Cleared Traditional

K973464 - QUANTEX RF PLUS (LATEX

K973464 is the FDA 510(k) clearance for QUANTEX RF PLUS (LATEX by Instrumentation Laboratory CO. It is a Class 2 Immunology device (product code DHR) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K973464 · Instrumentation Laboratory CO · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
40d
Days
Class 2
Risk

K973464 is an FDA 510(k) clearance for the QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL). Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on October 22, 1997 after a review of 40 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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K973464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1997
Decision Date October 22, 1997
Days to Decision 40 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
64d faster than avg
Panel avg: 104d · This submission: 40d
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 67
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K973464.
QUANTA LITE RF IGG ELISA
K983083 · Inova Diagnostics, Inc. · Nov 1998
QUANTA LITE RF IGA ELISA
K983084 · Inova Diagnostics, Inc. · Nov 1998
DIAMEDIX IS-RF TEST SYSTEM
K974889 · Diamedix Corp. · Mar 1998
RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT
K972220 · Randox Laboratories, Ltd. · Sep 1997
ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT
K971602 · Beckman Instruments, Inc. · Jun 1997
QUANTA LITE RF IGM
K971614 · Inova Diagnostics, Inc. · Jun 1997