# K160585: XN CAL

- Pathway: 510(k) (Traditional)
- Applicant: Streck
- Decided: Dec 22, 2016 after 296 days
- Product code: KRX (Calibrator For Cell Indices)
- Device class: 2
- Regulation: 21 CFR 864.8150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K840261 (1984). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141962: XN CAL, Streck (2014) Summary page 4.

## Indications for use
XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include: WBC (10"3/uL), RBC (10"6/uL), HGB (g/dL), HCT (%), PLT (1073/ uL), and RET (%)

Source page: https://510kreport.com/device/K160585
Methodology: https://510kreport.com/methodology