Cleared Traditional

K924394 - CLOTTING FACTOR V DEFICIENT PLASMA

K924394 is an FDA 510(k) clearance for CLOTTING FACTOR V DEFICIENT PLASMA, manufactured by Behring Diagnostics, Inc.. The device is a Class 2 Hematology device with product code GJT cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K924394 · Behring Diagnostics, Inc. · Hematology device
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Dec 1992
Decision
92d
Days
Class 2
Risk

K924394 is an FDA 510(k) clearance for the CLOTTING FACTOR V DEFICIENT PLASMA. Classified as Plasma, Coagulation Factor Deficient (product code GJT), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on December 1, 1992 after a review of 92 days - within the typical 510(k) review window.

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 Behring Diagnostics, Inc. devices

FDA 510(k) Submission Details - K924394

510(k) Number K924394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1992
Decision Date December 01, 1992
Days to Decision 92 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
21d faster than avg
Panel avg: 113d · This submission: 92d
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 K924394.
BIOMERIEUX HEMOLAB COFAC VIII
K933010 · Biomerieux Vitek, Inc. · Sep 1993
CLOTTING FACTOR-11,-VII, -X DEFICIENT PLASMA
K924400 · Behring Diagnostics, Inc. · Jun 1993
CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA
K924396 · Behring Diagnostics, Inc. · May 1993
DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA
K915411 · Baxter Diagnostics, Inc. · May 1992
DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN)
K912679 · Baxter Healthcare Corp · Sep 1991
CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE
K902083 · Helena Laboratories · Jun 1990