# K962269: Cedia Cardiac TDM Multi-Cals

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Oct 29, 1996 after 138 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 K830206 (1983). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910642: Cedia (R) Digoxin SC Assay, Microgenics Corp. (1991) Summary page 1.
- K834464: TDX Procainamide, Abbott Laboratories (1984) Summary page 1.
- K830206: TDX N-Acetylprocainamide, Abbott Laboratories (1983) Summary page 1.

## Most influential descendants
- K972433: Cedia Digoxin Calibrators (1997), 0 descendants of its own

## Indications for use
The CEDIA Cardiac TDM Multi-Cals are used to calibrate the CEDIA assays for digoxin, N-acetylprocainamide, and procainamide, in human serum and plasma.

Source page: https://510kreport.com/device/K962269
Methodology: https://510kreport.com/methodology