# K100790: Coulter Lin-X Linearity Control, Model A81196

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Dec 21, 2010 after 274 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 K955334 (1996). 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)
- K081641: Coulter Lin-X Linearity Control, Beckman Coulter, Inc. (2009) Summary page 2.

## Indications for use
COULTER® LIN-X Linearity Controls are intended to assess calibration and verify the reportable range of Coulter® Cellular Analysis Systems listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents. Refer to Instructions for Use.

Source page: https://510kreport.com/device/K100790
Methodology: https://510kreport.com/methodology