(27 days)
CalSet IGF-1 is used for calibrating the quantitative Elecsys IGF-1 assay on the Elecsys and cobas e immunoassay analyzers.
CalSet IGF-1 is used for calibrating the quantitative Elecsys IGF-1 assay on the Elecsys and cobas e immunoassay analyzers. CalSet IGF-1 is a two concentration level set of lyophilized human serum matrix that is traceable to the WHO IS 02/254 Reference Material. The CalSet includes:
- IGF-1 Call: 2 bottles, each for 1.0 mL of calibrator 1 .
- IGF-1 Cal2: 2 bottles, each for 1.0 mL of calibrator 2 .
IGF-1 in two concentration ranges (approximately 20 ng/mL and approximately 500 ng/mL) in a human serum matrix.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CalSet IGF-1 device:
Acceptance Criteria and Device Performance Study for CalSet IGF-1
The CalSet IGF-1 is a calibrator used for the quantitative Elecsys IGF-1 assay. Its performance is primarily evaluated through studies demonstrating the stability and accurate value assignment of the calibrator itself.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Value Assignment | Assigned values must fall within specified acceptable ranges for each lot. | The assigned value of each calibrator is defined as the median value obtained over at least six (6) runs on at least three (3) modules of the respective calibrator. Values must fall within specified acceptable ranges for each lot. (Implied met, as the overall conclusion states the device performs as well or better than the predicate). |
| Reconstituted Stability at -20°C | Stable for at least 31 days at -20 ± 5°C. | The reconstituted CalSet IGF-1 is stable for at least 31 days at -20 ± 5℃. |
| Reconstituted Stability at 2-8°C | Stable for at least 72 hours at 2-8°C. | The reconstituted CalSet IGF-1 is stable for at least 72 hours at 2-8°C. |
| On-board Stability (20-25°C) | Stable for at least 6 hours on-board the analyzers at 20-25°C. | The reconstituted CalSet IGF-1 is stable for at least 6 hours on-board the analyzers at 20-25°C. |
| Accelerated Stability (35°C) | The accelerated stability model employed met the specification (specific quantitative criteria not provided in the text). | The accelerated stability model employed met the specification. |
| Real-time Stability (Lyophilized) | Stable up to the stated expiration date (e.g., 12 months). | The lyophilized CalSet IGF-1 is stable up to the stated expiration date. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes performance validation studies for the calibrator itself, rather than a diagnostic device tested on patient samples. Therefore, the concept of a "test set" in the context of patient data with country of origin and retrospective/prospective nature doesn't directly apply here.
- Value Assignment Test Set: For value assignment, calibrators are run in duplicate on four (4) cobas e 411 modules and four (4) modules of the MODULAR ANALYTICS E170/cobas e 602 with all Elecsys IGF-1 reagent lots available. The assigned value is the median over at least six (6) runs on at least three (3) modules.
- Stability Studies Test Set: For stability studies, "on-test and reference materials" (which are CalSet IGF-1 samples under different storage conditions) were tested in duplicate on the cobas e 411 immunoassay analyzer. A "freshly reconstituted set of CalSet IGF-1 (stored at 2 - 8°C)" served as the reference material for accelerated stability.
- Data Provenance: The studies were performed by Roche Diagnostics, a global company with facilities in Germany and the United States (as per the establishment registration numbers). The specific location where these studies were conducted is not explicitly stated, but it's internal company data for product validation. The data is prospective as it describes studies performed to validate the manufactured calibrator.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device is a calibrator, not a diagnostic tool requiring expert interpretation of patient data. The "ground truth" for the calibrator's value assignment is based on its traceability to a defined international standard (WHO IS 02/254 Reference Material) and the analytical performance of the Elecsys IGF-1 assay on specific immunoassay analyzers.
4. Adjudication Method for the Test Set
This is not applicable as the device is a calibrator. The value assignment process involves calculating a median value from multiple runs on multiple modules, which is an objective statistical calculation, not a subjective adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that require human interpretation (e.g., radiologists reading images) where the AI assists the human reader. CalSet IGF-1 is a calibrator for an automated immunoassay, and human interpretation is not part of its intended use or evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a calibrator, which functions without "human-in-the-loop" once it's used in the automated immunoassay system. The performance studies described (value assignment, stability) are essentially "standalone" evaluations of the calibrator's characteristics and its interaction with the specified immunoassay system. There isn't an "algorithm" in the typical sense; rather, it's a precisely defined chemical reference material.
7. The Type of Ground Truth Used
The ground truth for the CalSet IGF-1 is the WHO IS 02/254 Reference Material. This is an internationally recognized standard for IGF-1 quantification, providing the basis for traceability and accurate value assignment to the calibrator.
8. The Sample Size for the Training Set
This information is not applicable. The CalSet IGF-1 is a calibrator, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The calibrator's formulation and manufacturing processes are established based on scientific principles and analytical chemistry, not data training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As stated above, there is no training set for this device. The ground truth for the calibrator's values is established through traceability to the WHO IS 02/254 Reference Material.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.