Cleared Traditional

K853144 - CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036

K853144 is an FDA 510(k) clearance for CARD THREE IM TEST ITEM #2035, manufactured by Preco, Inc.. The device is a Class 2 Immunology device with product code KTN cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K853144 · Preco, Inc. · Immunology device
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Oct 1985
Decision
79d
Days
Class 2
Risk

K853144 is an FDA 510(k) clearance for the CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Preco, Inc. (Oakland, US). The FDA issued a Cleared decision on October 16, 1985 after a review of 79 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 Preco, Inc. devices

FDA 510(k) Submission Details - K853144

510(k) Number K853144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1985
Decision Date October 16, 1985
Days to Decision 79 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 105d · This submission: 79d
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 43
Devices cleared under the same product code (KTN) and FDA review panel - the closest regulatory comparables to K853144.
DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO
K864207 · Gamma Biologicals, Inc. · Dec 1986
MONO-LATEX (TM) SLIDE TEST
K862008 · Armkel, LLC · Jul 1986
GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS
K861016 · Gamma Biologicals, Inc. · Apr 1986
MONOSTICON UNI-DOT
K853388 · Organon, Inc. · Aug 1985
SERIES I/S INFECTIONS
K844289 · American Dade · Nov 1984
LEAP MONO TEST KIT
K840822 · Cooper Biomedical, Inc. · Apr 1984