510(k) Report

Devices descending from K000238

17 later devices reach HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900G through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243575ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsBiokit, S.A.20250—
+1K213987ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsBiokit, S.A.20230—
+1K181333ADVIA Centaur Herpes-1 IgGBiokit, S.A.20180—
+1K181334ADVIA Centaur Herpes-2 IgGBiokit, S.A.201801
+1K162276SeraQuest Herpes Type 1 Specific IgGQuest International, Inc.20160—
+1K143236Theranos Herpes Simplex Virus-1 IgG AssayTheranos, Inc.20150—
+1K131334Herpes Simplex Virus Type 1 Igg Elisa TestGold Standard Diagnostics20140—
+1K121895Elecsys HSV-2 Igg ImmunoassayRoche Diagnostics20121—
+1K120625Elecsys HSV-1 Igg Immunoassay Elecsys Precicontrol HSVRoche Diagnostics20121—
+1K093784Athena Multi-Lyte Torch Igg Plus Test SystemZeus Scientific, Inc.20100—
+1K090409Bioplex 2200 HSV-1 and HSV-2 Igg on the Bioplex 2200 Multi-Analyte Detection SystemBio-Rad Laboratories20091—
+1K081685Liaison HSV-1 Type Specific Igg Assay, Control HSV-1 IggDiaSorin, Inc.20080—
+1K081687Liaison HSV-2 Type Specific Igg Assay, Control HSV-2 IggDiaSorin, Inc.200801
+1K072178Athena Multi-Lyte HSV 1 & 2 Igg Test SystemZeus Scientific, Inc.20080—
+2K220923Elecsys HSV-1 IgG (08948844160)Roche Diagnostics20220—
+2K220924Elecsys HSV-2 IgG (08948887160)Roche Diagnostics20220—
+2K120959Bioplex 2200 HSV-1 and HSV-2 Igg KitBio-Rad Laboratories20120—