(98 days)
The Elecsys CA 125 II 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 CA 125 II reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.
The Elecsys CA 125 II CalCheck 5 is a lyophilized product consisting of equine serum in level 1 and human serum matrix for levels 2-5. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
The provided text describes a 510(k) submission for the Elecsys CA 125 II CalCheck 5, a device intended for calibration verification and assay range verification in immunoassay analyzers. The document focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a study with acceptance criteria in the manner typically seen for clinical diagnostic devices that provide patient-specific results.
Therefore, the requested information elements related to clinical study design, ground truth establishment, expert adjudication, MRMC studies, and training set information are not applicable in this context, as this submission is for a quality control material and not a diagnostic algorithm. The "performance characteristics" section is very brief and refers to "value assignment" and "stability," which are typically internal validation metrics for quality control materials.
Here's the breakdown of the information as it relates to the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical acceptance criteria in the format typically seen for diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence to existing predicate devices based on shared characteristics and intended use. The "Performance Characteristics" section merely states: "The Elecsys CA 125 II CalCheck 5 was evaluated for value assignment and stability."
The comparison table implies equivalence based on similar design, intended use, format, handling, and stability characteristics with the predicate devices.
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Elecsys CA 125 II CalCheck 5 Performance (as reported) |
|---|---|---|
| Intended Use | Substantially equivalent to predicates (calibration verification, assay range verification for CA 125 II reagent on Elecsys/cobas e analyzers). | "The Elecsys CA 125 II 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 CA 125 II reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only." (Matches predicate K100810 in intent, and predicate K003967 in analyte) |
| Analyte | CA 125 (matching predicate K003967) | CA 125 |
| Levels | Five (matching predicate K100810) | Five |
| Format | Lyophilized (matching both predicates) | Lyophilized |
| Handling | Reconstitution with 1.0mL water, stand for 15 min, gently invert (similar to both predicates) | Reconstitution with 1.0mL water, stand for 15 min, gently invert |
| Stability (Unopened) | Store at 2-8°C until expiration date (matching both predicates) | Store at 2-8°C until expiration date |
| Stability (Reconstituted) | 20-25°C: 4 hours (matching both predicates) | 20-25°C: 4 hours |
| Matrix | Equine serum (Level 1), Human serum (Levels 2-5) (similar to both predicates' variations) | Level 1: Equine serum; Levels 2-5: Human serum matrix |
| Performance (general) | Must demonstrate appropriate "value assignment" and "stability" for a quality control material. | "The Elecsys CA 125 II CalCheck 5 was evaluated for value assignment and stability." (Specific data not provided in this summary but would be in the full submission). |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the document describes a 510(k) submission for a quality control material, not a clinical diagnostic device requiring a "test set" from patient data. The "evaluation" for value assignment and stability would involve a series of laboratory experiments on the manufacturing lots of the CalCheck 5 product itself. The provenance of such data would be internal to the manufacturer (Roche Diagnostics).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable. The concept of "ground truth" derived from expert consensus is typically relevant for diagnostic devices that interpret patient results (e.g., imaging devices, pathology slides). For a quality control material, "ground truth" (or target values) for analyte concentration are established through a robust value assignment process using reference methods and calibrated instruments, overseen by internal experts in analytical chemistry and quality control, not clinical experts for diagnostic interpretation.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as #3. Adjudication is relevant for resolving discrepancies in expert interpretations of diagnostic findings, which is not pertinent to the evaluation of a quality control material.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance
This is not applicable. MRMC studies are used to evaluate the diagnostic performance of devices, especially those involving human interpretation, and are particularly relevant for AI-assisted diagnostic tools. The Elecsys CA 125 II CalCheck 5 is a quality control product, not a diagnostic device, and does not involve human readers interpreting cases or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This is not applicable. This device is a biochemical control material, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for a quality control material like Elecsys CA 125 II CalCheck 5 would be the assigned target values for CA 125 concentration at each of the five levels, determined through rigorous analytical methods using reference standards and calibrated instruments. This is an analytical/chemical ground truth, not a clinical one (like pathology, expert consensus on images, or patient outcomes).
8. The Sample Size for the Training Set
This is not applicable. The device is a quality control material and does not involve an AI algorithm with a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8.
§ 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.