Cleared Traditional

K020831 - PT S TEST STRIPS AND CONTROLS FOR THE C...

K020831 is the FDA 510(k) clearance for PT S TEST STRIPS AND CONTROLS FOR THE C... by Roche Diagnostics Corp.. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K020831 · Roche Diagnostics Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
224d
Days
Class 2
Risk

K020831 is an FDA 510(k) clearance for the PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND .... Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 24, 2002 after a review of 224 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K020831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2002
Decision Date October 24, 2002
Days to Decision 224 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
111d slower than avg
Panel avg: 113d · This submission: 224d
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 75
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K020831.
HEMOSIL RECOMBIPLASTIN
K043184 · Instrumentation Laboratory CO · Dec 2004
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
DADE THROMBOPLASTIN C PLUS
K013155 · Dade Behring, Inc. · Jan 2002
HEMOSIL RECOMBI PLASTIN
K012768 · Instrumentation Laboratory CO · Sep 2001
THROMBOREL S
K003870 · Dade Behring, Inc. · Feb 2001