(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.
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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.
§ 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.