# K070820: Architect Tacrolimus: Model 1L77

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Aug 1, 2007 after 128 days
- Product code: MLM (Enzyme Immunoassay, Tracrolimus)
- Device class: 2
- Regulation: 21 CFR 862.1678
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P970007 (1997). 1 ancestor in all.
4 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P970007: Imx Tacrolimus II Assay, Abbott Laboratories (1997) Summary page 4.

## Most influential descendants
- K203833: Tacrolimus Assay Kit (2023), 0 descendants of its own
- K173857: Elecsys Tacrolimus (2018), 0 descendants of its own
- K150168: Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) (2015), 0 descendants of its own
- K123343: Thermo Scientific QMS Tacrolimus Assay and Calibrators (2013), 0 descendants of its own

## Recalls of this device
- Sep 7, 2010 · Not classified · Z-0068-2011: There are reagent barcode read errors when using reagent lot 86599M500 due to the print quality of the barcode.

## Indications for use
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.

Source page: https://510kreport.com/device/K070820
Methodology: https://510kreport.com/methodology