# K190773: Elecsys TSH

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Apr 16, 2019 after 21 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K191899: Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions (2019), 3 descendants of its own
- K253491: ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions (2026), 0 descendants of its own
- K253490: Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (2026), 0 descendants of its own
- K220134: cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH (2022), 0 descendants of its own

Source page: https://510kreport.com/device/K190773
Methodology: https://510kreport.com/methodology