Cleared Traditional

K895997 - RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES

K895997 is an FDA 510(k) clearance for RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES, manufactured by Lipogen, Inc.. The device is a Class 2 Immunology device with product code LKO cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K895997 · Lipogen, Inc. · Immunology device
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Nov 1989
Decision
24d
Days
Class 2
Risk

K895997 is an FDA 510(k) clearance for the RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES. Classified as Anti-rnp Antibody, Antigen And Control (product code LKO), Class II - Special Controls.

Submitted by Lipogen, Inc. (Knoxville, US). The FDA issued a Cleared decision on November 6, 1989 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 Lipogen, Inc. devices

FDA 510(k) Submission Details - K895997

510(k) Number K895997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1989
Decision Date November 06, 1989
Days to Decision 24 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 105d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKO Device Classification - Class 2, Special Controls

Product Code LKO Anti-rnp 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 - LKO Anti-rnp Antibody, Antigen And Control

All 17
Devices cleared under the same product code (LKO) and FDA review panel - the closest regulatory comparables to K895997.
IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST
K911850 · General Biometrics, Inc. · May 1991
DIASTAT ANTI-LA (SS-B)
K905193 · Shield Diagnostics, Ltd. · Dec 1990
DIASTAT ANTI-RO (SS-A)
K905194 · Shield Diagnostics, Ltd. · Dec 1990
ANTI-RNP AND ANTI-SM ANTIBODY TEST
K895338 · Immco Diagnostics, Inc. · Oct 1989