# K983442: Abbott Architect TSH

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Nov 20, 1998 after 51 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.
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 assay: named in the summary without a submission number

## Recalls of this device
- Nov 21, 2018 · Class II · Z-0664-2019: Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it ma

## Indications for use
Abbott ARCHITECT™ TSH is a Chemiluminescent Microparticle Inmunoassay (CMIA) for the quantitative determination of thyroid stimulating hormone (TSH) in human serum and plasma. The ARCHITECT TSH assay is to be 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/K983442
Methodology: https://510kreport.com/methodology