Cleared Traditional

K984476 - LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207

K984476 is an FDA 510(k) clearance for LIQUICHEK ANTI-RNP CONTROL, manufactured by Bio-Rad. The device is a Class 2 Immunology device with product code LKO cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K984476 · Bio-Rad · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
6d
Days
Class 2
Risk

K984476 is an FDA 510(k) clearance for the LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207. Classified as Anti-rnp Antibody, Antigen And Control (product code LKO), Class II - Special Controls.

Submitted by Bio-Rad (Irvine, US). The FDA issued a Cleared decision on December 22, 1998 after a review of 6 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 Bio-Rad devices

FDA 510(k) Submission Details - K984476

510(k) Number K984476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1998
Decision Date December 22, 1998
Days to Decision 6 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
99d faster than avg
Panel avg: 105d · This submission: 6d
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 15
Devices cleared under the same product code (LKO) and FDA review panel - the closest regulatory comparables to K984476.
ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01
K083117 · Phadia US, Inc. · May 2009
VARELISA RNP ANTIBODIES
K993589 · Pharmacia & Upjohn Co. · Nov 1999
AUTOSTAT II ANTI-SM/RNP ELISA
K990624 · Cogent Diagnotics , Ltd. · Apr 1999
THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
K983465 · Zeus Scientific, Inc. · Nov 1998
ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY
K954831 · Orgentec · May 1996
HYTEC AUTOIMMUNE KITS (RNP)
K954897 · Hycor Biomedical, Inc. · Mar 1996