Cleared Traditional

K822859 - DIRECT FA CONJUGATE FOR LEGIONELLA SPP

K822859 is an FDA 510(k) clearance for DIRECT FA CONJUGATE FOR LEGIONELLA SPP, manufactured by Zeus Technologies. The device is a Class 2 Microbiology device with product code LHL cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K822859 · Zeus Technologies · Microbiology device
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Feb 1983
Decision
142d
Days
Class 2
Risk

K822859 is an FDA 510(k) clearance for the DIRECT FA CONJUGATE FOR LEGIONELLA SPP. Classified as Reagents, Antibody, Legionella, Direct & Indirect Fluorescent (product code LHL), Class II - Special Controls.

Submitted by Zeus Technologies (Mchenry, US). The FDA issued a Cleared decision on February 16, 1983 after a review of 142 days - within the typical 510(k) review window.

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 Zeus Technologies devices

FDA 510(k) Submission Details - K822859

510(k) Number K822859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1982
Decision Date February 16, 1983
Days to Decision 142 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 102d · This submission: 142d
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 11
Devices cleared under the same product code (LHL) and FDA review panel - the closest regulatory comparables to K822859.
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