# K120744: XN Check BF

- Pathway: 510(k) (Traditional)
- Applicant: Streck
- Decided: Oct 19, 2012 after 221 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: 3 generations back to K000076 (2000). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053362: Cell-Chex Auto, Streck (2006) Summary page 1.

## Most influential descendants
- K141957: XN Check BF (2014), 1 descendant of its own
- K160588: XN Check BF (2016), 0 descendants of its own

## Indications for use
XN CHECK BF is used for control and calibration verification of Sysmex XN series (XN-10, XN-20) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include: WBC-BF (103/1d), RBC-BF (lO6 /p1), MN#(103/pI1), FMN# (I10 3/pl1), MN% (%), PMN% (%), TC-BF# (103/pl)

Source page: https://510kreport.com/device/K120744
Methodology: https://510kreport.com/methodology