Cleared Traditional

K853105 - IMMUNO-IM

K853105 is the FDA 510(k) clearance for IMMUNO-IM by Immunostics Co., Inc.. It is a Class 2 Immunology device (product code KTN) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K853105 · Immunostics Co., Inc. · Immunology device
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Sep 1985
Decision
42d
Days
Class 2
Risk

K853105 is an FDA 510(k) clearance for the IMMUNO-IM. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Immunostics Co., Inc. (Metuchen, US). The FDA issued a Cleared decision on September 3, 1985 after a review of 42 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 Immunostics Co., Inc. devices

Submission Details

510(k) Number K853105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1985
Decision Date September 03, 1985
Days to Decision 42 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 104d · This submission: 42d
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 26
Devices cleared under the same product code (KTN) and FDA review panel - the closest regulatory comparables to K853105.
DIFFERENTIAL I.M. SCREENING TEST
K873297 · Sclavo, Inc. · Dec 1987
VENTRESCREEN (TM) MONO
K872032 · Ventrex Laboratories, Inc. · Jun 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
CORDIA IM
K812540 · Cordis Corp. · Sep 1981