# K991839: Abx Pentra 120 Retic Automated Hematology Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Abx Diagnostics
- Decided: Aug 11, 1999 after 75 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 K912494 (1991). 4 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990311: Vega Retic Automated Hematology Analyzer, Abx Diagnostics (1999) Summary page 1.
- K971736: Sysmex Immature Reticulocyte Fraction (Irf) Parameter, Sysmex Corp. (1997) Summary page 1.

## Most influential descendants
- K022200: Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120 (2002), 2 descendants of its own
- K050719: Abx Pentra DX 120: Option SPS Evolution (2005), 1 descendant of its own
- K151133: Pentra XLR (2015), 0 descendants of its own

## Indications for use
The ABX PENTRA 120 RETIC Automated Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC), differential leucocyte count (DIFF) as well as reticulocyte count for in vitro diagnostic use in clinical laboratories. The ABX PENTRA 120 RETIC Automated Hematology Analyzer provides appropriate flags and alarms to assist users in final checking and identification of abnormal cell populations. The clinical use of the reticulocyte count, specifically the immature reticulocyte fraction (IRF), is to monitor erythropoietic activity in patients.

Source page: https://510kreport.com/device/K991839
Methodology: https://510kreport.com/methodology