510(k) · Cleared
ClearedElecsys T3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · CDP Radioimmunoassay, Total Triiodothyronine
Cleared on Aug 15, 1996 after a 49-day review. The FDA summary names its predicate without a number.
- Decided
- Aug 15, 1996
- Review
- 49 days
- Class
- Class II
- Product code
- CDP
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 CDP? 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 |
|---|---|---|---|
| * | — | Enzymun-Test® T3 Named without a submission number |
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.
How does its category compare?
All CDP devicesCDP Radioimmunoassay, Total Triiodothyronine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CDP
FDA has decided no CDP device since 2007.
Median 510(k) review, days · CDP
Too few CDP 510(k)s in any year since 2007 to give a median.
Recalls per year · CDP
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDP
25in 2025
MAUDE reports naming product code CDP, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 8 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 2 | 10 |
| 2014 | 0 | — | 1 | 111 |
| 2015 | 0 | — | 1 | 158 |
| 2016 | 0 | — | 0 | 150 |
| 2017 | 0 | — | 1 | 151 |
| 2018 | 0 | — | 3 | 365 |
| 2019 | 0 | — | 0 | 343 |
| 2020 | 0 | — | 0 | 209 |
| 2021 | 0 | — | 0 | 120 |
| 2022 | 0 | — | 0 | 123 |
| 2023 | 0 | — | 0 | 131 |
| 2024 | 0 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 25 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Triiodothyronine (T3) is the hormone principally responsible for the development of the effects of the thyroid hormones on the various target organs. T3 (3,5,3" Triiodothyronine) is mainly formed extra-thyroidally, particularly in the liver, by enzymatic 5’-deiodination of T4. Accordingly, the T3 concentration in serum is more a reflection of the functional state of the peripheral tissue than the secretory performance of the thyroid gland. A reduction in…
Read the full statement (160 words)
Triiodothyronine (T3) is the hormone principally responsible for the development of the effects of the thyroid hormones on the various target organs.
T3 (3,5,3" Triiodothyronine) is mainly formed extra-thyroidally, particularly in the liver, by enzymatic 5’-deiodination of T4. Accordingly, the T3 concentration in serum is more a reflection of the functional state of the peripheral tissue than the secretory performance of the thyroid gland.
A reduction in the conversion of T4 to T3 results in a fall in the T3 concentration. It occurs under the influence of medications such as propanolol, glucocorticoids or amiodarone and in severe non-thyroidal general diseases - “non-thyroidal illness” (NTI) - and is referred to as the “low T3 syndrome.” Like T4, over 99% of T3 is bound to transport proteins, but its affinity to them is around 10-fold lower.
The determination of T3 is utilized in the diagnosis of T3-hyperthyroidism, the detection of early stages of hyperthyroidism and for indicating a diagnosis of thyrotoxicosis factitia.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962508 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962508: Elecsys T3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962508
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026