Cleared Traditional

K922297 - INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST

K922297 is an FDA 510(k) clearance for INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY..., manufactured by Ampcor, Inc.. The device is a Class 2 Immunology device with product code KTN cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K922297 · Ampcor, Inc. · Immunology device
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Jul 1992
Decision
60d
Days
Class 2
Risk

K922297 is an FDA 510(k) clearance for the INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Ampcor, Inc. (Bridgeport, US). The FDA issued a Cleared decision on July 14, 1992 after a review of 60 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 Ampcor, Inc. devices

FDA 510(k) Submission Details - K922297

510(k) Number K922297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1992
Decision Date July 14, 1992
Days to Decision 60 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 105d · This submission: 60d
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 K922297.
EYE SPOT IM TEST
K932688 · J.S. Medical Assoc. · Sep 1993
ACCUTEX IM LATEX TEST
K932551 · J.S. Medical Assoc. · Aug 1993
ACCUTEX IM RBC TEST
K924037 · J.S. Medical Assoc. · Nov 1992
CARDS O.S. MONO
K902510 · Pacific Biotech, Inc. · Jul 1990
MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX
K902541 · Trinity Laboratories, Inc. · Jun 1990
MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET
K900625 · Armkel, LLC · Feb 1990