Cleared Traditional

K790012 - RHEUMOGEN TEST SYSTEM

K790012 is the FDA 510(k) clearance for RHEUMOGEN TEST SYSTEM by Calbiochem-Behring Corp.. It is a Class 2 Immunology device (product code DHR) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K790012 · Calbiochem-Behring Corp. · Immunology device
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Jan 1979
Decision
24d
Days
Class 2
Risk

K790012 is an FDA 510(k) clearance for the RHEUMOGEN TEST SYSTEM. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Calbiochem-Behring Corp. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1979 after a review of 24 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 Calbiochem-Behring Corp. devices

Submission Details

510(k) Number K790012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1979
Decision Date January 26, 1979
Days to Decision 24 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
80d faster than avg
Panel avg: 104d · This submission: 24d
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 K790012.
NORMAL GLOBULIN REAGENT
K792697 · Meridian Diagnostics, Inc. · Jan 1980
AGGLUTINOTEST-RHEUMATOID ARTHRITIS
K791507 · Volu Sol Medical Industries · Dec 1979
CORDIA RF
K792061 · Cordis Corp. · Nov 1979
QUANTROLS RF
K771940 · Organon, Inc. · Nov 1977
RHEUMANOSTICON R
K771410 · Organon, Inc. · Sep 1977
LAS-R RHEUMATOID FACTOR TEST
K771552 · Hyland Therapeutic Div., Travenol Laboratories · Aug 1977