510(k) Report

Devices descending from K954418

25 later devices reach Intact Parathyroid Hormone (PTH) Immunoassay (Modification) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020217Acs:180 and Advia Centaur Ipth ImmunoassayBayer Diagnostics Corp.2002124
+1K992680Elecsys Parathyroid Hormone Test SystemRoche Diagnostics Corp.1999111
+2K132515Liaison N-Tact PTH Gen II, Control Set, Calibration VerifiersDiaSorin, Inc.20134—
+2K133124Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration…Siemens Healthcare Diagnostics, Inc.20135—
+2K132391Immulite 2000 Anti-TG AB Calibration Verification Material, Immulite 2000 Anti-Tpo AB…Siemens Helathcare Diagnostics, Inc.20130—
+2K070709Roche Elecsys PTH Test SystemRoche Diagnostics Corp.20072—
+2K063605ST Aia-Pack Intact PTH AssayTosoh Bioscience, Inc.20070—
+2K063232Architect Intact PTH Reagents, Calibrators (a-F) and Controls (Low, Medium, High)…Biokit, S.A.200734
+2K070391Elecsys PTH Test SystemRoche Diagnostics Corp.20070—
+2K061190Access Intact PTH and Calibrators, Models a 16972 and a 16953Beckman Coulter, Inc.200611
+3K231927Elecsys PTH , Elecsys PTH STATRoche Diagnostics20240—
+3K232791Access Intact PTHBeckman Coulter, Inc.202401
+3K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical Diagnostics20230—
+3K143687ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur…Siemens Healthcare Diagnostics, Inc.20150—
+3K141463Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration VerifiersDiaSorin, Inc.20143—
+3K141444Immulite 2000; Cortisol Calibration Verification Material, Folic Acid Calibration…Siemens Healthcare Diagnostics, Inc.20141—
+3K140818Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration…Siemens Healthcare Diagnostics, Inc.20143—
+3K121981Advia Centaur Inact Parathyroid Hormone (Ipth) AssaySiemens Healthcare Diagnostics201322
+4K182698LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration…DiaSorin, Inc.20181—
+4K173683LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN…DiaSorin, Inc.20180—
+4K143636IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin…Siemens Healthcare Diagnostics, Inc.20150—
+4K143352IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3…Siemens Healthcare Diagnostics, Inc.20140—
+4K133601Advia Centaur Intact Parathyroid Hormone (Ipth) AssaySiemens Healthcare Diagnostics, Inc.20141—
+5K213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusDiaSorin, Inc.202201
+5K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc.20170—