# K972586: Aia-Pack TSH 3RD-Gen Assay

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Medics, Inc.
- Decided: Aug 29, 1997 after 49 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K131928: Frend TSH (Reagent Cartridge) (2014), 0 descendants of its own

## Recalls of this device
- Mar 5, 2018 · Class II · Z-2077-2018: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

## Indications for use
AIA-PACK TSH 3rd-Gen is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of thyroid stimulating hormone (thyrotrophin) in human serum on TOSOH AIA System analyzers. Measurements obtained by this device are used in the diagnosis of thyroid or pituitary disorders.

Source page: https://510kreport.com/device/K972586
Methodology: https://510kreport.com/methodology