# K053059: Roche Diagnostics Elecsys Prolactin II Calcheck

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics
- Decided: Nov 28, 2005 after 28 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: 2 generations back to K924863 (1992). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970147: Elecsys Calcheck Prolactin, Boehringer Mannheim Corp. (1997) Summary page 2.

## Most influential descendants
- K060585: Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol Acth (2006), 4 descendants of its own
- K111335: ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321 (2011), 1 descendant of its own
- K223867: Ids Acth II (2023), 0 descendants of its own
- K143296: AIA-PACK C-Peptide Control Set (2014), 0 descendants of its own
- K131662: Immulite 2000 Acth Calibration Verification Material (2013), 0 descendants of its own

## Indications for use
For use in the verification of the calibration established by the Elecsys Prolactin II reagent on Elecsys 1010/2010 and MODULAR ANALYTICS E170 Immunoassay analyzers.

Source page: https://510kreport.com/device/K053059
Methodology: https://510kreport.com/methodology