(36 days)
For use in the verification of the calibration established by the Elecsys proBNP II reagent on the Elecsys and cobas e immunoassay analyzers.
The Elecsys proBNP II CalCheck is a lyophilized product consisting of NT-proBNP (1-76) amide human serum and potassium phosphate buffered matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
This document describes the Elecsys proBNP II CalCheck, a quality control material intended for use in verifying the calibration of the Elecsys proBNP II reagent on specific immunoassay analyzers. As this is a quality control material and not a diagnostic device for patient diagnosis, the typical acceptance criteria and study designs for diagnostic accuracy (like sensitivity, specificity, accuracy against a gold standard in patient datasets) are not applicable in the same way.
Instead, the "performance" of such a device is evaluated by its ability to provide stable and accurate assigned values over time and under various conditions, ensuring it can properly verify the calibration of the main diagnostic assay.
Here's an analysis based on the provided text, addressing the requested information where applicable for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical "acceptance criteria" for the Elecsys proBNP II CalCheck in the format typically seen for diagnostic devices (e.g., sensitivity >X%, specificity >Y%). Instead, the performance is demonstrated through its intended function as a calibration verification material and its stability characteristics, compared to a predicate device.
| Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Intended Use | Must effectively verify calibration for Elecsys proBNP II reagent on Elecsys and cobas e immunoassay analyzers, similar to predicate. | "For use in the verification of the calibration established by the Elecsys proBNP II reagent on the Elecsys and cobas e immunoassay analyzers." (Identical functional intent to predicate, but for the 'proBNP II' reagent). |
| Levels | Must provide three calibration verification levels, similar to predicate. | "Three" (same as predicate). |
| Format | Must be a lyophilized product, similar to predicate. | "Lyophilized" (same as predicate). |
| Handling | Must have similar reconstitution and handling instructions as predicate. | "Reconstitute with exactly 1.0 mL distilled or deionized water and allow standing closed for 15 minutes, then mixing gently." (same as predicate). |
| Stability (Unopened) | Must demonstrate stability comparable to or better than predicate (2-8℃ until expiration date). | "Unopened: · Store at 2-8℃ until expiration date" (same as predicate). |
| Stability (Reconstituted) | Must demonstrate stability comparable to or better than predicate (20-25℃: 4 hrs). | "Reconstituted: ● 20-25℃:4 hrs" (same as predicate). |
| Matrix Composition | Must have a matrix suitable for its intended use, comparable to predicate. | "Level 1: NT-proBNP free human serum matrix; Levels 2/3: synthetic NT-proBNP in human serum / buffer matrix" (same as predicate). |
| Overall Performance | Must demonstrate satisfactory "value assignment" and "stability" for its intended purpose. | "The Elecsys proBNP II CalCheck was evaluated for value assignment and Performance Characteristics stability." (Specific data not provided in the summary, but implied to be acceptable for 510(k) clearance). |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide specific details on the sample size (number of replicate measurements, number of lots, etc.) or data provenance (e.g., country of origin, retrospective/prospective) for the "value assignment and stability" evaluation of the Elecsys proBNP II CalCheck. Such details would typically be found in the full 510(k) submission and not in the summary. For a quality control material, the "test set" would generally refer to batches of the control material tested for analyte concentration, consistency, and stability over time and varying conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. For a quality control material used to verify calibration of an assay measuring a specific analyte (NT-proBNP), the "ground truth" is established through analytical methods and metrology, not by expert consensus or clinical interpretation. The assigned values for the control material are determined by precise laboratory measurements using reference methods or by comparison to primary standards.
4. Adjudication Method for the Test Set
Not applicable for a quality control material. Adjudication methods (like 2+1, 3+1) are used in studies where human readers are making subjective interpretations, typically with imaging or pathology. For analytical controls, the "truth" is determined by quantitative measurement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Not applicable. MRMC studies are designed to assess the performance of diagnostic devices (especially those involving human interpretation, like imaging AI) by comparing the accuracy of multiple readers across multiple cases, often with and without AI assistance. The Elecsys proBNP II CalCheck is an analytical control material, not a diagnostic device that involves human interpretation or diagnosis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a biochemical control material, not an algorithm or AI system.
7. The Type of Ground Truth Used
For a quality control material like Elecsys proBNP II CalCheck, the "ground truth" for the assigned values is established through analytical laboratory measurements and metrological traceability. This means the concentration of NT-proBNP in each level of the control material is precisely quantified using validated analytical methods, often traceable to internationally recognized standards or highly characterized reference materials for NT-proBNP. It is a value assigned through rigorous scientific measurement rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This device is an analytical control material, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted in point 8, there is no training set for this type of device.
§ 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.