510(k) Report

Devices descending from K100130

4 later devices reach Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231974PATHFAST®hs-cTnI-IIPhc Corporation20242—
+1K130603Pathfast CTNL CalibratorsMitsubishi Chemical Medience Corporation20140—
+2K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20251—
+3K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc.20260—