# K062581: Olympus TSH Reagent, Calibrator and Control and AU3000I Immunoassay System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Nov 29, 2006 after 90 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
Longest line of descent: 3 generations back to K915195 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961491: Elecsys TSH Assay, Boehringer Mannheim Corp. (1996) Summary page 1.
- K060754: Elecsys TSH Calset W/Models 04738551, Roche Diagnostics Corp. (2006) Summary page 1.
- K962573: Elecsys Precicontrol TSH, Boehringer Mannheim Corp. (1996) Summary page 1.
- K961481: Elecsys 2010 Analyzer, Boehringer Mannheim Corp. (1996) Summary page 1.

## Indications for use
The Olympus thyroid stimulating hormone (TSH) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of TSH levels in human serum and plasma using the Olympus AU3000iTM Immunoassay System. Measurements of TSH produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The Olympus TSH Calibrator is used for calibrating the quantitative Olympus TSH Assay on the Olympus AU3000i Immunoassay System. The Olympus TSH Control is used for quality control of the Olympus TSH test system on the Olympus AU3000i Immunoassay System. The Olympus AU3000i Immunoassay System is a chemiluminescent discrete photometric chemistry analyzer for the quantitative determination of analytes in human serum and plasma.

Source page: https://510kreport.com/device/K062581
Methodology: https://510kreport.com/methodology