510(k) Report

Devices descending from K973075

9 later devices reach Ontrak Teststik for Amphetamines, Ontrak Teststik for Cocaine, Ontrak Teststik… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K994164Ontrak Teststik 2 for Cocaine/THC, Cat. 1118579Roche Diagnostics Corp.20006—
+1K994165Ontrak Teststik 3 for Cocaine/Morphine/THC,Cat. 1118595Roche Diagnostics Corp.20000—
+1K994020Ontrak Teststik for PCP, Cat. 07 6654 2Roche Diagnostics Corp.20000—
+2K033902Ontrak Testcup II and Onsite CupkitVarian, Inc.20045—
+3K060896Modification to Ontrak Testcup II and Onsite CupkitVarian, Inc.20064—
+4K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen…Chemtron Biotech, Inc.20162—
+4K143599Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000Chemtron Biotech, Inc.20150—
+5K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen…Chemtron Biotech, Inc.20231—
+6K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.20260—