Cleared Traditional

K981946 - CLEARVIEW IM

K981946 is an FDA 510(k) clearance for CLEARVIEW IM, manufactured by Unipath , Ltd.. The device is a Class 2 Immunology device with product code KTN cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K981946 · Unipath , Ltd. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
190d
Days
Class 2
Risk

K981946 is an FDA 510(k) clearance for the CLEARVIEW IM. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Unipath , Ltd. (Bedford, GB). The FDA issued a Cleared decision on December 10, 1998 after a review of 190 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 Unipath , Ltd. devices

FDA 510(k) Submission Details - K981946

510(k) Number K981946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1998
Decision Date December 10, 1998
Days to Decision 190 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 105d · This submission: 190d
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 42
Devices cleared under the same product code (KTN) and FDA review panel - the closest regulatory comparables to K981946.
BIORAPID MONONUCLEOSIS
K030215 · Instrumentation Laboratory CO · Feb 2003
COLOR-MONOGEN
K012901 · Instrumentation Laboratory CO · Sep 2001
DRYSPOT INFECTIOUS MONONUCLEOSIS KIT
K982634 · Oxoid , Ltd. · Jan 1999
MONOCOL/LEX-IM TEST
K972457 · Immunostics Inc., · Dec 1997
OSOM MONO TEST 143
K972231 · Wyntek Diagnostics, Inc. · Aug 1997
GENZYME DIAGNOSTICS CONTRAST MONO
K963425 · Genzyme Diagnostics · Feb 1997