The FDA required new testing measures for medical thawers when FreMon Scientific created ZipThaw, an advanced dry thawer. Old water baths didn’t have this level of scrutiny.
When evaluating ZipThaw at the San Diego Blood Bank, with the help of UC San Diego, ZipThaw cleared the new standards by a mile.
Dirty, sloppy water baths are out-of-date for more reasons than one.
The San Diego Blood Bank/UC San Diego 510(k) application results: ZipThaw preserves more coagulation factorsthan water baths.
- Study tested 197 samples and performed over 1,700 assays
- ZipThaw demonstrated a lower increase in mean TAT concentration (18%) compared to the standard water bath method (33%)
- ZipThaw is easy to use, light weight and precise