# K111335: ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Bioscience, Inc.
- Decided: Dec 1, 2011 after 203 days
- Product code: CKG (Radioimmunoassay, Acth)
- Device class: 2
- Regulation: 21 CFR 862.1025
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K931172 (1993). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060585: Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol Acth, Roche Diagnostics Corp. (2006) Summary page 1.

## Most influential descendants
- K143296: AIA-PACK C-Peptide Control Set (2014), 0 descendants of its own

## Recalls of this device
- Nov 30, 2018 · Class II · Z-0676-2019: 
- Jun 5, 2018 · Class III · Z-2827-2018: Distribution of unapproved product labeling

## Indications for use
ST AlA-PACK ACTH is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of adrenocorticotropic hormone (ACTH) in human EDTA plasma. Measurements of ACTH are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome. ST AlA-PACK ACTH Calibrator Set is designed for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AlA-PACK ACTH assay on Tosoh AlA System Analyzers ST ALA-PACK ACTH Control Set is designed for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AlA-PACK ACTH assay on Tosoh AlA System Analyzers

Source page: https://510kreport.com/device/K111335
Methodology: https://510kreport.com/methodology