Cleared Traditional

K024082 - HEMOSIL FACTOR VII DEFICIENT PLASMA

K024082 is the FDA 510(k) clearance for HEMOSIL FACTOR VII DEFICIENT PLASMA by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code GJT) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K024082 · Instrumentation Laboratory CO · Hematology device
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Feb 2003
Decision
63d
Days
Class 2
Risk

K024082 is an FDA 510(k) clearance for the HEMOSIL FACTOR VII 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 February 12, 2003 after a review of 63 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

Submission Details

510(k) Number K024082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2002
Decision Date February 12, 2003
Days to Decision 63 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
50d faster than avg
Panel avg: 113d · This submission: 63d
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 55
Devices cleared under the same product code (GJT) and FDA review panel - the closest regulatory comparables to K024082.
HEMOSIL FACTOR IX DEFICIENT PLASMA
K031829 · Instrumentation Laboratory CO · Jul 2003
HEMOSIL FACTOR X DEFICIENT PLASMA
K031122 · Instrumentation Laboratory CO · May 2003
HEMOSIL FACTOR XI DEFICIENT PLASMA
K030287 · Instrumentation Laboratory CO · Mar 2003
HEMOSIL FACTOR V DEFICIENT PLASMA
K023839 · Instrumentation Laboratory CO · Jan 2003
COAGULATION FACTOR V DEFICIENT PLASMA
K981709 · Dade Behring, Inc. · Oct 1998
STA - LIATEST VWF TEST KIT
K962675 · American Bioproducts Co. · Oct 1996