Cleared Traditional

K964946 - SYSMEX CA-1000/SYSMEX CA-5000

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

K964946 · Sysmex Corp. · Hematology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K964946

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
Combination Product No
PCCP Authorized No
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.

JPA Device Classification - Class 2, Special Controls

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 158
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
PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS
K954202 · Medtronic Hemotec, Inc. · Jun 1996