Cleared Traditional

RHEUMATOID FACTOR (RF) (K024067) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K024067 · Abbott Laboratories · Immunology device
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Optimized for regulatory review, auditing and printing
Jan 2003
Decision
36d
Days
Class 2
Risk

K024067 is an FDA 510(k) clearance for the RHEUMATOID FACTOR (RF). Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on January 15, 2003 after a review of 36 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 Abbott Laboratories devices

Submission Details

510(k) Number K024067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2002
Decision Date January 15, 2003
Days to Decision 36 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
68d faster than avg
Panel avg: 104d · This submission: 36d
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 44
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K024067.
OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.
K060201 · Olympus America, Inc. · Jun 2006
ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM
K033802 · Zeus Scientific, Inc. · Feb 2004
MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
K032535 · Roche Diagnostics Corp. · Sep 2003
WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET
K020972 · Wako Chemicals USA, Inc. · Sep 2002
TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
K002609 · Roche Diagnostics Corp. · Sep 2000
COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II
K000534 · Roche Diagnostics Corp. · Apr 2000