(15 days)
The Roche Diagnostics/Boehringer Mannheim Corporation Elecsys® CalCheck™ CA 125II is used to verify the calibration assignment for the Roche Diagnostics/Boehringer Mannheim Corporation Elecsys CA 125II assay.
Elecsys® CalCheck™ CA 125II calibration verification solutions comprise three levels - low, mid, and high - each with a defined CA 125II concentration. The low solution concentration is near the lower detection limit of the assay. The mid solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.
The Elecsys® CalCheck™ CA 125II is intended for use in periodic verification of the calibration of the Elecsys® CA 125II assay.
The Roche Diagnostics/Boehringer Mannheim Corporation Elecsys CalCheck CA 125II is manufactured using human serum albumin, CA 125, stabilizers, and preservatives. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calcheck are in process checked and quality controlled against ID-GC/MS.
The provided text is for a 510(k) summary for a calibration verification material (Elecsys® CalCheck™ CA 125II), not a medical device in the typical sense of diagnosing or treating a disease. Therefore, many of the requested categories related to clinical performance studies (e.g., expert ground truth, MRMC studies, standalone performance) are not applicable or would not be performed for such a product.
However, I can extract information related to its "performance characteristics" as described for this type of product.
Here's the breakdown of what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For a calibration verification material, "performance" typically refers to its value assignment and stability to ensure it can accurately verify the calibration of an assay. The document states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Value Assignment | Evaluated (Implied satisfactory for clearance) |
| Stability | Evaluated (Implied satisfactory for clearance) |
Note: The document states these were "evaluated" but does not provide specific numerical criteria or results. For a calibration verification material, the acceptance criteria would typically involve demonstrating that the assigned values are accurate and that the material remains stable over its declared shelf life when stored properly.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical images or patient data. For a calibration verification material, testing involves manufacturing lots and stability studies.
- Sample Size for Test Set: Not specified in the provided text, but it would pertain to the number of lots or units of the Elecsys® CalCheck™ CA 125II manufactured and tested.
- Data Provenance: Not explicitly stated, but assumed to be from internal lab studies conducted by Roche Diagnostics/Boehringer Mannheim Corporation. This would be prospective manufacturing and stability testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This concept is not applicable for a calibration verification material. "Ground truth" for this product type is established through analytical methods for assigning analyte concentrations and stability assessments, not expert interpretation of clinical data.
4. Adjudication Method for the Test Set
Not applicable for a calibration verification material.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, this type of study is not applicable for a calibration verification material. MRMC studies are used for diagnostic devices involving human interpretation of clinical data.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a consumable for laboratory assay calibration.
7. The Type of Ground Truth Used
For this device (calibration verification material):
- Ground Truth: Established by analytical methods for determining the concentration of CA 125II in the material (e.g., against reference methods or highly accurate internal standards) and stability studies to confirm the integrity of these concentrations over time. The document mentions it is "in process checked and quality controlled against ID-GC/MS," which implies a rigorous analytical method for quantification, likely for components or precursors, and overall quality control.
8. The Sample Size for the Training Set
Not applicable in the context of machine learning or AI models. The "training set" for this product would be the historical data and expertise used in developing the formulation and manufacturing process of the calibration verification material, and the initial validation batches.
9. How the Ground Truth for the Training Set Was Established
Not applicable in the context of machine learning. The "ground truth" for developing this product would stem from:
- Analytical chemistry principles: To formulate a stable matrix and spike it with known concentrations of CA 125.
- Method validation expertise: To design studies for value assignment and stability testing.
- Manufacturing and Quality Control standards: To ensure consistency across production lots.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.