# K980574: Auraflex TSH-3 200 Test Pack Model Number 80600, Auraflex  TSH-3 Calibrator Pack Model Number Number 80601 Auraflex DIL0

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Biotech (Uk), Ltd.
- Decided: Mar 24, 1998 after 35 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
AuraFlex TSH-3 is a “third generation” fluorescent enzyme immunoassay for the quantitative determination of thyroid stimulating hormone (TSH) in human serum or plasma using the AuraFlex system. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

Source page: https://510kreport.com/device/K980574
Methodology: https://510kreport.com/methodology