# K022331: Advia 120 Hematology System, Cerebrospinal Fluid Method

- Pathway: 510(k) (Special)
- Applicant: Bayer Diagnostics Corp.
- Decided: Sep 11, 2002 after 55 days
- Product code: GKL (Counter, Cell, Automated (Particle Counter))
- Device class: 2
- Regulation: 21 CFR 864.5200
- 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 K003796 (2001). 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)
- K003796: Advia 120 Hematology, Bayer Corp. (2001) Summary page 1.

## Indications for use
The ADVIA 120 cerebrospinal fluid (CSF) cell count is intended to provide an in vitro diagnostic, quantitative determination of blood cells in CSF specimens analyzed in the manual open tube mode. The ADVIA 120 provides leukocyte (WBC) and erythrocyte (REX) counts along with both absolute and proportional counts for the WBC differential.

Source page: https://510kreport.com/device/K022331
Methodology: https://510kreport.com/methodology