Cleared Traditional

K960987 - LIQUICHEK RHEUMATOID FACTOR CONTROL

K960987 is the FDA 510(k) clearance for LIQUICHEK RHEUMATOID FACTOR CONTROL by Bio-Rad. It is a Class 2 Immunology device (product code DHR) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K960987 · Bio-Rad · Immunology device
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Optimized for regulatory review, auditing and printing
Jun 1996
Decision
85d
Days
Class 2
Risk

K960987 is an FDA 510(k) clearance for the LIQUICHEK RHEUMATOID FACTOR CONTROL. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Bio-Rad (Anaheim, US). The FDA issued a Cleared decision on June 4, 1996 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5775 - 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 K960987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1996
Decision Date June 04, 1996
Days to Decision 85 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
19d faster than avg
Panel avg: 104d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHR System, Test, Rheumatoid Factor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5775
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 - DHR System, Test, Rheumatoid Factor

All 82
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K960987.
IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
K963048 · Beckman Instruments, Inc. · Nov 1996
HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)
K962836 · Hemagen Diagnostics, Inc. · Sep 1996
RHEUMATOID FACTOR LATEX SLIDE TEST KIT
K961169 · Randox Laboratories, Ltd. · Jun 1996
RF IGM ELISA TEST SYSTEM
K961277 · Zeus Scientific, Inc. · May 1996
HYTEC AUTOMIMMUNE KIT (RF)
K954892 · Hycor Biomedical, Inc. · Dec 1995
OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT
K953520 · Olympus America, Inc. · Aug 1995