(62 days)
This assay is designed for the in vitro measurement of human transferrin in serum using the Minineph®.
Not Found
I am sorry, but the provided text from the FDA 510(k) notification for "Minineph® a-1 Transferrin Antiserum" does not contain information regarding:
- Acceptance criteria and device performance table
- Sample size and data provenance for a test set
- Number of experts and their qualifications for ground truth establishment
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone algorithm performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
This document is primarily a clearance letter confirming substantial equivalence to a predicate device and outlining the indications for use. It does not delve into the detailed study design, performance data, or ground truth methodologies that would typically be found in a more comprehensive clinical or analytical validation report.
§ 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).