# K191562: Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx Sas
- Decided: Mar 6, 2020 after 267 days
- Product code: DBF (Ferritin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5340
- 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 K951595 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092505: Beckman Coulter Ferritin Reagent, Model: OSR61203, Beckman Coulter, Inc. (2009) Summary page 6.
- K012393: Tina-Quant Transferrin Ver.2, Roche Diagnostics Corp. (2001) Summary page 6.
- K060201: Olympus RF Latex Calibrator, and Olympus RF Latex Reagent with Model (S): ODC0028, and OSR61105., Olympus America, Inc. (2006) Summary page 6.

## Indications for use
Yumizen C1200 Ferritin reagent is intended for the quantitative in vitro diagnostic determination of Ferritin in human serum by latex-enhanced immunoturbidimetric assay. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, hemochromatosis (iron overload) and iron deficiency anemia. Yumizen C1200 Transferrin reagent is intended for the quantitative in vitro diagnostic determination of transferrin in human serum and lithium heparin plasma by turbidimetry. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia. Yumizen C1200 Rheumatoid Factor reagent is intended for the quantitative in vitro diagnostic determination of rheumatoid factor in human serum by latex-enhanced immunoturbidimetric assay. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

Source page: https://510kreport.com/device/K191562
Methodology: https://510kreport.com/methodology