# K962508: Elecsys T3

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Aug 15, 1996 after 49 days
- Product code: CDP (Radioimmunoassay, Total Triiodothyronine)
- Device class: 2
- Regulation: 21 CFR 862.1710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Enzymun-Test® T3: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K962508
Methodology: https://510kreport.com/methodology