Cleared Traditional

K854108 - POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO

K854108 is an FDA 510(k) clearance for POLYVALENT FLUORESCENT ANTIBODY REAGENT..., manufactured by Medical Diagnostic Technologies, Inc.. The device is a Class 2 Microbiology device with product code LHL cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K854108 · Medical Diagnostic Technologies, Inc. · Microbiology device
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Nov 1985
Decision
35d
Days
Class 2
Risk

K854108 is an FDA 510(k) clearance for the POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO. Classified as Reagents, Antibody, Legionella, Direct & Indirect Fluorescent (product code LHL), Class II - Special Controls.

Submitted by Medical Diagnostic Technologies, Inc. (Augusta, US). The FDA issued a Cleared decision on November 12, 1985 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3300 - the FDA microbiology 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 Medical Diagnostic Technologies, Inc. devices

FDA 510(k) Submission Details - K854108

510(k) Number K854108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1985
Decision Date November 12, 1985
Days to Decision 35 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 102d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHL Device Classification - Class 2, Special Controls

Product Code LHL Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3300
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 Microbiology devices follow this clearance model.

Regulatory Peers - LHL Reagents, Antibody, Legionella, Direct & Indirect Fluorescent

All 10
Devices cleared under the same product code (LHL) and FDA review panel - the closest regulatory comparables to K854108.
LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY
K921421 · Pro-Lab, Inc. · Jul 1992
DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT
K871328 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1987
LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST
K864006 · Medical Diagnostic Technologies, Inc. · Apr 1987
LEGIONELLA INDIRECT FLUORESCENT ANTIBOD
K832896 · Biodan Medical Systems, Ltd. · Oct 1983
LEGIONELLA PNEUMOPHILA
K822066 · Biodan Medical Systems, Ltd. · Sep 1982
LEGIONELLA DIRECT FLUORESCENT ANTIBODY
K812006 · Centers For Disease Control and Prevention · Sep 1981