# K111211: Cell-Dyn 22 Plus Control

- Pathway: 510(k) (Traditional)
- Applicant: Streck
- Decided: Dec 22, 2011 after 237 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
Longest line of descent: 1 generation back to K901875 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901875: Para 12 Plus, Streck Laboratories, Inc. (1990)

## Indications for use
CELL-DYN 22 Pius Control is an assayed hematology control for evaluating the accuracy and precision of the CELL-DYN Emerald 22 system. Assayed parameters include: WBC (10 /), RBC (10' 2/L), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MOHO (g/dL), RDW () PLT (1091L), MPV (fQy, NEU (/),NEU (109/L), LYM (%), LYM (109/L), MON (%), MON (109 L), EQS (%), EQS (100/L), BAS (%,BAS (10 /)

Source page: https://510kreport.com/device/K111211
Methodology: https://510kreport.com/methodology