# K101234: Ventana Anti-Helicobacter Pylori (SP48) Rabbit Monoclonal Primary Antibody

- Pathway: 510(k) (Traditional)
- Applicant: Ventana Medical Systems, Inc.
- Decided: Aug 25, 2011 after 479 days
- Product code: OWF (Immunohistochemical Assay, Helicobacter Pylori)
- Device class: 1
- Regulation: 21 CFR 866.3110
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K052708 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052708: Pylo-Plus, Arj Medical, Inc. (2006) Summary page 2.

## Recalls of this device
- Aug 2, 2018 · Class I · Z-3010-2018: Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.

## Indications for use
VENTANA anti-Helicobacter pylori (5P48) Rabbit Monoclonal Primary Antibody (VENTANA anti-H. pyloni (5P48)) is designed to qualitatively detect the presence of Helicobacterpyloriin formalin-fixed, paraffin-embedded gastric biopsy tissue via light microscopy. Inmmohistochemical staining with this antibody product may aid in the diagnosis of I-felicobacterpylori 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.

Source page: https://510kreport.com/device/K101234
Methodology: https://510kreport.com/methodology