# K961659: Cedia Core TDM Multi-Cal

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jun 13, 1996 after 44 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 K904413 (1990). 4 ancestors in all.
1 later device descends 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)
- K914857: Cedia (R) Carbamazepine Assay, Microgenics Corp. (1992) Summary page 1.
- K904413: Cedia (TM) Phenobarbital Assay, Microgenics Corp. (1990) Summary page 1.
- K905689: Cedia Phenytoin Assay, Microgenics Corp. (1991) Summary page 1.
- K930734: Cedia Valporic Acid Assay, Microgenics Corp. (1993) Summary page 1.

## Cited in the summary but kept off the family tree
- K961462: Cedia Theophylline Assay, Boehringer Mannheim Corp. (1996). Our OCR of the scanned summary read K961462, which FDA decided on Jun 27, 1996, after this device was decided (Jun 13, 1996), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 1.

## Most influential descendants
- K120936: Abbott TDM Multiconstituent Calibrator, Thermo Scientific QMS Multi-Constituent Calibrators (2012), 0 descendants of its own

## Indications for use
The CEDIA Core TDM Multi-Cals are used to calibrate the CEDIA assays for carbamazepine, phenobarbital, phenytoin, theophylline, and valproic acid in human serum and plasma.

Source page: https://510kreport.com/device/K961659
Methodology: https://510kreport.com/methodology