# K151133: Pentra XLR

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx Sas
- Decided: Dec 9, 2015 after 225 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: 5 generations back to K912494 (1991). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024002: Pentra 80, Abx Diagnostics (2003) Summary page 4.
- K050719: Abx Pentra DX 120: Option SPS Evolution, Horiba Abx (2005) Summary page 10.
- K991839: Abx Pentra 120 Retic Automated Hematology Analyzer, Abx Diagnostics (1999) Summary page 10.
- K990311: Vega Retic Automated Hematology Analyzer, Abx Diagnostics (1999) Summary page 10.

## Indications for use
The PENTRA XLR is a quantitative multi-parameter automated hematology analyzer for in vitro diagnostic use in clinical laboratories to identify and enumerate the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, LYM (#, %), MON (#, %), NEU (#, %), EOS (#, %), BAS (#, %), as well as the Reticulocyte parameters RET (#, %), CRC, and IRF in K2EDTA and K3EDTA anticoagulated venous whole blood samples from patients ≥ 18 years of age.

Source page: https://510kreport.com/device/K151133
Methodology: https://510kreport.com/methodology