Cleared Traditional

K874195 - LA ANTIBODY TEST KIT

K874195 is the FDA 510(k) clearance for LA ANTIBODY TEST KIT by Lipogen, Inc.. It is a Class 2 Immunology device (product code LJM) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K874195 · Lipogen, Inc. · Immunology device
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Mar 1988
Decision
149d
Days
Class 2
Risk

K874195 is an FDA 510(k) clearance for the LA ANTIBODY TEST KIT. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Lipogen, Inc. (Knoxville, US). The FDA issued a Cleared decision on March 11, 1988 after a review of 149 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 Lipogen, Inc. devices

Submission Details

510(k) Number K874195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1987
Decision Date March 11, 1988
Days to Decision 149 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 104d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 39
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K874195.
HEMAGEN ENA [RNP/SM] KIT (EIA METHOD)
K915272 · Hemagen Diagnostics, Inc. · Mar 1992
ANTI-SCI-70 MICROASSAY
K902915 · Diamedix Corp. · Sep 1990
ANTI-SM MICROASSAY
K894894 · Diamedix Corp. · Aug 1989
ENZYME ANA TEST SYSTEM
K833148 · Immuno Concepts, Inc. · Nov 1983
HISTIMUNE ENZYME-ANA TEST
K822346 · Icl Scientific · Oct 1982