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510(k) Data Aggregation
(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.
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(32 days)
The Elecsys Estradiol III 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 Estradiol III reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys Estradiol III CalCheck 5 is a lyophilized product consisting of 5 different levels of synthetic Estradiol in a human serum matrix. It has been standardized against ID-GC/MS (isotope dilution gas chromatography mass spectrometry).
This document is a 510(k) summary for the Elecsys Estradiol III CalCheck 5, a control material used for calibrating and verifying the assay range of the Elecsys Estradiol III reagent on Roche immunoassay analyzers. It outlines the device description, intended use, and substantial equivalence to a predicate device. The document details studies performed to establish stability claims.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily related to recovery rates and target values for the different CalCheck levels, as well as the comparison of assigned values across different analyzer platforms.
| Acceptance Criterion | Reported Device Performance | Study |
|---|---|---|
| Value Assignment:For each CalCheck 5 lot, the assigned value is the mean over at least 6 determinations (duplicate runs on at least 3 analyzers). | Value assignment testing was conducted and passed pre-defined acceptance criteria. Assigned values are those obtained from the master platform (cobas e 601). | Value Assignment Procedure |
| Value Assignment:CalCheck assigned range is ±27% of the assigned value for levels 2 through 5. | This is a calculated range, not a performance metric to be passed in a study in the same way as recovery. The document states laboratories should establish their own acceptance criteria within this range. | Value Assignment Procedure |
| Value Assignment (Cross-platform comparability):Mean value obtained on additional analyzers (e.g., cobas e 411/Elecsys 2010) must be within 10% of the master platform (cobas e 601) assigned value. | The acceptance criterion was met, indicating consistency across analyzer platforms. | Value Assignment Procedure |
| Open-Vial Stability (CalCheck Level 1):≤ 10 pg/mL | Not explicitly stated if the on-test recovery for level 1 was ≤ 10 pg/mL, but the conclusion states "The data support the package insert claim that reconstituted Estradiol III CalCheck 5 is stable up to 4 hours at 20-25°C." This implies the criterion was met. | Open-Vial Stability Study |
| Open-Vial Stability (CalCheck Level 2):85-115% recovery of the reference material value | The data supports the package insert claim, implying this criterion was met. | Open-Vial Stability Study |
| Open-Vial Stability (CalCheck Levels 3-5):90-110% recovery of the reference material value | The data supports the package insert claim, implying this criterion was met. | Open-Vial Stability Study |
| Accelerated Stability (CalCheck Level 1):≤ 10 pg/mL | Not explicitly stated if the on-test recovery for level 1 was ≤ 10 pg/mL, but the conclusion states "The accelerated stability model employed supports an initial shelf-life claim of 18 months..." This implies the criterion was met. | Accelerated Stability Study |
| Accelerated Stability (CalCheck Level 2):85-115% recovery of the reference material value | The accelerated stability model supports the shelf-life claim, implying this criterion was met. | Accelerated Stability Study |
| Accelerated Stability (CalCheck Levels 3-5):90-110% recovery of the reference material value | The accelerated stability model supports the shelf-life claim, implying this criterion was met. | Accelerated Stability Study |
2. Sample Size Used for the Test Set and Data Provenance
- Open-Vial Stability Study: One Elecsys Estradiol III CalCheck 5 lot was evaluated. Each condition (on-test and reference) was tested in duplicate.
- Accelerated Stability Study: One Elecsys Estradiol III CalCheck 5 lot was evaluated. Each condition (on-test and reference) was tested in duplicate.
- Value Assignment Procedure: For each lot, the CalChecks are run in duplicate on at least three cobas e 601/MODULAR ANALYTICS E170 analyzers (total of at least 6 determinations). For cross-platform comparison, mean values are also obtained on other specified analyzers.
Data Provenance: The document does not explicitly state the country of origin of the data, but the submitter is Roche Diagnostics, an international company. The studies appear to be laboratory-based verification/validation studies, not clinical studies. The data is likely prospective within the context of these specific laboratory tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as this device is a quality control material and the studies are laboratory-based stability and value assignment tests, not studies involving expert interpretation of patient data. The "ground truth" for the CalChecks are the defined target values and precise measurements, not expert consensus.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. There is no concept of adjudication by human experts in these types of laboratory studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation or decision-making. The Elecsys Estradiol III CalCheck 5 is a quality control material for an immunoassay, and its performance is assessed through analytical accuracy and stability, not human interpretation.
6. Standalone (Algorithm Only) Performance
This is not applicable in the traditional sense of a standalone algorithm for medical image analysis or complex diagnostic interpretation. This device is a control material used to verify the performance of an immunoassay analyzer. The "performance" being evaluated is the chemical and analytical stability and assigned values of the control material itself, and its interaction with the immunoassay system. The system (immunoassay analyzer) operates in a standalone fashion in terms of detecting the analyte, and the control material helps verify its proper functioning.
7. Type of Ground Truth Used
The ground truth used for this device is based on analytical measurements and standardization against a highly accurate reference method:
- Assigned Values/Target Values: Defined by the manufacturer through rigorous laboratory testing. For Estradiol, the device was standardized against ID-GC/MS (isotope dilution gas chromatography mass spectrometry), which is considered a highly accurate and precise reference method.
- Reference Material values: For stability studies, "reference material" refers to freshly reconstituted CalChecks stored under optimal conditions, which serve as the baseline for comparison.
8. Sample Size for the Training Set
This information is not applicable. This device is a quality control material; it is not based on a machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this device.
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