Cleared Traditional

ANTI-ENA ANTIBODY TEST KIT (K920386) - FDA 510(k) Clearance

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

K920386 · Immco Diagnostics, Inc. · Immunology device
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Mar 1992
Decision
60d
Days
Class 2
Risk

K920386 is an FDA 510(k) clearance for the ANTI-ENA ANTIBODY TEST KIT. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on March 30, 1992 after a review of 60 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 Immco Diagnostics, Inc. devices

Submission Details

510(k) Number K920386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1992
Decision Date March 30, 1992
Days to Decision 60 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 104d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 56
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K920386.
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NOVA GEL(TM) T SM/RNP
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NOVA GEL(TM) T SS-A/SS-B
K896460 · Inova Diagnostics, Inc. · Nov 1989