# K022668: Advia 120 Hematology System Complete Blood Count (CBC) Method

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Diagnostics Corp.
- Decided: Oct 15, 2002 after 64 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 K971998 (1997). 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)
- K971998: Advia 120 Hematology System, in Vitro Diagnostic System, Bayer Corp. (1997) Summary page 1.

## Indications for use
The ADVLATM120 Hematology System Complete Blood Count (CBC) method is intended to quantitatively measure the following hematological parameters: White Blood Cell count (WBC) Red Blood Cell count (RBC) Hematocrit (HCT) Mean Corpuscular Volume (MCV) Mean Corpuscular Hemoglobin (MCH) Mean Corpuscular Hemoglobin Concentration (MCHC) Corpuscular Hemoglobin Concentration Mean (CHCM) Cellular Hemoglobin Content (CH) Red Cell Volume Distribution Width (RDW) Hemoglobin Concentration Distribution Width (HDW) Platelet Count (PLT) Mean Platelet Volume (MPV)

Source page: https://510kreport.com/device/K022668
Methodology: https://510kreport.com/methodology