# K963498: Ferr Flex Reagent Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Dade Chemistry Systems, Inc.
- Decided: Jan 24, 1997 after 143 days
- Product code: JMG (Radioimmunoassay (Two-Site Solid Phase), Ferritin)
- 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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: named in the summary without a submission number

## Most influential descendants
- K112999: Dimension Clinical Chemistry System (2011), 0 descendants of its own
- K070552: Dimension Vista Ferritin Flex Reagent Cartridge (Ferr) (2007), 0 descendants of its own

## Recalls of this device
- Jul 15, 2019 · Class II · Z-2229-2019: Negative Bias with Lot EA9227.
- Jul 15, 2014 · Class II · Z-2238-2014: Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) of QC and patient sample result accuracy shifts on Troponin I, CTNI (RF421C), LTNI (RF521C); Free T4, FT
- May 6, 2013 · Class II · Z-0561-2014: Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shifts on CTN1, LTN1, FT4, TSH, PBNP and LPBN when using Chemistry Wash lots RD23031, RD23111,

## Indications for use
The FERR Flex™ reagent cartridge is used on the Dimension™ RxL. clinical chemistry system to quantitatively measure ferritin in human serum and plasma.

Source page: https://510kreport.com/device/K963498
Methodology: https://510kreport.com/methodology