Cleared Traditional

K830820 - LEGIONELLA DFA KIT I

K830820 is an FDA 510(k) clearance for LEGIONELLA DFA KIT I, manufactured by Bionetic Laboratory Products. The device is a Class 2 Immunology device with product code LHL cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K830820 · Bionetic Laboratory Products · Immunology device
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Jun 1983
Decision
85d
Days
Class 2
Risk

K830820 is an FDA 510(k) clearance for the LEGIONELLA DFA KIT I. Classified as Reagents, Antibody, Legionella, Direct & Indirect Fluorescent (product code LHL), Class II - Special Controls.

Submitted by Bionetic Laboratory Products (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3300 - 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 Bionetic Laboratory Products devices

FDA 510(k) Submission Details - K830820

510(k) Number K830820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1983
Decision Date June 08, 1983
Days to Decision 85 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 105d · This submission: 85d
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 Immunology devices follow this clearance model.

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

All 11
Devices cleared under the same product code (LHL) and FDA review panel - the closest regulatory comparables to K830820.
LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST
K864006 · Medical Diagnostic Technologies, Inc. · Apr 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
LEGIONELLA DIRECT FLUORESCENT ANTIBODY
K812006 · Centers For Disease Control and Prevention · Sep 1981
LEGIONELLA INDIRECT FLUOR. ANTIBODY
K812007 · Centers For Disease Control and Prevention · Sep 1981