# K993711: Additional Ims Assays for the Bayer Advia Ims System (Invitro Diagnostic System with 5 Additional Assays)

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Dec 16, 1999 after 43 days
- Product code: JZG (System, Test, Beta-2-Microglobulin Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5630
- 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) Immuno 1 B2-Microglobulin Assay: named in the summary without a submission number
- (no number) Immuno 1 CK-MB: named in the summary without a submission number
- (no number) Immuno 1 Myoglobin: named in the summary without a submission number
- (no number) Immuno 1 Testosterone Assay: named in the summary without a submission number
- (no number) Immuno 1 Troponin: named in the summary without a submission number
- (no number) Immuno 1 Ferritin: named in the summary without a submission number
- (no number) Immuno 1 hCG Assay: named in the summary without a submission number
- (no number) Immuno 1 TSH Assay: named in the summary without a submission number

## Indications for use
The Bayer Advia IMS B2-Microglobulin (B2M) assay is an in vitro diagnostic device intended to quantitatively measure B2-Microglobulin in human serum and urine. When used in conjunction with clinical data and other diagnostic procedures, measurements of B2-Microglobulin aid in the management of patients with renal dysfunction and rheumatoid arthritis. The Bayer Advia IMS Creatine Kinase (CKMB) assay is an in vitro diagnostic device intended to quantitatively measure the MB isoenzyme in human serum and plasma. When used in conjunction with other clinical data such as presenting symptoms and diagnostic procedures, measurements of CK-MB aid in the diagnosis of acute myocardial infarction (AMI). The Bayer Advia IMS Myoglobin assay is an in vitro diagnostic device intended to quantitatively measure the myoglobin in human serum and plasma. When used in conjunction with other clinical data such as presenting symptoms and diagnostic procedures, measurements of myoglobin aid in the diagnosis of acute myocardial infarction (AMI). The Bayer Advia IMS Testosterone assay is an in vitro diagnostic device intended to quantitatively measure total testosterone in human serum. Measurements of testosterone are used in the diagnosis and treatment of various hormonal sexual disorders. This diagnostic method is not intended for use on any other diagnostic system. The Bayer Advia IMS Troponin I assay is an in vitro diagnostic device intended to quantitatively measure the cardiac Troponin I in human serum and plasma. When used in conjunction with other clinical data such as presenting symptoms and diagnostic procedures, measurements of cardiac Troponin I aid in the diagnosis of acute myocardial infarction (AMI). 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) human chorionic gonadotropin (hCG) in human serum, plasma, and urine. Measurements of human chorionic gonadotropin are used in the detection of pregnancy. The Bayer Advia IMS TSH assay is an in vitro diagnostic device intended to quantitatively measure thyroid stimulating hormone (TSH) in human serum, plasma. This assay allows the determination of TSH with 3rd generation sensitivity of less than 20% total coefficient of variation (CV) at 0.01 to 0.02 mIU/L or uIU/mL, as defined by the American Thyroid Association. Measurements of thyroid stimulating hormone are used in the diagnosis of thyroid or pituitary disorders.

Source page: https://510kreport.com/device/K993711
Methodology: https://510kreport.com/methodology