Cleared Traditional

K001067 - DADE BEHRING COAGULATION ANALYZER (BCT)

K001067 is the FDA 510(k) clearance for DADE BEHRING COAGULATION ANALYZER (BCT) by Dade Behring, Inc.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K001067 · Dade Behring, Inc. · Hematology device
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Jun 2000
Decision
78d
Days
Class 2
Risk

K001067 is an FDA 510(k) clearance for the DADE BEHRING COAGULATION ANALYZER (BCT). Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Dade Behring, Inc. (P.O. Box 6101, Newark, US). The FDA issued a Cleared decision on June 20, 2000 after a review of 78 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 K001067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2000
Decision Date June 20, 2000
Days to Decision 78 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
35d faster than avg
Panel avg: 113d · This submission: 78d
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 K001067.
COAGUCHEK S SYSTEM, MODEL 2138280
K994349 · Roche Diagnostics Corp. · Sep 2000
MODIFICATION OF ACL ADVANCE
K002400 · Instrumentation Laboratory CO · Aug 2000
BEHRING COAGULATION TIMER ANALYZER (BCT)
K001064 · Dade Behring, Inc. · Jun 2000
BEHRING COAGULATION SYSTEM (BCS)
K000973 · Dade Behring, Inc. · May 2000
ACL 9000 SYSTEM
K000053 · Instrumentation Laboratory CO · Mar 2000
BEHRING COAGULATION SYSTEM (BCS)
K992959 · Dade Behring, Inc. · Jan 2000