8 Additional Assays for the Bayer Advia 1650 Chemistry System

• • Ongoing Z-1003-2024 FDA Class II ·initiated 15 Dec 2023 ·on shared 510(k) K992662

  Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K992662 ↗

FDA Product Code

MSJ

Device Class

Class I

Regulation

21 CFR Part 862.1475

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Estradiol Assay for the Technicon Immuno 1 System in-Vitro Diagnostic System

  Class I

  FDA 510(k) K951360 Active Cleared 2 May 1995

• Complexed Prostate Specific Antigen (Cpsa) Assay for the Bayer Advia Integrated Module System

  Class II

  FDA 510(k) K022288 Active Cleared 17 Dec 2002

• Clinitek Hcg Test Strips

  Class II

  FDA 510(k) K971209 Active Cleared 4 Apr 1997

• Bayer Diagnostics ACS:180 VB12, Bayer Diagnostics Advia Centaue VB12

  Class II

  FDA 510(k) K993571 Active Cleared 16 Dec 1999

• Glucometer Elite Xl Blood Glucose Meter

  Class II

  FDA 510(k) K990649 Active Cleared 9 Jul 1999

• Rbcfolate Assay for the Technicon Immuno 1 System

  Class II

  FDA 510(k) K954332 Active Cleared 24 Jan 1996

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