Cleared Traditional

PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794

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

About This 510(k) Submission

K023857 is an FDA 510(k) clearance for the PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794, 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 May 16, 2003, 177 days after receiving the submission on November 20, 2002. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3040.

Submission Details

510(k) Number K023857 FDA.gov
FDA Decision Cleared 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

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.