# K992662: 8 Additional Assays for the Bayer Advia 1650 Chemistry System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Feb 15, 2000 after 190 days
- Product code: MSJ (Apolipoproteins)
- Device class: 1
- Regulation: 21 CFR 862.1475
- Recalls of this device: 1 (0 Class I)
- 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) Behring Nephelometer: named in the summary without a submission number
- (no number) Technicon DAX: named in the summary without a submission number

## Most influential descendants
- K072658: Advia Chemistry C-Reactive Protein_2, (CRP_2) and Calibrators (2008), 0 descendants of its own

## Recalls of this device
- Dec 15, 2023 · Class II · Z-1003-2024: Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.

## Indications for use
The Bayer ADVIA 1650 Apolipoprotein A-1 (APO-A) assay is an in vitro diagnostic method intended to measure Apolipoprotein A-1 concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the assessment of risk for arteriosclerosis and coronary artery disease. The Bayer ADVIA 1650 Apolipoprotein B (APO-B) assay is an in vitro diagnostic method intended to measure Apolipoprotein B concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the assessment of risk for arteriosclerosis and coronary artery disease. The Bayer ADVIA 1650 Carbon Dioxide (CO2) assay is an in vitro diagnostic method intended to measure Carbon Dioxide concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements obtained using this method assist in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. The Bayer ADVIA 1650 C-Reactive Protein (CRP) assay is an in vitro diagnostic method intended to measure C-Reactive Protein concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the evaluation of the amount of injury to body tissues. This test is useful in following the progress of rheumatic fever, rheumatoid arthritis, myocardial infarction, and malignancies. The Bayer ADVIA 1650 Immunoglobulin A (IGA) assay is an in vitro diagnostic method intended to measure Immunoglobulin A (IGA) concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents. The Bayer ADVIA 1650 Immunoglobulin G (IGG) assay is an in vitro diagnostic method intended to measure Immunoglobulin G (IGG) concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents. The Bayer ADVIA 1650 Immunoglobulin M (IGM) assay is an in vitro diagnostic method intended to measure Immunoglobulin M (IGM) concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents. The Bayer ADVIA 1650 Transferrin (TFR) assay is an in vitro diagnostic device intended to measure Transferrin concentration in human serum and plasma on an Advia 1650 Chemistry System. Such measurements are used to aid in the diagnosis of malnutrition, chronic infection, acute hepatitis, polycythemia, pernicious anemia, and red blood cell disorders, such as iron deficiency anemia.

Source page: https://510kreport.com/device/K992662
Methodology: https://510kreport.com/methodology