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510(k) Data Aggregation
(91 days)
Elecsys PreciControl ThyroAB is used for quality control of the Elecsys Anti-TSHR, Anti-TPO and Anti-Tg immunoassays on the Elecsys and cobas e immunoassay analyzers.
The Elecsys PreciControl ThyroAB is a lyophilized product consisting of antibodies in a human serum matrix. During manufacture, the antibodies are spiked into the matrix at the desired concentration levels.
Here's an analysis of the provided text regarding the Elecsys PreciControl ThyroAB, focusing on acceptance criteria and the study that proves the device meets them:
Disclaimer: The provided text is a 510(k) summary for a quality control device. These types of submissions primarily focus on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical efficacy studies typical of diagnostic or therapeutic devices. Therefore, the details requested in your prompt regarding patient data, experts, and human reader studies are generally not applicable to this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
For a quality control material like Elecsys PreciControl ThyroAB, the "performance" primarily relates to its characteristics as a control, such as stability and its ability to provide target values for the assays it controls. The acceptance criteria are essentially what Roche Diagnostics established for the modified product to be considered equivalent and suitable for its expanded intended use.
| Acceptance Criteria Category | Specific Criteria/Reported Performance | Notes on Acceptance (Based on Document) |
|---|---|---|
| Intended Use | Expanded to include Elecsys Anti-TPO and Anti-Tg immunoassays. | Met. The submission details the addition of Anti-TPO and Anti-Tg antibodies to extend current functionality. |
| Analyte Concentration | Specific concentration levels for Anti-TSHR, Anti-TPO, and Anti-Tg. | Met. The submission lists the target concentrations for each analyte at two levels. |
| Antibody Source and Type | Anti-TSHR: Human monoclonal; Anti-TPO: Sheep polyclonal; Anti-TG: Sheep polyclonal. | Met. The submission details the antibody sources and types for each analyte. |
| Handling (Reconstitution) | Dissolve contents with 2.0 mL distilled/deionized water, stand for 30 minutes, mix carefully. | Met. This is a specific instruction provided for the modified device. |
| Stability (Unopened) | Store at 2-8°C until expiration date. | Met. No change from predicate, implying continued acceptance. |
| Stability (Reconstituted on Analyzer) | Up to 5 hours at 20-25°C. | Met. Improved from predicate (previously 3 hours). This is a positive change, suggesting acceptance. |
| Stability (Reconstituted frozen) | At -20°C: 1 month (freeze only once). | Met. Decreased from predicate (previously 3 months), but still an accepted stability specification for the modified product. |
| Stability (Reconstituted refrigerated for Anti-TG & Anti-TPO only) | At 2-8°C for 3 days. | Met. This is a new stability specification for the added analytes, implying acceptance for their specific handling. |
| Performance Characteristics | Evaluation for value assignment, stability, and duration of reconstitution. | Met. The document states these evaluations were performed, implying they demonstrated satisfactory results for the product's function as a control. The specific quantitative results are not provided in this summary but would have been part of the full submission. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in this 510(k) summary. For a quality control material, the "test set" would typically refer to the various batches of the control material manufactured and tested during the validation process. The number of individual measurements or experiments performed on these batches would constitute the sample size. However, the summary does not provide these numbers.
- Data Provenance: Not specified. Given that Roche Diagnostics is a global company, the studies could have been conducted at various internal facilities. The summary does not indicate retrospective or prospective and is not typically relevant for a quality control material validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device. "Ground truth" in the context of a diagnostic device often refers to clinical diagnoses established by expert clinicians (e.g., radiologists, pathologists). For a quality control material, the "ground truth" or reference values are established through rigorous analytical testing using reference methods and certified reference materials, typically performed by laboratory scientists and statisticians at the manufacturer's facility, not clinical experts.
4. Adjudication Method for the Test Set
This information is not applicable to this type of device. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies among multiple human readers or interpreters of clinical data for diagnostic devices. For a quality control material, analytical results are compared to predefined analytical specifications or reference values, not adjudicated clinical interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not applicable to this type of device. MRMC studies are used to evaluate the performance of diagnostic imaging devices (often AI-assisted) by assessing how human readers' performance changes with or without the device. As Elecsys PreciControl ThyroAB is a quality control material for immunoassays, such a study would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable to this type of device. "Standalone" performance generally refers to the accuracy of an AI algorithm in performing a diagnostic task without human intervention. This device is a control material used to monitor the performance of immunoassays, not an AI algorithm itself.
7. The Type of Ground Truth Used
For a quality control material, the "ground truth" (or more appropriately, the assigned values or reference values) for the analytes (Anti-TSHR, Anti-TPO, Anti-Tg) are established through:
- Reference Methods and Materials: The concentrations of the antibodies (Anti-TSHR, Anti-TPO, Anti-Tg) are "spiked into the matrix at the desired concentration levels" during manufacture. The accuracy of these concentrations and their stability are verified using highly accurate, traceable reference methods and often against international reference preparations or certified reference materials, where available.
- Value Assignment Studies: These studies involve multiple measurements across different instruments and laboratories to assign a consensus target value and acceptable range for each analyte in the control material.
The text explicitly mentions "The Elecsys PreciControl ThyroAB was evaluated for value assignment, stability, and duration of reconstitution," which confirms these types of analytical ground truth establishment processes were followed.
8. The Sample Size for the Training Set
This information is not applicable to this type of device. The concept of a "training set" applies to machine learning algorithms. Elecsys PreciControl ThyroAB is a physical chemical control material, not an AI algorithm, and therefore does not have a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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