# K982802: Bayer Advia 60 Hematology System (in Vitro Diagnostic System)

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Sep 22, 1998 after 43 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ABX MICROS Hematology System: named in the summary without a submission number

## Most influential descendants
- K032524: Advia 60 Hematology Analyzer (2003), 0 descendants of its own

## Indications for use
The Bayer ADVIA 60 is an automated in vitro diagnostic hematology analyzer capable of determining the following eighteen (18) hematological parameters: white blood cells (leukocytes) WBC red blood cells (erythrocytes) RBC hemoglobin HGB hematocrit HCT mean corpuscular volume MCV mean corpuscular hemoglobin MCH mean corpuscular hemoglobin concentration MCHC red blood cell distribution width RDW platelets PLT mean platelet volume MPV lymphocyte (number) #LYM lymphocyte (percent of WBC) %LYM monocyte (number) #MON monocyte-(percent of WBC) %MON granulocyte (number) #GRA granulocyte (percent of WBC) %GRA The ADVIA 60 Hematology Analyzer can be programmed to printout any of the following groups of parameters: 16 parameters 8 parameters (WBC (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, and PLT) 5 parameters (WBC, RBC, MPV, HGB, HCT) Only the eight (8) and sixteen (16) parameter printout will be made available for diagnostic use in the United States.

Source page: https://510kreport.com/device/K982802
Methodology: https://510kreport.com/methodology