Cleared Traditional

K042333 - CONTROL PLASMA N

K042333 is the FDA 510(k) clearance for CONTROL PLASMA N by Dade Behring, Inc.. It is a Class 2 Hematology device (product code GGN) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K042333 · Dade Behring, Inc. · Hematology device
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Dec 2004
Decision
93d
Days
Class 2
Risk

K042333 is an FDA 510(k) clearance for the CONTROL PLASMA N, PROC CONTROL PLASMA. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on December 1, 2004 after a review of 93 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 K042333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2004
Decision Date December 01, 2004
Days to Decision 93 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
20d faster than avg
Panel avg: 113d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGN Plasma, Coagulation Control
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 - GGN Plasma, Coagulation Control

All 52
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K042333.
TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS
K062840 · Biosite Incorporated · Mar 2007
COAGUCHEK XS PT CONTROLS
K063823 · Roche Diagnostics Corp. · Jan 2007
TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS
K050799 · Biosite Incorporated · Jun 2005
CONTROL PLASMA N AND CONTROL PLASMA P
K042209 · Dade Behring, Inc. · Oct 2004
HEPARINASE HR ACT CONTROL, MODEL 550-12
K042175 · Medtronic Vascular · Oct 2004
PURPLE/BLACK HEPARIN ASSAY CONTROL
K042206 · Medtronic Vascular · Oct 2004