# K981060: Abbott Axsym 3RD Generation TSH Assay

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Apr 29, 1998 after 37 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) AxSYM Ultrasensitive hTSH II assay: named in the summary without a submission number

## Indications for use
AxSYM® 3rd Generation TSH is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of thyroid stimulating hormone (TSH) in human serum or plasma on the AXSYM System. The AxXSYM 3rd Generation TSH assay is used as an aid in the assessment of thyroid status, diagnosis of thyroid disease, and treatment of thyroid disease.

Source page: https://510kreport.com/device/K981060
Methodology: https://510kreport.com/methodology