Cleared Traditional

K972231 - OSOM MONO TEST 143

K972231 is an FDA 510(k) clearance for OSOM MONO TEST 143, manufactured by Wyntek Diagnostics, Inc.. The device is a Class 2 Immunology device with product code KTN cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K972231 · Wyntek Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
71d
Days
Class 2
Risk

K972231 is an FDA 510(k) clearance for the OSOM MONO TEST 143. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Wyntek Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on August 26, 1997 after a review of 71 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 Wyntek Diagnostics, Inc. devices

FDA 510(k) Submission Details - K972231

510(k) Number K972231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1997
Decision Date August 26, 1997
Days to Decision 71 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 105d · This submission: 71d
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 K972231.
DRYSPOT INFECTIOUS MONONUCLEOSIS KIT
K982634 · Oxoid , Ltd. · Jan 1999
CLEARVIEW IM
K981946 · Unipath , Ltd. · Dec 1998
MONOCOL/LEX-IM TEST
K972457 · Immunostics Inc., · Dec 1997
BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB
K961024 · Princeton BioMeditech Corp. · Feb 1997
QUALITROL MONO CONTROL SERUM SET
K961550 · Consolidated Technologies, Inc. · Sep 1996
IMMUNOCARD MONO
K930778 · Meridian Diagnostics, Inc. · Dec 1993