# K970147: Elecsys Calcheck Prolactin

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Feb 10, 1997 after 26 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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: 1 generation back to K924863 (1992). 1 ancestor in all.
6 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)
- K924863: Aia-Pack FSH Calibration Verification Test Set, Tosoh Medics, Inc. (1992) Summary page 1.

## Most influential descendants
- K053059: Roche Diagnostics Elecsys Prolactin II Calcheck (2005), 5 descendants of its own
- 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

## Indications for use
The Boehringer Mannheim Elecsys® CalCheck™ Prolactin is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Prolactin assay.

Source page: https://510kreport.com/device/K970147
Methodology: https://510kreport.com/methodology