# K993867: Bayer Advia Ims System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Apr 10, 2000 after 147 days
- Product code: CIG (Diazo Colorimetry, Bilirubin)
- Device class: 2
- Regulation: 21 CFR 862.1110
- 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) Technicon CHEM 1® D. Bilirubin: named in the summary without a submission number
- (no number) Bayer RA-1000 HbA1c: named in the summary without a submission number
- (no number) Bayer Immuno 1 Gentamicin: named in the summary without a submission number
- (no number) Technicon CHEM 1: named in the summary without a submission number
- (no number) Bayer RA-1000 Theophylline: named in the summary without a submission number
- (no number) Bayer Immuno 1 Tobramycin: named in the summary without a submission number
- (no number) Technicon CHEM 1® Uric Acid: named in the summary without a submission number

## Indications for use
The Bayer Advia IMS Direct Bilirubin assay is an in vitro diagnostic device intended to measure conjugated bilirubin in human serum or plasma. Measurements of direct or total bilirubin organic compounds formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis, monitoring and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder disorders. The Bayer Advia IMS Hemoglobin Alc (HbAlc) method is an in vitro diagnostic device intended to measure Hemoglobin A lc, a diabetes marker, in human blood. Measurements of HbA ¢ can be used for monitoring the long term care of persons with diabetes. The HbAl¢ and total hemoglobin (1Hb) values generated as part of the HbA 1 ¢ assay are intended for use in the calculation of the HbA 1¢/THb ratio, and must not be used individually for diagnostic purposes. The Bayer Advia IMS Gentamicin assay is an in vitro diagnostic device intended to measure gentamicin, an antibiotic drug, in human serum. Measurements of gentamicin are used as an aid in the diagnosis and treatment of gentamicin overdose and in monitoring therapeutic levels of gentamicin to ensure appropriate therapy. The Bayer Advia IMS Magnesium method is an in vitro diagnostic device intended to measure magnesium in human serum, plasma or urine. Measurements of magnesium are used in the diagnosis and treatment of hypomagnesemia, hypermagnesemia and monitoring of paticnts receiving prolonged magnesium-free intravenous therapv. The Bayer Advia IMS Theophyiline assay is an in vitro diagnostic device intended to measure theophylline in human serum. Measurements of theophyllinc arc used as an aid in the diaguosis and treatment theophylline overdose and in monitoring therapeutic levels of theophylline to ensure appropriate therapy. The Bayer Advia IMS Tobramycin assay is an in virro diagnostic device intended to quantitatively measure tobramycin, an antibiotic drug, human serum. Measurements of tobramycin are used in the diagnosis and treatment of tobramycin overdose and in monitoring therapeutic levels of tobramycin to ensure appropriate therapy. The Bayer Advia IMS Uric Acid (UA) method is an in vitre diagnostic device intended to measure uric acid in human serum, plasma, and urine. Such measurements are used as an aid in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, and of patients receiving cytotoxic drugs.

Source page: https://510kreport.com/device/K993867
Methodology: https://510kreport.com/methodology