Cleared Traditional

K872032 - VENTRESCREEN (TM) MONO

K872032 is the FDA 510(k) clearance for VENTRESCREEN (TM) MONO by Ventrex Laboratories, Inc.. It is a Class 2 Immunology device (product code KTN) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K872032 · Ventrex Laboratories, Inc. · Immunology device
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Jun 1987
Decision
33d
Days
Class 2
Risk

K872032 is an FDA 510(k) clearance for the VENTRESCREEN (TM) MONO. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Ventrex Laboratories, Inc. (Portland, US). The FDA issued a Cleared decision on June 29, 1987 after a review of 33 days - a notably fast clearance cycle.

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: 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 Ventrex Laboratories, Inc. devices

Submission Details

510(k) Number K872032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1987
Decision Date June 29, 1987
Days to Decision 33 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
71d faster than avg
Panel avg: 104d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 25
Devices cleared under the same product code (KTN) and FDA review panel - the closest regulatory comparables to K872032.
MODIFICATION OF MONO-PLUS(TM)
K883709 · Armkel, LLC · Dec 1988
OXOID INFECTIOUS MONONUCLEOSIS KIT
K883540 · Unipath , Ltd. · Oct 1988
DIFFERENTIAL I.M. SCREENING TEST
K873297 · Sclavo, Inc. · Dec 1987
MONO-LATEX (TM) SLIDE TEST
K862008 · Armkel, LLC · Jul 1986
MONOSTICON UNI-DOT
K853388 · Organon, Inc. · Aug 1985
SERIES I/S INFECTIONS
K844289 · American Dade · Nov 1984