K101234 is an FDA 510(k) clearance for the VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY. This device is classified as a Immunohistochemical Assay, Helicobacter Pylori (Class I - General Controls, product code OWF).
Submitted by Ventana Medical Systems, Inc. (Tucson, 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 FDA review panel. Regulated under 21 CFR 866.3110. 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.
| 510(k) Number | K101234 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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 |