Cleared Traditional

K922416 - FIBRINOGEN RID TEST KIT

K922416 is the FDA 510(k) clearance for FIBRINOGEN RID TEST KIT by The Binding Site, Ltd.. It is a Class 2 Hematology device (product code KQJ) cleared through the Traditional 510(k) pathway after a 292-day FDA review.

K922416 · The Binding Site, Ltd. · Hematology device
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Mar 1993
Decision
292d
Days
Class 2
Risk

K922416 is an FDA 510(k) clearance for the FIBRINOGEN RID TEST KIT. Classified as System, Fibrinogen Determination (product code KQJ), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on March 9, 1993 after a review of 292 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 The Binding Site, Ltd. devices

Submission Details

510(k) Number K922416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1992
Decision Date March 09, 1993
Days to Decision 292 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
179d slower than avg
Panel avg: 113d · This submission: 292d
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 21
Devices cleared under the same product code (KQJ) and FDA review panel - the closest regulatory comparables to K922416.
SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)
K971858 · Sigma Diagnostics, Inc. · Oct 1997
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
HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS
K923593 · International Technidyne Corp. · Sep 1992
QBC FIBRINOGEN
K920258 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1992