Cleared Traditional

K942096 - TOA MEDICAL ELECTRONICS CA-1000

K942096 is an FDA 510(k) clearance for TOA MEDICAL ELECTRONICS CA-1000, 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 344-day FDA review.

K942096 · Sysmex Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
344d
Days
Class 2
Risk

K942096 is an FDA 510(k) clearance for the TOA MEDICAL ELECTRONICS CA-1000. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Sysmex Corp. (Los Alamitos, US). The FDA issued a Cleared decision on March 24, 1995 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K942096

510(k) Number K942096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1994
Decision Date March 24, 1995
Days to Decision 344 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
231d slower than avg
Panel avg: 113d · This submission: 344d
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 K942096.
ACL FUTURA COAGULATION SYSTEM
K951891 · Instrumentation Laboratory CO · Nov 1995
CASCASE 480 SNSLYZER
K951497 · Helena Laboratories · Sep 1995
BEHRING FIBRINTIMER A
K926551 · Behring Diagnostics, Inc. · Apr 1995
TOA MEDICAL ELECTRONICS CA-5000
K942097 · Sysmex Corp. · Mar 1995
HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM
K940957 · International Technidyne Corp. · Oct 1994
ACT CONTROL SET
K940840 · Sigma Diagnostics, Inc. · Jul 1994