Cleared Traditional

K813339 - DIRECT FA CONJUGATE FOR LEGIONELLA SP

K813339 is the FDA 510(k) clearance for DIRECT FA CONJUGATE FOR LEGIONELLA SP by Springwood Microbiologicals. It is a Class 2 Microbiology device (product code LHL) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K813339 · Springwood Microbiologicals · Microbiology device
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Dec 1981
Decision
24d
Days
Class 2
Risk

K813339 is an FDA 510(k) clearance for the DIRECT FA CONJUGATE FOR LEGIONELLA SP. Classified as Reagents, Antibody, Legionella, Direct & Indirect Fluorescent (product code LHL), Class II - Special Controls.

Submitted by Springwood Microbiologicals (Mchenry, US). The FDA issued a Cleared decision on December 18, 1981 after a review of 24 days - a notably fast clearance 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: 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 Springwood Microbiologicals devices

Submission Details

510(k) Number K813339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1981
Decision Date December 18, 1981
Days to Decision 24 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 102d · This submission: 24d
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

All 8
Devices cleared under the same product code (LHL) and FDA review panel - the closest regulatory comparables to K813339.
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
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