Cleared Traditional

K974889 - DIAMEDIX IS-RF TEST SYSTEM

K974889 is an FDA 510(k) clearance for DIAMEDIX IS-RF TEST SYSTEM, manufactured by Diamedix Corp.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K974889 · Diamedix Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
66d
Days
Class 2
Risk

K974889 is an FDA 510(k) clearance for the DIAMEDIX IS-RF 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 March 6, 1998 after a review of 66 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

FDA 510(k) Submission Details - K974889

510(k) Number K974889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1997
Decision Date March 06, 1998
Days to Decision 66 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
39d faster than avg
Panel avg: 105d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHR Device Classification - Class 2, Special Controls

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 110
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K974889.
QUANTA LITE RF IGG ELISA
K983083 · Inova Diagnostics, Inc. · Nov 1998
QUANTA LITE RF IGA ELISA
K983084 · Inova Diagnostics, Inc. · Nov 1998
COLOR-SLIDE RF
K981496 · Seradyn, Inc. · Jun 1998
RAPET RF
K974370 · Stanbio Laboratory · Feb 1998
RHEUMACOL RHEUMATOID FACTOR TEST
K972456 · Immunostics Inc., · Nov 1997
QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)
K973464 · Instrumentation Laboratory CO · Oct 1997