Cleared Traditional

K946218 - MARDX ENA EIA TEST SYSTEM

K946218 is an FDA 510(k) clearance for MARDX ENA EIA TEST SYSTEM, manufactured by Hogan & Hartson. The device is a Class 2 Immunology device with product code LJM cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K946218 · Hogan & Hartson · Immunology device
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Optimized for regulatory review, auditing and printing
May 1995
Decision
145d
Days
Class 2
Risk

K946218 is an FDA 510(k) clearance for the MARDX ENA EIA TEST SYSTEM. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Hogan & Hartson (Washington, D.C., US). The FDA issued a Cleared decision on May 15, 1995 after a review of 145 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hogan & Hartson devices

FDA 510(k) Submission Details - K946218

510(k) Number K946218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1994
Decision Date May 15, 1995
Days to Decision 145 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 104d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJM Device Classification - Class 2, Special Controls

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 51
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K946218.
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K954380 · Inova Diagnostics, Inc. · Feb 1996
VARELISA ANA-4 SCREEN
K951186 · Elias U.S.A., Inc. · Apr 1995
VARELISA ANA PROFILE
K951205 · Elias U.S.A., Inc. · Apr 1995
VARELISA HISTONE ANTIBODIES
K951207 · Elias U.S.A., Inc. · Apr 1995