# K971152: Abbott Cell-Dyn 4000 Immature Reticulocyte Fraction (Irf)

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Aug 12, 1997 after 137 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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 Cell-Dyn® 4000 System: named in the summary without a submission number
- (no number) Abbott Cell-Dyn® 3500 System: named in the summary without a submission number
- (no number) Becton Dickinson FACScan™: named in the summary without a submission number
- (no number) Sysmex™ R-3000: named in the summary without a submission number

## Most influential descendants
- K991605: Cell-Dyn 3500 System with Immature Reticulocyte Fraction (Irf), Cell-Dyn 3700 System with Immature Reticulocyte Fraction (1999), 3 descendants of its own
- K110381: Cell-Dyn Emerald 22 System (2011), 1 descendant of its own
- K190294: CELL-DYN Emerald 22 AL System (2019), 0 descendants of its own
- K112755: Abacus 5 (2012), 0 descendants of its own

## Recalls of this device
- Oct 16, 2002 · Not classified · Z-0648-03: Product elicits fluorescent signal interference due to contamination.

## Indications for use
The Cell-Dyn 4000 System with Immature Reticulocyte Fraction is a fully automated hematology analyzer, including reporting of the Immature Reticulocyte Fraction, intended for in vitro diagnostic use in the clinical hematology laboratory of a hospital, medical clinic, or reference laboratory.

Source page: https://510kreport.com/device/K971152
Methodology: https://510kreport.com/methodology