Cleared Traditional

K984478 - LIQUICHEK ANTI-SS-B CONTROL

K984478 is the FDA 510(k) clearance for LIQUICHEK ANTI-SS-B CONTROL by Bio-Rad. It is a Class 2 Immunology device (product code LKJ) cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K984478 · Bio-Rad · Immunology device
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Dec 1998
Decision
6d
Days
Class 2
Risk

K984478 is an FDA 510(k) clearance for the LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210. Classified as Antinuclear Antibody, Antigen, Control (product code LKJ), 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

Submission Details

510(k) Number K984478 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
98d faster than avg
Panel avg: 104d · This submission: 6d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LKJ Antinuclear Antibody, Antigen, 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 - LKJ Antinuclear Antibody, Antigen, Control

All 26
Devices cleared under the same product code (LKJ) and FDA review panel - the closest regulatory comparables to K984478.
LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209
K984470 · Bio-Rad · Dec 1998
LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205
K984473 · Bio-Rad · Dec 1998
LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212
K984475 · Bio-Rad · Dec 1998
HYTEC AUTOIMMUNE KIT (SS-A)
K954392 · Hycor Biomedical, Inc. · Dec 1995
HYTEC AUTOIMMUNE KITS (SS-B)
K954891 · Hycor Biomedical, Inc. · Dec 1995
SYNELISA CENP-B ANTIBODIES
K931255 · Elias U.S.A., Inc. · Sep 1993