# K983548: Ferritin Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Oct 27, 1998 after 18 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963493 (1996). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963493: Ferritin Calibrator, Dade Chemistry Systems, Inc. (1996) Summary page 1.

## Most influential descendants
- K071224: Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4 Calibrator (2007), 4 descendants of its own
- K121994: Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension Vista Loci 4 Calibrator (2012), 1 descendant of its own
- K133512: Loci Vitamin B12 (VB12) Flex Reagent Cartridge, Loci Anemia Calibrator (Anem Cal) (2014), 0 descendants of its own
- K093645: Exl Anem Cal, Model RC640 (2010), 0 descendants of its own
- K093631: B12 Reagent Cartridge and Fol Flex Reagent Cartridge, Model RF642 and RF644 (2010), 0 descendants of its own

## Indications for use
The Ferritin Calibrator is intended to be used to calibrate the Ferritin (FERR) Method on the Dimension® RxL clinical chemistry system.

Source page: https://510kreport.com/device/K983548
Methodology: https://510kreport.com/methodology