510(k) · Cleared
Recalled · Class II · 2013Dimension TSHL Flex Reagent Cartridge and TSH Sample Diluent with Models RF 612 and KD691
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Cleared on May 23, 2008 as substantially equivalent to K060090 (Dade Behring, Inc., 2006) after a 37-day review. Its family tree reaches back 1 generation to 2006. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- May 23, 2008
- Review
- 37 days
- Class
- Class II
- Product code
- JLW
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060090 (2006). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK060090 Dimension Vista Thyroid Stimulating Hormone Flex Reagent CartridgeDade Behring, Inc. · 2006 · Recalled
- This deviceK081074 Dimension TSHL Flex Reagent Cartridge and TSH Sample Diluent with…Siemens Healthcare Diagnostics, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK243570 Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge…Siemens Healthcare Diagnostics · 2025
- Descendant · cites it directly · 0 of its ownK140842 Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L…Siemens Healthcare Diagnostics, Inc. · 2014 · Recalled
Most influential descendants
Showing 2 of 2 · See all- 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 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060090 | Dimension Vista Thyroid Stimulating Hormone Flex Reagent Cartridge | Dade Behring, Inc. | 2006 | 1 |
| 0 (this device) | K081074 | Dimension TSHL Flex Reagent Cartridge and TSH Sample Diluent with Models RF… | Siemens Healthcare Diagnostics, Inc. | 2008 | — |
| +1 | K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL)… | Siemens Healthcare Diagnostics | 2025 | — |
| +1 | 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 |
|---|---|---|
| 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 JLW? 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 JLW device
- #1 K251543 Atellica® IM TSH3-Ultra II (TSH3ULII)score 11.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K060090 | Dimension Vista Thyroid Stimulating Hormone Flex Reagent CartridgeSummary page 1…agent cartridge / Class II TSH Sample Diluent / Class II 3. Identification of the Predicate Device Dimension VistaTM TSH Flex® reagent cartridge, K060090 4. Device Description The Dimension® TSHL Flex® reagent cartridge is an in vitro diagnostic device that… | 2006 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 10, 2013 | Class II | Z-1882-2013 | Device Design | A rare variant of TSH, identified in a small cluster of patients, is not detected. |
| May 10, 2013 | Class II | Z-1883-2013 | Device Design | A rare variant of TSH, identified in a small cluster of patients, is not detected. |
| Apr 12, 2010 | Not classified | Z-0459-2011 | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JLW devicesJLW Radioimmunoassay, Thyroid-Stimulating Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JLW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JLW
194in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JLW
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JLW
103in 2025
MAUDE reports naming product code JLW, 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 | — | 1 | 19 |
| 2008 | 5 | 143 | 0 | 10 |
| 2009 | 2 | — | 0 | 41 |
| 2010 | 1 | — | 1 | 34 |
| 2011 | 0 | — | 1 | 167 |
| 2012 | 1 | — | 3 | 144 |
| 2013 | 1 | — | 0 | 168 |
| 2014 | 1 | — | 0 | 155 |
| 2015 | 3 | 142 | 0 | 203 |
| 2016 | 3 | 238 | 1 | 183 |
| 2017 | 4 | 194 | 0 | 235 |
| 2018 | 0 | — | 4 | 249 |
| 2019 | 1 | — | 1 | 216 |
| 2020 | 0 | — | 2 | 145 |
| 2021 | 0 | — | 0 | 146 |
| 2022 | 1 | — | 0 | 137 |
| 2023 | 1 | — | 0 | 162 |
| 2024 | 2 | — | 2 | 169 |
| 2025 | 1 | — | 2 | 103 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The TSHL method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone (TSH, thyrotropin) in human serum and plasma on the Dimension® EXLTM with LM System. Measurements of TSH are used in the diagnosis and monitoring of thyroid disease.
The TSH Sample Diluent is an in vitro diagnostic product fot manual dilution of samples with elevated TSH results processed on the Dimension Vista® and Dimension® EXLTM with LM systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081074 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081074: Dimension TSHL Flex Reagent Cartridge and TSH Sample Diluent with Models RF 612 and KD691.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081074
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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