Cleared Traditional

K900625 - MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET

K900625 is an FDA 510(k) clearance for MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET, 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 18-day FDA review.

K900625 · Armkel, LLC · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1990
Decision
18d
Days
Class 2
Risk

K900625 is an FDA 510(k) clearance for the MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET. 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 February 26, 1990 after a review of 18 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 - K900625

510(k) Number K900625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1990
Decision Date February 26, 1990
Days to Decision 18 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
87d faster than avg
Panel avg: 105d · This submission: 18d
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 K900625.
ACCUTEX IM RBC TEST
K924037 · J.S. Medical Assoc. · Nov 1992
CARDS O.S. MONO
K902510 · Pacific Biotech, Inc. · Jul 1990
MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX
K902541 · Trinity Laboratories, Inc. · Jun 1990
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS
K896926 · Quidel Corp. · Jan 1990
LEECO PREVIEW(R) EBV (EIA)
K895765 · Leeco Diagnostics, Inc. · Oct 1989
DETECTADOT SYSTEM 2000 HETEROPHILE TEST
K895891 · Gull Laboratories, Inc. · Oct 1989