time points tested, number of assays run) are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable in the context of this 510(k) summary. The ground truth for a calibrator's performance is established through analytical validation studies (e.g., measuring known concentrations, assessing stability over time with reference materials), not through expert interpretation of clinical cases. The "ground truth" for the calibrator's assigned values would be its traceable reference standard (NIBSC 66/387 International Standard).
4. Adjudication method for the test set:
- This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human interpretation of medical images or patient data requires consensus from multiple experts. This is an analytical device submission for a calibrator, where performance is measured objectively against analytical standards and specifications.
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:
- This information is not applicable. This is not a diagnostic device that relies on human interpretation of images or data, nor does it involve AI assistance. It is a calibrator for an immunoassay.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. This is an analytical calibrator, not a software algorithm or AI device. Its "performance" is its ability to accurately calibrate an immunoassay.
7. The type of ground truth used:
- The ground truth for the assigned values of the calibrator is the NIBSC (National Institute for Biological Standards and Controls) 66/387 International Standard. This standard provides a reference point for the concentration of Anti-TPO antibodies.
8. The sample size for the training set:
- This information is not applicable. "Training set" refers to data used to train machine learning models. This device is a calibrator for a laboratory assay, not a machine learning or AI-based product.
9. How the ground truth for the training set was established:
- This information is not applicable as there is no "training set" for this type of device.
Ask a specific question about this device
Page 1 of 1