Gen-Probe Prodesse, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Gen-Probe Prodesse, Inc.” (first 2010, latest 2013), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 36 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Hologic, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 7 | 34 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 4 | 4 |
| OEM | Human Metapneumovirus (Hmpv) Rna Assay System | 2 | 2 |
| OQW | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification | 2 | 2 |
| OOU | Parainfluenza Multiplex Nucleic Acid Assay | 1 | 1 |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 1 | 1 |
Review panels
- Microbiology (10)
Most recent Gen-Probe Prodesse, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K132238 | PROPARAFLU+ ASSAY | OOU | 2013-08-26 | 39 |
| K132237 | PRODESSE PROFAST+ ASSAY | OQW | 2013-08-26 | 39 |
| K132200 | PRO HMPV+ ASSAY | OEM | 2013-08-14 | 29 |
| K132159 | PROADENO+ ASSAY | OCC | 2013-08-14 | 33 |
| K132129 | PRODESSE PROFLU+ ASSAY | OCC | 2013-08-09 | 30 |
| K123838 | PRO HMPV+ ASSAY | OEM | 2013-01-16 | 34 |
| K123274 | PROGASTRO SSCS ASSAY | PCH | 2013-01-16 | 89 |
| K110968 | PROFLU+ ASSAY | OCC | 2011-06-27 | 82 |
| K102952 | PRODESSE PROADENO | OCC | 2010-12-03 | 59 |
| K101855 | PROFAST+ ASSAY | OQW | 2010-07-23 | 22 |
Recalls
openFDA lists no recalls under a recalling firm named Gen-Probe Prodesse, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Gen-Probe Prodesse, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Gen-Probe Prodesse, Inc.” (first 2010, latest 2013), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Gen-Probe Prodesse, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gen-Probe Prodesse, Inc. is 36 days.
Which FDA product codes appear under Gen-Probe Prodesse, Inc.?
The most frequent FDA product codes under this applicant name are OCC (Respiratory Virus Panel Nucleic Acid Assay System, 4); OEM (Human Metapneumovirus (Hmpv) Rna Assay System, 2); OQW (2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification, 2).
Next steps
- See all 10 Gen-Probe Prodesse, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OCC, Gen-Probe Prodesse, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.