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The Elecsys CA 15-3 II CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys CA 15-3 II reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostics use only.

The Elecsys CA 15-3 II CalCheck 5 is a lyophilized product consisting of CA 15-3 in equine serum matrix (Level 1) or human serum matrix (Levels 2-5). During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Elecsys CA 15-3 II CalCheck 5

Intended Use: An assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys CA 15-3 II reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostics use only.

1. Table of Acceptance Criteria and Reported Device Performance

• Level 1 assigned value: ≤ 2.5 U/mL.
• % CV: 5% for levels 2-5.
• Median value on additional analyzers (Elecsys 2010, cobas e 411, cobas e 601, and cobas e 602) must be within 10% of the master platform (MODULAR ANALYTICS E170) assigned value. | - Value assignment testing was conducted and passed pre-defined acceptance criteria (specific numerical results for each level are not detailed, but the summary states they passed).
• Assigned values from the master platform (MODULAR ANALYTICS E170) were deemed valid for the other platforms (Elecsys 2010, cobas e 411, cobas e 601, and cobas e 602). |
  | Open-Vial Stability (after reconstitution) | Reconstituted Elecsys CA 15-3 II CalCheck 5 must be stable for up to 4 hours at 20-25°C. | Real-time testing was performed, and the data support the claim of stability for up to 4 hours at 20-25°C. |
  | Shelf-Life Stability | - Initial shelf-life claim: 18 months at 2-8°C.
• Long-term shelf-life claim: 36 months at 2-8°C (supported by ongoing real-time testing). | - Accelerated stability testing at 35°C supports an initial shelf-life claim of 18 months at 2-8°C.
• Real-time testing at 2-8°C is ongoing to support a claim of 36 months. |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Value Assignment): For each CalCheck lot, the CalChecks are run in duplicate on at least three E170 analyzer measuring cells. The assigned value is the median of at least 6 determinations. This process is repeated for each of the five CalCheck levels (levels 1-5). The same procedure is performed on four additional analyzers (Elecsys 2010, cobas e 411, cobas e 601, and cobas e 602) for comparison.
• Sample Size (Stability): Not explicitly stated, but "real-time and accelerated stability tests were conducted."
• Data Provenance: Not explicitly stated, but presumably from internal laboratory studies conducted by Roche Diagnostics in the context of their in vitro diagnostic device development. This would be considered prospective data generation for regulatory submission. The country of origin is not specified but Roche Diagnostics is based in Indianapolis, IN, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not applicable for this type of device. The "ground truth" for in vitro diagnostic control materials is established through extensive analytical validation (value assignment, stability, precision) against reference methods or established procedures, rather than expert interpretation of results. The "truth" is the analytically determined value and its expected performance characteristics.

4. Adjudication Method for the Test Set

• Not applicable. As this device is an assayed control for calibration verification, there is no subjective adjudication of results by experts. Results are evaluated against predefined analytical precision and accuracy criteria. The median value from multiple determinations is used as the assigned value.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This type of study (MRMC) is relevant for diagnostic imaging or interpretation tasks where human readers (interpreters) are involved. The Elecsys CA 15-3 II CalCheck 5 is an in vitro diagnostic control material used to verify instrument performance, not to aid in the interpretation of patient samples by human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, in essence. The performance characteristics (value assignment, stability) are determined for the control material itself, independent of immediate human intervention in the result determination process for patient samples. The evaluation described is of the analytical performance of the control material on specified automated immunoassay analyzers.

7. The Type of Ground Truth Used

• Analytically Determined/Assigned Values: The ground truth for the CalChecks are their "assigned values," which are determined through a rigorous internal testing process involving multiple runs on multiple analyzer measuring cells. These assigned values are then used as the reference points for subsequent quality control and calibration verification by end-users. The stability data are also based on analytically measured changes in concentration over time.

8. The Sample Size for the Training Set

• Not applicable. This device is an assayed control material, not a machine learning algorithm that requires a "training set." The development of the product and its performance characteristics rely on analytical validation studies, not on training data in the context of AI/ML.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as it's not an AI/ML device requiring a training set.

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