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510(k) K020828

CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM by Bayer Corp. — Product Code LTK

K020828 is an FDA 510(k) premarket notification submitted by Bayer Corp. for the device "CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM". The FDA issued a decision of Substantially Equivalent on July 24, 2002. The device falls under product code LTK (Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)), a Class II device regulated under 21 CFR 866.6010. Bayer Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2002
Date Received
March 14, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

Other clearances by Bayer Corp.

  • K024062 — ASCENSIA BREEZE BLOOD GLUCOSE METER (March 3, 2003)
  • K023944 — BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST (February 11, 2003)
  • K024017 — BAYER ADVIA CENTAUR HER-2/NEU ASSAY (January 30, 2003)
  • K024234 — ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL (January 23, 2003)
  • K022288 — COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED (December 17, 2002)
  • K023584 — ASCENSIA DEX 2 DIABETES CARE SYSTEM (November 20, 2002)
  • K021428 — CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM (July 5, 2002)
  • K020806 — ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY (March 27, 2002)
  • K013568 — CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (December 21, 2001)
  • K012337 — BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM (December 6, 2001)

Other clearances for product code LTK

  • K240479 — Access OV Monitor (May 10, 2024)
  • K213510 — IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA (September 8, 2023)
  • K221355 — VITROS Immuodiagnostic Products CA 125 II Reagent Pack (December 12, 2022)
  • K200199 — ADVIA Centaur CA 125II (April 6, 2020)
  • K143534 — Elecsys CA-125 II assay (August 6, 2015)
  • K142895 — LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULS (May 21, 2015)
  • K100321 — DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 C (April 12, 2011)
  • K080469 — VIDAS CA 15-3 ASSAY (June 22, 2009)
  • K080561 — VIDAS CA 125 II ASSAY (April 10, 2009)
  • K072794 — IMMULITE 2500 OM-MA, MODEL L5KOP (November 5, 2007)

FDA data resources