# K991907: Additional Ims Assays for the Bayer Advia Ims System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Nov 9, 1999 after 155 days
- Product code: CZW (Complement C3, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dade Behring BNA Complement C3 method: named in the summary without a submission number
- (no number) Dade Behring BNA Complement C4 method: named in the summary without a submission number
- (no number) Dade Behring BNA Immunoglobulin A method: named in the summary without a submission number
- (no number) Dade Behring BNA Immunoglobulin G method: named in the summary without a submission number
- (no number) Dade Behring BNA Immunoglobulin M method: named in the summary without a submission number
- (no number) Dade Behring BNA Transferrin method: named in the summary without a submission number
- (no number) Bayer Immuno 1 Vancomycin method: named in the summary without a submission number
- (no number) Abbott TDx Valproic Acid method: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K991907
Methodology: https://510kreport.com/methodology