Cleared Traditional

K964139 - SYSMEX CA-6000

K964139 is an FDA 510(k) clearance for SYSMEX CA-6000, manufactured by Dade Intl., Inc.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K964139

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
Combination Product No
PCCP Authorized No
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.

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 K964139.
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
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TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)
K981206 · Cardiovascular Diagnostics, Inc. · May 1998
COAG-A-MATE MTX
K962857 · Organon Teknika Corp. · Jan 1997
ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER
K962664 · Medical Laboratory Automation Systems, Inc. · Sep 1996
ACL 6000 SYSTEM (ACL 6000)
K961991 · Instrumentation Laboratory CO · Sep 1996