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510(k) Data Aggregation
(37 days)
Elecsys® PreciControl Varia 3 is used for quality control of specified Elecsys immunoassays on the Elecsys and cobas e immunoassay analyzers. See the package insert for the list of all analytes claimed.
Elecsys® PreciControl Varia 3 is a lyophilized product consisting of analytes in a human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
The provided 510(k) summary for the Elecsys® PreciControl Varia 3 is for a quality control material, not a diagnostic device that interprets clinical data or images. As such, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable to this type of submission.
The "study" referenced in the document is a performance evaluation demonstrating the device's suitability for its intended purpose as a quality control material, rather than a clinical study of diagnostic accuracy.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific quantitative targets. Instead, it describes performance characteristics that were evaluated to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion is that the new device performs comparably to the legally marketed predicate devices for its intended use as a quality control material.
| Performance Characteristic | Reported Device Performance (Elecsys® PreciControl Varia 3) | Implicit Acceptance Criteria (based on Predicate Devices) |
|---|---|---|
| Value Assignment | Evaluated (details not provided) | Consistent and accurate analyte concentration values across various analytes. |
| Stability | Unopened at 2 – 8 °C: up to stated expiration dateReconstituted/thawed serum at -20 °C: 31 days (freeze only once)Reconstituted/thawed serum at 2 – 8 °C: 72 hoursReconstituted/thawed serum on-board analyzers (20 – 25 °C): up to 5 hours | Comparable or improved stability profiles (unopened, reconstituted, on-board) to predicate devices. |
| Duration of Reconstitution | Evaluated (details not provided) | Reconstitution process is effective and allows for stable control material. |
| Analyte Content | Combines analytes of Elecsys® PreciControl Anemia and Elecsys® PreciControl Bone. Specific concentrations listed in Tables 3 & 4. | Contains the specified analytes at intended concentration levels. |
| Format | Lyophilized | Matches predicate device format. |
| Matrix | Human serum | Matches predicate device matrix. |
| Levels | Three | Matches predicate device levels. |
| Traceability | Vitamin B12—Commercially available radio-binding assay; Ferritin—NIBSC Standard 80/602; Folate—Elecsys Folate II Assay; β-CrossLaps/serum (β-CTx)—Gravimetry; Osteocalcin—In-house reference system; Parathyroid Hormone (PTH and PTH STAT)—In-house reference system | Traceability comparable to predicate devices for accurate assay calibration and quality control. |
| Intended Use | Quality control of specified Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers. | Meets the quality control function for the specified immunoassay platforms. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated. The evaluation was for the performance of the control material itself (value assignment, stability, reconstitution), rather than its performance in detecting specific patient conditions.
- Data Provenance: Not specified in terms of country of origin. The study appears to be a laboratory validation of the control material's characteristics, likely conducted internally by Roche Diagnostics. It would be a prospective study in the sense of evaluating the manufactured control material.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. For a quality control material, "ground truth" is established by the accurate assignment of analyte concentrations during manufacturing, often traceable to international standards or well-characterized reference materials and methods.
- Qualifications of Experts: N/A.
4. Adjudication method for the test set
- Adjudication Method: Not applicable.
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
- MRMC Study: Not applicable. This device is a quality control material, not a diagnostic imaging or AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a laboratory reagent, not an algorithm. Its "performance" refers to its chemical and biological stability and accurately assigned values.
7. The type of ground truth used
- Type of Ground Truth: For the analyte concentrations, the ground truth is established through:
- Reference materials/standards: e.g., NIBSC Standard 80/602 for Ferritin.
- Commercially available assays: e.g., radio-binding assay for Vitamin B12.
- Gravimetry: e.g., for β-CrossLaps/serum.
- In-house reference systems: developed and calibrated against established methods or standards for Osteocalcin and PTH.
Essentially, the "ground truth" for a quality control material is its accurately characterized and assigned analyte concentrations.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Not applicable.
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