FDA Product Code LTK: Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
Leading manufacturers include Bayer Corp., Beckman Coulter, Inc. and Tosoh Medics, Inc..
26
Total
26
Cleared
209d
Avg days
1997
Since
Declining activity -
0 submissions in the last 2 years
vs 3 in the prior period
FDA 510(k) Cleared Test, Epithelial Ovarian Tumor-associated Antigen (ca125) Devices (Product Code LTK)
26 devices
Cleared
May 10, 2024
Access OV Monitor
Beckman Coulter, Inc.
Immunology
80d
Cleared
Sep 08, 2023
IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA
Siemens Healthcare Diagnostics Products, Ltd.
Immunology
675d
Cleared
Dec 12, 2022
VITROS Immuodiagnostic Products CA 125 II Reagent Pack
Ortho-Clinical Diagnostics
Immunology
216d
Cleared
Apr 06, 2020
ADVIA Centaur CA 125II
Siemens Healthcare Diagnostics, Inc.
Immunology
70d
Cleared
May 21, 2015
LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators
Fujirebio Diagnostics,Inc.
Immunology
230d
Cleared
Apr 12, 2011
DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604
Siemens Healthcare Diagnostics
Immunology
432d
Cleared
Jun 22, 2009
VIDAS CA 15-3 ASSAY
bioMerieux, Inc.
Immunology
487d
Cleared
Apr 10, 2009
VIDAS CA 125 II ASSAY
bioMerieux, Inc.
Immunology
407d
Cleared
Nov 19, 2004
ARCHITECT CA 125 II ASSAY
Fujirebio Diagnostics,Inc.
Immunology
49d
Cleared
May 02, 2003
ACCESS OV MONITOR ASSAY
Beckman Coulter, Inc.
Immunology
8d
Cleared
Dec 11, 2002
ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY
Beckman Coulter, Inc.
Immunology
44d
Cleared
Dec 06, 2002
ST AIA-PACK CA 125 ENZYME IMMUNOASSAY
Tosoh Medics, Inc.
Immunology
14d
Cleared
Jul 24, 2002
CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
Bayer Corp.
Immunology
132d
Cleared
Jun 03, 1999
AIA-PACK CA 125
Tosoh Medics, Inc.
Immunology
112d
Cleared
May 14, 1999
THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
Bayer Corp.
Immunology
205d
Cleared
May 14, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK
Ortho-Clinical Diagnostics, Inc.
Immunology
193d
Cleared
Oct 15, 1998
IMMULITE 2000 OM-MA MODEL L2KOP2
Diagnostic Products Corp.
Immunology
20d
Cleared
Sep 18, 1998
IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5
Diagnostic Products Corp.
Immunology
163d
Cleared
Mar 25, 1998
ELECSYS CA 125II ON THE ELECSYS 1010
Boehringer Mannheim Corp.
Immunology
61d
Cleared
Mar 18, 1998
ELECSYS CA 125 II
Boehringer Mannheim Corp.
Immunology
282d
Cleared
Nov 04, 1997
AXSYM CA 125
Abbott Laboratories
Immunology
393d
Cleared
Oct 31, 1997
CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
Bayer Corp.
Immunology
385d
About Product Code LTK - Regulatory Context
510(k) Submission Activity
26 total 510(k) submissions under product code LTK since 1997, with 26 receiving FDA clearance (average review time: 209 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.