Cleared Traditional

K841020 - FIBRINOGEN ASSAY KIT

K841020 is an FDA 510(k) clearance for FIBRINOGEN ASSAY KIT, manufactured by Helena Laboratories. The device is a Class 2 Hematology device with product code KQJ cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K841020 · Helena Laboratories · Hematology device
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May 1984
Decision
51d
Days
Class 2
Risk

K841020 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 Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on May 2, 1984 after a review of 51 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 Helena Laboratories devices

FDA 510(k) Submission Details - K841020

510(k) Number K841020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1984
Decision Date May 02, 1984
Days to Decision 51 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
62d faster than avg
Panel avg: 113d · This submission: 51d
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 K841020.
FIBRINOGEN ASSAY KIT
K896052 · Medical Diagnostic Technologies, Inc. · Nov 1989
TURBOX FIBRINOGEN
K884179 · Unipath , Ltd. · Dec 1988
DIA FIBRIN
K841366 · Diatech, Inc. · Jun 1984
FIBRI-PREST AUTOMATE HA34
K840211 · Wellcome Diagnostics · Mar 1984
FIBRINOGEN TEST
K834571 · Diatech, Inc. · Feb 1984
ACA FIBRINOGEN TEST PACK
K812629 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1981