# K963493: Ferritin Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Dade Chemistry Systems, Inc.
- Decided: Dec 3, 1996 after 91 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
No predicates in its family tree.
7 later devices descend from it; 1 cites 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)
- None. The FDA summary names its predicate without a number.
- (no number) Abbott Laboratories IMx® Ferritin Calibrator: named in the summary without a submission number

## Most influential descendants
- K983548: Ferritin Calibrator (1998), 6 descendants of its own
- 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

## 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/K963493
Methodology: https://510kreport.com/methodology