Cleared Traditional

K841366 - DIA FIBRIN

K841366 is an FDA 510(k) clearance for DIA FIBRIN, manufactured by Diatech, Inc.. The device is a Class 2 Hematology device with product code KQJ cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K841366 · Diatech, Inc. · Hematology device
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Jun 1984
Decision
60d
Days
Class 2
Risk

K841366 is an FDA 510(k) clearance for the DIA FIBRIN. Classified as System, Fibrinogen Determination (product code KQJ), Class II - Special Controls.

Submitted by Diatech, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 1, 1984 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Diatech, Inc. devices

FDA 510(k) Submission Details - K841366

510(k) Number K841366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1984
Decision Date June 01, 1984
Days to Decision 60 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 113d · This submission: 60d
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 K841366.
COAG-A-MATE - RA4
K900895 · Organon Teknika Corp. · Apr 1990
FIBRINOGEN ASSAY KIT
K896052 · Medical Diagnostic Technologies, Inc. · Nov 1989
TURBOX FIBRINOGEN
K884179 · Unipath , Ltd. · Dec 1988
FIBRINOGEN ASSAY KIT
K841020 · Helena Laboratories · May 1984
FIBRI-PREST AUTOMATE HA34
K840211 · Wellcome Diagnostics · Mar 1984
FIBRINOGEN TEST
K834571 · Diatech, Inc. · Feb 1984