Search Results

This CalCheck set is an assayed control for use in calibration and for use in the verification of the assay range established by the Elecsys ß-CrossLaps/serum reagent on the cobas e immunoassay analyzers.

The ß-CrossLaps CalCheck 5 is used for the calibration verification and the assessment of the measuring range as needed by the laboratory certification agencies such as College of American Pathologists or CLIA certification. The CalChecks are a customer convenience product and not required to assess the performance.

The provided document describes the ß-CrossLaps CalCheck 5, a quality control material intended for calibration verification and assay range verification on cobas e immunoassay analyzers.

Here's an analysis of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

• Value Assignment: For each lot, CalChecks are run in duplicate on at least two modules (with two measuring cells each) of the cobas e 801, with at least two runs. This results in at least six (6) determinations (runs) for the median assigned value.
• Stability Studies:
  • Open Vial Stability: On-test and reference materials were tested in duplicate.
  • Accelerated Stability: Test and reference materials were tested in duplicate.
  • Real-time Stability: Data for time-points at 0, 7, 13 and 19 months tested in duplicate for an on-going study.
• Data Provenance: The studies were conducted by Roche Diagnostics, presumably in their facilities (Mannheim, Germany; Penzberg, Germany; or the United States, as per establishment registrations). The data is prospective for the stability studies, as specific studies were performed to verify claims.

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

Not applicable. This device is a quality control material whose "ground truth" is its own assigned value and specified stability characteristics, as determined by internal validation procedures using the stated analytical instruments. It does not rely on expert interpretation for its function or evaluation.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this is a quality control material, not an AI or diagnostic device requiring human adjudication of results. The "adjudication" is based on meeting the pre-defined quantitative acceptance criteria.

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

No. This is a quality control material for an immunoassay analyzer and does not involve human readers interpreting cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, in essence. The performance evaluations described (Value Assignment, Stability Studies) are intrinsic tests of the quality control material itself and its behavior on the immunoassay analyzer. There is no "human-in-the-loop" aspect to the performance of the control material, beyond the laboratory technician performing routine quality control tasks. The device's performance is standalone in the context of its intended use to verify the performance of an immunoassay analyzer.

7. The Type of Ground Truth Used:

The ground truth for the ß-CrossLaps CalCheck 5 is its assigned value, which is determined by a rigorous internal value assignment process (median of multiple determinations as described previously). For stability studies, the "ground truth" or reference is either a freshly reconstituted set of CalChecks or unstressed reference material, against which the test material's recovery is compared. This is a form of analytical reference standard determination.

8. The Sample Size for the Training Set:

Not applicable. This device is a quality control material; it is not an algorithm that requires a "training set" in the context of machine learning.

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

Not applicable, as there is no training set.

Ask a specific question about this device