510(k) · Cleared
Recalled · Class II · 2015Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge, and Loci Thyroid Calibrator, Mod
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 13, 2008 as substantially equivalent to K053531 (Dade Behring, Inc., 2006) after an 83-day review. Its family tree reaches back 2 generations to 1997. 5 later devices descend from it. It has been recalled 7 times.
- Decided
- Mar 13, 2008
- Review
- 83 days
- Class
- Class II
- Product code
- CEC
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 2 generations to K970389 (1997). 5 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK970389 Thyroid CalibratorDade Chemistry Systems, Inc. · 1997
- 1 generation backK053531 Dimension Vista Free Thyroxine Flex Reagent Cartridge and Loci 1…Dade Behring, Inc. · 2006
- This deviceK073604 Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex…Dade Behring, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK130276 Dimension Exl with LM SystemSiemens Healthcare Diagnostics, Inc. · 2013 · Recalled
- Descendant · cites it directly · 0 of its ownK243570 Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge…Siemens Healthcare Diagnostics · 2025
- Descendant · 2 generations on · 0 of its ownK140842 Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L…Siemens Healthcare Diagnostics, Inc. · 2014 · Recalled
- Descendant · cites it directly · 0 of its ownK100778 Dimension Exl Loci Thyroid Calibrator, Model RC 610ASiemens Healthcare Diagnostics · 2010
- Descendant · cites it directly · 0 of its ownK081103 Loci Thyroid Calibrator with Model RC610Siemens Healthcare Diagnostics, Inc. · 2008
Most influential descendants
Showing 5 of 5 · See all- K130276Dimension Exl with LM SystemSiemens Healthcare Diagnostics, Inc. · 2013 · cites it directly1descendant
- K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI…Siemens Healthcare Diagnostics · 2025 · cites it directly0descendants
- K140842Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L, Dimension Loci Thyroid…Siemens Healthcare Diagnostics, Inc. · 2014 · 2 generations on0descendants
- K100778Dimension Exl Loci Thyroid Calibrator, Model RC 610ASiemens Healthcare Diagnostics · 2010 · cites it directly0descendants
- K081103Loci Thyroid Calibrator with Model RC610Siemens Healthcare Diagnostics, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970389 | Thyroid Calibrator | Dade Chemistry Systems, Inc. | 1997 | — |
| −1 | K053531 | Dimension Vista Free Thyroxine Flex Reagent Cartridge and Loci 1 Calibrator | Dade Behring, Inc. | 2006 | — |
| 0 (this device) | K073604 | Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent… | Dade Behring, Inc. | 2008 | — |
| +1 | K130276 | Dimension Exl with LM System | Siemens Healthcare Diagnostics, Inc. | 2013 | 6 |
| +1 | K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL)… | Siemens Healthcare Diagnostics | 2025 | — |
| +2 | K140842 | Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L, Dimension Loci… | Siemens Healthcare Diagnostics, Inc. | 2014 | 2 |
| +1 | K100778 | Dimension Exl Loci Thyroid Calibrator, Model RC 610A | Siemens Healthcare Diagnostics | 2010 | — |
| +1 | K081103 | Loci Thyroid Calibrator with Model RC610 | Siemens Healthcare Diagnostics, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 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 |
|---|---|---|---|
| * | K053531 | Dimension Vista Free Thyroxine Flex Reagent Cartridge and Loci 1 CalibratorSummary page 1…L Max is a family member of the Dimension® XL clinical chemistry system, which was cleared under K944093) Dimension VistaTM FT4 Flex® reagent cartridge, K053531 Dimension Vista TM LOCI I Calibrator, K053531… | 2006 |
| * | — | Dimension® RxL Max® clinical chemistry system Named without a submission number |
What descends from it? (5)
4 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 |
|---|---|---|---|---|
| Apr 2, 2015 | Class II | Z-1615-2015 | Under Investigation by firm | Certain Dimension Integrated Chemistry Systems Instrument Power Configurations may have been installed with a non-standard instrument power plug.The use of a non-standard plug configuration as described may lead to a potential electrical… |
| May 27, 2014 | Class III | Z-2133-2014 | Employee error | There is a misassembly issue with the photometer installed on Dimension¿ Integrated Chemistry Systems instruments. Through internal investigation by Siemens Healthcare Diagnostics has confirmed that a limited number of Dimension… |
| Feb 27, 2013 | Class III | Z-1046-2013 | Under Investigation by firm | Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these… |
| Feb 27, 2013 | Class III | Z-1047-2013 | Under Investigation by firm | Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these… |
| Feb 27, 2013 | Class III | Z-1048-2013 | Under Investigation by firm | Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these… |
| Apr 12, 2010 | Not classified | Z-0458-2011 | Other | Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high elevations, causing the cartridge to leak. Use of leaking cartridges may result in inaccurate test results. |
| Sep 30, 2008 | Not classified | Z-0581-2009 | Software design | Error messages, "Wash Aspirator Failure" and "Wash station unable to recover" are not generated when one or both HM wash probes are totally occluded. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 9.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K130276 (Siemens Healthcare Diagnostics, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K053531.
How does its category compare?
All CEC devicesCEC Radioimmunoassay, Free Thyroxine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 FT4L method is an in vitro diagnostic test for the quantitative measurement of Free Thyroxine in human serum and plasma on the Dimension® EXLTM with LM system. Measurements of free thyroxine are used in the diagnosis and monitoring of thyroid disease. The LOCI® Thyroid Calibrator is an in vitro diagnostic product for the calibration of the FT4L method on the Dimension® EXLTM with LM system. The Dimension® EXLTM with LM system is an in vitro…
Read the full statement (111 words)
The FT4L method is an in vitro diagnostic test for the quantitative measurement of Free Thyroxine in human serum and plasma on the Dimension® EXLTM with LM system. Measurements of free thyroxine are used in the diagnosis and monitoring of thyroid disease.
The LOCI® Thyroid Calibrator is an in vitro diagnostic product for the calibration of the FT4L method on the Dimension® EXLTM with LM system.
The Dimension® EXLTM with LM system is an in vitro diagnostic device that is intended to measure a variety of analytes in human body fluids. The system utilizes photometric, turbidimetric, chemiluminescence and integrated ion selective multisensor technology for chemical and immunochemical applications for clinical use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073604 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073604: Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge, and Loci Thyroid Calibrator, Mod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073604
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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