Cleared Traditional

K981709 - COAGULATION FACTOR V DEFICIENT PLASMA

K981709 is an FDA 510(k) clearance for COAGULATION FACTOR V DEFICIENT PLASMA, manufactured by Dade Behring, Inc.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K981709

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.

GJT Device Classification - Class 2, Special Controls

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 74
Devices cleared under the same product code (GJT) and FDA review panel - the closest regulatory comparables to K981709.
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA
K990046 · Pacific Hemostasis · Feb 1999
CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)
K981173 · Precision Biologicals, Inc. · Jan 1999
CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)
K981174 · Precision Biologicals, Inc. · Jan 1999
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056)
K972627 · Pacific Hemostasis · Aug 1997
CRYO CHECK FACTOR V DEFICIENT PLASMA
K971223 · Precision Biologicals, Inc. · Jul 1997
CRYO CHECK FACTOR IX DEFICIENT PLASMA
K971226 · Precision Biologicals, Inc. · Jul 1997