Enzyme Immunoassay, Tracrolimus
The Enzyme Immunoassay for Tacrolimus is an in vitro diagnostic device used to measure tacrolimus (FK506) concentrations in patient whole blood to support therapeutic drug monitoring in solid organ transplant recipients, where maintaining appropriate drug levels is critical to preventing graft rejection while minimizing drug toxicity. Classified as a Class 2 device under 21 CFR 862.1678 within the Clinical Chemistry specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- MLM
- Device Class
- FDA class 2
- Regulation Number
- 862.1678
- Medical Specialty
- Clinical Chemistry
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K203833 | Tacrolimus Assay Kit | Jan 27, 2023 | Substantially Equivalent | Shanghai Genext Medical Technology Co., Ltd. |
| K173857 | Elecsys Tacrolimus | Nov 06, 2018 | Substantially Equivalent | Roche Diagnostics |
| K150168 | Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) | Nov 04, 2015 | Substantially Equivalent | Siemens Healthcare Diagnostics |
| K123343 | THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS | Jul 11, 2013 | Substantially Equivalent | Microgenics Corp. |
| K070820 | ARCHITECT TACROLIMUS: MODEL 1L77 | Aug 01, 2007 | Substantially Equivalent | Fujirebio Diagnostics,Inc. |
| K063868 | MASSTRAK IMMUNOSUPPRESSANTS KIT | May 25, 2007 | Substantially Equivalent | Waters Corporation |
| K060502 | DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 | May 18, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K060385 | EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT | Apr 06, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K050206 | CEDIA TACROLIMUS ASSAY | Mar 15, 2005 | Substantially Equivalent | Microgenics Corp. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.