Cleared Traditional

K942050 - HEMOLAB COFAC IX

K942050 is an FDA 510(k) clearance for HEMOLAB COFAC IX, manufactured by Biomerieux Vitek, Inc.. The device is a Class 2 Hematology device with product code GJT cleared through the Traditional 510(k) pathway after a 386-day FDA review.

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

FDA 510(k) Submission Details - K942050

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
Combination Product No
PCCP Authorized No
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.

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 K942050.
STA - LIATEST VWF TEST KIT
K962675 · American Bioproducts Co. · Oct 1996
STA-VWF CALIBRATOR KIT
K962671 · American Bioproducts Co. · Sep 1996
BIOMERIEUX HEMOLAB COFAC II
K942049 · Biomerieux Vitek, Inc. · May 1995
BIOMERIEUX HEMOLAB COFAC VII
K935850 · Biomerieux Vitek, Inc. · Jan 1995
BIOMERIEUX HEMOLAB COFAC X
K935851 · Biomerieux Vitek, Inc. · Jan 1995
FACTOR VIII DEFICIENT PLASMA
K935057 · Sigma Diagnostics, Inc. · Mar 1994