FDA product code OWF: Immunohistochemical Assay, Helicobacter Pylori
OWF is the FDA product code for immunohistochemical assay, helicobacter pylori. It is a Class I device, regulated under 21 CFR 866.3110 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under OWF. The average 510(k) review took 479 days (median 479). FDA has posted 2 recalls for OWF devices.
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
Classification
| Field | Value |
|---|---|
| Device name | Immunohistochemical Assay, Helicobacter Pylori |
| Device class | Class I |
| Regulation | 21 CFR 866.3110 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every OWF clearance
Top OWF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ventana Medical Systems, Inc. | 1 | 2011-08-25 |
Most recent OWF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K101234 | Ventana Medical Systems, Inc. | VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY | 2011-08-25 | 479 |
Recalls for OWF devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-08-02.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
Frequently asked questions
What is FDA product code OWF?
OWF is the FDA product code for immunohistochemical assay, helicobacter pylori. It is a Class I device, regulated under 21 CFR 866.3110 and reviewed by the Microbiology panel.
What device class is OWF?
Class I, regulation 21 CFR 866.3110. Typical premarket route: 510(k).
How long does a 510(k) take for product code OWF?
Across 1 cleared submissions the average was 479 days from receipt to decision (median 479).
Which companies have the most OWF clearances?
Ventana Medical Systems, Inc. (1).
Have OWF devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2018-08-02.
Next steps
- Run an FDA pathway report with predicate devices for product code OWF
- Run a recall and safety report across every OWF manufacturer
- Watch product code OWF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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