Cleared Traditional

K893737 - DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST

K893737 is an FDA 510(k) clearance for DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOS..., manufactured by Quidel Corp.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K893737

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
75d faster than avg
Panel avg: 105d · This submission: 30d
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 41
Devices cleared under the same product code (KTN) and FDA review panel - the closest regulatory comparables to K893737.
LEECO PREVIEW(R) EBV (EIA)
K895765 · Leeco Diagnostics, Inc. · Oct 1989
DETECTADOT SYSTEM 2000 HETEROPHILE TEST
K895891 · Gull Laboratories, Inc. · Oct 1989
IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST
K894975 · General Biometrics, Inc. · Sep 1989
MONO-CUBE(TM)
K890991 · Difco Laboratories, Inc. · Mar 1989
V-TREND TARGET IM TEST
K890041 · Texas Immunology, Inc. · Jan 1989
MODIFICATION OF MONO-PLUS(TM)
K883709 · Armkel, LLC · Dec 1988