(230 days)
Not Found
Not Found
This document is an FDA 510(k) clearance letter for the N-Assay TIA Transferrin Test Kit. It does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.
The letter explicitly states that the FDA has reviewed the 510(k) notification of intent to market and has determined the device is substantially equivalent to pre-amendment devices or reclassified devices. This implies that the manufacturer submitted data to demonstrate substantial equivalence, but the letter itself does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set or data provenance.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method for the test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information about a standalone performance study.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
To obtain this information, you would typically need to review the actual 510(k) summary, which often contains details on the analytical and clinical performance studies conducted to support the substantial equivalence claim. This letter is merely the FDA's formal notification of clearance.
§ 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).