510(k) · Cleared
Recalled · Class II · 2021Bayer Advia 1650 Chemistry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · JGS Electrode, Ion Specific, Sodium
Cleared on May 21, 1999 after a 106-day review. The FDA summary names its predicate without a number. 8 later devices descend from it. It has been recalled 14 times.
- Decided
- May 21, 1999
- Review
- 106 days
- Class
- Class II
- Product code
- JGS
- Recalls
- 14
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK990346 Bayer Advia 1650 Chemistry SystemBayer Corp. · 1999
- Descendant · cites it directly · 3 of its ownK151767 Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI)…Siemens Healthcare Diagnostics, Inc. · 2015 · Recalled
- Descendant · cites it directly · 2 of its ownK162020 VITROS Chemistry Products Cl- SlidesOrtho Clinical Diagnostics · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK182072 VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2…Ortho-Clinical Diagnostics, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK222438 A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK222116 Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone…Siemens Healthcare Diagnostics, Inc. · 2023 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K151767Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A…Siemens Healthcare Diagnostics, Inc. · 2015 · cites it directly3descendants
- K162020VITROS Chemistry Products Cl- SlidesOrtho Clinical Diagnostics · 2016 · cites it directly2descendants
- K182072VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS…Ortho-Clinical Diagnostics, Inc. · 2018 · 2 generations on1descendant
- K222438A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc. · 2023 · 2 generations on0descendants
- K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL)…Siemens Healthcare Diagnostics, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990346 | Bayer Advia 1650 Chemistry System | Bayer Corp. | 1999 | — |
| +1 | K151767 | Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT… | Siemens Healthcare Diagnostics, Inc. | 2015 | 12 |
| +1 | K162020 | VITROS Chemistry Products Cl- Slides | Ortho Clinical Diagnostics | 2016 | 2 |
| +2 | K182072 | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides… | Ortho-Clinical Diagnostics, Inc. | 2018 | 2 |
| +2 | K222438 | A-LYTE® Integrated Multisensor (IMT Na K Cl) | Siemens Healthcare Diagnostics, Inc. | 2023 | — |
| +2 | K222116 | Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra… | Siemens Healthcare Diagnostics, Inc. | 2023 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JGS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JGS device
- #1 K252475 ABL90 FLEX PLUS Systemscore 12.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (10)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Technicon DAX Named without a submission number | |
| * | — | Beckman Synchron CX Named without a submission number | |
| * | — | Beckman Synchron CX7 Named without a submission number | |
| * | — | DuPont Dimension Named without a submission number | |
| * | — | Beckman Synchron CX3 Named without a submission number | |
| * | — | Hitachi Named without a submission number | |
| * | — | Titach Named without a submission number | |
| * | — | Boehringer Mannheim on RA-XT Named without a submission number | |
| * | — | Cobas Fara Named without a submission number | |
| * | — | Sigma RA1000 Named without a submission number |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 18, 2021 | Class II | Z-2014-2021 | Software design | 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; an erroneously elevated or depressed… |
| Oct 7, 2015 | Class II | Z-0755-2016 | Software design | 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) communication/Laboratory Automation (LAS)… |
| Aug 28, 2015 | Class II | Z-0183-2016 | Device Design | 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 calibration and 2-level QC will fail if the… |
| Feb 11, 2015 | Class II | Z-1399-2015 | Software design | 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 held Inprocess will not transmit to… |
| Dec 17, 2013 | Class II | Z-0800-2014 | Software design | 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 absorbance limits, and it is possible… |
| Nov 6, 2013 | Class II | Z-0940-2014 | Software design | 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 | Software design | 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 Systems. |
| Sep 3, 2013 | Class II | Z-0343-2014 | Software design | 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 Systems. |
| Sep 8, 2006 | Not classified | Z-0351-2007 | Software design | 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 observed by the customer was… |
| Sep 8, 2006 | Not classified | Z-0352-2007 | Software design | 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 observed by the customer was… |
| Sep 8, 2006 | Not classified | Z-0353-2007 | Software design | 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 observed by the customer was… |
| Feb 17, 2006 | Not classified | Z-1450-06 | Other | 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 low (as much as -25%). PHNY was… |
| Feb 17, 2006 | Not classified | Z-1448-06 | Other | 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 low (as much as -25%). PHNY was… |
| Feb 17, 2006 | Not classified | Z-1449-06 | Other | 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 low (as much as -25%). PHNY was… |
The 5 latest of 14 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K151767 (Siemens Healthcare Diagnostics, Inc., 2015) has gone furthest, with 3 descendants of its own.
How does its category compare?
All JGS devicesJGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JGS
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JGS
347in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JGS
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JGS
64in 2025
MAUDE reports naming product code JGS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 7 | 33 |
| 2008 | 2 | — | 1 | 3 |
| 2009 | 2 | — | 0 | 57 |
| 2010 | 1 | — | 1 | 361 |
| 2011 | 3 | 191 | 1 | 912 |
| 2012 | 1 | — | 2 | 412 |
| 2013 | 2 | — | 5 | 510 |
| 2014 | 1 | — | 0 | 251 |
| 2015 | 1 | — | 1 | 158 |
| 2016 | 4 | 198 | 0 | 84 |
| 2017 | 1 | — | 0 | 292 |
| 2018 | 3 | 180 | 0 | 158 |
| 2019 | 3 | 58 | 5 | 105 |
| 2020 | 2 | — | 1 | 89 |
| 2021 | 0 | — | 1 | 91 |
| 2022 | 1 | — | 0 | 60 |
| 2023 | 3 | 347 | 4 | 98 |
| 2024 | 0 | — | 0 | 96 |
| 2025 | 0 | — | 0 | 64 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990346: Bayer Advia 1650 Chemistry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990346
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026