BAYER ADVIA CENTAUR CA 19-9 ASSAY— 510(k) K031393

Clearance details

Applicant

Bayer Healthcare, LLC

Product code

Code NIG

Device class

Class 2

Regulation

21 CFR 866.6010

Advisory panel

Immunology

Date received

2003-05-02

Decision date

2003-06-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Tarrytown, NY, US

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Malfunction

618

Total

618

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-3100-2024 — Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10995490Class II·Ongoing·Siemens Healthcare Diagnostics, Inc.·20240726
• Z-3101-2024 — Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN:10995489Class II·Ongoing·Siemens Healthcare Diagnostics, Inc.·20240726
• Z-3102-2024 — Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 11206239Class II·Ongoing·Siemens Healthcare Diagnostics, Inc.·20240726
• Z-3103-2024 — ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10491379 SMN: 11206239Class II·Ongoing·Siemens Healthcare Diagnostics, Inc.·20240726
• Z-3104-2024 — ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10491244Class II·Ongoing·Siemens Healthcare Diagnostics, Inc.·20240726
• Z-0612-2017 — ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491379 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT instrument. Siemens stated that the assay is being marketed on the XPT following FDAs Reagent Replacement Policy. Siemens plans to request CLIA Categorization for the CA19-9 assay on XPT the week of 11/21/2016.Class II·Terminated·Siemens Healthcare Diagnostics, Inc·20161019
• Z-0613-2017 — ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491244 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT instrument. Siemens stated that the assay is being marketed on the XPT following FDAs Reagent Replacement Policy. Siemens plans to request CLIA Categorization for the CA19-9 assay on XPT the week of 11/21/2016.Class II·Terminated·Siemens Healthcare Diagnostics, Inc·20161019
• Z-0508-2013 — Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use The ADVIA Centaur CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas.Class II·Terminated·Siemens Healthcare Diagnostics, Inc·20121114

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031393.