| Trade Name | VYSIS ALK BREAK APART FISH PROBE KIT |
| Generic Name | |
| Applicant | ABBOTT MOLECULAR, INC. |
| PMA Number | P110012 |
| Recent Supplement Number | S002 |
| Contact | 1300 EAST TOUHY AVENUE DES PLAINES, IL, 60018 |
| Date Received | Nov 27, 2012 |
| Decision Date | Dec 26, 2012 |
| Product Code | OWE |
| Advisory Committee | IM |
| Supplement Type | 30-DAY NOTICE |
| Supplement Reason | PROCESS CHANGE: MANUFACTURING |
| Expedited Review Granted? | N |
| Order Approval Statement | QUALIFY THE GENEPREP INSTRUMENT, QUALIFY THE OVERHEAD MIXING SYSTEM AND VALIDATE THE MIXING PROCESS IN THE MANUFACTURE OF THE HYBRIDIZATION BUFFER, AND TRANSFER AN EXISTING IN-PROCESS TESTING OF LABELED DNA. |
| source | fda.gov |
| # | Decision Date | Reason/Type | Change |
|---|---|---|---|
| S001 | Jun 07, 2012 | PROCESS CHANGE: MANUFACTURING/135 REVIEW TRACK FOR 30-DAY NOTICE | APPROVAL FOR ADDITION OF AN ALTERNATE SUPPLIER FOR THE HUMAN PLACENTAL (HP) DNA COMPONENT FOR THE DEVICE, PER DESIGN VERIFICATION PROTOCOL MD17892. |
| Aug 26, 2011 | Original Approval | APPROVAL FOR THE VYSIS ALK BREAK APART FISH PROBE KIT; VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT; PROBECHEK ALK NEGATIVE CONTROL SLIDES; AND PROBECHEK ALK POSITIVE CONTROL SLIDES. THIS DEVICE IS INDICATED FOR: THE VYSIS ALK BREAK APART FISH PROBE KIT IS A QUALITATIVE TEST TO DETECT REARRANGEMENTS INVOLVING THE ALK GENE VIA FLUORESCENCE IN SITU HYBRIDIZATION (FISH) IN FORMALIN-FIXED PARAFFIN -EMBEDDED (FFPE) NON-SMALL CELL LUNG CANCER (NSCLC) TISSUE SPECIMENS TO AID IN IDENTIFYING THOSE PATIENTS ELIGIBLE FOR TREATMENT WITH XALKORI CRIZOTINIB). THE TEST IS FOR PRESCRIPTION USE ONLY. THE VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT IS USED TO PREPARE PARAFFIN-EMBEDDED LUNG CANCER TISSUE SECTIONS FIXED ON POSITIVELY CHARGED SLIDES FOR USE IN FLUORESCENCE IN SITU HYBRIDIZATION (FISH) WITH VYSIS DNA FISH PROBES. THE PROBECHEK ALK NEGATIVE CONTROL SLIDES ARE INTENDED FOR USE AS AN ASSAY CONTROL FOR APPROPRIATE HYBRIDIZATION CONDITIONS DURING ROUTINE USE OF THE VYSIS ALK BREAK APART FISH PROBE KIT (LIST NO. 06N38-020). THE PROBECHEK ALK NEGATIVE CONTROL SLIDES SHOULD BE ASSAYED IN CONJUNCTION WITH THE USER'S SPECIMEN SLIDES ACCORDING THE PACKAGE INSERT FOR THE VYSIS ALK BREAK APART FISH PROBE KIT (LIST NO. 06N38-020). THE PROBECHEK ALK POSITIVE CONTROL SLIDES ARE INTENDED FOR USE AS AN ASSAY CONTROL FOR APPROPRIATE HYBRIDIZATION CONDITIONS DURING ROUTINE USE OF THE VYSIS ALK BREAK APART FISH PROBE KIT (LIST NO. 06N38-020). THE PROBECHEK ALK POSITIVE CONTROL SLIDES SHOULD BE ASSAYED IN CONJUNCTION WITH THE USER'S SPECIMEN SLIDES ACCORDING THE PACKAGE INSERT FOR THE VYSIS ALK BREAK APART FISH PROBE KIT (LIST NO. 06N38-020). |