Cleared Traditional

K023141 - MODIFICATION TO STANDARD HUMAN PLASMA

K023141 is the FDA 510(k) clearance for MODIFICATION TO STANDARD HUMAN PLASMA by Dade Behring, Inc.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K023141 · Dade Behring, Inc. · Hematology device
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Jan 2003
Decision
118d
Days
Class 2
Risk

K023141 is an FDA 510(k) clearance for the MODIFICATION TO STANDARD HUMAN PLASMA. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on January 16, 2003 after a review of 118 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 Dade Behring, Inc. devices

Submission Details

510(k) Number K023141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2002
Decision Date January 16, 2003
Days to Decision 118 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
5d slower than avg
Panel avg: 113d · This submission: 118d
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 K023141.
HEMOCHRON SIGNATURE ELITE
K050016 · International Technidyne Corp. · Feb 2005
HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2
K040359 · Instrumentation Laboratory CO · Mar 2004
HEMOCHRON RESPONSE/SYSTEM
K030818 · International Technidyne Corp. · Apr 2003
AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED
K021162 · Sigma Diagnostics, Inc. · Aug 2002
HEMOCHRON JR. SIGNATURE +
K020798 · International Technidyne Corp. · Mar 2002
BCS SYSTEM
K013114 · Dade Behring, Inc. · Nov 2001