(24 days)
CANTROL Iron /TIBC Controls provide a simple, but effective, method for the performance of intra- or inter- laboratory quality control in the quantitation of Serum Iron and Total Iron Binding Capacity.
CANTROL Iron/TIBC Controls are manufactured from human serum and provide a means for monitoring Serum Iron and TIBC testing procedures by the use of control materials in a manner identical to patient samples. CANTROL Iron/TIBC Control materials are equivalent to other human serum based chemistry control products.
Here's an analysis of the provided text regarding acceptance criteria and study details for the CANTROL Iron/TIBC Controls, structured according to your request.
Based on the provided text, it's important to note that this is a 510(k) submission summary for a control material (CANTROL Iron/TIBC Controls), not a diagnostic device that interprets medical images or patient data to make a diagnosis. Therefore, many of the requested elements (like "multi-reader multi-case comparative effectiveness study," "standalone algorithm performance," "number of experts," "adjudication method," "ground truth type for test/training sets") are not applicable to this type of product and its evaluation.
The submission focuses on the performance of the control material itself (stability and precision) rather than the performance of a diagnostic algorithm or a human-in-the-loop system.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria for stability or precision. It describes the types of tests performed.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Short-term Stability: The product maintains its specified characteristics over a short period. | "Short term stability was demonstrated by real time product storage." (Specific duration and performance metrics are not provided in this summary.) |
| Long-term Stability: The product maintains its specified characteristics over an extended period. | "Long term stability was conducted by an accelerated testing protocol as described in the submission data." (Specific duration, protocol details, and performance metrics are not provided in this summary.) |
| Precision: The product exhibits consistent results upon repeated analyses. | "Product precision performance was demonstrated through replicate analyses in the conductance during stability testing." (Specific precision metrics like %CV or standard deviation are not provided in this summary.) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified in the summary. The stability testing would involve multiple samples tested over time. Precision testing would involve multiple replicate analyses.
- Data Provenance: Not explicitly stated, but implicitly, the testing would have been conducted by Canyon Diagnostics, Inc., in the USA (their address is in Anaheim, CA). The data would be prospective, as it describes testing done on the manufactured control material.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not Applicable. As this is a control material, the "ground truth" refers to the target values and variability of the control material itself, established through analytical methods and manufacturing specifications, not through expert clinical interpretation.
4. Adjudication Method for the Test Set
- Not Applicable. See explanation above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study is not relevant for a quality control material. MRMC studies are used to evaluate the impact of diagnostic aids on human reader performance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Not Applicable. This product is a control material, not a diagnostic algorithm. Its "performance" refers to its consistency and stability, not its ability to interpret data independently.
7. Type of Ground Truth Used
- For a control material, the "ground truth" would be established by:
- Analytical Methods: Laboratory assays determining the concentration/activity of analytes (Iron and TIBC) within the control material.
- Manufacturing Specifications: Pre-defined ranges and target values for the control material that it must consistently meet to be deemed acceptable.
- Reference Methods/Materials: Comparison to established analytical reference methods or reference materials.
8. Sample Size for the Training Set
- Not Applicable. This product is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See explanation above.
§ 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.