Cleared Traditional

K963275 - RELISA ENA SINGLE WELL SCREEN ANTIBODY ...

K963275 is the FDA 510(k) clearance for RELISA ENA SINGLE WELL SCREEN ANTIBODY ... by Immuno Concepts, Inc.. It is a Class 2 Immunology device (product code LLL) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K963275 · Immuno Concepts, Inc. · Immunology device
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Sep 1996
Decision
24d
Days
Class 2
Risk

K963275 is an FDA 510(k) clearance for the RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Immuno Concepts, Inc. (Dallas, US). The FDA issued a Cleared decision on September 13, 1996 after a review of 24 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 Immuno Concepts, Inc. devices

Submission Details

510(k) Number K963275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1996
Decision Date September 13, 1996
Days to Decision 24 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 104d · This submission: 24d
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 117
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K963275.
HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY
K962727 · Hycor Biomedical, Inc. · Mar 1997
HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY
K962728 · Hycor Biomedical, Inc. · Mar 1997
HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY
K962731 · Hycor Biomedical, Inc. · Mar 1997
QUANTA LITE ENA 6 ELISA
K961913 · Inova Diagnostics, Inc. · Jul 1996
RELSIA SCL-70 ANTIBODY TEST SYSTEM
K955602 · Immuno Concepts, Inc. · Apr 1996
RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM
K955603 · Immuno Concepts, Inc. · Apr 1996