# K970452: Elecsys Calcheck Cea

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Mar 6, 1997 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 K924862 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963147: Elecsys Calcheck TSH, Boehringer Mannheim Corp. (1996) Summary page 1.

## Most influential descendants
- K101856: Elecsys Cea Calcheck 5 (2010), 0 descendants of its own

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

Source page: https://510kreport.com/device/K970452
Methodology: https://510kreport.com/methodology