Cleared Traditional

K994349 - COAGUCHEK S SYSTEM, MODEL 2138280

K994349 is an FDA 510(k) clearance for COAGUCHEK S SYSTEM, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K994349

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.

JPA Device Classification - Class 2, Special Controls

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 145
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