510(k) · Cleared
ClearedAdditional Ims Assays for the Bayer Advia Ims System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · CZW Complement C3, Antigen, Antiserum, Control
Cleared on Nov 9, 1999 after a 155-day review. The FDA summary names its predicate without a number.
- Decided
- Nov 9, 1999
- Review
- 155 days
- Class
- Class II
- Product code
- CZW
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CZW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (8)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Dade Behring BNA Complement C3 method Named without a submission number | |
| * | — | Dade Behring BNA Complement C4 method Named without a submission number | |
| * | — | Dade Behring BNA Immunoglobulin A method Named without a submission number | |
| * | — | Dade Behring BNA Immunoglobulin G method Named without a submission number | |
| * | — | Dade Behring BNA Immunoglobulin M method Named without a submission number | |
| * | — | Dade Behring BNA Transferrin method Named without a submission number | |
| * | — | Bayer Immuno 1 Vancomycin method Named without a submission number | |
| * | — | Abbott TDx Valproic Acid method Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All CZW devicesCZW Complement C3, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CZW
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · CZW
Too few CZW 510(k)s in any year since 2007 to give a median.
Recalls per year · CZW
No recall names CZW since 2007.
Adverse event reports per year · CZW
2in 2024
MAUDE reports naming product code CZW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Bayer ADVIA IMS C3 assay is an in vitro diagnostic device intended to measure Complement C3 (C3) in human serum. Such measurements are used as an aid in the diagnosis and treatment of immunologic disorders. The Bayer ADVIA IMS C4 assay is an in vitro diagnostic device intended to measure Complement C4 (C4) in human serum. Such measurements are used as an aid in the diagnosis and treatment of immunologic disorders. The Bayer ADVIA IMS IgA assay is an…
Read the full statement (357 words)
The Bayer ADVIA IMS C3 assay is an in vitro diagnostic device intended to measure Complement C3 (C3) in human serum. Such measurements are used as an aid in the diagnosis and treatment of immunologic disorders.
The Bayer ADVIA IMS C4 assay is an in vitro diagnostic device intended to measure Complement C4 (C4) in human serum. Such measurements are used as an aid in the diagnosis and treatment of immunologic disorders.
The Bayer ADVIA IMS IgA assay is an in vitro diagnostic device intended to measure Immunoglobulin A (IgA) in human serum. Such measurements are used as an aid in the diagnosis and treatment of abnormal protein metabolism and the body’s inability to resist infectious agents.
The Bayer ADVIA IMS 1gG assay is an in vitro diagnostic device intended to measure Immunoglobulin G (IgG) in human serum. Such measurements are used as an aid in the diagnosis and treatment of autoimmune diseases, chronic or recurrent infections and abnormal protein metabolism.
The Bayer ADVIA IMS Immunoglobulin M (IgM) assay is an in vitro diagnostic device intended to measure IgM in human serum. Such measurements are used as an aid in the diagnosis and treatment of chronic or recurrent infections and abnormal protein metabolism.
The Bayer ADVIA IMS Transferrin assay is an in vitro diagnostic device intended to measure transferrin (TRF) in human serum. Such measurements are used as an aid in the diagnosis and treatment of malnutrition, chronic infection, acute hepatitis, polycythemia, pernicious anemia, and red blood cell disorders, such as iron deficiency anemia.
The Bayer ADVIA IMS Vancomycin assay is an in vitro diagnostic device intended to measure vancomycin, an antibiotic drug, in human serum. Measurements of vancomycin are used as an aid in the diagnosis and treatment of vancomycin overdose and in monitoring therapeutic levels of vancomycin to ensure appropriate therapy.
The Bayer ADVIA IMS Valproic Acid Assay is an in vitro diagnostic device intended to measure valproic acid, an anti-epileptic drug, in human serum. Measurements of valproic acid are used as an aid in the diagnosis and treatment of valproic acid overdose and in monitoring therapeutic levels of valproic acid to ensure appropriate therapy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991907 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991907: Additional Ims Assays for the Bayer Advia Ims System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991907
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026