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510(k) K012777

ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS by Bayer Corp. — Product Code JZO

K012777 is an FDA 510(k) premarket notification submitted by Bayer Corp. for the device "ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS". The FDA issued a decision of Substantially Equivalent on October 22, 2001. The device falls under product code JZO (System, Test, Thyroid Autoantibody), a Class II device regulated under 21 CFR 866.5870. Bayer Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2001
Date Received
August 20, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Thyroid Autoantibody
Device Class
Class II
Regulation Number
866.5870
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)
  • K020828 — CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM (July 24, 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)

Other clearances for product code JZO

  • K250250 — ADVIA Centaur Anti-Thyroid Peroxidase II (October 17, 2025)
  • K240469 — Access TPO Antibody (August 9, 2024)
  • K213517 — Access Thyroglobulin Antibody II (September 26, 2023)
  • K222610 — Elecsys Anti-Tg (September 15, 2023)
  • K193313 — Elecsys Anti-TSHR (February 27, 2020)
  • K151799 — EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Contr (March 25, 2016)
  • K152061 — IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material (March 3, 2016)
  • K092229 — THYRETAIN TM TSI REPORTER BIOASSAY (May 18, 2010)
  • K090760 — THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-12 (September 3, 2009)
  • K083391 — THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY (May 21, 2009)

FDA data resources