# K990311: Vega Retic Automated Hematology Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Abx Diagnostics
- Decided: Mar 31, 1999 after 58 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: 1 generation back to K912494 (1991). 2 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 7 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.
- K912494: Sysmex (TM) R-3000 Automated Reticulocyte Analyzer, Toa Medical Electronics USA, Inc. (1991) Summary page 1.

## Most influential descendants
- K991839: Abx Pentra 120 Retic Automated Hematology Analyzer (1999), 3 descendants of its own
- 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 VEGA 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 VEGA RETIC Automated Hematology Analyzer provides appropriate flags and alarms to assist users in final checking and identification of abnormal cell populations.

Source page: https://510kreport.com/device/K990311
Methodology: https://510kreport.com/methodology