(51 days)
Measurement of transferrin levels aid in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.
The Wako Transferrin test is an in vitro diagnostic assay for the quantitative determination of transferrin in serum.
Here's an analysis of the provided text regarding the Wako Transferrin test, focusing on acceptance criteria and supporting study details:
The provided 510(k) summary for the Wako Transferrin test is quite limited in detail regarding specific acceptance criteria and the comprehensive study design. It primarily focuses on demonstrating substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the specific numerical acceptance criteria are not explicitly stated, nor is a detailed breakdown of different performance metrics (e.g., sensitivity, specificity, accuracy against a reference standard). Instead, the performance is described in terms of a correlation to a predicate device and a minimum detection limit.
| Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|
| Substantial Equivalency to Predicate Device: | Correlation Coefficient: 0.988 with the Beckman Transferrin product. |
| Linearity/Relationship to Predicate: (Not explicitly stated as an acceptance criterion, but demonstrated) | Regression Equation: y = 0.975x + 0.41 (where y is Wako Transferrin, x is Beckman Transferrin). |
| Precision: (Acceptable for day-to-day use) | "Precision studies indicate acceptable values can be obtained on a day-to-day basis." (No specific numerical range or CV% provided). |
| Limit of Detection/Minimum Detectable Level: (Acceptance criterion implied for defining lower detection limit) | Minimum Detectable Level: 4.7 mg/dL. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: Not explicitly stated. The document mentions "comparison studies against the predicate assay," but does not provide the number of samples or subjects used in these studies.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be a retrospective or prospective comparison study, but details are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an in vitro diagnostic assay for quantitative measurement. The "ground truth" for its performance is typically established by comparison to a reference method, a predicate device, or by evaluating its analytical performance (e.g., linearity, precision, accuracy) against known standards or spiked samples. Clinical expert interpretation of results is not the primary ground truth for the device's technical performance.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for studies where independent experts interpret results (e.g., imaging studies) and their consensus forms the ground truth. For a quantitative diagnostic assay, the "adjudication" is inherent in the reference method or predicate comparison.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study design is typically relevant for interpretative diagnostic devices (e.g., AI in radiology) where human readers are involved in the diagnostic process. The Wako Transferrin test is a standalone in vitro diagnostic assay.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are essentially "standalone" in this context. The Wako Transferrin test is an automated in vitro diagnostic assay. Its performance is evaluated intrinsically through analytical studies (precision, detection limits) and by comparison to another diagnostic assay (predicate device), without human interpretive intervention being part of the primary performance evaluation.
7. The Type of Ground Truth Used
The ground truth for the device's performance was established through:
- Comparison to a Predicate Device: The Beckman Transferrin product served as the reference for comparative studies, establishing substantial equivalence.
- Analytical Validation: "Precision studies" and determination of a "minimum detectable level" indicate internal analytical validation against established scientific principles for quantitative assays.
8. The Sample Size for the Training Set
Not applicable. The Wako Transferrin test is a chemical immunoassay, not a machine learning or AI-based device that requires a "training set" in the computational sense. Its performance relies on the inherent chemical reactions and optical measurement principles.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
§ 866.5880 Transferrin immunological test system.
(a)
Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.(b)
Classification. Class II (performance standards).