510(k) · Cleared
Recalled · Class II · 2022Additional Assays for the Bayer Advia 1650 Chemistry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · CIX Bromcresol Green Dye-Binding, Albumin
Cleared on Jun 30, 1999 after a 55-day review. The FDA summary names its predicate without a number. 17 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 30, 1999
- Review
- 55 days
- Class
- Class II
- Product code
- CIX
- Recalls
- 3
- Predicates
- 0
17 later devices descend from it, 12 citing it directly.
- This deviceK991576 Additional Assays for the Bayer Advia 1650 Chemistry SystemBayer Corp. · 1999
- Descendant · cites it directly · 4 of its ownK070727 Advia Chemistry Enzymatic Creatinine_2Siemens Medical Solutions Diagnostics · 2007 · Recalled
- Descendant · 2 generations on · 2 of its ownK161494 Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator…Siemens Healthcare Diagnostics, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 1 of its ownK242685 Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK083386 Advia Chemistry Calcium_2 (CA_2) Method, Models P/M 02189699 (40 ML…Siemens Healthcare Diagnostics · 2009 · Recalled
- Descendant · 4 generations on · 0 of its ownK251058 Tru Kidney Health Test Panel; Tru AnalyzerTruvian Health · 2025
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K070727Advia Chemistry Enzymatic Creatinine_2Siemens Medical Solutions Diagnostics · 2007 · cites it directly4descendants
- K161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Siemens Healthcare Diagnostics, Inc. · 2016 · 2 generations on2descendants
- K242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc. · 2024 · 3 generations on1descendant
- K083386Advia Chemistry Calcium_2 (CA_2) Method, Models P/M 02189699 (40 ML Fill), P/N 02189915…Siemens Healthcare Diagnostics · 2009 · cites it directly1descendant
- K251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian Health · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991576 | Additional Assays for the Bayer Advia 1650 Chemistry System | Bayer Corp. | 1999 | — |
| +1 | K070727 | Advia Chemistry Enzymatic Creatinine_2 | Siemens Medical Solutions Diagnostics | 2007 | 5 |
| +2 | K161494 | Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) | Siemens Healthcare Diagnostics, Inc. | 2016 | 1 |
| +3 | K242685 | Atellica® CH Creatinine_3 (Crea3) | Siemens Healthcare Diagnostics, Inc. | 2024 | — |
| +1 | K083386 | Advia Chemistry Calcium_2 (CA_2) Method, Models P/M 02189699 (40 ML Fill), P/N… | Siemens Healthcare Diagnostics | 2009 | 1 |
| +4 | K251058 | Tru Kidney Health Test Panel; Tru Analyzer | Truvian Health | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 CIX? 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 CIX device
- #1 K251157 Core Metabolicscore 11.0 · 2 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 | |
| * | — | Beckman Synchron CX3/7® 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? (17)
See all 1712 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070727 | Advia Chemistry Enzymatic Creatinine_2 | 2007 | 4 |
| K083386 | Advia Chemistry Calcium_2 (CA_2) Method, Models P/M 02189699 (40 ML Fill), P/N 02189915… | 2009 | 1 |
| K162200 | Randox RX Daytona Plus Magnesium (MG) | 2017 | 0 |
| K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP) | 2017 | 0 |
| K160724 | ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator | 2016 | 0 |
| K122323 | Dimension Vista Alkaline Phosphatase (Alpi) Flex Reagent Cartridge Dimension Vista… | 2012 | 0 |
| K121907 | Dimension Alkaline Phosphatase Flex Reagent Cartridge, Dimension Alkaline Phosphatase… | 2012 | 0 |
| K073295 | Urea/Bun, Scal, Nortrol, Abtrol | 2008 | 0 |
| K073612 | Uric Acid (Aox), Scal, Nortrol, Abtrol | 2008 | 0 |
| K073355 | Calcium, Scal, Nortrol, Abtrol | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 28, 2022 | Class II | Z-1498-2022 | Under Investigation by firm | 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 | Material/Component Contamination | 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 | Device Design | 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 depressed results may occur on samples… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K070727 (Siemens Medical Solutions Diagnostics, 2007) has gone furthest, with 4 descendants of its own.
How does its category compare?
All CIX devicesCIX Bromcresol Green Dye-Binding, Albumin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CIX
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · CIX
168in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CIX
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIX
4in 2025
MAUDE reports naming product code CIX, 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 | 1 | — | 0 | 1 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 74 |
| 2011 | 3 | 168 | 0 | 8 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 1 | — | 1 | 0 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 2 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 4 |
| 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 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.
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/K991576 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991576: Additional Assays for the Bayer Advia 1650 Chemistry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991576
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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