(17 days)
COMBITROL PLUS B / AUTOTROL PLUS B assayed controls are intended to be used to monitor and evaluate the analytical performance of the Roche OMNI S for analytes listed in the package insert. For In Vitro Diagnostic Use
COMBITROL PLUS B / AUTOTROL PLUS B is a specially formulated, threelevel, aqueous liquid material intended for use to monitor all analytes measured by the Roche OMNI S Analyzer. COMBITROL PLUS B / AUTOTROL PLUS B provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. COMBITROL PLUS B / AUTOTROL PLUS B contains clinically relevant quantities of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, glucose, lactate, urea, and hematocrit, and suitable concentrations of dyes to simulate clinically relevant values of bilirubin, hemoglobin and hemoglobin derivatives: 02Hb, COHb, MetHb and HHb. COMBITROL PLUS B / AUTOTROL PLUS B is a non-hazardous aqueous solution containing no biological materials.
The provided text describes a 510(k) summary for the Roche COMBITROL PLUS B and Roche AUTOTROL PLUS B Multi Analyte Controls. This is a quality control material intended for monitoring and evaluating the analytical performance of the Roche OMNI S analyzer.
As this is a quality control device rather than a diagnostic or therapeutic device, the typical acceptance criteria and study designs (like those for AI algorithms or clinical efficacy) for patient-facing devices do not apply in the same way. The studies conducted are focused on the stability and precision of the control material itself, and its substantial equivalence to predicate devices.
Here's an analysis based on the information provided, tailored to a quality control device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in terms of specific performance metrics (like sensitivity, specificity, accuracy) with numerical targets. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices and verifying performance requirements related to stability and precision.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices: | Comparison of technological characteristics, formulation, and intended use to predicate devices supports the claim of substantial equivalence. |
| - Similar intended use | Intended for use to monitor and evaluate the analytical performance of the Roche OMNI S for analytes listed in the package insert. (Similar to predicate's monitoring function) |
| - Similar technological characteristics (analytes, matrix, container, fill volume, color) | See "Comparison of COMBITROL PLUS B and AUTOTROL PLUS B to predicate devices for substantial equivalency" table above. Generally similar, with some modifications (e.g., more analytes, different fill volume, color). These modifications are addressed by showing performance is maintained. |
| Performance Requirements: | |
| - Stability | Real-time evaluation of products with essentially similar formulation and failure mode supported stability. |
| - Precision | Test precision was conducted. (Specific results not detailed in this summary) |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: Not explicitly stated. The "test precision" study would have involved multiple measurements, but the number of runs or samples is not provided in this 510(k) summary.
- Data Provenance: Not explicitly stated. Given it's a product from Bionostics, Inc. in Devens, MA, USA, the testing was likely conducted in-house or by a contracted lab, presumably in the USA. The studies are non-clinical tests described as "real-time evaluation" and "test precision," implying prospective testing of the manufactured control material.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not directly applicable to a quality control material. Ground truth in this context refers to the expected or reference values of the analytes within the control solution. These values are established through rigorous analytical methods and calibration processes inherent in the manufacturing of such controls, not typically by clinical experts establishing diagnostic "ground truth."
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human readers evaluate cases and their interpretations need to be reconciled, especially in diagnostic imaging or pathology. For a quality control material, the performance is assessed against established analytical reference values or expected variations, not through human adjudication of diagnostic interpretations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. MRMC studies are designed for assessing the impact of a diagnostic tool (often AI) on human performance in interpreting cases. This device is a quality control material, not a diagnostic tool, and involves no "human readers" or "AI assistance" in the context of diagnostic interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a chemical quality control solution, not an algorithm.
7. The Type of Ground Truth Used
For quality control materials, the "ground truth" (or reference values) for the analytes (pH, PCO2, PO2, sodium, etc.) is established through:
- Reference Methods and Calibration: Precise analytical methods and highly calibrated instruments used during the manufacturing and assaying process to determine the concentration or activity of each analyte in the control material.
- Batch-to-Batch Consistency: Ensuring that each batch of control material consistently falls within a specified range relative to these reference values.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm, so there is no "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.