Cleared Traditional

FIBRINOGEN ASSAY KIT (K896052) - FDA 510(k) Clearance

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

K896052 · Medical Diagnostic Technologies, Inc. · Hematology device
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Nov 1989
Decision
22d
Days
Class 2
Risk

K896052 is an FDA 510(k) clearance for the FIBRINOGEN ASSAY KIT. Classified as System, Fibrinogen Determination (product code KQJ), Class II - Special Controls.

Submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on November 9, 1989 after a review of 22 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 Medical Diagnostic Technologies, Inc. devices

Submission Details

510(k) Number K896052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1989
Decision Date November 09, 1989
Days to Decision 22 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 113d · This submission: 22d
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 10
Devices cleared under the same product code (KQJ) and FDA review panel - the closest regulatory comparables to K896052.
SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)
K971858 · Sigma Diagnostics, Inc. · Oct 1997
IL TEST FIBRINOGEN-C
K931721 · Instrumentation Laboratory CO · Aug 1993
QBC FIBRINOGEN
K920258 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1992
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