Cleared Traditional

K143470 - Diazyme Fibrinogen Assay

K143470 is an FDA 510(k) clearance for Diazyme Fibrinogen Assay, manufactured by Diazyme Laboratories. The device is a Class 2 Hematology device with product code GIS cleared through the Traditional 510(k) pathway after a 422-day FDA review.

K143470 · Diazyme Laboratories · Hematology device
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Optimized for regulatory review, auditing and printing
Jan 2016
Decision
422d
Days
Class 2
Risk

K143470 is an FDA 510(k) clearance for the Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinog.... Classified as Test, Fibrinogen (product code GIS), Class II - Special Controls.

Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on January 31, 2016 after a review of 422 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Diazyme Laboratories devices

FDA 510(k) Submission Details - K143470

510(k) Number K143470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2014
Decision Date January 31, 2016
Days to Decision 422 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
309d slower than avg
Panel avg: 113d · This submission: 422d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GIS Device Classification - Class 2, Special Controls

Product Code GIS Test, Fibrinogen
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 - GIS Test, Fibrinogen

All 7
Devices cleared under the same product code (GIS) and FDA review panel - the closest regulatory comparables to K143470.
K-ASSAY FIBRINOGEN
K993482 · Kamiya Biomedical Co. · Dec 1999
QUANTITATIVE FIBRINOGEN ASSAY
K963902 · Ortho Diagnostic Systems, Inc. · Nov 1996
BIOMERIEUX HEMOLAB FIBRINOMAT
K925494 · Biomerieux Vitek, Inc. · May 1993
IL TEST PT FIBRINOGEN HS
K923921 · Instrumentation Laboratory CO · Oct 1992
FIBRINOGEN DETERMINATION KIT
K913061 · Sigma Diagnostics, Inc. · Oct 1991
KINETIC FIBRINOGEN ASSAY
K881150 · Bio/Data Corp. · Mar 1988