Cleared Traditional

K023857 - PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 (FDA 510(k) Clearance)

Class I Microbiology device.

K023857 · Bio-Rad · Microbiology device
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May 2003
Decision
177d
Days
Class 1
Risk

K023857 is an FDA 510(k) clearance for the PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794. 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 May 16, 2003 after a review of 177 days - an extended review 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: 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.

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Submission Details

510(k) Number K023857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2002
Decision Date May 16, 2003
Days to Decision 177 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
75d slower than avg
Panel avg: 102d · This submission: 177d
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.