Cleared Traditional

K895765 - LEECO PREVIEW EBV (EIA)

K895765 is the FDA 510(k) clearance for LEECO PREVIEW EBV (EIA) by Leeco Diagnostics, Inc.. It is a Class 2 Immunology device (product code KTN) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K895765 · Leeco Diagnostics, Inc. · Immunology device
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Oct 1989
Decision
35d
Days
Class 2
Risk

K895765 is an FDA 510(k) clearance for the LEECO PREVIEW(R) EBV (EIA). Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Leeco Diagnostics, Inc. (Southfield, US). The FDA issued a Cleared decision on October 31, 1989 after a review of 35 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 Leeco Diagnostics, Inc. devices

Submission Details

510(k) Number K895765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1989
Decision Date October 31, 1989
Days to Decision 35 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
69d faster than avg
Panel avg: 104d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 25
Devices cleared under the same product code (KTN) and FDA review panel - the closest regulatory comparables to K895765.
MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX
K902541 · Trinity Laboratories, Inc. · Jun 1990
MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET
K900625 · Armkel, LLC · Feb 1990
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS
K896926 · Quidel Corp. · Jan 1990
DETECTADOT SYSTEM 2000 HETEROPHILE TEST
K895891 · Gull Laboratories, Inc. · Oct 1989
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST
K893737 · Quidel Corp. · Jun 1989
MONO-CUBE(TM)
K890991 · Difco Laboratories, Inc. · Mar 1989