Cleared Traditional

K031377 - SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560

K031377 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 GKP cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K031377 · Dade Behring, Inc. · Hematology device
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Sep 2003
Decision
130d
Days
Class 2
Risk

K031377 is an FDA 510(k) clearance for the SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540..... Classified as Instrument, Coagulation, Automated (product code GKP), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on September 8, 2003 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5400 - 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 - K031377

510(k) Number K031377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2003
Decision Date September 08, 2003
Days to Decision 130 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
17d slower than avg
Panel avg: 113d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKP Device Classification - Class 2, Special Controls

Product Code GKP Instrument, Coagulation, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5400
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 - GKP Instrument, Coagulation, Automated

All 45
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K031377.
ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
K073377 · Instrumentation Laboratory CO · May 2008
ACL TOP
K063679 · Instrumentation Laboratory CO · Jan 2007
ACL TOP MODEL, TOP
K033414 · Instrumentation Laboratory CO · Jan 2004
FISHER DIAGNOSTICS THROMBOSCREEN 1000
K023362 · Fisher Diagnostics · Dec 2002
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000
K020979 · Dade Behring, Inc. · Jun 2002
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K001645 · Dade Behring, Inc. · Aug 2000