# K230878: QScout Lab; QScout RLD

- Pathway: 510(k) (Traditional)
- Applicant: Ad Astra Diagnostics, Inc.
- Decided: Nov 14, 2023 after 229 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: 2 generations back to K120771 (2013). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140911: Unicel DXH 800 Coulter Cellular Analysis System/ Unicel DXH Slidemaker Stainer Coulter Cellular Analysis System, Beckman Coulter, Inc. (2014) Summary page 5.

## Indications for use
The QScout™ Lab is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations 18 years and older found in clinical laboratories and point-of-care (POC) settings. The QScout Lab is used with the QScout RLD test to enumerate and classify the following parameters in venous K2/K3EDTA whole blood: • White blood cell count (WBC) • Neutrophils (NEUT#) • Lymphocytes (LYMPH#) • Monocytes (MONO#) • Eosinophils (EOS#) • Basophils (BASO#) • Immature Granulocytes (IG#) • Percent Neutrophils (NEUT%) • Percent Lymphocytes (LYMPH%) • Percent Monocytes (MONO%) • Percent Eosinophils (EOS%) • Percent Basophils (BASO%) • Percent Immature Granulocytes (IG%) • Neutrophil to Lymphocyte Ratio (NLR)

Source page: https://510kreport.com/device/K230878
Methodology: https://510kreport.com/methodology