Cleared Traditional

K965113 - N-ASSAY TIA FIBRINOGEN TEST KIT

K965113 is an FDA 510(k) clearance for N-ASSAY TIA FIBRINOGEN TEST KIT, manufactured by Crestat Diagnostics, Inc.. The device is a Class 2 Hematology device with product code KQJ cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K965113 · Crestat Diagnostics, Inc. · Hematology device
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Apr 1997
Decision
117d
Days
Class 2
Risk

K965113 is an FDA 510(k) clearance for the N-ASSAY TIA FIBRINOGEN TEST KIT. Classified as System, Fibrinogen Determination (product code KQJ), Class II - Special Controls.

Submitted by Crestat Diagnostics, Inc. (Weston, US). The FDA issued a Cleared decision on April 16, 1997 after a review of 117 days - within the typical 510(k) review window.

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 Crestat Diagnostics, Inc. devices

FDA 510(k) Submission Details - K965113

510(k) Number K965113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1996
Decision Date April 16, 1997
Days to Decision 117 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
4d slower than avg
Panel avg: 113d · This submission: 117d
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 K965113.
DADE THROMBIN REAGENT
K050928 · Dade Behring, Inc. · Jun 2005
SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)
K971858 · Sigma Diagnostics, Inc. · Oct 1997
FIF TM
K970189 · Panbio, Inc. · May 1997
MULTIFIBREN U
K934326 · Behring Diagnostics, Inc. · Apr 1994
IL TEST FIBRINOGEN-C
K931721 · Instrumentation Laboratory CO · Aug 1993
FIBRINOGEN RID TEST KIT
K922416 · The Binding Site, Ltd. · Mar 1993