Search Results

Elecsys CalCheck T 3 is intended for use in the quantitative verification of the calibration curve established by the Elecsys T 3 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.

The Elecsys CalCheck T 3 is a three level single analyte set of lyophilized, human based materials. After reconstitution they are assayed in triplicate and the results are compared to the target values.

This document (K963167) describes a 510(k) premarket notification for the Elecsys® CalCheck™ T 3, which is a calibration verification material. This type of device is used to check the calibration curve of an immunoassay analyzer and is not a diagnostic device for patient care. Therefore, many of the typical acceptance criteria and study designs for diagnostic devices (e.g., sensitivity, specificity, reader studies, pathology ground truth) are not applicable here.

Based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria in terms of numerical thresholds (e.g., "accuracy must be >95%"). However, the core acceptance criterion for a calibration verification material is that it successfully verifies the calibration curve. The performance is demonstrated by showing that the device works as intended, leading to "calibration verification."

The reported device performance would be the successful use of the Elecsys CalCheck T 3 to verify the calibration curve of Elecsys T 3 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers, as intended. The text indicates that after reconstitution, the materials "are assayed in triplicate and the results are compared to the target values." The performance is deemed acceptable if these results fall within expected ranges for calibration verification.

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

The text states that the Elecsys CalCheck T 3 is a "three level single analyte set." It further says, "After reconstitution they are assayed in triplicate."

• Sample size for test set: This refers to the number of individual test measurements. For each of the three levels of the CalCheck, it is assayed in triplicate. So, it's 3 levels * 3 replicates = 9 assays per verification event.
• Data provenance: Not specified, but generally, studies for such devices are conducted internally by the manufacturer during development and validation. This would be considered prospective data generation for the purpose of validating the device. Country of origin not specified, but the submitter (Boehringer Mannheim Corporation) is based in Indianapolis, IN, USA.

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

For a calibration verification material, the "ground truth" is typically the assigned target values for each of the three levels. These target values are established through rigorous reference methods and/or internal validation processes using highly calibrated instruments and expert laboratory personnel. The document does not specify the number or qualifications of experts involved in establishing these target values.

4. Adjudication Method for the Test Set

Not applicable. This is not a diagnostic device where disagreements between readers or interpretations would need adjudication. The performance is based on instrumental readings against pre-established target values.

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

No, an MRMC comparative effectiveness study was not done, and it would not be applicable for this type of device. This device is an analytical tool to verify instrument performance, not a diagnostic imaging or interpretive device that requires human readers.

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

This device itself is a material that is analyzed by an automated immunoassay analyzer. The "performance" of the device is its ability to elicit expected results on the analyzer. The measurement process is largely standalone in the sense that the instrument produces a quantitative result without human subjective interpretation for each measurement. However, human operators are involved in reconstituting the material and initiating the assay, and then comparing the instrument's results to target values. So, it's not an "algorithm-only" performance evaluation in the software sense, but rather a performance evaluation of the material with an automated instrument.

7. The Type of Ground Truth Used

The ground truth used for calibration verification materials are assigned target values for each level of the material. These are derived from reference methods and extensive internal validation by the manufacturer.

8. The Sample Size for the Training Set

Not applicable in the typical sense of machine learning algorithms. This device is a biochemical material rather than a software algorithm that requires a "training set" of data. Its "design" is based on chemical formulation and stability rather than data-driven learning.

9. How the Ground Truth For The Training Set Was Established

Not applicable. As explained above, there is no "training set" for this type of device. The "ground truth" (target values) is established through analytical validation and reference methods during the product's development.

Ask a specific question about this device