Cleared Traditional

K895995 - RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBO...

K895995 is the FDA 510(k) clearance for RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBO... by Lipogen, Inc.. It is a Class 2 Immunology device (product code LJM) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K895995 · Lipogen, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
14d
Days
Class 2
Risk

K895995 is an FDA 510(k) clearance for the RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES. 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 October 27, 1989 after a review of 14 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 Lipogen, Inc. devices

Submission Details

510(k) Number K895995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1989
Decision Date October 27, 1989
Days to Decision 14 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 104d · This submission: 14d
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 K895995.
KALESTAD ANA MICROPLATE EIA
K924087 · Bio-Rad Laboratories, Inc. · Nov 1992
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