Cleared Traditional

K994349 - COAGUCHEK S SYSTEM

K994349 is the FDA 510(k) clearance for COAGUCHEK S SYSTEM by Roche Diagnostics Corp.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K994349 · Roche Diagnostics Corp. · Hematology device
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Sep 2000
Decision
258d
Days
Class 2
Risk

K994349 is an FDA 510(k) clearance for the COAGUCHEK S SYSTEM, MODEL 2138280. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 6, 2000 after a review of 258 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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 K994349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1999
Decision Date September 06, 2000
Days to Decision 258 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
145d slower than avg
Panel avg: 113d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 84
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K994349.
SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500
K011235 · Dade Behring, Inc. · Jul 2001
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K010494 · Dade Behring, Inc. · May 2001
BEHRING COAGULATION SYSTEM, MODEL BCS
K002080 · Dade Behring, Inc. · Nov 2000
MODIFICATION OF ACL ADVANCE
K002400 · Instrumentation Laboratory CO · Aug 2000
BEHRING COAGULATION TIMER ANALYZER (BCT)
K001064 · Dade Behring, Inc. · Jun 2000
DADE BEHRING COAGULATION ANALYZER (BCT)
K001067 · Dade Behring, Inc. · Jun 2000