Cleared Traditional

K981709 - COAGULATION FACTOR V DEFICIENT PLASMA

K981709 is the FDA 510(k) clearance for COAGULATION FACTOR V DEFICIENT PLASMA by Dade Behring, Inc.. It is a Class 2 Hematology device (product code GJT) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K981709 · Dade Behring, Inc. · Hematology device
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Oct 1998
Decision
162d
Days
Class 2
Risk

K981709 is an FDA 510(k) clearance for the COAGULATION FACTOR V DEFICIENT PLASMA. Classified as Plasma, Coagulation Factor Deficient (product code GJT), Class II - Special Controls.

Submitted by Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on October 13, 1998 after a review of 162 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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 K981709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1998
Decision Date October 13, 1998
Days to Decision 162 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
49d slower than avg
Panel avg: 113d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJT Plasma, Coagulation Factor Deficient
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 - GJT Plasma, Coagulation Factor Deficient

All 60
Devices cleared under the same product code (GJT) and FDA review panel - the closest regulatory comparables to K981709.
HEMOSIL FACTOR XI DEFICIENT PLASMA
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K024082 · Instrumentation Laboratory CO · Feb 2003
HEMOSIL FACTOR V DEFICIENT PLASMA
K023839 · Instrumentation Laboratory CO · Jan 2003
STA - LIATEST VWF TEST KIT
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STA-VWF CALIBRATOR KIT
K962671 · American Bioproducts Co. · Sep 1996
BIOMERIEUX HEMOLAB COFAC II
K942049 · Biomerieux Vitek, Inc. · May 1995