# K992511: Abx Pentra 60   Hematology Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Abx Diagnostics
- Decided: Oct 15, 1999 after 80 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
Longest line of descent: 1 generation back to K962633 (1996). 1 ancestor in all.
3 later devices descend from it; 2 cite 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)
- K962633: Vega Hematology Analyzer, Abx, Inc. (1996) Summary page 1.

## Most influential descendants
- K030799: Micros 60 (2003), 1 descendant of its own
- K141161: Abx Micros ES 60 CT; (Open Tube Model), (Close Tube Model) (2014), 0 descendants of its own
- K030144: Modification to Pentra 60 and Pentra 60C+ (2003), 0 descendants of its own

## Recalls of this device
- Sep 8, 2003 · Not classified · Z-0039-04: Samples with high fat content will not count platelets accurately.

## Indications for use
The ABX PENTRA 60™ Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens. The ABX PENTRA 60™ 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/K992511
Methodology: https://510kreport.com/methodology