Cleared Traditional

K020355 - I-STAT PROTHROMBIN TIME TEST

K020355 is an FDA 510(k) clearance for I-STAT PROTHROMBIN TIME TEST, manufactured by I-Stat Corporation. The device is a Class 2 Hematology device with product code GJS cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K020355 · I-Stat Corporation · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
99d
Days
Class 2
Risk

K020355 is an FDA 510(k) clearance for the I-STAT PROTHROMBIN TIME TEST. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by I-Stat Corporation (East Windsor, US). The FDA issued a Cleared decision on May 14, 2002 after a review of 99 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.

FDA 510(k) Submission Details - K020355

510(k) Number K020355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2002
Decision Date May 14, 2002
Days to Decision 99 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
14d faster than avg
Panel avg: 113d · This submission: 99d
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 126
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K020355.
INRATIO SELF-TEST
K021923 · Hemosense, Inc. · Oct 2002
HARMONY INR MONITORING SYSTEM
K022922 · Lifescan, Inc. · Sep 2002
VITAL SCIENTIFIC PT WITH CALCIUM
K020840 · Vital Scientific N.V. · May 2002
INRATIO
K020679 · Hemosense, Inc. · May 2002
DADE THROMBOPLASTIN C PLUS
K013155 · Dade Behring, Inc. · Jan 2002
HEMOSIL RECOMBI PLASTIN
K012768 · Instrumentation Laboratory CO · Sep 2001
K020355 · I-STAT PROTHROMBIN TIME TEST
Download PDF FDA Summary I-Stat Corporation