# K853717: Allegro TM HS-TSH Immunoassay System

- Pathway: 510(k) (Traditional)
- Applicant: Nichols Institute Diagnostics
- Decided: Oct 2, 1985 after 27 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K990658: Thyrochek One-Step Whole Blood Rapid TSH Assay (1999), 1 descendant of its own
- K030912: Thyro Test (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K853717
Methodology: https://510kreport.com/methodology