Cleared Traditional

K021394 - DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM

K021394 is the FDA 510(k) clearance for DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM by Diamedix Corp.. It is a Class 2 Immunology device (product code DHR) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K021394 · Diamedix Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
68d
Days
Class 2
Risk

K021394 is an FDA 510(k) clearance for the DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on July 9, 2002 after a review of 68 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 Diamedix Corp. devices

Submission Details

510(k) Number K021394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2002
Decision Date July 09, 2002
Days to Decision 68 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
36d faster than avg
Panel avg: 104d · This submission: 68d
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 72
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K021394.
MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
K032535 · Roche Diagnostics Corp. · Sep 2003
RHEUMATOID FACTOR (RF)
K024067 · Abbott Laboratories · Jan 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
ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01
K990587 · Bio-Rad · Apr 1999