Cleared Traditional

K060641 - PLATELIA ASPERGILLUS EIA, MODEL 62793 (FDA 510(k) Clearance)

Class I Microbiology device.

K060641 · Bio-Rad · Microbiology device
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Jun 2006
Decision
84d
Days
Class 1
Risk

K060641 is an FDA 510(k) clearance for the PLATELIA ASPERGILLUS EIA, MODEL 62793. Classified as Antigen, Galactomannan, Aspergillus Spp. (product code NOM), Class I - General Controls.

Submitted by Bio-Rad (Redmond, US). The FDA issued a Cleared decision on June 2, 2006 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3040 - 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.

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Submission Details

510(k) Number K060641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2006
Decision Date June 02, 2006
Days to Decision 84 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 102d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NOM Antigen, Galactomannan, Aspergillus Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3040
Definition The Platelia Aspergillus Eia Is An Immunoenzymatic Sandwich Microplate Assay For The Detection Of Aspergillus Galactomannan Antigen In Human Serum. It Is A Test Which, When Used In Conjunction With Other Diagnostic Procedures Such As Microbiological Culture, Histological Examination Of Biopsy Samples And Radiographic Evidence, Can Be Used As An Aid In The Diagnosis Of Invasive Aspergillosis.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.