2006D-0347
  

  
 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC1
  



  

  
Submitter : 
  

  
Mr. Phil Ferraro
  

  
Date & Time: 
  

  
09/22/2006 08:09:11
  



  

  
Organization : 
  

  
self
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 As someone who has had a radical prostectomy for prostate cancer and an engineer involved in writing equipment specifications (not for medical devices) I would like to pass along a comment based on my observation. I beleive that the guidelines you produce for medical test equipment should specify a minimum level for the paramter they test. For example, when I have my PSA checked, the answer varies from lab to lab. The lab I have to use depends on my ionsurance company and I can't always get the same machine. Bacause my prostate was removed, I should have a zero PSA. However, machines can't measure zero, some machines can measure a minimum of 0.1 and others can measure 0.01. That's a big difference for me. The guideline you are producing should require a minimum level they are required to measure and they all should be consistent.