# K131662: Immulite 2000 Acth Calibration Verification Material

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Oct 10, 2013 after 125 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- 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.
No later device cites it as a predicate yet.
0 of 12 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.

## Indications for use
The IMMULITE ACTH Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration and reportable range of the IMMULITE ACTH assay on the IMMULITE 2000 systems

Source page: https://510kreport.com/device/K131662
Methodology: https://510kreport.com/methodology