510(k) · Cleared
ClearedDimension Exl Loci Thyroid Calibrator, Model RC 610A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · JIX Calibrator, Multi-Analyte Mixture
Cleared on May 5, 2010 as substantially equivalent to K073604 (Dade Behring, Inc., 2008) after a 47-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- May 5, 2010
- Review
- 47 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970389 (1997). No later device cites it as a predicate yet.
- Root · 3 generations backK970389 Thyroid CalibratorDade Chemistry Systems, Inc. · 1997
- 2 generations backK053531 Dimension Vista Free Thyroxine Flex Reagent Cartridge and Loci 1…Dade Behring, Inc. · 2006
- 1 generation backK073604 Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex…Dade Behring, Inc. · 2008 · Recalled
- This deviceK100778 Dimension Exl Loci Thyroid Calibrator, Model RC 610ASiemens Healthcare Diagnostics · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970389 | Thyroid Calibrator | Dade Chemistry Systems, Inc. | 1997 | — |
| −2 | 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 |
| 0 (this device) | K100778 | Dimension Exl Loci Thyroid Calibrator, Model RC 610A | Siemens Healthcare Diagnostics | 2010 | — |
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 JIX? 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? (1)
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 |
|---|---|---|---|
| * | K073604 | Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge…Summary page 1…. Predicate Device: The predicate device used to demonstrate substantial equivalence to the LOCI Thyroid Calibrator is the current LOCI Thyroid Calibrator cleared under k073604. G. Device Description: The LOCI THYR CAL is a multi-analyte, liquid, bovine serum albumin based product contain… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 3 other devices also cite its predicate K073604.
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · JIX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JIX
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIX
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIX
18in 2025
MAUDE reports naming product code JIX, 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 | 6 | 53 | 2 | 140 |
| 2008 | 5 | 69 | 3 | 173 |
| 2009 | 4 | 121 | 2 | 39 |
| 2010 | 5 | 100 | 1 | 0 |
| 2011 | 7 | 77 | 2 | 9 |
| 2012 | 2 | — | 1 | 3 |
| 2013 | 4 | 50 | 0 | 24 |
| 2014 | 1 | — | 1 | 35 |
| 2015 | 3 | 29 | 0 | 4 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 1 | 17 |
| 2018 | 0 | — | 1 | 16 |
| 2019 | 0 | — | 1 | 12 |
| 2020 | 0 | — | 2 | 22 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 7 | 13 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The LOCI THYR CAL is an in vitro diagnostic product for the calibration of the LOCI Free Trilodothyronine (FT3), LOCI Free Thyroxine (FT4L) and LOCI Thyroid Stimulating Hormone (TSHL) methods on the Dimension®)EXLTm integrated chemistry system with LOCI®Module.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100778 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100778: Dimension Exl Loci Thyroid Calibrator, Model RC 610A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100778
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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