Cleared Traditional

K893737 - DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOS...

K893737 is the FDA 510(k) clearance for DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOS... by Quidel Corp.. It is a Class 2 Immunology device (product code KTN) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K893737 · Quidel Corp. · Immunology device
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Jun 1989
Decision
30d
Days
Class 2
Risk

K893737 is an FDA 510(k) clearance for the DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on June 16, 1989 after a review of 30 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 Quidel Corp. devices

Submission Details

510(k) Number K893737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1989
Decision Date June 16, 1989
Days to Decision 30 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
74d faster than avg
Panel avg: 104d · This submission: 30d
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 19
Devices cleared under the same product code (KTN) and FDA review panel - the closest regulatory comparables to K893737.
IMMUNOCARD MONO
K930778 · Meridian Diagnostics, Inc. · Dec 1993
MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET
K900625 · Armkel, LLC · Feb 1990
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS
K896926 · Quidel Corp. · Jan 1990
MONO-CUBE(TM)
K890991 · Difco Laboratories, Inc. · Mar 1989
MODIFICATION OF MONO-PLUS(TM)
K883709 · Armkel, LLC · Dec 1988
OXOID INFECTIOUS MONONUCLEOSIS KIT
K883540 · Unipath , Ltd. · Oct 1988