# K973973: Elecsys Callcheck Digoxin

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Nov 4, 1997 after 15 days
- Product code: DMP (Digoxin Control Serum, Ria)
- Device class: 1
- Regulation: 21 CFR 862.3280
- 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.
3 later devices descend from it; 1 cites it directly.
0 of 6 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
- K102044: Elecsys Digoxin Calcheck 5 (2010), 2 descendants of its own
- K140267: Advia Centaur Tni-Ultra Master Curve Material (MCM), Advia Centaur Digoxin Master Curve Material (MCM) (2014), 0 descendants of its own
- K112113: Elecsys Myoglobin Calcheck 5 (2011), 0 descendants of its own

## Indications for use
Elecsys® CalCheck™ DIGOXIN calibration verification solutions comprise three levels - low, mid, and high - each with a defined DIGOXIN concentration. The low solution concentration is near the lower detection limit of the assay. The mid solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range. The Elecsys® CalCheck™ DIGOXIN is intended for use in periodic verification of the calibration of the Elecsys® DIGOXIN reagent.

Source page: https://510kreport.com/device/K973973
Methodology: https://510kreport.com/methodology