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RE: UTAK Feedback Request - RUO Blank Matrix Labeling
Nov 10, 2025 07:58 PM
Thank you, Woody,
Analytical Chemistry uses UTAK controls exclusively as part of LDTs; we are responsible for qualifying these materials during our method validation. Perhaps there is concern with the FDA issuing a letter to UTAK regarding RUO products if it decides that UTAK’s marketing or package inserts imply diagnostic use for their products. In trying to read the tea leaves about what FDA might do in the future, I suppose I would prefer the second approach they list:
“General Biological Raw Material classification for biological matrices and General Laboratory Reagent classification for synthetic matrices”
Regarding the rest of their inquiry, see my responses below in red
• Whether a shift from IVD to non-diagnostic use would affect your use of our products. Not for Analytical Chemistry at SRL
• Whether RUO or General Biological Raw Material/General Laboratory Reagent classification would be preferable for your operations. Biological Raw Material/General Laboratory is preferrable
• Any regulatory or operational considerations on your side that we should be aware of. N/A
• The preferred channels through which you would like to be notified of future updates (e.g., point of contact). Please include nlaude@sonicreferencelab.com; nbhavsar@sonicreferencelab.com