Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1678](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1678) → MLM — Enzyme Immunoassay, Tracrolimus

# MLM · Enzyme Immunoassay, Tracrolimus

_Clinical Chemistry · 21 CFR 862.1678 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MLM

## Overview

- **Product Code:** MLM
- **Device Name:** Enzyme Immunoassay, Tracrolimus
- **Regulation:** [21 CFR 862.1678](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1678)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## Identification

A tacrolimus test system is a device intended to quantitatively determine tacrolimus concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for tacrolimus.

## Classification Rationale

Class II (special controls). The special control is “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA.” See § 862.1(d) for the availability of this guidance document.

## Special Controls

*Classification.* Class II (special controls). The special control is “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA.” See § 862.1(d) for the availability of this guidance document.

## Recent Cleared Devices (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K203833](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MLM/K203833.md) | Tacrolimus Assay Kit | Shanghai Genext Medical Technology Co., Ltd. | Jan 27, 2023 | SESE |
| [K173857](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MLM/K173857.md) | Elecsys Tacrolimus | Roche Diagnostics | Nov 6, 2018 | SESE |
| [K150168](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MLM/K150168.md) | Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) | Siemens Healthcare Diagnostics | Nov 4, 2015 | SESE |
| [K123343](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MLM/K123343.md) | THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS | Microgenics Corp. | Jul 11, 2013 | SESE |
| [K070820](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MLM/K070820.md) | ARCHITECT TACROLIMUS: MODEL 1L77 | Fujirebio Diagnostics,Inc. | Aug 1, 2007 | SESE |
| [K063868](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MLM/K063868.md) | MASSTRAK IMMUNOSUPPRESSANTS KIT | Waters Corporation | May 25, 2007 | SESE |
| [K060502](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MLM/K060502.md) | DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 | Dade Behring, Inc. | May 18, 2006 | SESE |
| [K060385](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MLM/K060385.md) | EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT | Dade Behring, Inc. | Apr 6, 2006 | SESE |
| [K050206](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MLM/K050206.md) | CEDIA TACROLIMUS ASSAY | Microgenics Corp. | Mar 15, 2005 | SESE |
| [P970025](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MLM/P970025.md) | PRO-TRAC II TACROLIMUS ELISA KIT | DiaSorin, Inc. | Apr 27, 1999 | APRL |
| [P970007](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MLM/P970007.md) | IMX TACROLIMUS II ASSAY | Abbott Laboratories | Aug 26, 1997 | APRL |

## Top Applicants

- Dade Behring, Inc. — 2 clearances
- Microgenics Corp. — 2 clearances
- Abbott Laboratories — 1 clearance
- DiaSorin, Inc. — 1 clearance
- Fujirebio Diagnostics,Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MLM](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MLM)

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