# K063218: E-Check (XE)

- Pathway: 510(k) (Traditional)
- Applicant: Streck
- Decided: Dec 14, 2006 after 51 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
No predicates in its family tree.
4 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)
- None. The FDA summary names its predicate without a number.
- (no number) e-CHECK: named in the summary without a submission number

## Most influential descendants
- K120742: XN Check (2012), 3 descendants of its own
- 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
e-CHECK (XE) TM is intended to be used as a control for complete blood cell count (CBC), white blood cell differential, reticulocyte and nucleated red blood cell (NRBC) parameters on Sysmex XE - series instruments.

Source page: https://510kreport.com/device/K063218
Methodology: https://510kreport.com/methodology