# K981312: 3RD Generation TSH Assay for the Bayer Immuno 1 System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Jun 5, 1998 after 56 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) Bayer Immuno 1 TSH Assay: named in the summary without a submission number
- (no number) Ciba-Corning ACS™ TSH-3 Assay: named in the summary without a submission number
- (no number) Boehringer-Mannheim Elecsys® TSH Assay: named in the summary without a submission number

## Indications for use
This in vitro diagnostic method is intended to quantitatively measure thyroid stimulating hormone in human serum or plasma on the Bayer Immuno 1 System. Measurements of TSH, with a 3™ Generation sensitivity of <20% total CV at 0.01 pIU/mL to 0.02 pIU/mL (as defined by the American Thyroid Association), are used as an aid in the diagnosis of thyroid or pituitary disorders. This diagnostic method is not intended for use on any other system.

Source page: https://510kreport.com/device/K981312
Methodology: https://510kreport.com/methodology