Cleared Traditional

K981711 - SYSMEX AUTOMATED COAGULATION ANALYZER CA-500

K981711 is an FDA 510(k) clearance for SYSMEX AUTOMATED COAGULATION ANALYZER C..., manufactured by Dade Behring, Inc.. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K981711 · Dade Behring, Inc. · Hematology device
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Sep 1998
Decision
156d
Days
Class 2
Risk

K981711 is an FDA 510(k) clearance for the SYSMEX AUTOMATED COAGULATION ANALYZER CA-500. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on September 30, 1998 after a review of 156 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 Dade Behring, Inc. devices

FDA 510(k) Submission Details - K981711

510(k) Number K981711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1998
Decision Date September 30, 1998
Days to Decision 156 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
43d slower than avg
Panel avg: 113d · This submission: 156d
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 152
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K981711.
HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE
K990449 · International Technidyne Corp. · Apr 1999
STAR AUTOMATED MULTI-PARAMETRIC ANALYZER
K983460 · American Bioproducts Co. · Nov 1998
AVOCET PT
K980839 · Avocet Medical, Inc. · Sep 1998
HEPTRAC ELECTRONIC QUALITY CONTROL
K981815 · Medtronic Blood Management · Jul 1998
HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE
K974799 · International Technidyne Corp. · Jul 1998
COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING
K974569 · Boehringer Mannheim Corp. · Jan 1998