Cleared Traditional

HEMOLAB COFAC IX (K942050) - FDA 510(k) Clearance

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

K942050 · Biomerieux Vitek, Inc. · Hematology device
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May 1995
Decision
386d
Days
Class 2
Risk

K942050 is an FDA 510(k) clearance for the HEMOLAB COFAC IX. Classified as Plasma, Coagulation Factor Deficient (product code GJT), Class II - Special Controls.

Submitted by Biomerieux Vitek, Inc. (Hazelwood, US). The FDA issued a Cleared decision on May 19, 1995 after a review of 386 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Biomerieux Vitek, Inc. devices

Submission Details

510(k) Number K942050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1994
Decision Date May 19, 1995
Days to Decision 386 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
273d slower than avg
Panel avg: 113d · This submission: 386d
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 K942050.
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K110237 · Instrumentation Laboratory CO · Jul 2011
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K050661 · Instrumentation Laboratory CO · May 2005
HEMOSIL FACTOR XII DEFICIENT PLASMA
K043459 · Instrumentation Laboratory CO · Feb 2005
HEMOSIL FACTOR VIII DEFICIENT PLASMA
K034007 · Instrumentation Laboratory CO · Feb 2004