Cleared Traditional

K812007 - LEGIONELLA INDIRECT FLUOR. ANTIBODY (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K812007 · Centers For Disease Control and Prevention · Microbiology device
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Sep 1981
Decision
54d
Days
Class 2
Risk

K812007 is an FDA 510(k) clearance for the LEGIONELLA INDIRECT FLUOR. ANTIBODY. Classified as Reagents, Antibody, Legionella, Direct & Indirect Fluorescent (product code LHL), Class II - Special Controls.

Submitted by Centers For Disease Control and Prevention (Mchenry, US). The FDA issued a Cleared decision on September 8, 1981 after a review of 54 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 Centers For Disease Control and Prevention devices

Submission Details

510(k) Number K812007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1981
Decision Date September 08, 1981
Days to Decision 54 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 102d · This submission: 54d
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.