# K090346: Advia 2120/2120I Body Fluids

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Jul 28, 2010 after 532 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- 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 K030606 (2003). 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)
- K030606: Coulter LH 750 Body Fluids Application, Beckman Coulter, Inc. (2003) Summary page 1.

## Indications for use
The ADVIA 2120/2120i auto-analyzer Body Fluid Application is an in vitro diagnostic test for the enumeration of the total nucleated cell (IN) count and RBC count for pleural, peritoneal, and peritoneal dialysis (PD) specimens collected in K2 or K3 EDTA.

Source page: https://510kreport.com/device/K090346
Methodology: https://510kreport.com/methodology