Cleared Traditional

K791455 - AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS

K791455 is an FDA 510(k) clearance for AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS, manufactured by Volu Sol Medical Industries. The device is a Class 2 Immunology device with product code KTN cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K791455 · Volu Sol Medical Industries · Immunology device
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Dec 1979
Decision
147d
Days
Class 2
Risk

K791455 is an FDA 510(k) clearance for the AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS. Classified as System, Test, Infectious Mononucleosis (product code KTN), 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 147 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5640 - 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 - K791455

510(k) Number K791455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1979
Decision Date December 31, 1979
Days to Decision 147 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
42d slower than avg
Panel avg: 105d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTN Device Classification - Class 2, Special Controls

Product Code KTN System, Test, Infectious Mononucleosis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5640
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 - KTN System, Test, Infectious Mononucleosis

All 42
Devices cleared under the same product code (KTN) and FDA review panel - the closest regulatory comparables to K791455.
IM-CHECK
K834345 · Diagnostic Technology, Inc. · Feb 1984
SERO/TEX MONO TEST
K821386 · Texas Immunology, Inc. · Jul 1982
CORDIA IM
K812540 · Cordis Corp. · Sep 1981
MONOSTICON TEST
K771397 · Organon, Inc. · Aug 1977
TEST, MONO., CARD (MACRO-VUE)
K760040 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1976