Cleared Traditional

K935413 - ENA EIA TEST KIT

K935413 is an FDA 510(k) clearance for ENA EIA TEST KIT, manufactured by David A. Fuccillo, Ph.D.. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K935413 · David A. Fuccillo, Ph.D. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
205d
Days
Class 2
Risk

K935413 is an FDA 510(k) clearance for the ENA EIA TEST KIT. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by David A. Fuccillo, Ph.D. (Washington, D.C., US). The FDA issued a Cleared decision on June 2, 1994 after a review of 205 days - an extended review 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: 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 David A. Fuccillo, Ph.D. devices

FDA 510(k) Submission Details - K935413

510(k) Number K935413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1993
Decision Date June 02, 1994
Days to Decision 205 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
100d slower than avg
Panel avg: 105d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLL Device Classification - Class 2, Special Controls

Product Code LLL Extractable Antinuclear Antibody, Antigen And Control
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 - LLL Extractable Antinuclear Antibody, Antigen And Control

All 148
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K935413.
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