510(k) Report

Devices descending from K994164

6 later devices reach Ontrak Teststik 2 for Cocaine/THC, Cat. 1118579 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033902Ontrak Testcup II and Onsite CupkitVarian, Inc.20045—
+2K060896Modification to Ontrak Testcup II and Onsite CupkitVarian, Inc.20064—
+3K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen…Chemtron Biotech, Inc.20162—
+3K143599Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000Chemtron Biotech, Inc.20150—
+4K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen…Chemtron Biotech, Inc.20231—
+5K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.20260—