# K120742: XN Check

- 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: 1 generation back to K063218 (2006). 1 ancestor in all.
3 later devices descend from it; 1 cites 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)
- K063218: E-Check (XE), Streck (2006) Summary page 1.

## Most influential descendants
- K141964: XN Check (2014), 2 descendants of its own
- 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-20) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include: RBC(10 6/pL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(10 3/pL), PLT-F(10 3/pL), ROW-SD(fL), RDW-CV(%), MPV(fL), WBC(10 3/pL), NEUT(%), LYMPH (%), MONO(%), EO(%), BASO(%), IG(%), NEUT#(10 3/pL), LYMPH#(10 3/pL), MONO# (10/pL), EO#(10 3/pL), BASO#(10 3/pL), IG#(10 3/pL), IPF(%), RET#(10 6/pL), RET%, IRF%, RET-HE(pg), NRBC(10 3/pL), NRBC% (/100 WBC)

Source page: https://510kreport.com/device/K120742
Methodology: https://510kreport.com/methodology