# K112755: Abacus 5

- Pathway: 510(k) (Traditional)
- Applicant: Diatron U.S., Inc.
- Decided: Mar 27, 2012 after 188 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K971152 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991605: Cell-Dyn 3500 System with Immature Reticulocyte Fraction (Irf), Cell-Dyn 3700 System with Immature Reticulocyte Fraction, Abbott Laboratories (1999) Summary page 1.

## Recalls of this device
- Oct 21, 2016 · Class II · Z-0723-2017: Siemens is investigating an issue which may cause an incorrect result to be reported. Siemens received two reports of multiple discordant records for the same Sample ID in the ADVIA 560 Hematology Sys

## Indications for use
The Diatron Abacus 5 System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro-diagnostic use in clinical laboratories for enumeration of the following parameters in K3EDTA anti-coagulated venous whole blood* samples: WBC, LYM%, LYM#, MON%, MON#, NEU%, NEU#, EOS%, EOS#, BAS%, BAS#, RBC, HGB, HCT, MCV, MCH, MCHC, RDWcv, RDWsd, PLT and MPV. The Diatron Abacus 5 is indicated for use to identify patients with hematologic parameters within and outside of established reference ranges.

Source page: https://510kreport.com/device/K112755
Methodology: https://510kreport.com/methodology