# K991539: Excell 22

- Pathway: 510(k) (Traditional)
- Applicant: Mwi, Inc.
- Decided: Jul 1, 1999 after 59 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K890491 (1989). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890491: Cell-Dyn 3000 Multi-Parameter Hematology Analyer, Abbott Diagnostics (1989) Summary page 2.
- K945678: Datacell 18MS, Danam Electronics (1995) Summary page 2.
- (no number) Coulter S+IV: named in the summary without a submission number

## Most influential descendants
- K072869: Pointcare Now System (2008), 0 descendants of its own

## Recalls of this device
- Sep 20, 2006 · Not classified · Z-0450-2007: System has given inaccurate readings when running samples that trigger an extra rinse due to very high WBC, RBC or Platlet counts.
- Sep 20, 2006 · Not classified · Z-0451-2007: System has given inaccurate readings when running samples that trigger an extra rinse due to very high WBC, RBC or Platlet counts.
- Aug 24, 2006 · Not classified · Z-0448-2007: Flags and alerts on the user interface will not automatically transfering to the LIS.
- Aug 24, 2006 · Not classified · Z-0449-2007: Flags and alerts on the user interface will not automatically transfering to the LIS.

## Indications for use
The EXCELL™ 22, is an in-vitro diagnostic instrument for use in counting blood cells, classifying white blood cells (WBC) and flagging specimens containing abnormal blood cells in clinical laboratories at diverse sites. Per NCCLS H20A section 4(9), flagging is defined as “identifying a sample or blood film for further attention or review”.

Source page: https://510kreport.com/device/K991539
Methodology: https://510kreport.com/methodology