Cleared Traditional

K852237 - LEGIONELLA IMMUNOFLUORESCENT ANTIBODY T...

K852237 is the FDA 510(k) clearance for LEGIONELLA IMMUNOFLUORESCENT ANTIBODY T... by Genetic Systems Corp.. It is a Class 2 Microbiology device (product code LHL) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K852237 · Genetic Systems Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1985
Decision
92d
Days
Class 2
Risk

K852237 is an FDA 510(k) clearance for the LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT. Classified as Reagents, Antibody, Legionella, Direct & Indirect Fluorescent (product code LHL), Class II - Special Controls.

Submitted by Genetic Systems Corp. (Seattle, US). The FDA issued a Cleared decision on August 22, 1985 after a review of 92 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 Genetic Systems Corp. devices

Submission Details

510(k) Number K852237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1985
Decision Date August 22, 1985
Days to Decision 92 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 102d · This submission: 92d
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 Microbiology 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 K852237.
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