# K022200: Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120

- Pathway: 510(k) (Special)
- Applicant: Abx Diagnostics
- Decided: Jul 29, 2002 after 24 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: 3 generations back to K912494 (1991). 14 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 17 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.
- K962988: Coulter Gen-S System, Coulter Corp. (1996) Summary page 2.
- K961439: Abbott Cell-Dyn 4000 System, Abbott Diagnostics (1996) Summary page 2.
- K953598: Series 9100 Plus Automated Differential Hematology Analyzers, Serono Diagnostics, Inc. (1996) Summary page 2.

## Most influential descendants
- K050719: Abx Pentra DX 120: Option SPS Evolution (2005), 1 descendant of its own
- 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.
- Jun 24, 2004 · Not classified · Z-1342-04: Power failure having impact on software.

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

Source page: https://510kreport.com/device/K022200
Methodology: https://510kreport.com/methodology