Cleared Special

K180684 - CoaguChek XS Plus System

K180684 is the FDA 510(k) clearance for CoaguChek XS Plus System by Roche Diagnostics. It is a Class 2 Hematology device (product code GJS) cleared through the Special 510(k) pathway after a 35-day FDA review.

K180684 · Roche Diagnostics · Hematology device
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Apr 2018
Decision
35d
Days
Class 2
Risk

K180684 is an FDA 510(k) clearance for the CoaguChek XS Plus 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 April 19, 2018 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Roche Diagnostics devices

Submission Details

510(k) Number K180684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2018
Decision Date April 19, 2018
Days to Decision 35 days
Submission Type Special
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
78d faster than avg
Panel avg: 113d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

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 K180684.
microINR System
K201185 · Iline Microsystems, S.L. · Dec 2020
Coag-Sense Prothrombin Time (PT) / INR Monitoring Device
K183255 · Coagusense, Inc. · Feb 2019
microINR System
K180780 · Iline Microsystems, S.L. · Jan 2019
CoaguChek XS Pro System
K180693 · Roche Diagnostics · Apr 2018
CoaguChek Vantus System
K170960 · Roche Diagnostics · Dec 2017
Xprecia Stride Coagulation System, Xprecia System PT Controls
K151964 · Siemens Healthcare Diagnostics · Sep 2016