(10 days)
The Elecsys LH CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys LH reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys LH CalCheck 5 is a lyophilized product consisting of human luteinizing hormone (LH) in a human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
Here's a summary of the acceptance criteria and study details for the Elecsys LH CalCheck 5, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Value Assignment | On Master Platform (MODULAR ANALYTICS E170): |
- Assigned range: ±30% of the assigned value for levels 2-5.
- % CV: ≤10% for levels 2-5 (level 1 free of analyte).
(For other non-master analyzers: Elecsys 2010, cobas e 411, cobas e 601, cobas e 602): - Median value on additional analyzers must be within 10% of the master platform assigned value. | Value assignment testing was conducted and must pass pre-defined acceptance criteria. The text states: "After this acceptance criterion is met, the assigned values from the master platform are deemed valid for the..." implying successful performance. The exact performance values are not explicitly stated, but the passing of criteria is confirmed. |
| Open-Vial Stability | Reconstituted product stable up to 4 hours at 20-25°C. | "Real-time testing was performed and the data support the package insert claim that reconstituted Elecsys LH CalCheck 5 is stable up to 4 hours at 20-25°C." |
| Shelf-Life Stability | Initial shelf-life claim of 18 months at 2-8°C. (Real-time testing ongoing for 36 months claim). | "The accelerated stability testing performed at 35℃ supports an initial shelflife claim of 18 months at 2-8°C." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a single "test set" in the traditional sense for algorithm evaluation.
- For Value Assignment: "at least 6 determinations" (duplicate runs on at least 3 analyzer measuring cells) for each CalCheck level. This was done for the master platform and for each of the four additional analyzer platforms.
- For Stability: The sample size for real-time and accelerated stability testing (number of lots, vials, or replicates) is not specified.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing was conducted internally by Roche Diagnostics. This appears to be prospective data generated specifically for device validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This device is a control material, not a diagnostic algorithm that interprets complex data. Therefore, the concept of "ground truth" derived from expert consensus by radiologists or similar specialists is not applicable. The "ground truth" here is the assigned value and stability of the control, which is determined through rigorous laboratory testing protocols executed by skilled laboratory personnel using standardized methods and instruments.
4. Adjudication Method for the Test Set
Not applicable as this is not an expert-driven adjudication of medical images or patient outcomes. The "adjudication" is inherent in the pre-defined acceptance criteria for the analytical performance of the control material (e.g., median values, % CV, and acceptable deviations between platforms).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not applicable to a laboratory control material.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a standalone product (a control material) whose performance is evaluated analytically, not an "algorithm" in the sense of AI or image analysis. Its performance is its standalone performance in providing accurate and stable target values for calibration verification.
7. The Type of Ground Truth Used
The "ground truth" for the Elecsys LH CalCheck 5 is:
- Target Concentration Values: Established by laboratory testing against the 2nd International Standard (NIBSC) 80/552.
- Stability: Determined through real-time and accelerated laboratory stability studies.
8. The Sample Size for the Training Set
There is no "training set" in the context of machine learning for this device. The values and performance characteristics are established through analytical testing and standardization, not by training an algorithm on a dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI algorithm, this question is not applicable. The device's "ground truth" (its assigned values and stability) is established through precise laboratory measurements and standardization against recognized international reference standards.
§ 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.