(93 days)
The Elecsys HCG STAT 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 HCG STAT reagent on the indicated Elecsys and cobas e immunoassay analyzers.
The Elecsys HCG STAT CalCheck 5 is a lyophilized product consisting of HCG in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
The provided text describes the Elecsys HCG STAT CalCheck 5, a control solution used for calibration verification and assay range verification of the Elecsys HCG STAT reagent on specific immunoassay analyzers.
Here's an analysis of the acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states, "The Elecsys HCG STAT CalCheck 5 was evaluated for value assignment." However, it does not explicitly define specific numerical acceptance criteria (e.g., target ranges, precision limits, deviation thresholds) for this "value assignment." Instead, it relies on the similarity of its formulation to a previously cleared device.
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance |
|---|---|
| Value Assignment: (Implied to be consistent and accurate for calibration verification and assay range verification) | "The Elecsys HCG STAT CalCheck 5 was evaluated for value assignment." (No specific performance data is provided beyond this statement). |
| Stability: (Implied to meet the same stability profiles as the predicate device) | "Because Elecsys HCG STAT CalCheck 5 formulation is identical to the Elecsys HCG+B CalCheck 5, the stability studies presented and cleared in the HCG+ ß CalCheck 5 submission, K092168, apply." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for the "value assignment" evaluation.
- Data Provenance: Not explicitly stated. Given that it's a control solution for in-vitro diagnostics, the "test set" would refer to the characteristics of the control material itself rather than patient samples. The information indicates the device was internally evaluated by Roche Diagnostics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This type of information is generally not applicable to a control solution which is itself used to establish the "truth" of an assay's performance against known values. The "ground truth" for the control solution's own value assignment would be based on highly precise and accurate analytical methods, typically performed by expert analytical chemists or qualified laboratory personnel. The document does not specify the number or qualifications of individuals involved in the value assignment process.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically employed in studies involving human interpretation or subjective assessments, which is not the case for the value assignment of an assayed control.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies compare the performance of human readers, sometimes with and without AI assistance, on diagnostic tasks. This device is an assayed control for an immunoassay, not a diagnostic imaging or interpretive AI device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a biochemical control solution, not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for the Elecsys HCG STAT CalCheck 5 is its assigned HCG concentration values. These are established through:
- Analytical Methods: Precise and accurate laboratory measurements using reference methods or highly calibrated instruments.
- Manufacturing Specifications: The analyte is "spiked into the matrix at the desired concentration levels" during manufacture, indicating a known, engineered ground truth.
8. Sample Size for the Training Set
Not applicable. This device is a control solution, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of 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.