510(k) · Cleared
Recalled · Class I · 2018Ventana Anti-Helicobacter Pylori (SP48) Rabbit Monoclonal Primary Antibody
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ventana Medical Systems, Inc. · OWF Immunohistochemical Assay, Helicobacter Pylori
Cleared on Aug 25, 2011 as substantially equivalent to K052708 (Arj Medical, Inc., 2006) after a 479-day review. Its family tree reaches back 1 generation to 2006. 1 of the 2 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Aug 25, 2011
- Review
- 479 days
- Class
- Class I
- Product code
- OWF
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052708 (2006). No later device cites it as a predicate yet. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK052708 Pylo-PlusArj Medical, Inc. · 2006
- This deviceK101234 Ventana Anti-Helicobacter Pylori (SP48) Rabbit Monoclonal Primary…Ventana Medical Systems, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052708 | Pylo-Plus | Arj Medical, Inc. | 2006 | — |
| 0 (this device) | K101234 | Ventana Anti-Helicobacter Pylori (SP48) Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. | 2011 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052708 | Pylo-PlusSummary page 2…VENTANA anti-H. pyloni (SP48). COMPARISON OF VENTANA ANTI-HEUICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY TO PREDICATE DEVICE, PYLO-PLUS, K052708 PARAMETER PREDICATE DEVICE PROPOSED DEVICE PROPRIETARY… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 2, 2018 | Class I | Z-3010-2018 | Under Investigation by firm | Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All OWF devicesOWF Immunohistochemical Assay, Helicobacter Pylori: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OWF
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · OWF
Too few OWF 510(k)s in any year since 2007 to give a median.
Recalls per year · OWF
No recall names OWF since 2007.
Adverse event reports per year · OWF
No MAUDE report names OWF since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101234: Ventana Anti-Helicobacter Pylori (SP48) Rabbit Monoclonal Primary Antibody.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101234
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026