Cleared Traditional

VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY

K101234 · Ventana Medical Systems, Inc. · Microbiology
Aug 2011
Decision
479d
Days
Class 1
Risk

About This 510(k) Submission

K101234 is an FDA 510(k) clearance for the VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY, a Immunohistochemical Assay, Helicobacter Pylori (Class I — General Controls, product code OWF), submitted by Ventana Medical Systems, Inc. (Tucso, US). The FDA issued a Cleared decision on August 25, 2011, 479 days after receiving the submission on May 3, 2010. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K101234 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 2010
Decision Date August 25, 2011
Days to Decision 479 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code OWF — Immunohistochemical Assay, Helicobacter Pylori
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3110
Definition Anti-helicobacter Pylori Rabbit Monoclonal Primary Antibody Is Designed To Qualitatively Detect The Presence Of Helicobacter Pylori In Formalin-fixed, Paraffin-embedded Gastric Biopsy Tissue Via Light Microscopy. Immunohistochemical Staining With This Antibody Product May Aid In The Diagnosis Of Helicobacter Pylori Infection. This Product Should Be Interpreted By A Qualified Pathologist In Conjunction With Histological Examination, Relevant Clinical Information And Proper Controls. This Antibody Is Intended For In Vitro Diagnostic (ivd) Use