510(k) · Cleared
ClearedDimension Vista Free Thyroxine Flex Reagent Cartridge and Loci 1 Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · CEC Radioimmunoassay, Free Thyroxine
Cleared on Mar 3, 2006 as substantially equivalent to K970389 (Dade Chemistry Systems, Inc., 1997) after a 74-day review. Its family tree reaches back 1 generation to 1997. 7 later devices descend from it.
- Decided
- Mar 3, 2006
- Review
- 74 days
- Class
- Class II
- Product code
- CEC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970389 (1997). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK970389 Thyroid CalibratorDade Chemistry Systems, Inc. · 1997
- This deviceK053531 Dimension Vista Free Thyroxine Flex Reagent Cartridge and Loci 1…Dade Behring, Inc. · 2006
- Descendant · cites it directly · 5 of its ownK073604 Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex…Dade Behring, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 1 of its ownK130276 Dimension Exl with LM SystemSiemens Healthcare Diagnostics, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK243570 Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge…Siemens Healthcare Diagnostics · 2025
- Descendant · cites it directly · 0 of its ownK140859 Dimension Vista Free Thyroxine Flex Reagent Cartridge, FT4…Siemens Healthcare Diagnostics, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK140842 Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L…Siemens Healthcare Diagnostics, Inc. · 2014 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K073604Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge…Dade Behring, Inc. · 2008 · cites it directly5descendants
- K130276Dimension Exl with LM SystemSiemens Healthcare Diagnostics, Inc. · 2013 · 2 generations on1descendant
- K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI…Siemens Healthcare Diagnostics · 2025 · 2 generations on0descendants
- K140859Dimension Vista Free Thyroxine Flex Reagent Cartridge, FT4, Dimension Vista Thyroid…Siemens Healthcare Diagnostics, Inc. · 2014 · cites it directly0descendants
- K140842Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L, Dimension Loci Thyroid…Siemens Healthcare Diagnostics, Inc. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970389 | Thyroid Calibrator | Dade Chemistry Systems, Inc. | 1997 | — |
| 0 (this device) | K053531 | Dimension Vista Free Thyroxine Flex Reagent Cartridge and Loci 1 Calibrator | Dade Behring, Inc. | 2006 | — |
| +1 | K073604 | Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent… | Dade Behring, Inc. | 2008 | 7 |
| +2 | K130276 | Dimension Exl with LM System | Siemens Healthcare Diagnostics, Inc. | 2013 | 6 |
| +2 | K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL)… | Siemens Healthcare Diagnostics | 2025 | — |
| +1 | K140859 | Dimension Vista Free Thyroxine Flex Reagent Cartridge, FT4, Dimension Vista… | Siemens Healthcare Diagnostics, Inc. | 2014 | 3 |
| +3 | K140842 | Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L, Dimension Loci… | Siemens Healthcare Diagnostics, Inc. | 2014 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 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 CEC? 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 CEC device
- #1 K240273 Access Free T4score 7.0 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K970389 | Thyroid CalibratorSummary page 1…Centaur -FrT4 unknown II 8_62.16_95 _CEC Thyroxine (FT4) Flex® reagent assay cartridge Dimension VistaTM Thyroid Calibrator K970389 II 862.1150 JIT LOCI I Calibrator Device Description: The FT4 nmethod is a homogenous, sequential, chemifluminesce… | 1997 |
| * | — | ADVIA Centaur FrT4 assay Named without a submission number |
What descends from it? (7)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K073604 (Dade Behring, Inc., 2008) has gone furthest, with 5 descendants of its own.
How does its category compare?
All CEC devicesCEC Radioimmunoassay, Free Thyroxine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CEC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CEC
238in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CEC
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEC
213in 2025
MAUDE reports naming product code CEC, 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 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 3 | 7 |
| 2011 | 0 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 6 |
| 2013 | 2 | — | 1 | 6 |
| 2014 | 3 | 238 | 0 | 40 |
| 2015 | 1 | — | 0 | 166 |
| 2016 | 1 | — | 0 | 148 |
| 2017 | 1 | — | 0 | 196 |
| 2018 | 2 | — | 1 | 199 |
| 2019 | 0 | — | 0 | 167 |
| 2020 | 0 | — | 0 | 106 |
| 2021 | 0 | — | 0 | 96 |
| 2022 | 0 | — | 0 | 81 |
| 2023 | 1 | — | 0 | 99 |
| 2024 | 1 | — | 0 | 276 |
| 2025 | 0 | — | 0 | 213 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Dimension VistaTM Free Thyroxine Flex® reagent cartridge (ET4) is a device intended to measure Free (not protein bound) thyroxine (thyroid hormone) in serum and plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid disease. The…
Read the full statement (120 words)
The Dimension VistaTM Free Thyroxine Flex® reagent cartridge (ET4) is a device intended to measure Free (not protein bound) thyroxine (thyroid hormone) in serum and plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid disease.
The Dimension VistaTM LOCI I Calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of Free Thyroxine (FT4), Free Triiodothyronine (FT3), and Thyroid Stimulating Hormone (TSH) in human specimens.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053531 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053531: Dimension Vista Free Thyroxine Flex Reagent Cartridge and Loci 1 Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053531
Report an extraction error
Are you the manufacturer?
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