Cleared Traditional

K011235 - SYSMEX AUTOMATED COAGULATION ANALYZER /...

K011235 is the FDA 510(k) clearance for SYSMEX AUTOMATED COAGULATION ANALYZER /... by Dade Behring, Inc.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K011235 · Dade Behring, Inc. · Hematology device
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Jul 2001
Decision
88d
Days
Class 2
Risk

K011235 is an FDA 510(k) clearance for the SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Miami, US). The FDA issued a Cleared decision on July 20, 2001 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K011235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2001
Decision Date July 20, 2001
Days to Decision 88 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
25d faster than avg
Panel avg: 113d · This submission: 88d
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 95
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K011235.
HEMOCHRON JR. SIGNATURE +
K020798 · International Technidyne Corp. · Mar 2002
BCS SYSTEM
K013114 · Dade Behring, Inc. · Nov 2001
BCT SYSTEM
K011665 · Dade Behring, Inc. · Aug 2001
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K010494 · Dade Behring, Inc. · May 2001
BEHRING COAGULATION SYSTEM, MODEL BCS
K002080 · Dade Behring, Inc. · Nov 2000
COAGUCHEK S SYSTEM, MODEL 2138280
K994349 · Roche Diagnostics Corp. · Sep 2000