510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Dimension Tacr Flex Reagent Cartridge, Model DF107

K060502510(k) TraditionalCleared May 18, 200683-day reviewClass II21 CFR 862.1678Recalls 3

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

Dade Behring, Inc. · MLM Enzyme Immunoassay, Tracrolimus

Cleared on May 18, 2006 as substantially equivalent to P970007 (Abbott Laboratories, 1997) after an 83-day review. Its family tree reaches back 1 generation to 1997. It has been recalled 3 times.

Decided
May 18, 2006
Review
83 days
Class
Class II
Product code
MLM
Recalls
3
Predicates
1

Its longest line of descent runs back 1 generation to P970007 (1997). No later device cites it as a predicate yet.

P970007 · Imx Tacrolimus II Assay · Abbott Laboratories · 1997 · recalled1996199820002002200420062008
P970007 · Imx Tacrolimus II Assay · Abbott Laboratories · 1997 · recalled0
  1. Root · 1 generation backP970007 Imx Tacrolimus II AssayAbbott Laboratories · 1997 · Recalled
  2. This deviceK060502 Dimension Tacr Flex Reagent Cartridge, Model DF107Dade Behring, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1P970007Imx Tacrolimus II AssayAbbott Laboratories19972
0 (this device)K060502Dimension Tacr Flex Reagent Cartridge, Model DF107Dade Behring, Inc.2006—
FIG. 1 — Lineage of K060502, 1997–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203833 Tacrolimus Assay Kitscore 5.0 · 2 generations · no Class I recall
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*P970007Imx Tacrolimus II Assay
Summary page 1
…ame / Classification Dimension® TACR Flex® reagent cartridge / Class II 3. Identification of the Predicate Device Abbott IMx® Tacrolimus II Assay, P970007 (Note: Tacrolimus test systems have been reclassified into Class II since the predicate was approved.) 4. Dev…
Abbott Laboratories19972

Also cleared against P970007: 4 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

DateClassRecallRoot causeReason
Jul 1, 2013Class IIZ-1924-2013Process controlSiemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimension TACR Flex Reagent cartridge (DF107) lot BB4087 and its linked calibrator (DC 107) lot 3BD029. Falsely low Tacrolimus results across the…
Nov 27, 2012Class IIZ-0957-2013Process controlSiemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA3085. Quality Control (QC) materials have not exhibited low recovery of the same magnitude. Internal method regression testing…
Jun 15, 2010Not classifiedZ-2407-2010OtherLow patient sample recovery results in all affected lots, with possibility of inappropriate increase in tacrolimus dosage based on false low result.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • 4 other devices also cite its predicate P970007.

How does its category compare?

All MLM devices

MLM Enzyme Immunoassay, Tracrolimus: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MLM

1in 2023

2007: 22013: 12015: 12018: 12023: 1
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

2010: 22012: 12013: 12026 (partial year): 1
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

2007: 42010: 52011: 42012: 312013: 752014: 62015: 12016: 22017: 22018: 262019: 72020: 42021: 12022: 232023: 542024: 622025: 8
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—04
20080—00
20090—00
20100—25
20110—04
20120—131
20131—175
20140—06
20151—01
20160—02
20170—02
20181—026
20190—07
20200—04
20210—01
20220—023
20231—054
20240—062
20250—08
20260—1—

What is it indicated for?

The Dimension® TACR Flex® reagent cartridge is an in vitro diagnostic test intended to quantitatively measure 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 kidney and liver transplant patients.

Indications for use as stated in the FDA summary.

Also cleared against P970007

4 other devices cite the same predicate.

  • K070820Architect Tacrolimus: Model 1L77Fujirebio Diagnostics,Inc. · 20071 recall
  • K060503Dimension Tacr Calibrator, Model DC107Dade Behring, Inc. · 2006
  • K060385Emit 2000 Tacrolimus Assay and Sample Pretreatment ReagentDade Behring, Inc. · 20061 recall
  • K060371The Emit 2000 Tacrolimus CalibratorsDade Behring, Inc. · 2006

More from Dade Behring, Inc.

347 FDA decisions under this applicant name. See the company

  • K093848PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc. · 2010
  • K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and…Dade Behring, Inc. · 2008
  • K081249Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension…Dade Behring, Inc. · 2008
  • K071603Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)Dade Behring, Inc. · 2008
  • K071597Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci 5 Calibrator…Dade Behring, Inc. · 2008

Recent decisions in MLM

The MLM category page

  • K203833Tacrolimus Assay KitShanghai Genext Medical Technology Co., Ltd. · 2023
  • K173857Elecsys TacrolimusRoche Diagnostics · 2018
  • K150168Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)Siemens Healthcare Diagnostics · 20152 recalls
  • K123343Thermo Scientific QMS Tacrolimus Assay and CalibratorsMicrogenics Corp. · 20132 recalls
  • K070820Architect Tacrolimus: Model 1L77Fujirebio Diagnostics,Inc. · 20071 recall

https://510kreport.com/device/K060502 · printed Nov 5, 2026

Cite this page

510(k) Report. “K060502: Dimension Tacr Flex Reagent Cartridge, Model DF107.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060502

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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