Cleared Traditional

K920221 - HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY

K920221 is an FDA 510(k) clearance for HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY, manufactured by Akers Research Corp.. The device is a Class 2 Immunology device with product code KTN cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K920221 · Akers Research Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
57d
Days
Class 2
Risk

K920221 is an FDA 510(k) clearance for the HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Akers Research Corp. (Thorofare, US). The FDA issued a Cleared decision on March 13, 1992 after a review of 57 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 Akers Research Corp. devices

FDA 510(k) Submission Details - K920221

510(k) Number K920221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1992
Decision Date March 13, 1992
Days to Decision 57 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 104d · This submission: 57d
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 35
Devices cleared under the same product code (KTN) and FDA review panel - the closest regulatory comparables to K920221.
CLEARVIEW IM
K981946 · Unipath , Ltd. · Dec 1998
BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB
K961024 · Princeton BioMeditech Corp. · Feb 1997
IMMUNOCARD MONO
K930778 · Meridian Diagnostics, Inc. · Dec 1993
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