Cleared Traditional

K001645 - SYSMEX AUTOMATED COAGULATION ANALYZER

K001645 is the FDA 510(k) clearance for SYSMEX AUTOMATED COAGULATION ANALYZER by Dade Behring, Inc.. It is a Class 2 Hematology device (product code GKP) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K001645 · Dade Behring, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Aug 2000
Decision
66d
Days
Class 2
Risk

K001645 is an FDA 510(k) clearance for the SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500. Classified as Instrument, Coagulation, Automated (product code GKP), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Miami, US). The FDA issued a Cleared decision on August 4, 2000 after a review of 66 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K001645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2000
Decision Date August 04, 2000
Days to Decision 66 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
47d faster than avg
Panel avg: 113d · This submission: 66d
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 33
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K001645.
ACL TOP MODEL, TOP
K033414 · Instrumentation Laboratory CO · Jan 2004
SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560
K031377 · Dade Behring, Inc. · Sep 2003
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000
K020979 · Dade Behring, Inc. · Jun 2002
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
K001145 · Dade Behring, Inc. · May 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K993299 · Dade Behring, Inc. · Dec 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
K993174 · Dade Behring, Inc. · Nov 1999