510(k) Report

Devices descending from K990337

7 later devices reach Ontrak Testcup-5 M2K through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K994017Ontrak Testcup 5 M2K, Cat. 11 1850 1Roche Diagnostics Corp.20006—
+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—