Cleared Traditional

K864006 - LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST

K864006 is an FDA 510(k) clearance for LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN L..., 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 187-day FDA review.

K864006 · Medical Diagnostic Technologies, Inc. · Microbiology device
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Apr 1987
Decision
187d
Days
Class 2
Risk

K864006 is an FDA 510(k) clearance for the LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST. 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 April 20, 1987 after a review of 187 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Diagnostic Technologies, Inc. devices

FDA 510(k) Submission Details - K864006

510(k) Number K864006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1986
Decision Date April 20, 1987
Days to Decision 187 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
85d slower than avg
Panel avg: 102d · This submission: 187d
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 K864006.
LEGIONELLA IGG/IGM ELISA TEST SYSTEM
K963318 · Armkel, LLC · Mar 1997
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
POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO
K854108 · Medical Diagnostic Technologies, Inc. · Nov 1985
LEGIONELLA INDIRECT FLUORESCENT ANTIBOD
K832896 · Biodan Medical Systems, Ltd. · Oct 1983
LEGIONELLA PNEUMOPHILA
K822066 · Biodan Medical Systems, Ltd. · Sep 1982