# K981208: TFR

- Pathway: 510(k) (Traditional)
- Applicant: Ramco Laboratories, Inc.
- Decided: Oct 21, 1998 after 202 days
- Product code: JNM (Immunochemical, Transferrin)
- Device class: 2
- Regulation: 21 CFR 866.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K926221 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970718: Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa), R&D Systems, Inc. (1997) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K981208
Methodology: https://510kreport.com/methodology