Cleared Traditional

K920258 - QBC FIBRINOGEN

K920258 is an FDA 510(k) clearance for QBC FIBRINOGEN, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Hematology device with product code KQJ cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K920258 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology device
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Jun 1992
Decision
157d
Days
Class 2
Risk

K920258 is an FDA 510(k) clearance for the QBC FIBRINOGEN. Classified as System, Fibrinogen Determination (product code KQJ), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on June 26, 1992 after a review of 157 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7340 - 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K920258

510(k) Number K920258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1992
Decision Date June 26, 1992
Days to Decision 157 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 113d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KQJ Device Classification - Class 2, Special Controls

Product Code KQJ System, Fibrinogen Determination
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7340
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 - KQJ System, Fibrinogen Determination

All 27
Devices cleared under the same product code (KQJ) and FDA review panel - the closest regulatory comparables to K920258.
FIBRINOGEN RID TEST KIT
K922416 · The Binding Site, Ltd. · Mar 1993
MULTIFIBREN
K925988 · Behring Diagnostics, Inc. · Mar 1993
HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS
K923593 · International Technidyne Corp. · Sep 1992
SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.)
K900939 · Incstar Corp. · May 1990
COAG-A-MATE - RA4
K900895 · Organon Teknika Corp. · Apr 1990
FIBRINOGEN ASSAY KIT
K896052 · Medical Diagnostic Technologies, Inc. · Nov 1989