510(k) · Cleared
ClearedCiba Corning Acs T4 Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ciba Corning Diagnostics Corp. · CDX Radioimmunoassay, Total Thyroxine
Cleared on Jan 15, 1991 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jan 15, 1991
- Review
- 36 days
- Class
- Class II
- Product code
- CDX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK905532 Ciba Corning Acs T4 ImmunoassayCiba Corning Diagnostics Corp. · 1991
- Descendant · cites it directly · 4 of its ownK082638 Advia Centaur System with Streamlab Analytical WorkcellSiemens Healthcare Diagnostics, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 3 of its ownK093318 Accelerator ApsAbbott Laboratories · 2010 · Recalled
- Descendant · 3 generations on · 1 of its ownK213486 GLP systems TrackAbbott Laboratories · 2022
- Descendant · 4 generations on · 0 of its ownK230937 Alinity i Total ß-hCG Reagent Kit, GLP systems TrackAbbott Laboratories · 2023
- Descendant · 3 generations on · 0 of its ownK121012 Flexlab 3.6, Accelerator A3600Inpeco S.P.A. · 2012 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K082638Advia Centaur System with Streamlab Analytical WorkcellSiemens Healthcare Diagnostics, Inc. · 2009 · cites it directly4descendants
- K093318Accelerator ApsAbbott Laboratories · 2010 · 2 generations on3descendants
- K213486GLP systems TrackAbbott Laboratories · 2022 · 3 generations on1descendant
- K230937Alinity i Total ß-hCG Reagent Kit, GLP systems TrackAbbott Laboratories · 2023 · 4 generations on0descendants
- K121012Flexlab 3.6, Accelerator A3600Inpeco S.P.A. · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K905532 | Ciba Corning Acs T4 Immunoassay | Ciba Corning Diagnostics Corp. | 1991 | — |
| +1 | K082638 | Advia Centaur System with Streamlab Analytical Workcell | Siemens Healthcare Diagnostics, Inc. | 2009 | 3 |
| +2 | K093318 | Accelerator Aps | Abbott Laboratories | 2010 | 2 |
| +3 | K213486 | GLP systems Track | Abbott Laboratories | 2022 | — |
| +4 | K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | Abbott Laboratories | 2023 | — |
| +3 | K121012 | Flexlab 3.6, Accelerator A3600 | Inpeco S.P.A. | 2012 | 33 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CDX? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082638 | Advia Centaur System with Streamlab Analytical Workcell | 2009 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K082638 (Siemens Healthcare Diagnostics, Inc., 2009) has gone furthest, with 4 descendants of its own.
How does its category compare?
All CDX devicesCDX Radioimmunoassay, Total Thyroxine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CDX
FDA has decided no CDX device since 2007.
Median 510(k) review, days · CDX
Too few CDX 510(k)s in any year since 2007 to give a median.
Recalls per year · CDX
No recall names CDX since 2007.
Adverse event reports per year · CDX
8in 2025
MAUDE reports naming product code CDX, 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K905532 · printed Nov 4, 2026
Cite this page
510(k) Report. “K905532: Ciba Corning Acs T4 Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K905532
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026