Cleared Traditional

PLATELIA ASPERGILLUS EIA MODEL 62793

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

About This 510(k) Submission

K093678 is an FDA 510(k) clearance for the PLATELIA ASPERGILLUS EIA MODEL 62793, a Antigen, Galactomannan, Aspergillus Spp. (Class I — General Controls, product code NOM), submitted by Bio-Rad (Redmond, US). The FDA issued a Cleared decision on January 13, 2011, 412 days after receiving the submission on November 27, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3040.

Submission Details

510(k) Number K093678 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code NOM — Antigen, Galactomannan, Aspergillus Spp.
Device Class Class I — 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.