# K992136: Bayer Advia Integrated Modular System (Ims)

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Nov 9, 1999 after 138 days
- Product code: CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot)
- Device class: 2
- Regulation: 21 CFR 862.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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 AST method: named in the summary without a submission number
- (no number) Bayer CHEM 1® CK method: named in the summary without a submission number
- (no number) Bayer Chem 1® Creatinine method: named in the summary without a submission number
- (no number) Technicon RA-1000 method: named in the summary without a submission number

## Most influential descendants
- K071580: Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and Abtrol (2007), 0 descendants of its own

## Indications for use
The Bayer ADVIA IMS Asparate Aminotransferase (AST) assay is an in vitro diagnostic device intended to measure AST activity in human serum or plasma. Such measurements are used in the diagnosis and treatment of certain types of liver and heart diseases. The Bayer ADVIA IMS Creatine Kinase (CK) assay is an in vitro diagnostic device intended to measure CK activity in human serum or plasma. Such measurements are used as an aid in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne’s dystrophy. The Bayer ADVIA IMS Creatinine assay is an in vitro diagnostic device intended to measure creatinine in human serum, plasma or urine. Such measurements are used as an aid in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring urine analytes. The Bayer ADVIA IMS Phenobarbital assay is an in vitro diagnostic device intended to measure phenobarbital in human serum. Measurements of phenobarbital are used as an aid in the diagnosis and treatment of phenobarbital overdose and in monitoring therapeutic levels of phenobarbital to ensure appropriate therapy.

Source page: https://510kreport.com/device/K992136
Methodology: https://510kreport.com/methodology