# K961491: Elecsys TSH Assay

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jul 22, 1996 after 95 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
Longest line of descent: 1 generation back to K915195 (1992). 1 ancestor in all.
7 later devices descend from it; 5 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915195: Enzymun-Test TSH, Boehringer Mannheim Corp. (1992) Summary page 1.

## Most influential descendants
- K962573: Elecsys Precicontrol TSH (1996), 2 descendants of its own
- K162606: Elecsys TSH assay, cobas e 801 Immunoassay analyzer (2017), 1 descendant of its own
- K060754: Elecsys TSH Calset W/Models 04738551 (2006), 1 descendant of its own
- K223690: iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) (2023), 0 descendants of its own
- K140534: Elecsys Precicontrol TS (2014), 0 descendants of its own

## Indications for use
Immunoassay for the in vitro quantitative determination of Thyroid Stimulating Hormone in human serum and plasma.

Source page: https://510kreport.com/device/K961491
Methodology: https://510kreport.com/methodology