# K160586: XN-L 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-L CHECK is used for control and calibration verification of Sysmex XN-L analyzers. It is not, however, intended for actual calibration of this analyzer. Assayed parameters include: RBC (1076/uL), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), PLT (1073/uL), RDW-SD (fL), RDW-CV (%), MPV (fL), WBC (1073/uL), NEUT (%), LYMPH (%), MONO (%), EO (%), BASO (%), 1G (%), NEUT# (10"3/pL), LYMPH# (1073/uL), MONO# (10"3/uL), EO# (1073/uL), BASO# (1073/uL), IG# (10"3/pL), RET# (1076/uL), RET%. IRF%, RET-He (pg).

Source page: https://510kreport.com/device/K160586
Methodology: https://510kreport.com/methodology