510(k) · Cleared

Recalled · Class II · 2023

Thermo Scientific QMS Tacrolimus Assay and Calibrators

K123343510(k) TraditionalCleared Jul 11, 2013253-day reviewClass II21 CFR 862.1678Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Microgenics Corp. · MLM Enzyme Immunoassay, Tracrolimus

Cleared on Jul 11, 2013 as substantially equivalent to K070820 (Fujirebio Diagnostics,Inc., 2007) after a 253-day review. Its family tree reaches back 2 generations to 1997. It has been recalled 2 times.

Decided: Jul 11, 2013
Review: 253 days
Class: Class II
Product code: MLM
Recalls: 2
Predicates: 1

Its longest line of descent runs back 2 generations to P970007 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backP970007 Imx Tacrolimus II AssayAbbott Laboratories · 1997 · Recalled
1 generation backK070820 Architect Tacrolimus: Model 1L77Fujirebio Diagnostics,Inc. · 2007 · Recalled
This deviceK123343 Thermo Scientific QMS Tacrolimus Assay and CalibratorsMicrogenics Corp. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	P970007	Imx Tacrolimus II Assay	Abbott Laboratories	1997	2
−1	K070820	Architect Tacrolimus: Model 1L77	Fujirebio Diagnostics,Inc.	2007	1
0 (this device)	K123343	Thermo Scientific QMS Tacrolimus Assay and Calibrators	Microgenics Corp.	2013	—

FIG. 1 — Lineage of K123343, 1997–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MLM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MLM device

#1 K203833 Tacrolimus Assay Kitscore 5.0 · 2 generations · no Class I recall

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K070820	Architect Tacrolimus: Model 1L77 Summary page 2 …Which Equivalency is Claimed The Thermo Scientific QMS® Tacrolimus Immunoassay is substantially equivalent to the previously cleared Abbott ARCHITECT® Tacrolimus Assay (k070820). Device Description The QMS® Tacrolimus Immunoassay consists of separately packaged reagents (Reagent 1. Reagent 2 and Extracti…	Fujirebio Diagnostics,Inc.	2007	1

Also cleared against K070820: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 21, 2023	Class II	Z-0712-2024	Storage	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 render it unsuitable for use. Use of…
Jan 20, 2022	Class II	Z-1284-2022	Process control	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.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
2 of the 2 ancestors have a recall of any class.
3 other devices also cite its predicate K070820.

How does its category compare?

All MLM devices

MLM Enzyme Immunoassay, Tracrolimus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · MLM

1in 2023

2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MLM

Too few MLM 510(k)s in any year since 2007 to give a median.

Recalls per year · MLM

1in 2013

2007high 2 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MLM

8in 2025

2007high 75 (2013) · low 0 (2008)2025

MAUDE reports naming product code MLM, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	4
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	2	5
2011	0	—	0	4
2012	0	—	1	31
2013	1	—	1	75
2014	0	—	0	6
2015	1	—	0	1
2016	0	—	0	2
2017	0	—	0	2
2018	1	—	0	26
2019	0	—	0	7
2020	0	—	0	4
2021	0	—	0	1
2022	0	—	0	23
2023	1	—	0	54
2024	0	—	0	62
2025	0	—	0	8
2026	0	—	1	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123343 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123343: Thermo Scientific QMS Tacrolimus Assay and Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123343

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026