(29 days)
For use in the verification of the callbration established by the Elecsys Estradiol III reagent on the indicated Electys and cobas e immunoassay analyzers.
The Elecsys Estradiol III CalCheck is a lyophilized product consisting of synthetic Estradiol in a human serum matrix. It has been standardized against CRM6004a via ID-GC/MS (isotope dilution gas chromatography mass spectrometry).
The provided document describes the Elecsys Estradiol III CalCheck device, an in vitro diagnostic quality control material. It details its intended use, comparison to a predicate device, and studies conducted to support its stability claims.
Here's an analysis of the provided information according to your criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and performance are reported for two stability studies: Open-Vial Stability and Accelerated Stability.
| Study | Characteristic | Acceptance Criterion | Reported Performance |
|---|---|---|---|
| Value Assignment | Assigned Range | ±27% of the assigned value for all levels (1, 2, and 3). | "Value assignment testing was conducted and passed pre-defined acceptance criteria." |
| Analyser Consistency | Mean value on additional analyzer | Within 10% of the master platform assigned value. | "The assigned values from the master platform are deemed valid for the MODULAR ANALYTICS E170, Elecsys 2010, cobas e 411, cobas e 601, and cobas e 602 immunoassay analyzers." |
| Open-Vial Stability | Recovery (Level 1) | 85-115% recovery of the reference material vlaue | "The data support the package insert claim that reconstituted Estradiol III CalCheck is stable up to 4 hours at 20-25°C." (Implies criteria met) |
| Open-Vial Stability | Recovery (Levels 2-3) | 90-110% recovery of the reference material value | "The data support the package insert claim that reconstituted Estradiol III CalCheck is stable up to 4 hours at 20-25°C." (Implies criteria met) |
| Accelerated Stability | Recovery (Level 1) | 85-115% recovery of the reference material value | "The accelerated stability model employed supports an initial shelf-life claim of 18 months when the Estradiol III CalCheck are stored under normal storage conditions of 2-8°C." (Implies criteria met) |
| Accelerated Stability | Recovery (Levels 2-3) | 90-110% recovery of the reference material value | "The accelerated stability model employed supports an initial shelf-life claim of 18 months when the Estradiol III CalCheck are stored under normal storage conditions of 2-8°C." (Implies criteria met) |
2. Sample Size Used for the Test Set and the Data Provenance
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Open-Vial Stability Study:
- Sample Size: "One Estradiol III CalCheck lot was evaluated in duplicate" for on-test and reference materials. This means a single lot of the control material was used, with duplicate measurements taken.
- Data Provenance: The study was conducted internally by Roche Diagnostics on a cobas e 411 analyzer. It's a prospective internal validation study. The country of origin of the data is not explicitly stated but can be inferred as the location of Roche Diagnostics' testing facility (likely USA or Europe, given the submission location).
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Accelerated Stability Study:
- Sample Size: "One Estradiol III CalCheck lot was evaluated in duplicate" for on-test and reference materials. Similar to the open-vial study, a single lot was used with duplicate measurements.
- Data Provenance: Conducted internally by Roche Diagnostics on a cobas e 411 analyzer. Prospective internal validation.
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Value Assignment Test:
- Sample Size: For each lot, CalChecks are run in duplicate on at least three cobas e 601/MODULAR ANALYTICS E170 analyzers and the cobas e 411/Elecsys 2010. This implies at least 6 determinations for the assigned value and additional comparisons for other analyzers.
- Data Provenance: Internal testing by Roche Diagnostics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the device is a quality control material for an in vitro diagnostic, not an AI or imaging device that requires expert interpretation for ground truth. The "ground truth" here refers to the reference values or stability characteristics, which are determined by established analytical methods and reference materials (CRM6004a via ID-GC/MS).
4. Adjudication Method for the Test Set
This is not applicable. Adjudication typically applies to studies where multiple human readers interpret data, and their interpretations need to be reconciled. For analytical performance of a quality control material, results are quantitative and compared against pre-defined analytical acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable. An MRMC study is relevant for AI or imaging devices that assist human readers in diagnosis or interpretation. The Elecsys Estradiol III CalCheck is a quality control material used for calibration verification of an immunoassay analyzer, not a diagnostic tool for human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is an in vitro diagnostic reagent, not an algorithm or AI. Its performance is evaluated through analytical studies, not through AI standalone performance metrics.
7. The Type of Ground Truth Used
The "ground truth" for the Elecsys Estradiol III CalCheck's performance is established by:
- Reference Material Traceability: Standardization against CRM6004a via ID-GC/MS (isotope dilution gas chromatography mass spectrometry). This is a highly accurate and precise analytical method that establishes the true value of Estradiol.
- Reference Measurements: For stability studies, "freshly reconstituted set of CalChecks" stored under optimal conditions (2-8°C) served as the reference material for comparison against stressed samples.
8. The Sample Size for the Training Set
This information is not applicable. The Elecsys Estradiol III CalCheck is not an AI or machine learning model that requires a training set. It is a manufactured reagent whose characteristics are determined by its chemical composition and analytical methods.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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.