510(k) · Cleared
ClearedTSH-CTK-3 Irma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Cleared on Jul 14, 2004 as substantially equivalent to K920856 (Hycor Biomedical, Inc., 1992) after an 85-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Jul 14, 2004
- Review
- 85 days
- Class
- Class II
- Product code
- JLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920856 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK920856 Ventrex Coated Tube High Sensit. TSH RadioimmunoasHycor Biomedical, Inc. · 1992
- This deviceK041014 TSH-CTK-3 IrmaDiaSorin, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920856 | Ventrex Coated Tube High Sensit. TSH Radioimmunoas | Hycor Biomedical, Inc. | 1992 | — |
| 0 (this device) | K041014 | TSH-CTK-3 Irma | DiaSorin, Inc. | 2004 | — |
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 |
|---|---|---|---|
| * | K920856 | Ventrex Coated Tube High Sensit. TSH RadioimmunoasSummary page 2…3 510(k) Premarket Notification 73 TECHNOLOGICAL COMPARISON TO PREDICATE: Feature Ventrex hTSH "'IIRMA (K920856) TSH-CTK-3 Analyte Thyroid Stimulating Hormone(hTSH) Thyroid Stimulating Hormone (hTSH)… | 1992 |
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?
- Its one ancestor has no recall.
How does its category compare?
All JLW devicesJLW Radioimmunoassay, Thyroid-Stimulating Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 DiaSorin TSH-CTK-3 is an imlunoradiometric assay for the quantitative determination of thyrotropin (TSH) in human serum. Measurements of TSH levels are used as an aid in the diagnosis of thyroid or pituitary disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041014 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041014: TSH-CTK-3 Irma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041014
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