Advandx, Inc.
Canton, MA, US
Advandx, Inc. appears in FDA device records in Canton, MA. FDA records list 21 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 7 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 21 510(k) clearances for Advandx, Inc. between 2006 and 2014. The busiest year on record is 2009, with 8. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 3 |
| 2008 | 2 |
| 2009 | 8 |
| 2010 | 4 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K140619 | MECA XPRESSFISH | MYI | Substantially Equivalent | |
| K123418 | GRAM-NEGATIVE QUICKFISH BC | JSS | Substantially Equivalent | |
| K121991 | ENTEROCOCCUS QUICKFISH BC | OAH | Substantially Equivalent | |
| K113371 | STAPHYLOCOCCUS QUICKFISH BC | NXX | Substantially Equivalent | |
| K101558 | GNR TRAFFIC LIGHT PNA FISH | JSS | Substantially Equivalent | |
| K093024 | YEAST TRAFFIC LIGHT PNA FISH | NZS | Substantially Equivalent | |
| K092784 | C. ALBICANS/C. GLABRATA PNA FISH | NZS | Substantially Equivalent | |
| K092655 | C. ALBICANS PNA FISH | NZS | Substantially Equivalent | |
| K092236 | E.COLI/P. AERUGINOSA PNA FISH | JSS | Substantially Equivalent | |
| K092166 | S. AUREUS/CNS PNA FISH, MODEL KT005 | NXX | Substantially Equivalent | |
| K092393 | EK/P. AERUGINOSA PNA FISH | JSS | Substantially Equivalent | |
| K091827 | S. AUREUS PNA FISH | NXX | Substantially Equivalent | |
| K083074 | AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT | OAH | Substantially Equivalent | |
| K082068 | E. COLI PNA FISH | JSS | Substantially Equivalent | |
| K082612 | GBS PNA FISH | OAH | Substantially Equivalent | |
| K081433 | EK/P. AERUGINOSA PNA FISH | JSS | Substantially Equivalent | |
| K081309 | E.COLI/P. AERUGINOSA PNA FISH | JSS | Substantially Equivalent | |
| K080719 | YEAST TRAFFIC LIGHT PNA FISH | JXB | Substantially Equivalent | |
| K063127 | ENTEROCOCCUS FAECALIS PNA FISH | OAH | Substantially Equivalent | |
| K062461 | C. ALBICANS PNA FISH | JXB | Substantially Equivalent | |
| K060099 | S. AUREUS PNA FISH | NXX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- OAHFish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
- NXXFish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
- NZSFish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast
- JSSKit, Identification, Enterobacteriaceae
- JXBKit, Identification, Yeast
- MYISystem, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2138-2014 | AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50) | Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC | Class II | Terminated | |
| Z-0619-2014 | AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood cultures | Kits incompatible with certain fluorescence microscope light sources | Class III | Terminated | |
| Z-0112-2013 | AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa Catalog number: KT011. GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods observed on Gram stain. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. The GNR Traffic Light PNA FISH assay is indicated for use as an aid in the diagnosis of coli, and/or K. pneumoniae, and/or P. aeruginosa bacteremia. | GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva | Class II | Terminated | |
| Z-0116-2013 | AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007 Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears of positive blood cultures containing Gram-negative rods. The E.coli/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia. | Some strains of Pseudomonas putida cross-react with the P. aeruginosa PNA probe used in E. coli/P. aeruginosa PNA FISH (KT007) due to a sequence similarity resulting in a cross-reaction that may produce a red-positive signal | Class II | Terminated | |
| Z-0491-2011 | AdvanDx EK/P. aeruginosa PNA FISH- Culture Identification Kit for identification of E. coli and/or K. pneumoniae and P. aeruginosa bacteremia (In-Vitro Diagnostic) Catalog number: KT008 EK/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and/or Klebsiella pneumoniae and Pseudomonas aeruginosa on smears made from positive blood cultures containing Gram-negative rods. | Strains of Acinetobacter radioresistens cross-react with both E. coli/P. aeruginosa PNA FISH and EK /P. aeruginosa PNA FISH to produce a false positive red signal | Terminated | ||
| Z-0490-2011 | AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for the diagnosis of E. coli and/or P. aeruginosa bacteremia Catalog Number: KT007 | Strains of Acinetobacter radioresistens cross-react with both E. coli/P. aeruginosa PNA FISH and EK/P. aeruginosa PNA FISH to produce a false positive red signal. | Terminated | ||
| Z-2315-2010 | E.faecalis/OE PNA FISH Intended Use: E. faecalis/OE PNA FISH" (Cat. No. KT003) is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and selected other enterococci (OE) from blood cultures. E. faecalis/OE PNA FISH provides rapid identification of E. faecalis and selected other enterococci (OE) on smears made from positive blood cultures and is compatible with all major blood culture media | Some strains of streptococus anginosus cross-reach with E. faecalis/OE PNA FISH to produce a false positive green signal. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain