510(k) Report

Devices descending from DEN200072

10 later devices reach Lumipulse G ß-Amyloid Ratio (1-42/1-40) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253240PrecivityAD2 TestC2N Diagnostics, LLC20260—
+1K242706Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioFujirebio Diagnostics,Inc.202517
+1K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc.20243Class I
+1K221842Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSFRoche Diagnostics20222—
+2K261447CVAC® Aspiration SystemCalyxo, Inc.20260—
+2K261686Elecsys Phospho-Tau (217P) PlasmaRoche Diagnostics20260—
+2K260965CVAC Aspiration SystemCalyxo, Inc.20260—
+2K260013CVAC Image ProcessorCalyxo, Inc.20260—
+2K252163Elecsys Phospho-Tau (181P) PlasmaRoche Diagnostics20250—
+2K231348Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSFRoche Diagnostics20230—