Cleared Traditional

K883540 - OXOID INFECTIOUS MONONUCLEOSIS KIT

K883540 is the FDA 510(k) clearance for OXOID INFECTIOUS MONONUCLEOSIS KIT by Unipath , Ltd.. It is a Class 2 Immunology device (product code KTN) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K883540 · Unipath , Ltd. · Immunology device
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Oct 1988
Decision
62d
Days
Class 2
Risk

K883540 is an FDA 510(k) clearance for the OXOID INFECTIOUS MONONUCLEOSIS KIT. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Unipath , Ltd. (Bedford Mk41 Oqg, GB). The FDA issued a Cleared decision on October 19, 1988 after a review of 62 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 Unipath , Ltd. devices

Submission Details

510(k) Number K883540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1988
Decision Date October 19, 1988
Days to Decision 62 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 faster than avg
Panel avg: 104d · This submission: 62d
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 K883540.
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST
K893737 · Quidel Corp. · Jun 1989
MONO-CUBE(TM)
K890991 · Difco Laboratories, Inc. · Mar 1989
MODIFICATION OF MONO-PLUS(TM)
K883709 · Armkel, LLC · Dec 1988
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