Cleared Traditional

K042333 - CONTROL PLASMA N, PROC CONTROL PLASMA

K042333 is an FDA 510(k) clearance for CONTROL PLASMA N, manufactured by Dade Behring, Inc.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K042333

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.

GGN Device Classification - Class 2, Special Controls

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 81
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