# K050719: Abx Pentra DX 120: Option SPS Evolution

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx
- Decided: Apr 26, 2005 after 36 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: 4 generations back to K912494 (1991). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 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 2.
- K990311: Vega Retic Automated Hematology Analyzer, Abx Diagnostics (1999) Summary page 2.
- K991839: Abx Pentra 120 Retic Automated Hematology Analyzer, Abx Diagnostics (1999) Summary page 2.
- K022200: Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120, Abx Diagnostics (2002) Summary page 2.
- K961439: Abbott Cell-Dyn 4000 System, Abbott Diagnostics (1996) Summary page 2.
- K992875: Sysmex XE-2100, Automatated Hematology Analyzer, Sysmex Corp. (1999) Summary page 2.
- (no number) SPS used on the ABX PENTRA 120: named in the summary without a submission number

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

## Recalls of this device
- Mar 24, 2006 · Not classified · Z-1334-06: Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample.

## Indications for use
The ABX PENTRA DX 120 Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC), differential leucocyte count (DIFF) as well as reticulocyte count (RET), and nucleated red blood cell count (NRBC) for the in vitro diagnostic use in clinical laboratories. The clinical use of the reticulocyte count, specifically the immature reticulocyte fraction (IRF), is to monitor erythropoietic activity in patients. The option of the SPS Evolution (Slide Preparation System) smears and stains on a clean microscope slide.

Source page: https://510kreport.com/device/K050719
Methodology: https://510kreport.com/methodology