510(k) Report

FDA applicant

Advandx, Inc.

Woburn, MA21 decisions2006–20145 recalls

FDA records 21 decisions for Advandx, Inc. (Woburn, MA) from 2006 to 2014: 21 510(k) clearances. Most are in product codes JSS (Kit, Identification, Enterobacteriaceae) and OAH (Fish (Fluorescent In Situ Hybridization) Kit…). Its devices cite 1 predicate, 0 of them its own earlier devices. 5 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Advandx, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2008: 22009: 82010: 42012: 12013: 22014: 1
2007high 8 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2014

2010: 32013: 12014: 1
2007high 3 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Advandx, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Advandx, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JSSKit, Identification, Enterobacteriaceae7decisions
  • OAHFish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis4decisions
  • NXXFish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus…4decisions
  • NZSFish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast3decisions
  • JXBKit, Identification, Yeast2decisions
  • MYISystem, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K123418Gram-Negative Quickfish BCAdvandx, Inc. · 20131cites it
  • K060099S. Aureus Pna FishAdvandx, Inc. · 20061cites it

What has FDA decided for it lately?

  • K140619Meca XpressfishAdvandx, Inc. · 2014
  • K123418Gram-Negative Quickfish BCAdvandx, Inc. · 20131 recall
  • K121991Enterococcus Quickfish BCAdvandx, Inc. · 2013
  • K113371Staphylococcus Quickfish BCAdvandx, Inc. · 20121 recall
  • K101558GNR Traffic Light Pna FishAdvandx, Inc. · 2010
  • K093024Yeast Traffic Light Pna FishAdvandx, Inc. · 2010
  • K092784C. Albicans/C. Glabrata Pna FishAdvandx, Inc. · 2010
  • K092655C. Albicans Pna FishAdvandx, Inc. · 2010

All 21 as Advandx, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K113371AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic.…Jul 4, 2014Class II
  • K123418AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of…Dec 11, 2013Class III
  • K092393AdvanDx EK/P. aeruginosa PNA FISH- Culture Identification Kit for identification of E.…Oct 8, 2010
  • K092236AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for the diagnosis of…Oct 6, 2010
  • K083074E.faecalis/OE PNA FISH Intended Use: E. faecalis/OE PNA FISH" (Cat. No. KT003) is a…Jun 8, 2010