Cleared Traditional

K964139 - SYSMEX CA-6000

K964139 is the FDA 510(k) clearance for SYSMEX CA-6000 by Dade Intl., Inc.. It is a Class 2 Hematology device (product code GKP) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K964139 · Dade Intl., Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
114d
Days
Class 2
Risk

K964139 is an FDA 510(k) clearance for the SYSMEX CA-6000. Classified as Instrument, Coagulation, Automated (product code GKP), Class II - Special Controls.

Submitted by Dade Intl., Inc. (Miami, US). The FDA issued a Cleared decision on February 6, 1997 after a review of 114 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 Intl., Inc. devices

Submission Details

510(k) Number K964139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1996
Decision Date February 06, 1997
Days to Decision 114 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 113d · This submission: 114d
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 37
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K964139.
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500
K992763 · Dade Behring, Inc. · Sep 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
K992321 · Dade Behring, Inc. · Sep 1999
COAG-A-MATE MAX
K991101 · Organon Teknika Corp. · Jun 1999
COAG-A-MATE MTX
K962857 · Organon Teknika Corp. · Jan 1997
ACL 6000 SYSTEM (ACL 6000)
K961991 · Instrumentation Laboratory CO · Sep 1996
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
K961579 · American Bioproducts Co. · Jul 1996