# K990346: Bayer Advia 1650 Chemistry System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: May 21, 1999 after 106 days
- Product code: JGS (Electrode, Ion Specific, Sodium)
- Device class: 2
- Regulation: 21 CFR 862.1665
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 3 cite it directly.
0 of 9 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) Titach: 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
- K151767: Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator (2015), 3 descendants of its own
- K162020: VITROS Chemistry Products Cl- Slides (2016), 2 descendants of its own
- K182072: VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides (2018), 1 descendant of its own
- K222438: A-LYTE® Integrated Multisensor (IMT Na K Cl) (2023), 0 descendants of its own
- K222116: Atellica® CI Analyzer,  Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) (2023), 0 descendants of its own

## Recalls of this device
- May 18, 2021 · Class II · Z-2014-2021: ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may not be aligned with customer expectations for the current default mixer failure detection setting of 2;
- Oct 7, 2015 · Class II · Z-0755-2016: Multiple Software issues. Auto Start-UP Fail, Calibration Interval Resets when a Reagent Blank is run, Control Definition screen assumes range defined is 2 SD, Laboratory Information System (LIS) comm
- Aug 28, 2015 · Class II · Z-0183-2016: ISE module may produce discrepant, unflagged results for Sodium, Potassium or Chloride when the respective electrode is left unplugged after replacement, washing or maintenance activities. The calibra
- Feb 11, 2015 · Class II · Z-1399-2015: Siemens Healthcare Diagnostics has confirmed an issue with ADVIA Chemistry XPT software version 1.0.2. The system may cause samples to remain in an Inprocess state. Test results on a sample that is 
- Dec 17, 2013 · Class II · Z-0800-2014: An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calculate a result or when the concentration cannot be determined because it is outside the ab
- Nov 6, 2013 · Class II · Z-0940-2014: The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (QC).
- Sep 3, 2013 · Class II · Z-0344-2014: Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Syste
- Sep 3, 2013 · Class II · Z-0343-2014: Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Syste
- Sep 8, 2006 · Not classified · Z-0351-2007: Bayer received a customer complaint where the Valproic Acid Quality control material recovered lower than target when it was run in a panel of other Therapeutic Drug (TDM) assays. The under recovery o
- Sep 8, 2006 · Not classified · Z-0352-2007: Bayer received a customer complaint where the Valproic Acid Quality control material recovered lower than target when it was run in a panel of other Therapeutic Drug (TDM) assays. The under recovery o
- Sep 8, 2006 · Not classified · Z-0353-2007: Bayer received a customer complaint where the Valproic Acid Quality control material recovered lower than target when it was run in a panel of other Therapeutic Drug (TDM) assays. The under recovery o
- Feb 17, 2006 · Not classified · Z-1450-06: Low QC recovery observed on carbamazepine (CARB) results immediately following a Gentamicin (GENT) assay or a Digoxin (DIG) assay. When GENT or DIG precedes CARB, the CARB test result is artificially 
- Feb 17, 2006 · Not classified · Z-1448-06: Low QC recovery observed on carbamazepine (CARB) results immediately following a Gentamicin (GENT) assay or a Digoxin (DIG) assay. When GENT or DIG precedes CARB, the CARB test result is artificially 
- Feb 17, 2006 · Not classified · Z-1449-06: Low QC recovery observed on carbamazepine (CARB) results immediately following a Gentamicin (GENT) assay or a Digoxin (DIG) assay. When GENT or DIG precedes CARB, the CARB test result is artificially 

## 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 electrolyte 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/K990346
Methodology: https://510kreport.com/methodology