Cleared Traditional

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

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 48
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K031377.
ACL TOP Family 50 Series (ACL TOP 750
K242127 · Instrumentation Laboratory (IL) Co. · Aug 2024
ACL TOP Family 70 Series
K231031 · Instrumentation Laboratory Company · Jun 2023
ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
K160276 · Instrumentation Laboratory CO · Mar 2016
ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS
K150877 · Instrumentation Laboratory CO · Dec 2015
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