# K111762: ST Aia-Pack Dhea-S Calibrator Set

- Pathway: 510(k) (Abbreviated)
- Applicant: Tosoh Bioscience, Inc.
- Decided: Aug 5, 2011 after 43 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K935806 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040181: Access Dhea-S Reagent Assay, Beckman Coulter, Inc. (2004) Summary page 1.

## Indications for use
ST MIA-PACK DHEA-S Calibrator Set is designed for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AlA-PACK DHEA-S assay on Tosoh AIA System Analyzers

Source page: https://510kreport.com/device/K111762
Methodology: https://510kreport.com/methodology