# K131928: Frend TSH (Reagent Cartridge)

- Pathway: 510(k) (Traditional)
- Applicant: Nanoentek USA, Inc.
- Decided: Mar 14, 2014 after 260 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 K972586 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972586: Aia-Pack TSH 3RD-Gen Assay, Tosoh Medics, Inc. (1997) Summary page 2.

## Indications for use
FREND TSH is designed for in vitro DIAGNOSTIC USE ONLY for the quantitative measurement of Thyroid Stimulating Hormone (thyrotropin or TSH) in human serum and lithium heparin plasma using the FREND system. FREND TSH is indicated for use in clinical laboratories upon prescription by the attending physician as an aid to clinicians in the diagnosis of thyroid disease.

Source page: https://510kreport.com/device/K131928
Methodology: https://510kreport.com/methodology