Cleared Traditional

K853105 - IMMUNO-IM

K853105 is an FDA 510(k) clearance for IMMUNO-IM, manufactured by Immunostics Co., Inc.. The device is a Class 2 Immunology device with 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.

FDA 510(k) Submission Details - K853105

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 105d · This submission: 42d
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 58
Devices cleared under the same product code (KTN) and FDA review panel - the closest regulatory comparables to K853105.
MONOSTAR SYSTEM: IM LATEX TEST
K861452 · U.S. Health Resources Corp. · May 1986
GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS
K861016 · Gamma Biologicals, Inc. · Apr 1986
CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036
K853144 · Preco, Inc. · Oct 1985
MONOSTICON UNI-DOT
K853388 · Organon, Inc. · Aug 1985
SERIES I/S INFECTIONS
K844289 · American Dade · Nov 1984
MONO-TEC
K841863 · Medilab Corp. · Jun 1984
K853105 · IMMUNO-IM
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