Advandx, Inc.: FDA clearances and approvals
Advandx, Inc. has 21 FDA 510(k) clearances (first 2006, latest 2014), across 6 product codes in 1 review panel. Median 510(k) review time: 183 days. openFDA lists 7 product recalls by a recalling firm named Advandx, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 139 |
| 2013 | 2 | 221 |
| 2014 | 1 | 213 |
| 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 |
|---|---|---|---|
| JSS | Kit, Identification, Enterobacteriaceae | 7 | 7 |
| NXX | Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus | 4 | 4 |
| OAH | Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis | 4 | 4 |
| NZS | Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast | 3 | 3 |
| JXB | Kit, Identification, Yeast | 2 | 2 |
| MYI | System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies | 1 | 1 |
Review panels
- Microbiology (21)
Most recent Advandx, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140619 | MECA XPRESSFISH | MYI | 2014-10-10 | 213 |
| K123418 | GRAM-NEGATIVE QUICKFISH BC | JSS | 2013-07-21 | 257 |
| K121991 | ENTEROCOCCUS QUICKFISH BC | OAH | 2013-01-07 | 185 |
| K113371 | STAPHYLOCOCCUS QUICKFISH BC | NXX | 2012-04-03 | 139 |
| K101558 | GNR TRAFFIC LIGHT PNA FISH | JSS | 2010-12-16 | 195 |
| K093024 | YEAST TRAFFIC LIGHT PNA FISH | NZS | 2010-07-15 | 289 |
| K092784 | C. ALBICANS/C. GLABRATA PNA FISH | NZS | 2010-03-12 | 183 |
| K092655 | C. ALBICANS PNA FISH | NZS | 2010-01-19 | 144 |
| K092236 | E.COLI/P. AERUGINOSA PNA FISH | JSS | 2009-12-16 | 146 |
| K092166 | S. AUREUS/CNS PNA FISH, MODEL KT005 | NXX | 2009-11-23 | 125 |
11 earlier clearances. See the full list in Caduvo.
Recalls
7 product recalls in 7 recall events; 0 initiated in the last five years. Most recent: 2014-07-04.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Advandx, Inc. have?
Advandx, Inc. has 21 FDA 510(k) clearances (first 2006, latest 2014), across 6 product codes in 1 review panel.
How long does FDA take to clear Advandx, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Advandx, Inc.'s cleared 510(k)s is 183 days.
What devices does Advandx, Inc. make?
Its most frequent FDA product codes are JSS (Kit, Identification, Enterobacteriaceae, 7); NXX (Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus, 4); OAH (Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis, 4).
Has Advandx, Inc. had device recalls?
openFDA lists 7 product recalls in 7 recall events by a recalling firm whose name matches Advandx, Inc; the most recent began 2014-07-04. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 21 Advandx, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JSS, Advandx, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.