Cleared Traditional

K791507 - AGGLUTINOTEST-RHEUMATOID ARTHRITIS

K791507 is an FDA 510(k) clearance for AGGLUTINOTEST-RHEUMATOID ARTHRITIS, manufactured by Volu Sol Medical Industries. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K791507 · Volu Sol Medical Industries · Immunology device
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Dec 1979
Decision
152d
Days
Class 2
Risk

K791507 is an FDA 510(k) clearance for the AGGLUTINOTEST-RHEUMATOID ARTHRITIS. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on December 31, 1979 after a review of 152 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Volu Sol Medical Industries devices

FDA 510(k) Submission Details - K791507

510(k) Number K791507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1979
Decision Date December 31, 1979
Days to Decision 152 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
47d slower than avg
Panel avg: 105d · This submission: 152d
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 111
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K791507.
AUTOMATED RHEMATOID FACTOR TEST (ARFT)
K800268 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1980
ANTI-GLOBULIN CONTROL
K792695 · Meridian Diagnostics, Inc. · Jan 1980
NORMAL GLOBULIN REAGENT
K792697 · Meridian Diagnostics, Inc. · Jan 1980
CORDIA RF
K792061 · Cordis Corp. · Nov 1979
RHEUMOGEN TEST SYSTEM
K790012 · Calbiochem-Behring Corp. · Jan 1979
QUANTROLS RF
K771940 · Organon, Inc. · Nov 1977