# K120936: Abbott TDM Multiconstituent Calibrator, Thermo Scientific QMS Multi-Constituent Calibrators

- Pathway: 510(k) (Abbreviated)
- Applicant: Microgenics Corporation
- Decided: Dec 13, 2012 after 260 days
- Product code: DKB (Calibrators, Drug Mixture)
- Device class: 2
- Regulation: 21 CFR 862.3200
- 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 K904413 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961659: Cedia Core TDM Multi-Cal, Boehringer Mannheim Corp. (1996) Summary page 2.

## Indications for use
Abbott TDM Multiconstituent Calibrator For in vitro diagnostic use in the calibration of the Amikacin, Carbamazepine, Digoxin, Gentamicin, Phenobatbital, Phenytoin, Quinidine, Theophylline, Valproic Acid, and Vancomycin human serum and plasma assays on the ARCHITECT cSystems. Lot-specific calibrator for the ARCHITECT cSystems are listed in the TDM MCC Value Sheet, packaged with the calibrator. Thermo Scientific QMSO Multi-Constituent Calibrator For in vitro diagnostic use in the calibration of assays for the detection of Amikacin, Carbamazepine, Digoxin, Gentamicin, Phenobarbital, Phenytoin, Quinidine, Theophylline, Vaiproic Acid, and Vancomycin in human serum and plasma for use on clinical laboratory analyzers. Lot-specific calibrator values with specific analyzers are provided in the value sheet packaged with the calibrator.

Source page: https://510kreport.com/device/K120936
Methodology: https://510kreport.com/methodology