# K030144: Modification to Pentra 60 and Pentra 60C+

- Pathway: 510(k) (Special)
- Applicant: Abx Diagnostics
- Decided: Jan 31, 2003 after 16 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
Longest line of descent: 2 generations back to K962633 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992511: Abx Pentra 60   Hematology Analyzer, Abx Diagnostics (1999) Summary page 2.
- K003677: Abx Pentra 60C+ Hematology Analyzer, Abx Diagnostics (2000) Summary page 2.

## Indications for use
The ABX PENTRA 60 and 60C+ Hematology Analyzer are fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens. The ABX PENTRA 60 and 60C+ Hematology Analyzer are 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/K030144
Methodology: https://510kreport.com/methodology