Cleared Traditional

COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM (K093243) - FDA 510(k) Clearance

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

K093243 · Coagusense, Inc. · Hematology device
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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

Submission Details

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.

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 69
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