Cleared Traditional

K972457 - MONOCOL/LEX-IM TEST

K972457 is an FDA 510(k) clearance for MONOCOL/LEX-IM TEST, manufactured by Immunostics Inc.,. The device is a Class 2 Immunology device with product code KTN cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K972457 · Immunostics Inc., · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
153d
Days
Class 2
Risk

K972457 is an FDA 510(k) clearance for the MONOCOL/LEX-IM TEST. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on December 1, 1997 after a review of 153 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Immunostics Inc., devices

FDA 510(k) Submission Details - K972457

510(k) Number K972457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1997
Decision Date December 01, 1997
Days to Decision 153 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
49d slower than avg
Panel avg: 104d · This submission: 153d
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 33
Devices cleared under the same product code (KTN) and FDA review panel - the closest regulatory comparables to K972457.
COLOR-MONOGEN
K012901 · Instrumentation Laboratory CO · Sep 2001
DRYSPOT INFECTIOUS MONONUCLEOSIS KIT
K982634 · Oxoid , Ltd. · Jan 1999
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