# K123343: Thermo Scientific QMS Tacrolimus Assay and Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Jul 11, 2013 after 253 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 2.

## Recalls of this device
- Nov 21, 2023 · Class II · Z-0712-2024: Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 2024, due to improper storage that is expected to degrade the quality of the calibrator and 
- Jan 20, 2022 · Class II · Z-1284-2022: Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result values when used with the QMS Tacrolimus Immunoassay.

## Indications for use
The QMS® Tacrolimus Immunoassay is intended for the quantitative determination of tacrolimus in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney, liver, and heart transplant patients receiving tacrolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only. The QMSO Tacrolimus Calibrator set is intended for use in calibration of the QMS® Tacrolimus Immunoassay.

Source page: https://510kreport.com/device/K123343
Methodology: https://510kreport.com/methodology