# K994388: XE Check

- Pathway: 510(k) (Traditional)
- Applicant: Streck Laboratories, Inc.
- Decided: Jan 14, 2000 after 17 days
- Product code: GLQ (Mixture, Control, White-Cell And Red-Cell Indices)
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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) SF Check: named in the summary without a submission number
- (no number) Retic Chex: named in the summary without a submission number

## Indications for use
XE-Check is intended to be used as a control for complete blood cell count (CBC), white cell 5-part differential, and reticulocyte parameters on Sysmex XE — 2100 hematology instrument.

Source page: https://510kreport.com/device/K994388
Methodology: https://510kreport.com/methodology