# K991576: Additional Assays for the Bayer Advia 1650 Chemistry System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Jun 30, 1999 after 55 days
- Product code: CIX (Bromcresol Green Dye-Binding, Albumin)
- Device class: 2
- Regulation: 21 CFR 862.1035
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 12 cite it directly.
0 of 18 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) Technicon DAX®: named in the summary without a submission number
- (no number) Beckman Synchron CX®: named in the summary without a submission number
- (no number) Beckman Synchron CX7®: named in the summary without a submission number
- (no number) DuPont Dimension: named in the summary without a submission number
- (no number) Beckman Synchron CX3®: named in the summary without a submission number
- (no number) Hitachi®: named in the summary without a submission number
- (no number) Beckman Synchron CX3/7®: named in the summary without a submission number
- (no number) Boehringer Mannheim on RA-XT: named in the summary without a submission number
- (no number) Cobas Fara®: named in the summary without a submission number
- (no number) Sigma RA1000: named in the summary without a submission number

## Most influential descendants
- K070727: Advia Chemistry Enzymatic Creatinine_2 (2007), 4 descendants of its own
- K161494: Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) (2016), 2 descendants of its own
- K242685: Atellica® CH Creatinine_3 (Crea3) (2024), 1 descendant of its own
- K083386: Advia Chemistry Calcium_2 (CA_2) Method, Models P/M 02189699 (40 ML Fill), P/N 02189915 (70 ML Fill) (2009), 1 descendant of its own
- K251058: Tru Kidney Health Test Panel; Tru Analyzer (2025), 0 descendants of its own

## Recalls of this device
- Jun 28, 2022 · Class II · Z-1498-2022: Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test.
- Mar 27, 2018 · Class II · Z-2062-2018: Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.
- Mar 17, 2016 · Class II · Z-1658-2016: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depre

## Indications for use
The ADVIA 1650 Chemistry System is an automated, clinical chemistry analyzer that can run tests on human serum, plasma, or urine in random access, batch, and STAT modes at a throughput rate of 1200 photometric tests per hour and 450 electrolyte tests per hour. The photometric analyzer performs clinical chemistry and immuno-turbidimetric methods. The electrylyte portion of the analyzer measures the sodium, potassium, and chloride concentrations in serum, plasma or urine samples based on a potentiometric procedure that uses ion-selective electrodes. The ADVIA 1650 is intended for use in conjunction with certain reagents to measure a variety of analytes contained in human fluids.

Source page: https://510kreport.com/device/K991576
Methodology: https://510kreport.com/methodology