# K991817: Additional Ims Assays for the Bayer Advia Ims System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Jul 22, 1999 after 56 days
- Product code: CIJ (Saccharogenic, Amylase)
- Device class: 2
- Regulation: 21 CFR 862.1070
- 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) Bayer RA-XT Amylase method: named in the summary without a submission number
- (no number) Immuno 1 Cortisol assay: named in the summary without a submission number
- (no number) Technicon CHEM 1 Iron-II method: named in the summary without a submission number
- (no number) Technicon Immuno 1 method: named in the summary without a submission number
- (no number) Bayer Immuno 1 FREE T4 Assay: named in the summary without a submission number
- (no number) Bayer Immuno 1 T3 Assay: named in the summary without a submission number
- (no number) Bayer Immuno 1 Free T3 Assay: named in the summary without a submission number
- (no number) Bayer Immuno 1 T-Uptake Assay: named in the summary without a submission number
- (no number) Technicon CHEM 1 Urea Nitrogen: named in the summary without a submission number

## Indications for use
The Bayer ADVIA IMS Amylase assay is an in vitro diagnostic device intended to measure amylase activity in human serum, plasma or urine. Such measurements are used as an aid primarily in the diagnosis and treatment of pancreatitis (inflammation of the pancreas). The Bayer ADVIA IMS Cortisol assay is an in vitro diagnostic device intended to quantitatively measure cortisol in human serum. Measurements of cortisol are used as an aid in the diagnosis and treatment of disorders of the adrenal gland. The Bayer ADVIA IMS Iron assay is an in vitro diagnostic device intended to measure iron in human serum or plasma: Measurements of iron are used as an aid in the diagnosis, monitoring and treatment of a variety of diseases including iron deficiency anemias, hemochromatosis, hemosiderosis from excessive iron intake, and hemolytic anemias. The Bayer ADVIA IMS Thyroxine assay is an in vitro diagnostic device intended to measure thyroxine (T4), both protein bound and free, in human serum and plasma. Measurements of T4 are used as an aid in the diagnosis and treatment of thyroid diseases. The Bayer ADVIA IMS Free Thyroxine (FT4) assay is an in vitro diagnostic device intended to quantitatively measure free thyroxine in human serum. Measurements of free thyroxine in conjunction with other thyroid tests and clinical indicators are used as an aid in the diagnostic discrimination and assessment of thyroid diseases. The Bayer ADVIA IMS Triiodothyronine (T3) assay is an in vitro diagnostic device intended to quantitatively measure triiodothyronine (T3) in human serum. Measurements of triiodothyronine, in conjunction with other thyroid tests and clinical indicators, are used as an aid in the diagnostic discrimination and assessment of thyroid diseases. The Bayer ADVIA IMS Free Triiodothyronine (FT3) assay is an in vitro diagnostic device intended to quantitatively measure free triiodothyronine in human serum. Measurements of free triiodothyronine, in conjunction with other first-line thyroid tests such as Thyroid Stimulating Hormone (TSH) and Free Thyroxine (Free T4), as well as other clinical indicators, are used as an aid in the diagnostic discrimination and assessment of thyroid diseases. The Bayer ADVIA IMS T Uptake (TUP) assay is an in vitro diagnostic device intended to quantitatively measure the total amount of available binding sites for thyroid hormone on the thyroxine-binding proteins, globulin, pre-albumin, and albumin in human serum. Measurements of T Uptake, in conjunction with other thyroid tests and clinical indicators, are used as an aid in the diagnostic discrimination and assessment of thyroid diseases. The Bayer ADVIA IMS Urea Nitrogen (BUN) method 1is an in vitro diagnostic device intended to measure urea nitrogen in human serum, plasma and urine. Such measurements are used as an aid in the diagnosis and treatment of certain renal and metabolic diseases.

Source page: https://510kreport.com/device/K991817
Methodology: https://510kreport.com/methodology