# K141964: XN Check

- Pathway: 510(k) (Traditional)
- Applicant: Streck
- Decided: Dec 5, 2014 after 140 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: 2 generations back to K063218 (2006). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120742: XN Check, Streck (2012) Summary page 4.

## Most influential descendants
- K160590: XN Check (2016), 0 descendants of its own
- K160586: XN-L Check (2016), 0 descendants of its own

## Indications for use
XN CHECK is used for control and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include: RBC(1076/uL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(10~3/uL), PLT-F(10"3/uL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(10"3/uL), NEUT(%), LYMPH (%), MONO(%), EO(%), BASO(%), IG(%), NEUT#(10°3/uL), LYMPH#(10"3/uL), MONO# (10°3/uL), EO#(10~3/uL), BASO#(10°3/uL), IG#(10°3/uL), IPF(%), IPF# (10°3/uL), RET#(1076/uL), RET%, IRF%, RET-HE(pg), NRBC#(10*3/uL), NRBC% (/100 WBC)

Source page: https://510kreport.com/device/K141964
Methodology: https://510kreport.com/methodology