(202 days)
The TFR assay is an in vitro enzyme immunoassay for quantifying the concentration of transferrin receptor in human serum or plasma to aid in the diagnosis of iron deficiency anemia, particularly in the presence of other disease states.
The TFR assay is an in vitro enzyme immunoassay based upon the double antibody sandwich method. Plasma or serum samples are diluted in buffer and pipetted into microwells pre-coated with polyclonal antibody to transferrin receptor. Horseradish peroxidase conjugated antibody specific for serum transferrin receptor (STR) is added to the wells and incubated. During this incubation, the STR binds to the polyclonal antibodies adsorbed to the wells and the HRP-conjugated second antibodies bind to the captured STR. Any unbound STR and excess HRP-conjugate are washed from the wells. Enzyme substrate is added to the wells and allowed to incubate, a stop solution is then added to stop the reaction and the intensity of the yellow product is measured in a microplate reader. The optical density of the resulting solution is directly proportional to the concentration of the STR in the standard samples. A standard curve is generated from the STR standards provided in the assay and the concentration of STR in the unknown sample is determined by comparing the unknown's optical density reading with the standard curve graph.
The provided text describes a 510(k) submission for the TFR assay, focusing on its substantial equivalence to a predicate device (Quantikine IVD sTfR Immunoassay or QSI). The study primarily demonstrates agreement between the TFR assay and the predicate device, as well as agreement with clinical definitions of anemia.
Here's an analysis of the acceptance criteria and study aspects based on the given information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in numerical thresholds, but rather implied by the comparison to the predicate device and clinical definitions. The 'agreement' percentages serve as the reported device performance against these implied criteria.
| Acceptance Criteria (Implied) | Reported Device Performance (TfR vs. Clinical/Predicate) |
|---|---|
| Agreement with clinical definition of IDA (TfR > 8.3 ug/ml) | 78.9% (30 out of 38 IDA samples) |
| Agreement with clinical definition of ACD (TfR |
§ 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).