# K024002: Pentra 80

- Pathway: 510(k) (Special)
- Applicant: Abx Diagnostics
- Decided: Jan 3, 2003 after 30 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K872166 (1987). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003677: Abx Pentra 60C+ Hematology Analyzer, Abx Diagnostics (2000) Summary page 2.
- K961439: Abbott Cell-Dyn 4000 System, Abbott Diagnostics (1996) Summary page 2.

## Most influential descendants
- K151133: Pentra XLR (2015), 0 descendants of its own

## Recalls of this device
- Aug 13, 2004 · Not classified · Z-0002-05: Device can generate overestimated platelet results.
- Aug 13, 2004 · Not classified · Z-0003-05: Device can generate overestimated platelet results.

## Indications for use
The ABX PENTRA 80 Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens. The ABX PENTRA 80 is able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode.

Source page: https://510kreport.com/device/K024002
Methodology: https://510kreport.com/methodology