Cleared Traditional

K964946 - SYSMEX CA-1000/SYSMEX CA-5000

K964946 is the FDA 510(k) clearance for SYSMEX CA-1000/SYSMEX CA-5000 by Sysmex Corp.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K964946 · Sysmex Corp. · Hematology device
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Optimized for regulatory review, auditing and printing
Mar 1997
Decision
98d
Days
Class 2
Risk

K964946 is an FDA 510(k) clearance for the SYSMEX CA-1000/SYSMEX CA-5000. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Sysmex Corp. (Long Grove, US). The FDA issued a Cleared decision on March 18, 1997 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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 Sysmex Corp. devices

Submission Details

510(k) Number K964946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1996
Decision Date March 18, 1997
Days to Decision 98 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
15d faster than avg
Panel avg: 113d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 117
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K964946.
COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING
K974569 · Boehringer Mannheim Corp. · Jan 1998
CS-400 COAGULATION ANALYZER SYSTEM (A1208)
K972260 · Sigma Diagnostics, Inc. · Oct 1997
BEHRING COAGULATION SYSTEM
K970431 · Behring Diagnostics, Inc. · May 1997
THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451
K961908 · Helena Laboratories · Dec 1996
KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)
K960875 · Sigma Diagnostics, Inc. · Sep 1996
AMAX CS-190 COAGULATION ANALYZER SYSTEM
K955720 · Sigma Diagnostics, Inc. · Mar 1996