Cleared Traditional

K170960 - CoaguChek Vantus System

K170960 is the FDA 510(k) clearance for CoaguChek Vantus System by Roche Diagnostics. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K170960 · Roche Diagnostics · Hematology device
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Dec 2017
Decision
269d
Days
Class 2
Risk

K170960 is an FDA 510(k) clearance for the CoaguChek Vantus System. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on December 25, 2017 after a review of 269 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - 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 Roche Diagnostics devices

Submission Details

510(k) Number K170960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2017
Decision Date December 25, 2017
Days to Decision 269 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
156d slower than avg
Panel avg: 113d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJS Test, Time, Prothrombin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7750
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 - GJS Test, Time, Prothrombin

All 94
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K170960.
microINR System
K180780 · Iline Microsystems, S.L. · Jan 2019
CoaguChek XS Plus System
K180684 · Roche Diagnostics · Apr 2018
CoaguChek XS Pro System
K180693 · Roche Diagnostics · Apr 2018
Xprecia Stride Coagulation System, Xprecia System PT Controls
K151964 · Siemens Healthcare Diagnostics · Sep 2016
HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)
K132722 · Instrumentation Laboratory CO · Jan 2014
HEMOSIL READIPLAS TIN
K122584 · Instrumentation Laboratory CO · Mar 2013