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510(k) Data Aggregation
(142 days)
CA 125 II CalSet II is used for calibrating the quantitative Elecsys CA 125 II assay on the Elecsys and cobas e immunoassay analyzers.
The CA 125 II CalSet II is a lyophilized product consisting of human CA 125 in an equine (Cal 1) and a human (Cal 2) serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
The provided text describes a 510(k) Summary for the CA 125 II CalSet II device, which is a calibrator for immunoassay analyzers. The purpose of the submission is to change the calibrator from a liquid to a lyophilized material and to decrease the concentration of Cal 1. The document focuses on establishing substantial equivalence to a predicate device rather than providing a detailed study demonstrating device performance against specific acceptance criteria.
However, based on the information provided, we can infer some aspects related to "acceptance criteria" through the comparative nature of the 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state acceptance criteria in a quantitative table format as might be seen for diagnostic accuracy studies. Instead, it demonstrates equivalence through a comparison of characteristics and states that performance was evaluated. The implicit acceptance criterion is that the new device's performance (value assignment, stability, and reconstitution) is substantially equivalent to that of the predicate device.
| Characteristic Evaluated | Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|---|
| Value Assignment | Performance should be comparable to the predicate device, ensuring accurate calibration of the Elecsys CA 125 II assay. | The data demonstrate that the performance of the CA 125 II CalSet II (including value assignment) is substantially equivalent to that of the predicate device, Elecsys® CA 125 II CalSet. |
| Stability | The lyophilized and reconstituted stability of the new device should be suitable for its intended use and comparable to the predicate's stability (considering the format change). | Candidate Device (Lyophilized): - Lyophilized: Up until labeled expiration date - Reconstituted (-20°C): 20 weeks (freeze only once) - Reconstituted (2-8°C): 12 weeks - On analyzer (20-25°C): up to 5 hours (multiple uses) / use only once (single use) |
| Reconstitution | The device should reconstitute correctly and consistently to provide accurate calibration. | The data demonstrate that the performance of the CA 125 II CalSet II (including reconstitution) is substantially equivalent to that of the predicate device. The handling instructions detail the reconstitution process. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of diagnostic accuracy, nor does it provide a sample size for such a test. It describes the device as a calibrator, and its performance evaluation focused on its ability to calibrate the Elecsys CA 125 II assay. The data provenance (country of origin, retrospective/prospective) is not mentioned for these performance evaluations.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable. The device is a calibrator, not a diagnostic device that requires expert interpretation for establishing ground truth data like pathology or imaging. The "ground truth" for a calibrator relates to the accuracy of its assigned values and its stability, which would be determined through laboratory analyses and comparisons to reference methods, not expert consensus on pathology/imaging.
4. Adjudication Method for the Test Set
This information is not applicable for a calibrator device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret patient cases, and the objective is to assess the impact of AI assistance on their performance. The CA 125 II CalSet II is a calibrator and does not involve human interpretation of cases.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The concept of "standalone performance" typically applies to AI algorithms for diagnostic interpretation. For a calibrator, the "performance" relates to its analytical characteristics (value assignment, stability, reconstitution) which are assessed in a laboratory setting through analytical methods, not an AI algorithm. The device itself (the calibrator) acts in a "standalone" analytical capacity by providing known concentration levels for instrument calibration.
7. The Type of Ground Truth Used
The "ground truth" for a calibrator concerns its traceability and the accuracy of its assigned target ranges.
- Target Ranges: Cal 1: 0 U/mL, Cal 2: 500 U/mL.
- Traceability: The Elecsys CA 125 II assay (which the calibrator supports) has been standardized against the Enzymun Test CA 125 II method. This in turn was standardized against the CA 125 II RIA from Fujirebio Diagnostics. This hierarchical standardization essentially establishes the "ground truth" for the CA 125 values being calibrated.
8. The Sample Size for the Training Set
This information is not applicable. The device is a calibrator, not an AI algorithm that undergoes training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable.
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