# K992188: Nichols Advantage Chemiluminescence Soluble Transferrin Receptor Immunoassay, Model 62-7028

- Pathway: 510(k) (Traditional)
- Applicant: Nichols Institute Diagnostics
- Decided: Dec 6, 1999 after 160 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 Nichols Advantage® Chemiluminescence Soluble Transferrin Receptor Immunoassay is intended for use on the Nichols Advantage® Specialty System for the quantitative determination of Soluble Transferrin Receptor in human serum, EDTA and Heparin plasma as an adjunct in the diagnosis of Iron Deficiency Anaemia and for the differential diagnosis of Iron Deficiency Anaemia and Anaemia of Chronic Disease.

Source page: https://510kreport.com/device/K992188
Methodology: https://510kreport.com/methodology