Cleared Traditional

K183255 - Coag-Sense Prothrombin Time (PT) / INR Monitoring Device (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 126
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K183255.
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microINR System
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Xprecia Prime Coagulation System
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i-STAT PTplus Cartridge with the i-STAT 1 System
K220282 · Abbott Laboratories · Jul 2023
microINR System
K231711 · Iline Microsystems, S.L. · Jul 2023