Pearl Pathways is proud of employee Heidi Strunk, as she earned a publication in the RAPS online journal Regulatory Focus.  The full article can be found on (Login and Password required) and is entitled Types of In Vitro Diagnostics: Clearing Up the Confusion.”

By definition, all in vitro diagnostics (IVDs) for human use are medical devices. This is easily understood – however, IVD classification can become complicated with an abundance of acronyms. To clear up the confusion, this article considers six types of IVDs:

  •  Research Use Only (RUO)
  •  Investigational Use Only (IUO)
  •  Analyte-Specific Reagents (ASRs)
  •  Laboratory-Developed Tests (LDTs)
  •  Companion Diagnostic IVDs
  •  In Vitro Diagnostic Multivariate Index Assays (IVDMIAs)

There are a number of hurdles to bringing a new medical device to the market, but product classification does not have to be one of them. If you are involved in the development of IVDs, this is a must read article.

Read full article here on