Cleared Traditional

K842683 - GENETIC SYS LEGIONELLA IMMUNOFLURORES

K842683 is the FDA 510(k) clearance for GENETIC SYS LEGIONELLA IMMUNOFLURORES by Genetic Systems Corp.. It is a Class 2 Immunology device (product code LHL) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K842683 · Genetic Systems Corp. · Immunology device
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Aug 1984
Decision
23d
Days
Class 2
Risk

K842683 is an FDA 510(k) clearance for the GENETIC SYS LEGIONELLA IMMUNOFLURORES. Classified as Reagents, Antibody, Legionella, Direct & Indirect Fluorescent (product code LHL), Class II - Special Controls.

Submitted by Genetic Systems Corp. (Mchenry, US). The FDA issued a Cleared decision on August 2, 1984 after a review of 23 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 Genetic Systems Corp. devices

Submission Details

510(k) Number K842683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1984
Decision Date August 02, 1984
Days to Decision 23 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 104d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Devices cleared under the same product code (LHL) and FDA review panel - the closest regulatory comparables to K842683.
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
POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO
K854108 · Medical Diagnostic Technologies, Inc. · Nov 1985