Cleared Traditional

ENA PROFILE-6 ELISA TEST SYSTEM (K941409) - FDA 510(k) Clearance

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

K941409 · Zeus Scientific, Inc. · Immunology device
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Jun 1994
Decision
79d
Days
Class 2
Risk

K941409 is an FDA 510(k) clearance for the ENA PROFILE-6 ELISA TEST SYSTEM. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on June 10, 1994 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - the FDA immunology 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 Zeus Scientific, Inc. devices

Submission Details

510(k) Number K941409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1994
Decision Date June 10, 1994
Days to Decision 79 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 104d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 Immunology devices follow this clearance model.

Regulatory Peers - LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls

All 10
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K941409.
QUANTA LITE SSDNA
K954380 · Inova Diagnostics, Inc. · Feb 1996
RADIAS ANA SCREEN ENZYME IMMUNOASSAY
K941509 · Bio-Rad · Jun 1994
ENA SCREEN ELISA TEST SYSTEM
K941014 · Zeus Scientific, Inc. · Jun 1994
AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM
K933267 · Zeus Scientific, Inc. · Dec 1993