Cleared Traditional

K183390 - QNext and DG-PT

K183390 is an FDA 510(k) clearance for QNext and DG-PT, manufactured by Diagnostic Grifols, S.A.. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K183390 · Diagnostic Grifols, S.A. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2019
Decision
258d
Days
Class 2
Risk

K183390 is an FDA 510(k) clearance for the QNext and DG-PT. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Diagnostic Grifols, S.A. (Partes Del Valles, ES). The FDA issued a Cleared decision on August 21, 2019 after a review of 258 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Grifols, S.A. devices

FDA 510(k) Submission Details - K183390

510(k) Number K183390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2018
Decision Date August 21, 2019
Days to Decision 258 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 113d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPA Device Classification - Class 2, Special Controls

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - JPA System, Multipurpose For In Vitro Coagulation Studies

All 158
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K183390.
ROTEM sigma Thromboelastometry System
K201440 · Tem Innovations GmbH · Jul 2022
GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2
K202101 · Accriva Diagnostics, Inc. · Dec 2021
Hemochron Signature Elite
K193041 · Accriva Diagnostics, Inc. · Nov 2019
TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge
K183160 · Haemonetics Corporation · May 2019
CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set
K173202 · Sekisui Medical Co., Ltd. · May 2018
Automated Blood Coagulation Analyzer CS-2500
K172286 · Siemens Healthcare Diagnostic Products GmbH · Dec 2017