# K110736: Advia Chemistry Ferritin (FRT) Method

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Aug 17, 2011 after 154 days
- Product code: DBF (Ferritin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5340
- 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: 2 generations back to K950707 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993273: N Latex Ferritin, Dade Behring, Inc. (1999) Summary page 1.
- K061056: Randox Liquid Protein Calibrator, Randox Laboratories, Ltd. (2006) Summary page 1.

## Recalls of this device
- Oct 9, 2012 · Class II · Z-0128-2015: Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system
- Oct 9, 2012 · Class II · Z-0129-2015: Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system
- Oct 9, 2012 · Class II · Z-0130-2015: Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system

## Indications for use
The ADVIA® 1650 Chemistry Ferritin (FRT) Reagent: For in vitro diagnostic use in the quantitative determination of ferritin in human serum and plasma on the ADVIA® 165OtChemistry system. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia. The AD VIA® Chemistry Liquid Specific Protein Calibrators: For in vitro diagnostic use in the calibration of AD VIA® Chemistry systems for the Alpha-Acid-Glycoprotein (AAG), Alpha- I-Antitrypsin (AAT), Anti-streptolysin-0_2 (ASO_2), Complement C3 (C3), Complement C4 (C4), Ferritin (ERT), Haptoglobin (HAPT), Immunoglobulin A_2 (IGA 2), Immunoglobulin G6_2 (lG_2), Immunoglobulin M_2 (IGM_2), Prealbumnin (PREALB), Rheumatoid Factor (RF), and Transferrin (TRF) methods.

Source page: https://510kreport.com/device/K110736
Methodology: https://510kreport.com/methodology