# K953116: White Iris Leukocyte Differential Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Intl. Remote Imaging Systems
- Decided: May 13, 1996 after 315 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Wright-stain/Light Microscope: named in the summary without a submission number
- (no number) The Yellow IRIS urinalysis workstation and body fluids cell counting system: named in the summary without a submission number

## Indications for use
The White IRIS is a leukocyte differential analyzer intended for in vitro diagnostic use in determining the proportional leukocyte count (WBC differential) on peripheral blood specimens that have been flagged by an automated hematology analyzer performing differential counts as well as for peripheral blood specimens for which no automated differential has been performed.

Source page: https://510kreport.com/device/K953116
Methodology: https://510kreport.com/methodology