Cleared Traditional

K093678 - PLATELIA ASPERGILLUS EIA MODEL 62793 (FDA 510(k) Clearance)

Class I Microbiology device.

K093678 · Bio-Rad · Microbiology device
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Jan 2011
Decision
412d
Days
Class 1
Risk

K093678 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 January 13, 2011 after a review of 412 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

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Submission Details

510(k) Number K093678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2009
Decision Date January 13, 2011
Days to Decision 412 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
310d slower than avg
Panel avg: 102d · This submission: 412d
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.