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510(k) K012183

BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY by Bayer Diagnostics Corp. — Product Code LGD

K012183 is an FDA 510(k) premarket notification submitted by Bayer Diagnostics Corp. for the device "BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY". The FDA issued a decision of Substantially Equivalent on December 27, 2001. The device falls under product code LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Bayer Diagnostics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2001
Date Received
July 12, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Device Class
Class II
Regulation Number
866.3780
Review Panel
MI
Submission Type

Other clearances by Bayer Diagnostics Corp.

  • K033379 — BAYER SPECIAL CHEMISTRY CONTROLS (December 19, 2003)
  • K033380 — BAYER SPECIAL CHEMISTRY CALIBRATORS (December 16, 2003)
  • K033007 — BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM (November 14, 2003)
  • K031857 — ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY (September 4, 2003)
  • K022096 — URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (March 18, 2003)
  • K030452 — BAYER LIGAND PLUS 1, 2, 3 CONTROLS (March 3, 2003)
  • K023840 — ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 (January 7, 2003)
  • K023841 — AMMONIA ASSAY FOR THE ADVIA 1650 (December 24, 2002)
  • K022177 — PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (December 17, 2002)
  • K022329 — CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM (November 27, 2002)

Other clearances for product code LGD

  • K242022 — Access Toxo IgG (March 28, 2025)
  • K242095 — Access Toxo IgM II (October 11, 2024)
  • K233932 — Alinity i Toxo IgM (August 30, 2024)
  • K210596 — ARCHITECT Toxo IgG (May 19, 2022)
  • K162678 — Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl (June 23, 2017)
  • K142826 — ADVIA Centaur Toxoplasma M (Toxo M) (December 22, 2015)
  • K132234 — LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II (August 28, 2013)
  • K131441 — LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II (August 9, 2013)
  • K101946 — VIDAS TOXO IGG AVIDITY (May 18, 2011)
  • K102681 — ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) (May 4, 2011)

FDA data resources