510(k) · Cleared
Recalled · Class II · 2018Advia Centaur System with Streamlab Analytical Workcell
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Cleared on Feb 26, 2009 as substantially equivalent to K041133 (Bayer Healthcare, LLC, 2004) and 2 other predicates after a 169-day review. Its family tree reaches back 4 generations to 1990. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 26, 2009
- Review
- 169 days
- Class
- Class II
- Product code
- KLI
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 4 generations to K902336 (1990). 6 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK902336 Ciba Corning Acs:180 Automated ChemiluminescenceCiba Corning Diagnostics Corp. · 1990
- 3 generations backK971418 Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur…Chiron Diagnostics Corp. · 1997 · Recalled
- 2 generations backK032525 Bayer Advia Centaur Automated Chemiluminescence AnalyzerBayer Healthcare, LLC · 2003
- 1 generation backK041133 Modification to Bayer Advia Centaur Automated Chemiluminescence…Bayer Healthcare, LLC · 2004 · Recalled
- This deviceK082638 Advia Centaur System with Streamlab Analytical WorkcellSiemens Healthcare Diagnostics, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK093318 Accelerator ApsAbbott Laboratories · 2010 · Recalled
- Descendant · 2 generations on · 1 of its ownK213486 GLP systems TrackAbbott Laboratories · 2022
- Descendant · 3 generations on · 0 of its ownK230937 Alinity i Total ß-hCG Reagent Kit, GLP systems TrackAbbott Laboratories · 2023
- Descendant · 2 generations on · 0 of its ownK121012 Flexlab 3.6, Accelerator A3600Inpeco S.P.A. · 2012 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K093318Accelerator ApsAbbott Laboratories · 2010 · cites it directly3descendants
- K213486GLP systems TrackAbbott Laboratories · 2022 · 2 generations on1descendant
- K230937Alinity i Total ß-hCG Reagent Kit, GLP systems TrackAbbott Laboratories · 2023 · 3 generations on0descendants
- K121012Flexlab 3.6, Accelerator A3600Inpeco S.P.A. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902336 | Ciba Corning Acs:180 Automated Chemiluminescence | Ciba Corning Diagnostics Corp. | 1990 | — |
| −3 | K971418 | Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer | Chiron Diagnostics Corp. | 1997 | 4 |
| −2 | K032525 | Bayer Advia Centaur Automated Chemiluminescence Analyzer | Bayer Healthcare, LLC | 2003 | — |
| −1 | K041133 | Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer | Bayer Healthcare, LLC | 2004 | 8 |
| 0 (this device) | K082638 | Advia Centaur System with Streamlab Analytical Workcell | Siemens Healthcare Diagnostics, Inc. | 2009 | — |
| +1 | K093318 | Accelerator Aps | Abbott Laboratories | 2010 | 2 |
| +2 | K213486 | GLP systems Track | Abbott Laboratories | 2022 | — |
| +3 | K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | Abbott Laboratories | 2023 | — |
| +2 | K121012 | Flexlab 3.6, Accelerator A3600 | Inpeco S.P.A. | 2012 | 33 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 KLI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K041133 | Modification to Bayer Advia Centaur Automated Chemiluminescence AnalyzerSummary page 1…t 5 or Method ·, 510(k) ' Product Code. ADVIA Centaur® K041133 JJE StreamLAB® K043546 JJE… | 2004 |
| * | K043546 | Dimension RXL Max with Streamlab Analytical Workcell and Sample Transfer ModuleSummary page 1…' Product Code. ADVIA Centaur® K041133 JJE StreamLAB® K043546 JJE Analytical Workcell ADVIA Centaur® T4 Assay K90… | 2005 |
| * | K905532 | Ciba Corning Acs T4 ImmunoassaySummary page 1…K043546 JJE Analytical Workcell ADVIA Centaur® T4 Assay K905532 CDX 4. Device Description(s): The ADVIA Centaur® is a continuous operation, immunochemi… | 1991 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093318 | Accelerator Aps | 2010 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 14, 2018 | Class II | Z-0215-2019 | Under Investigation by firm | The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. |
| Aug 14, 2018 | Class II | Z-0216-2019 | Under Investigation by firm | The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. |
| Aug 14, 2018 | Class II | Z-0217-2019 | Under Investigation by firm | The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K093318 (Abbott Laboratories, 2010) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K041133.
How does its category compare?
All KLI devicesKLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · KLI
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · KLI
Too few KLI 510(k)s in any year since 2007 to give a median.
Recalls per year · KLI
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLI
3in 2021
MAUDE reports naming product code KLI, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 3 |
| 2011 | 1 | — | 1 | 7 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 2 | 3 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The ADVIA Centaur with StreamLAB® Analytical Workcell is an automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assay analysis on clinical specimens. The system menu will include assays based on chemiluminescent technology, such as Thyroxine, along with other various chemiluminescent assays that may be adaptable to the analyzer depending on the reagent used to induce the chemiluminescent reaction. The ADVIA CentaurT4…
Read the full statement (103 words)
The ADVIA Centaur with StreamLAB® Analytical Workcell is an automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assay analysis on clinical specimens. The system menu will include assays based on chemiluminescent technology, such as Thyroxine, along with other various chemiluminescent assays that may be adaptable to the analyzer depending on the reagent used to induce the chemiluminescent reaction.
The ADVIA CentaurT4 assay is for in vitro diagnostic use in the quantitative determination of thyroxine (T4) in serum on the ADVIA Centaur and ADVIA Centaur XP systems. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082638: Advia Centaur System with Streamlab Analytical Workcell.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082638
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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