# K050721: Abx Erytrol

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx
- Decided: Jun 1, 2005 after 72 days
- Product code: JPK (Mixture, Hematology Quality Control)
- Device class: 2
- Regulation: 21 CFR 864.8625
- 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 K003534 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003534: Pentra 5D, R&D Systems, Inc. (2000) Summary page 1.

## Indications for use
ABX Erytrol is a tri-level control designed for use in monitoring the accuracy and precision of the HoribaABX hematology blood cell counters for NRBC parameter. Refer to the assay table for specific instrument models.

Source page: https://510kreport.com/device/K050721
Methodology: https://510kreport.com/methodology