Cleared Traditional

K060978 - COAGUCHEK XS SYSTEM

K060978 is the FDA 510(k) clearance for COAGUCHEK XS SYSTEM by Roche Diagnostics. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K060978 · Roche Diagnostics · Hematology device
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Aug 2006
Decision
123d
Days
Class 2
Risk

K060978 is an FDA 510(k) clearance for the COAGUCHEK XS 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 August 11, 2006 after a review of 123 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 K060978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2006
Decision Date August 11, 2006
Days to Decision 123 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
10d slower than avg
Panel avg: 113d · This submission: 123d
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 94
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K060978.
HEMOSIL RECOMBIPLASTIN 2G
K070005 · Instrumentation Laboratory CO · Aug 2007
COAGUCHEK XS PLUS SYSTEM
K071041 · Roche Diagnostics · May 2007
COAGUCHEK XS SYSTEM
K062925 · Roche Diagnostics Corp. · Jan 2007
HEMOSIL PT-FIBRINOGEN HS PLUS
K060931 · Instrumentation Laboratory CO · May 2006
HEMOSIL RECOMBIPLASTIN
K043184 · Instrumentation Laboratory CO · Dec 2004
COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING
K030845 · Roche Diagnostics Corp. · May 2003