Cleared Traditional

COAGULATION FACTOR V DEFICIENT PLASMA (K981709) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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 78
Devices cleared under the same product code (GJT) and FDA review panel - the closest regulatory comparables to K981709.
CRYOcheck Factor VIII Deficient Plasma with VWF
K222831 · Precision Biologic, Inc. · Sep 2023
HemosIL Factor XII Deficient Plasma
K180486 · Instrumentation Laboratory CO · Mar 2018
DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN)
K912679 · Baxter Healthcare Corp · Sep 1991
IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN
K880874 · Baxter Healthcare Corp · Mar 1988