# K150168: Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Nov 4, 2015 after 282 days
- Product code: MLM (Enzyme Immunoassay, Tracrolimus)
- Device class: 2
- Regulation: 21 CFR 862.1678
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P970007 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070820: Architect Tacrolimus: Model 1L77, Fujirebio Diagnostics,Inc. (2007) Summary page 4.
- K060503: Dimension Tacr Calibrator, Model DC107, Dade Behring, Inc. (2006) Summary page 4.

## Recalls of this device
- May 7, 2026 · Class II · Z-2398-2026: A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
- Jan 30, 2023 · Class II · Z-1258-2023: Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with Dimension Tacrolimus (TAC) lots GA2286, GA3047 and GA3171. The health 

## Indications for use
The Dimension Tacrolimus Flex® Reagent Cartridge (TAC) is an in vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension® clinical chemistry system. Measurements of tacrolimus are used as an aid in the management of tacrolimus therapy in renal and hepatic transplant patients. The Dimension Tacrolimus Calibrator (TAC CAL) is an in vitro diagnostic product for the calibration of the Tacrolimus (TAC) method on the Dimension® clinical chemistry system.

Source page: https://510kreport.com/device/K150168
Methodology: https://510kreport.com/methodology