# K160590: XN Check

- Pathway: 510(k) (Traditional)
- Applicant: Streck
- Decided: Dec 22, 2016 after 296 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 K063218 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141964: XN Check, Streck (2014) Summary page 4.

## Indications for use
XN CHECK is used for control and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include: RBC(106/pL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(103/pL), PLT-F*(103/uL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(103/uL), NEUT(%), LYMPH (%), MONO(%), EO(%), BASO(%), IG(%), NEUT#(103/uL), LYMPH#(103/uL), MONO# (103/pL), EO#(103/puL), BASO#(103/uL), IG#(103/ uL), IPF(%)*, IPF#* (103/uL), RET#(106/uL), RET%, IRF%, RET-HE(pg), NRBC#* (103/uL), NRBC%* (/100 WBC) *Not Available on the XN-L.

Source page: https://510kreport.com/device/K160590
Methodology: https://510kreport.com/methodology