510(k) Report

510(k) · Cleared

Recalled · 2010

Architect Tacrolimus: Model 1L77

K070820510(k) TraditionalCleared Aug 1, 2007128-day reviewClass II21 CFR 862.1678Recalls 1

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

Fujirebio Diagnostics,Inc. · MLM Enzyme Immunoassay, Tracrolimus

Cleared on Aug 1, 2007 as substantially equivalent to P970007 (Abbott Laboratories, 1997) after a 128-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it. It has been recalled once.

Decided
Aug 1, 2007
Review
128 days
Class
Class II
Product code
MLM
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to P970007 (1997). 4 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2023: 1 descendant cleared2018: 1 descendant cleared2015: 1 descendant clearedP970007 · Imx Tacrolimus II Assay · Abbott Laboratories · 1997 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 4 descendants P970007 · Imx Tacrolimus II Assay · Abbott Laboratories · 1997 · recalled0
  1. Root · 1 generation backP970007 Imx Tacrolimus II AssayAbbott Laboratories · 1997 · Recalled
  2. This deviceK070820 Architect Tacrolimus: Model 1L77Fujirebio Diagnostics,Inc. · 2007
  3. Descendant · cites it directly · 0 of its ownK203833 Tacrolimus Assay KitShanghai Genext Medical Technology Co., Ltd. · 2023
  4. Descendant · cites it directly · 0 of its ownK173857 Elecsys TacrolimusRoche Diagnostics · 2018
  5. Descendant · cites it directly · 0 of its ownK150168 Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension…Siemens Healthcare Diagnostics · 2015 · Recalled
  6. Descendant · cites it directly · 0 of its ownK123343 Thermo Scientific QMS Tacrolimus Assay and CalibratorsMicrogenics Corp. · 2013 · Recalled

Most influential descendants

Showing 4 of 4 · See all
  • K203833Tacrolimus Assay KitShanghai Genext Medical Technology Co., Ltd. · 2023 · cites it directly0descendants
  • K173857Elecsys TacrolimusRoche Diagnostics · 2018 · cites it directly0descendants
  • K150168Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC…Siemens Healthcare Diagnostics · 2015 · cites it directly0descendants
  • K123343Thermo Scientific QMS Tacrolimus Assay and CalibratorsMicrogenics Corp. · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1P970007Imx Tacrolimus II AssayAbbott Laboratories19972
0 (this device)K070820Architect Tacrolimus: Model 1L77Fujirebio Diagnostics,Inc.2007—
+1K203833Tacrolimus Assay KitShanghai Genext Medical Technology Co., Ltd.2023—
+1K173857Elecsys TacrolimusRoche Diagnostics2018—
+1K150168Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus…Siemens Healthcare Diagnostics20152
+1K123343Thermo Scientific QMS Tacrolimus Assay and CalibratorsMicrogenics Corp.20132

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201510
201810
202310
FIG. 1 — Lineage of K070820, 1997–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 4
…P707Device) P970007 l Device Type In vitro diagnostic In vitro diagnostic Classification and Classific…
Abbott Laboratories19972

Also cleared against P970007: 4 other devices →

What descends from it? (4)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K203833Tacrolimus Assay KitShanghai Genext Medical Technology Co., Ltd.20230
K173857Elecsys TacrolimusRoche Diagnostics20180
K150168Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC…Siemens Healthcare Diagnostics20150
K123343Thermo Scientific QMS Tacrolimus Assay and CalibratorsMicrogenics Corp.20130

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 7, 2010Not classifiedZ-0068-2011OtherThere are reagent barcode read errors when using reagent lot 86599M500 due to the print quality of the barcode.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K203833 (Shanghai Genext Medical Technology Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
  • 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. 2007, this device’s year, is highlighted.

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?

Reagent Kit The ARCHITECT Tacrolimus assay is a chemiluminescent Microparticle immunoassay (CMIA) for the quantitative determination of tacrolimus in human whole blood on the ARCHITECT i System. The ARCHITECT Tacrolimus assay is to be used as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy. Calibrator Kit The ARCHITECT Tacrolimus Calibrators are for the calibration of the ARCHITECT i System when used for the…

Read the full statement (114 words)

Reagent Kit

The ARCHITECT Tacrolimus assay is a chemiluminescent Microparticle immunoassay (CMIA) for the quantitative determination of tacrolimus in human whole blood on the ARCHITECT i System. The ARCHITECT Tacrolimus assay is to be used as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy.

Calibrator Kit

The ARCHITECT Tacrolimus Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of tacrolimus in human whole blood.

Whole Blood Precipitation Reagent

The ARCHITECT Tacrolimus Whole Blood Precipitation Reagent is for the extraction of tacrolimus from samples (human whole blood patient specimens, controls, and ARCHITECT Tacrolimus Calibrators) to be tested on the ARCHITECT i System.

Indications for use as stated in the FDA summary.

Also cleared against P970007

4 other devices cite the same predicate.

  • K060502Dimension Tacr Flex Reagent Cartridge, Model DF107Dade Behring, Inc. · 20063 recalls
  • 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 Fujirebio Diagnostics,Inc.

45 FDA decisions under this applicant name. See the company

  • K250925ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc. · 2025
  • K242706Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioFujirebio Diagnostics,Inc. · 20257 recalls
  • DEN200072Lumipulse G ß-Amyloid Ratio (1-42/1-40)Fujirebio Diagnostics,Inc. · 2022
  • K192524Lumipulse G CA15-3Fujirebio Diagnostics,Inc. · 2020
  • K192380ST Aia-Pack BNPFujirebio Diagnostics,Inc. · 2020

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
  • K063868Masstrak Immunosuppressants KitWaters Corporation · 2007

https://510kreport.com/device/K070820 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070820: Architect Tacrolimus: Model 1L77.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070820

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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