# K060503: Dimension Tacr Calibrator, Model DC107

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: May 18, 2006 after 83 days
- Product code: DLJ (Calibrators, Drug Specific)
- 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: 1 generation back to P970007 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P970007: Imx Tacrolimus II Assay, Abbott Laboratories (1997) Summary page 1.

## Most influential descendants
- K150168: Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) (2015), 0 descendants of its own

## Indications for use
The Dimension® TACR Calibrator is an in vitro diagnostic product intended to be used to calibrate the Tacrolimus (TACR) method for the Dimension® clinical chemistry system.

Source page: https://510kreport.com/device/K060503
Methodology: https://510kreport.com/methodology