Cleared Traditional

K062925 - COAGUCHEK XS SYSTEM

K062925 is the FDA 510(k) clearance for COAGUCHEK XS SYSTEM by Roche Diagnostics Corp.. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K062925 · Roche Diagnostics Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
123d
Days
Class 2
Risk

K062925 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 Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 29, 2007 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.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K062925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2006
Decision Date January 29, 2007
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 75
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K062925.
HANDHELD BASE UNIT
K072920 · Roche Diagnostics Corp. · Jan 2008
HEMOSIL RECOMBIPLASTIN 2G
K070005 · Instrumentation Laboratory CO · Aug 2007
COAGUCHEK XS PLUS SYSTEM
K071041 · Roche Diagnostics · May 2007
COAGUCHEK XS SYSTEM
K060978 · Roche Diagnostics · Aug 2006
HEMOSIL PT-FIBRINOGEN HS PLUS
K060931 · Instrumentation Laboratory CO · May 2006
HEMOSIL RECOMBIPLASTIN
K043184 · Instrumentation Laboratory CO · Dec 2004