Cleared Traditional

K935129 - RELISA ENA ANTIBODY SCREENING TEST SYSTEM

K935129 is an FDA 510(k) clearance for RELISA ENA ANTIBODY SCREENING TEST SYSTEM, manufactured by Immuno Concepts, Inc.. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K935129 · Immuno Concepts, Inc. · Immunology device
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Jan 1994
Decision
95d
Days
Class 2
Risk

K935129 is an FDA 510(k) clearance for the RELISA ENA ANTIBODY SCREENING TEST SYSTEM. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Immuno Concepts, Inc. (Sacramento, US). The FDA issued a Cleared decision on January 31, 1994 after a review of 95 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 Immuno Concepts, Inc. devices

FDA 510(k) Submission Details - K935129

510(k) Number K935129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1993
Decision Date January 31, 1994
Days to Decision 95 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
10d faster than avg
Panel avg: 105d · This submission: 95d
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 147
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K935129.
SYN ENA SCREEN (PIN PLATE)
K940229 · Elias U.S.A., Inc. · May 1994
ELIAS ENA SCREEN (MICROTITER PLATE)
K940622 · Elias U.S.A., Inc. · May 1994
HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)
K935828 · Hemagen Diagnostics, Inc. · Apr 1994
QUANTA LITE(TM) HISTONE ELISA
K934053 · Inova Diagnostics, Inc. · Dec 1993
DIASTAT ANTI-CENTROMERE KIT
K932877 · Shield Diagnostics, Ltd. · Oct 1993
SYNELISA JO-1 ANTIBODIES
K930281 · Elias U.S.A., Inc. · Apr 1993