Cleared Traditional

K183255 - Coag-Sense Prothrombin Time (PT) / INR ...

K183255 is an FDA 510(k) clearance for Coag-Sense Prothrombin Time (PT) / INR ..., manufactured by Coagusense, Inc.. The device is a Class 2 Hematology device with product code GJS cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K183255 · Coagusense, Inc. · Hematology device
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Feb 2019
Decision
92d
Days
Class 2
Risk

K183255 is an FDA 510(k) clearance for the Coag-Sense Prothrombin Time (PT) / INR Monitoring Device. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Coagusense, Inc. (Fremont, US). The FDA issued a Cleared decision on February 21, 2019 after a review of 92 days - within the typical 510(k) review window.

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 Coagusense, Inc. devices

FDA 510(k) Submission Details - K183255

510(k) Number K183255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2018
Decision Date February 21, 2019
Days to Decision 92 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
21d faster than avg
Panel avg: 113d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GJS Device Classification - Class 2, Special Controls

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 102
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K183255.
Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
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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