# K970718: Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa)

- Pathway: 510(k) (Traditional)
- Applicant: R&D Systems, Inc.
- Decided: May 27, 1997 after 90 days
- Product code: JNM (Immunochemical, Transferrin)
- Device class: 2
- Regulation: 21 CFR 866.5880
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K926221 (1993). 1 ancestor in all.
5 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926221: Access Ferritin Assay, Bio-Rad Laboratories, Inc. (1993) Summary page 1.

## Most influential descendants
- K080634: Access STFR, Access STFR Calibrators, and Access STFR QC with Models, A32493, A32494, and A32495 (2008), 1 descendant of its own
- K240987: Access sTfR (2024), 0 descendants of its own
- K992188: Nichols Advantage Chemiluminescence Soluble Transferrin Receptor Immunoassay, Model 62-7028 (1999), 0 descendants of its own
- K991157: N Latex STFR Reagent (1999), 0 descendants of its own
- K981208: TFR (1998), 0 descendants of its own

## Recalls of this device
- Jan 20, 2021 · Class II · Z-1255-2021: R&D Systems, Inc. received two complaints that the standard signal was low and controls were not within the specification range provided with the kit. Investigation confirmed low standard signal and c
- Nov 1, 2018 · Class III · Z-0691-2019: The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4.
- Aug 24, 2016 · Class II · Z-2887-2016: R&D Systems, Inc. received two customer complaints that results of the Controls provided with the Quantikine¿ IVD¿ Human sTfR Immunoassay kit were out of the range high. Internal testing within R&D Sy

## Indications for use
The Quantikine™ IVD™ sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or plasma as an aid in the diagnosis of iron deficiency anemia, especially the differential diagnosis of iron deficiency anemia and anemia of chronic disease.

Source page: https://510kreport.com/device/K970718
Methodology: https://510kreport.com/methodology