Cleared Traditional

QBC FIBRINOGEN (K920258) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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 12
Devices cleared under the same product code (KQJ) and FDA review panel - the closest regulatory comparables to K920258.
MULTIFIBREN U
K934326 · Behring Diagnostics, Inc. · Apr 1994
IL TEST FIBRINOGEN-C
K931721 · Instrumentation Laboratory CO · Aug 1993
MULTIFIBREN
K925988 · Behring Diagnostics, Inc. · Mar 1993
FIBRINOGEN ASSAY KIT
K841020 · Helena Laboratories · May 1984
ACA FIBRINOGEN TEST PACK
K812629 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1981
LABCER FIBRINOGEN ASSAY KIT & CALIBR.
K812570 · Sherwood Medical Co. · Oct 1981