# K160588: XN Check BF

- 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: 5 generations back to K000076 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141957: XN Check BF, Streck (2014) Summary page 4.

## Indications for use
XN CHECK BF 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: WBC-BF (10"3/uL), RBC-BF (1076/uL), MN# (1073/uL), PMN# (1073/uL), MN%, PMN%, TC-BF# (10"3/uL)

Source page: https://510kreport.com/device/K160588
Methodology: https://510kreport.com/methodology