# K982328: Bayer Advia Ims System (in Vitro Diagnostic System)

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Jan 29, 1999 after 211 days
- Product code: CJO (Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1050
- 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 Chem 1 ALP (AMP) method: named in the summary without a submission number
- (no number) Technicon CHEM 1 Calcium method: named in the summary without a submission number
- (no number) Bayer Technicon Chem 1 Glucose method: named in the summary without a submission number
- (no number) Immuno 1 Ferritin assay: named in the summary without a submission number
- (no number) Bayer Immuno 1 hCG Assay: named in the summary without a submission number
- (no number) Bayer Immuno 1 TSH Assay: named in the summary without a submission number

## Indications for use
The Bayer ADVIA IMS alkaline phosphatase (ALP) assay is an in vitro diagnostic device intended to measure ALP in human serum or plasma. Such measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This diagnostic method is not intended for use on any other diagnostic system. The Bayer ADVIA IMS Calcium assay is an in vitro diagnostic device intended to measure calcium in human serum or plasma. Measurements of calcium are used in the diagnosis, monitoring and treatment of a variety of diseases including parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany. This diagnostic method is not intended for use on any other diagnostic system. The Bayer ADVIA IMS Glucose assay is an in vitro diagnostic device intended to measure glucose in human serum or plasma. Such measurements are used in the diagnosis, monitoring and treatment of carbohydrate metabolism disorders, including diabetes mellitus and neonatal hypoglycemia. This diagnostic method is not intended for use on any other diagnostic system. The Bayer ADVIA IMS Ferritin assay is an in vitro diagnostic device intended to quantitatively measure ferritin (an iron-storage protein) in human serum. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency. This diagnostic method is not intended for use on any other diagnostic system. The Bayer ADVIA IMS hCG assay is an in vitro diagnostic device intended to quantitatively measure total beta (B) in human chorionic gonadotropin (hcG) in human serum. Measurements of human chorionic gonadotropin are used in the detection of pregnancy. This diagnostic method is not intended for use on any other diagnostic system. The Bayer ADVIA IMS TSH assay is an in vitro diagnostic device intended to quantitatively measure thyroid stimulating hormone (TSH)in human serum. This assay allows the determination of TSH with 3™ generation sensitivity of less than 20% total coefficient variation (CV) at 0.01 to 0.02 mIU/L or piU/mL, as defined by the American Thyroid Association. Measurements thyroid stimulating hormone are used in the diagnosis of thyroid or pituitary disorders. This diagnostic method is not intended for use on any other diagnostic system.

Source page: https://510kreport.com/device/K982328
Methodology: https://510kreport.com/methodology