Cleared Traditional

K771940 - QUANTROLS RF

K771940 is the FDA 510(k) clearance for QUANTROLS RF by Organon, Inc.. It is a Class 2 Immunology device (product code DHR) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K771940 · Organon, Inc. · Immunology device
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Nov 1977
Decision
16d
Days
Class 2
Risk

K771940 is an FDA 510(k) clearance for the QUANTROLS RF. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Organon, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 2, 1977 after a review of 16 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 Organon, Inc. devices

Submission Details

510(k) Number K771940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1977
Decision Date November 02, 1977
Days to Decision 16 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 104d · This submission: 16d
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 84
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K771940.
AGGLUTINOTEST-RHEUMATOID ARTHRITIS
K791507 · Volu Sol Medical Industries · Dec 1979
CORDIA RF
K792061 · Cordis Corp. · Nov 1979
RHEUMOGEN TEST SYSTEM
K790012 · Calbiochem-Behring Corp. · Jan 1979
RHEUMANOSTICON R
K771410 · Organon, Inc. · Sep 1977
LAS-R RHEUMATOID FACTOR TEST
K771552 · Hyland Therapeutic Div., Travenol Laboratories · Aug 1977
TEST, RHEUM. ARTH., CARD (MACRO-VUE)
K760043 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1976