Cleared Traditional

K023839 - HEMOSIL FACTOR V DEFICIENT PLASMA

K023839 is an FDA 510(k) clearance for HEMOSIL FACTOR V DEFICIENT PLASMA, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with product code GJT cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K023839 · Instrumentation Laboratory CO · Hematology device
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Jan 2003
Decision
57d
Days
Class 2
Risk

K023839 is an FDA 510(k) clearance for the HEMOSIL FACTOR V DEFICIENT PLASMA. Classified as Plasma, Coagulation Factor Deficient (product code GJT), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on January 14, 2003 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K023839

510(k) Number K023839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2002
Decision Date January 14, 2003
Days to Decision 57 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
56d faster than avg
Panel avg: 113d · This submission: 57d
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 K023839.
HEMOSIL FACTOR X DEFICIENT PLASMA
K031122 · Instrumentation Laboratory CO · May 2003
HEMOSIL FACTOR XI DEFICIENT PLASMA
K030287 · Instrumentation Laboratory CO · Mar 2003
HEMOSIL FACTOR VII DEFICIENT PLASMA
K024082 · Instrumentation Laboratory CO · Feb 2003
CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15
K990814 · Precision Biologic · Jun 1999
CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)
K990296 · Precision Biologic · Mar 1999
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA
K990046 · Pacific Hemostasis · Feb 1999