510(k) · Cleared
ClearedQNext and DG-PT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Grifols, S.A. · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Aug 21, 2019 as substantially equivalent to K160276 (Instrumentation Laboratory CO, 2016) and 1 other predicate after a 258-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Aug 21, 2019
- Review
- 258 days
- Class
- Class II
- Product code
- JPA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K002400 (2000). 8 ancestors in all, the oldest K933252 (1993). No later device cites it as a predicate yet.
- Root · 6 generations backK002400 Modification of Acl AdvanceInstrumentation Laboratory CO · 2000 · Recalled
- 5 generations backK033414 Acl Top Model, TopInstrumentation Laboratory CO · 2004 · Recalled
- 4 generations backK063679 Acl TopInstrumentation Laboratory CO · 2007 · Recalled
- 3 generations backK073377 Acl Top (with System Software V3.0.0)Instrumentation Laboratory CO · 2008
- 2 generations backK091980 Acl Top 700 LasInstrumentation Laboratory CO · 2009 · Recalled
- 1 generation backK160276 Acl Top (Acl Top 700, Acl Top 700 CTS, Acl Top 700 Las, Acl Top 500…Instrumentation Laboratory CO · 2016 · Recalled
- This deviceK183390 QNext and DG-PTDiagnostic Grifols, S.A. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002400 | Modification of Acl Advance | Instrumentation Laboratory CO | 2000 | 2 |
| −5 | K033414 | Acl Top Model, Top | Instrumentation Laboratory CO | 2004 | 1 |
| −4 | K063679 | Acl Top | Instrumentation Laboratory CO | 2007 | 1 |
| −3 | K073377 | Acl Top (with System Software V3.0.0) | Instrumentation Laboratory CO | 2008 | — |
| −2 | K091980 | Acl Top 700 Las | Instrumentation Laboratory CO | 2009 | 24 |
| −1 | K160276 | Acl Top (Acl Top 700, Acl Top 700 CTS, Acl Top 700 Las, Acl Top 500 CTS, Acl… | Instrumentation Laboratory CO | 2016 | 1 |
| 0 (this device) | K183390 | QNext and DG-PT | Diagnostic Grifols, S.A. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JPA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JPA device
- #1 K243858 TEG 6s Hemostasis System Citrated: K, KH, RT…score 12.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160276 | Acl Top (Acl Top 700, Acl Top 700 CTS, Acl Top 700 Las, Acl Top 500 CTS, Acl Top 300 CTS)Summary page 4…64.7750 Regulatory Class: Class II Product Codes: JPA and GJS 5.3 Predicate Devices Trade Names: ACL Top 700 (K160276) and HemosIL PT Fibrinogen HS Plus (K060931). Common Names: Instrument Coagulat… | 2016 |
| * | K060931 | Hemosil PT-Fibrinogen HS PlusSummary page 4…JPA and GJS 5.3 Predicate Devices Trade Names: ACL Top 700 (K160276) and HemosIL PT Fibrinogen HS Plus (K060931). Common Names: Instrument Coagulation Automated and Prothrombin Time. Regulation Number: 864.5400… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- 6 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K160276.
How does its category compare?
All JPA devicesJPA System, Multipurpose For In Vitro Coagulation Studies: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · JPA
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JPA
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JPA
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPA
11in 2025
MAUDE reports naming product code JPA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 1,744 |
| 2008 | 2 | — | 0 | 918 |
| 2009 | 6 | 91 | 0 | 1,363 |
| 2010 | 1 | — | 6 | 727 |
| 2011 | 1 | — | 4 | 161 |
| 2012 | 0 | — | 1 | 52 |
| 2013 | 1 | — | 0 | 43 |
| 2014 | 0 | — | 0 | 48 |
| 2015 | 2 | — | 0 | 45 |
| 2016 | 6 | 114 | 3 | 6 |
| 2017 | 4 | 117 | 0 | 15 |
| 2018 | 1 | — | 0 | 39 |
| 2019 | 3 | 175 | 0 | 27 |
| 2020 | 0 | — | 1 | 18 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 1 | — | 0 | 9 |
| 2023 | 3 | 506 | 0 | 11 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 3 | 30 | 0 | 11 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (112 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183390 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183390: QNext and DG-PT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183390
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026