Cleared Traditional

K030845 - COAGUCHEK PT.S TEST FOR PROTHROMBIN TIM...

K030845 is the FDA 510(k) clearance for COAGUCHEK PT.S TEST FOR PROTHROMBIN TIM... by Roche Diagnostics Corp.. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K030845 · Roche Diagnostics Corp. · Hematology device
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Optimized for regulatory review, auditing and printing
May 2003
Decision
66d
Days
Class 2
Risk

K030845 is an FDA 510(k) clearance for the COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING. 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 May 22, 2003 after a review of 66 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K030845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2003
Decision Date May 22, 2003
Days to Decision 66 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
47d faster than avg
Panel avg: 113d · This submission: 66d
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 K030845.
COAGUCHEK XS SYSTEM
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HEMOSIL RECOMBIPLASTIN
K043184 · Instrumentation Laboratory CO · Dec 2004
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
DADE THROMBOPLASTIN C PLUS
K013155 · Dade Behring, Inc. · Jan 2002