510(k) · Cleared
ClearedLoci Thyroid Calibrator with Model RC610
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · JIX Calibrator, Multi-Analyte Mixture
Cleared on May 23, 2008 as substantially equivalent to K073604 (Dade Behring, Inc., 2008) after a 35-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- May 23, 2008
- Review
- 35 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 deviceK081103 Loci Thyroid Calibrator with Model RC610Siemens Healthcare Diagnostics, Inc. · 2008
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) | K081103 | Loci Thyroid Calibrator with Model RC610 | Siemens Healthcare Diagnostics, Inc. | 2008 | — |
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…ce Name / Classification LOCI Thyroid Calibrator / 21 CFR 862.1150 / Class II 3. Identification of the Predicate Device LOCI Thyroid Calibrator, K073604 4. Device Description The LOCI Thyroid Calibrator is a liquid, bovine serum albumin based product containing th… | 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 11 years and passes through 3 companies; a new generation was cleared every 2.0 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. 2008, 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 Thyroid Calibrator is an in vitro diagnostic product for the calibration of the FT4L and TSHL methods on the Dimension® EXL TM with LM system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081103: Loci Thyroid Calibrator with Model RC610.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081103
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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