Cleared Traditional

K021923 - INRATIO SELF-TEST

K021923 is the FDA 510(k) clearance for INRATIO SELF-TEST by Hemosense, Inc.. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K021923 · Hemosense, Inc. · Hematology device
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Oct 2002
Decision
135d
Days
Class 2
Risk

K021923 is an FDA 510(k) clearance for the INRATIO SELF-TEST. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Hemosense, Inc. (Milpitas, US). The FDA issued a Cleared decision on October 24, 2002 after a review of 135 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 Hemosense, Inc. devices

Submission Details

510(k) Number K021923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2002
Decision Date October 24, 2002
Days to Decision 135 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
22d slower than avg
Panel avg: 113d · This submission: 135d
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 95
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K021923.
COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING
K030845 · Roche Diagnostics Corp. · May 2003
PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422
K021190 · Roche Diagnostics Corp. · Oct 2002
PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404
K020831 · Roche Diagnostics Corp. · Oct 2002
HARMONY INR MONITORING SYSTEM
K022922 · Lifescan, Inc. · Sep 2002
DADE THROMBOPLASTIN C PLUS
K013155 · Dade Behring, Inc. · Jan 2002
HEMOSIL RECOMBI PLASTIN
K012768 · Instrumentation Laboratory CO · Sep 2001