Cleared Traditional

K093243 - COAGUSENSE SELF-TEST PROTHROMBIN TIME/I...

K093243 is an FDA 510(k) clearance for COAGUSENSE SELF-TEST PROTHROMBIN TIME/I..., 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 174-day FDA review.

K093243 · Coagusense, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
174d
Days
Class 2
Risk

K093243 is an FDA 510(k) clearance for the COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM. 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 April 7, 2010 after a review of 174 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 Coagusense, Inc. devices

FDA 510(k) Submission Details - K093243

510(k) Number K093243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2009
Decision Date April 07, 2010
Days to Decision 174 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
61d slower than avg
Panel avg: 113d · This submission: 174d
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 103
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