Cleared Traditional

K093460 - COAGUCHEK XS PRO SYSTEM

K093460 is the FDA 510(k) clearance for COAGUCHEK XS PRO SYSTEM by Roche Diagnostics. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K093460 · Roche Diagnostics · Hematology device
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Mar 2010
Decision
132d
Days
Class 2
Risk

K093460 is an FDA 510(k) clearance for the COAGUCHEK XS PRO SYSTEM. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on March 18, 2010 after a review of 132 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.

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Submission Details

510(k) Number K093460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2009
Decision Date March 18, 2010
Days to Decision 132 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
19d slower than avg
Panel avg: 113d · This submission: 132d
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 87
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K093460.
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K070005 · Instrumentation Laboratory CO · Aug 2007