# K183390: QNext and DG-PT

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Grifols, S.A.
- Decided: Aug 21, 2019 after 258 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K002400 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160276: Acl Top (Acl Top 700, Acl Top 700 CTS, Acl Top 700 Las, Acl Top 500 CTS, Acl Top 300 CTS), Instrumentation Laboratory CO (2016) Summary page 4.
- K060931: Hemosil PT-Fibrinogen HS Plus, Instrumentation Laboratory CO (2006) Summary page 4.

## Indications for use
QNext: The QNext is a fully-automated, random-access instrument, intended for in vitro diagnostic use in clinical laboratories to perform hemostasis testing by detecting the changes in optical density. DG-PT: DG-PT is a thromboplastin reagent for the quantitative determination of Prothrombin Time on human plasma samples collected in 3.2% sodium citrate. The product is used for the evaluation of the extrinsic and common coagulation pathways in seconds and for the monitoring Oral Anticoagulant Therapy with warfarin in International Normalized Ratio (INR). For use with QNext. For clinical professional laboratory and prescription use only. For in vitro diagnostic use. The performance of this device has not been established in neonate and pediatric patient populations.

Source page: https://510kreport.com/device/K183390
Methodology: https://510kreport.com/methodology