Cleared Traditional

K862008 - MONO-LATEX (TM) SLIDE TEST

K862008 is an FDA 510(k) clearance for MONO-LATEX (TM) SLIDE TEST, manufactured by Armkel, LLC. The device is a Class 2 Immunology device with product code KTN cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K862008 · Armkel, LLC · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1986
Decision
37d
Days
Class 2
Risk

K862008 is an FDA 510(k) clearance for the MONO-LATEX (TM) SLIDE TEST. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on July 3, 1986 after a review of 37 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 Armkel, LLC devices

FDA 510(k) Submission Details - K862008

510(k) Number K862008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1986
Decision Date July 03, 1986
Days to Decision 37 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 105d · This submission: 37d
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 K862008.
DIFFERENTIAL I.M. SCREENING TEST
K873297 · Sclavo, Inc. · Dec 1987
VENTRESCREEN (TM) MONO
K872032 · Ventrex Laboratories, Inc. · Jun 1987
DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO
K864207 · Gamma Biologicals, Inc. · Dec 1986
GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS
K861016 · Gamma Biologicals, Inc. · Apr 1986
MONOSTICON UNI-DOT
K853388 · Organon, Inc. · Aug 1985
SERIES I/S INFECTIONS
K844289 · American Dade · Nov 1984