(15 days)
For use in the verification of the calibration established by the Elecsys Folate II reagent on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.
The Elecsys Folate II CalCheck II is a set of calibration verification solutions comprised of three levels, each with defined folate levels.
This is a 510(k) premarket notification for a calibration verification material, not a device that requires performance metrics like accuracy, sensitivity, or specificity against clinical data. Therefore, many of the requested elements (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable in the context of this submission.
The "acceptance criteria" for a calibration verification material typically relate to its ability to verify the calibration of an analyzer within expected performance parameters, often demonstrated by comparing its performance to a legally marketed predicate device.
Here's the closest interpretation of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. The performance is assessed by confirming that the new device functions similarly in its intended use as a calibration verification material.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Elecsys® Folate II CalCheck II) |
|---|---|
| Intended Use / Indications for Use: Verification of calibration for Elecsys® Folate assay on Elecsys 2010 and MODULAR ANALYTICS E170. | For use in the verification of the calibration established by the Elecsys® Folate II reagent on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers. (Matches) |
| Matrix: Buffer with human albumin | Human serum (Different, but typical for immunoassay calibration verification materials, and likely considered acceptable) |
| Storage Form: Liquid | Lyophilized (Different, common for these types of materials for stability, and likely considered acceptable) |
| Levels: Defined low, mid, and high folate levels consistent with calibration verification. | Low: 2.0 ng/ml |
| Mid: 7.5 ng/ml | |
| High: 15.3 ng/ml (Comparable to predicate levels, but not identical) | |
| Standardization: Against Elecsys Folate assay, which was standardized against a commercially available radiobinding folate assay. | The Elecsys Folate II assay has been standardized against the Elecsys Folate assay. (Similar standardization hierarchy) |
| Stability: Store at 2-8°C unopened up to expiration date; Opened: 5 hours at 20-25°C. | Same (Matches) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text. For a calibration verification material, the "test set" would typically involve running the material on the specified immunoassay analyzers multiple times to assess its performance against expected values and ensure it behaves as a control. The text does not provide this specific study detail.
- Data Provenance: Not explicitly stated (e.g., country of origin). The submission is from Roche Diagnostics in Indianapolis, IN, USA. The nature of the device (calibration material) suggests internal validation data.
- Retrospective or Prospective: Not specified. Performance evaluations of calibration materials are typically prospective, as they involve testing the manufactured product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Experts: Not applicable. For a calibration verification material, the "ground truth" (i.e., the target folate levels) is established during the manufacturing and standardization process of the material itself, not through expert consensus on interpretation.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no diagnostic interpretation involved that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No. This is a calibration verification material, not a diagnostic imaging or interpretive device that would benefit from an MRMC study.
- Effect Size of Human Readers Improve with AI vs without AI assistance: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This device is a material used as part of a larger immunoassay system; it does not operate as a standalone algorithm.
7. The Type of Ground Truth Used
- Ground Truth Type: For a calibration verification material, the "ground truth" is typically the assigned value (concentration) for each level of the material, established through a rigorous standardization process traceable to primary reference materials or methods. In this case, it's stated that the Elecsys Folate II assay was standardized against the Elecsys Folate assay, which in turn was standardized against a commercially available radiobinding folate assay.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a manufactured material, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable.
§ 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.