Cleared Traditional

K852519 - DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE

K852519 is an FDA 510(k) clearance for DUPONT ACA FIBRIN DEGRADATION PROD CLOT..., manufactured by E.I. Dupont DE Nemours & Co., Inc.. The device is a Class 2 Hematology device with product code JCO cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K852519 · E.I. Dupont DE Nemours & Co., Inc. · Hematology device
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Aug 1985
Decision
56d
Days
Class 2
Risk

K852519 is an FDA 510(k) clearance for the DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE. Classified as Bothrops Atrox Reagent (product code JCO), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on August 12, 1985 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8100 - 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 E.I. Dupont DE Nemours & Co., Inc. devices

FDA 510(k) Submission Details - K852519

510(k) Number K852519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1985
Decision Date August 12, 1985
Days to Decision 56 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
57d faster than avg
Panel avg: 113d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JCO Device Classification - Class 2, Special Controls

Product Code JCO Bothrops Atrox Reagent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8100
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 - JCO Bothrops Atrox Reagent

Devices cleared under the same product code (JCO) and FDA review panel - the closest regulatory comparables to K852519.
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