(27 days)
Elecsys® PreciControl Anemia is used for quality control of the Elecsys® Ferritin, Folate II, and Vitamin B12 immunoassays on the Elecsys® immunoassay systems.
The Elecsys® PreciControl Anemia is a lyophilized product consisting of added Ferritin and Aprotinine in human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
The provided 510(k) summary (K051517) describes a quality control device, Elecsys® PreciControl Anemia, for in-vitro diagnostic immunoassays. It is not a device that would typically involve acceptance criteria related to disease detection or diagnosis based on patient data, nor would it involve studies with human readers or ground truth established by experts in the context of diagnostic accuracy.
The acceptance criteria and supporting "study" for a quality control product are focused on its ability to perform consistently and provide expected values for the assays it controls.
Here's an interpretation based on the provided document and the typical evaluation of such devices:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "The Elecsys® PreciControl Anemia was evaluated for value assignment and Performance Characteristics stability." This indicates that the "acceptance criteria" for this device would revolve around:
- Accuracy of Value Assignment: The assigned values for Ferritin, Folate II, and Vitamin B12 in the control material must be within specified ranges and precisely determined.
- Stability: The control material must maintain its assigned values over time under various storage conditions (unopened, reconstituted at different temperatures, after freezing/thawing).
- Matrix Compatibility: The control's matrix (human serum) must be appropriate for the target immunoassays.
The document does not explicitly list quantitative acceptance criteria values or detailed performance data in the provided snippets. This level of detail is typically found in the full 510(k) submission or internal validation reports, not usually summarized in this specific section of the public summary.
However, based on the intent of the provided information, the table would look conceptually like this:
| Acceptance Criteria Category | Specific Criteria (Conceptual, Not Explicitly Stated in Provided Text) | Reported Device Performance (Conceptual, Not Explicitly Stated in Provided Text) |
|---|---|---|
| Value Assignment | Assigned values for analytes (Ferritin, Folate II, B12) must be within manufacturer-defined target ranges with a specified precision. | Values were successfully assigned for all analytes and levels. (Implied by the device being cleared). |
| Accuracy/Traceability | Assigned values should be traceable to reference methods or materials demonstrating accuracy. | Values are traceable and accurate for the intended assays. (Implied). |
| Unopened Stability | Control retains assigned values when stored at 2-8°C until expiration date. | Device demonstrated stability at 2-8°C until expiration. |
| Reconstituted Stability | Control retains assigned values for specified durations at various temperatures (e.g., 20-25°C, 2-8°C, -20°C). | Device demonstrated stability as outlined in the "Stability" section (e.g., 8 hrs at 20-25°C, 3 days at 2-8°C). |
| Freeze-Thaw Stability | Control retains assigned values after one freeze-thaw cycle. | Stable after one freeze-thaw cycle. |
| Matrix Compatibility | The control matrix (human serum) must not interfere with or negatively impact the performance of the Elecsys® immunoassays. | Compatible with the Elecsys® immunoassay systems. (Implied by intended use). |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "The Elecsys® PreciControl Anemia was evaluated for value assignment and Performance Characteristics stability." This implies a series of laboratory experiments.
- Test Set Sample Size: For a quality control material, the "sample size" would refer to the number of batches/lots of the product manufactured and tested, and the number of replicates run during stability and value assignment studies. This information is not provided in the summary. It would typically involve multiple lots tested at various time points and temperature conditions.
- Data Provenance: The studies would have been conducted by Roche Diagnostics, likely in their internal laboratories. The document does not specify the country of origin or if it's retrospective/prospective, but for a new product validation, these would be controlled, prospective laboratory studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This concept is not applicable to this type of device. The "ground truth" for a quality control material is its precisely assigned analyte concentration. This is established through rigorous laboratory methods, often traceable to international reference standards, rather than expert consensus on clinical images or patient outcomes.
4. Adjudication Method for the Test Set
This concept is not applicable. Adjudication methods (like 2+1 or 3+1) are used to resolve discrepancies in expert interpretations of clinical data or images. For a quality control material, analytical results are quantitative and objective within the measurement system's precision.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
This concept is not applicable. MRMC studies are used to evaluate the impact of a diagnostic aid (like AI) on physician performance. The Elecsys® PreciControl Anemia is a quality control reagent, not a diagnostic aid that human readers would use in clinical decision-making.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This concept is not applicable. This is a quality control material, not an algorithm.
7. The Type of Ground Truth Used
For a quality control material, the "ground truth" is established by:
- Assigned Values: The manufacturer meticulously determines the precise concentration of the target analytes (Ferritin, Folate II, Vitamin B12) in the control material. This often involves:
- Using highly accurate reference methods.
- Traceability to international reference materials or standards (if available).
- Extensive testing across multiple instruments and laboratories to ensure reproducibility and consistency.
- Analytical Performance Data: The "ground truth" for its performance would be the quantitative analytical results from experiments demonstrating that the control maintains its assigned values under specified conditions and performs as expected within the Elecsys® immunoassay systems.
8. The Sample Size for the Training Set
This concept is not applicable. The Elecsys® PreciControl Anemia is a chemical reagent, not a learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This concept 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.