IMX Tacrolimus II Assay
by Abbott Laboratories PMA
Active
PMA P970007
Overview
The IMX Tacrolimus II Assay is an enzyme immunoassay (EIA) designed for the quantitative determination of tacrolimus and its metabolites in human whole blood. Classified as a Class II device under FDA regulations, it serves as an in-vitro reagent system to aid in the clinical management of liver allograft patients undergoing tacrolimus therapy.
This assay is supplied as a single-use reagent system and is intended for use in clinical chemistry laboratories. It requires FDA_PMA authorization (PMA Number: P970007) and is regulated under the FDA’s device classification system (product code: MLM, regulation number: 862.1678). Storage and handling conditions are not specified in the provided data, but compliance with manufacturer instructions is essential for accurate results.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP970007 | Date26 Aug 1997 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
-
- Terminated Z-0230-04
Inadequate instructions for use resulting in calibration errors and the protein interference data in the package insert is not representative of assay performances.
-
- Terminated Z-0063-04
Invalid test results are being generated due to calibration errors when using calibrator lots 94165M100 and 94164M100.
Specification
- Full name
- Imx Tacrolimus Ii
- Trade Name
- Imx Tacrolimus Ii Assay
- Generic Name
- ENZYME IMMUNOASSAY, TRACROLIMUS
- PMA Number
- FDA Product Code
- MLM
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1678
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- APRL
Other devices from Abbott Laboratories
Questions
What clinical area is the IMX Tacrolimus II Assay primarily used in, and how does it assist in patient management?
The IMX Tacrolimus II Assay is designed for use in clinical chemistry laboratories and aids in the management of liver allograft patients undergoing tacrolimus therapy. It quantifies tacrolimus and its metabolites in human whole blood, helping clinicians monitor drug levels to optimize immunosuppression while minimizing toxicity risks.
Is the IMX Tacrolimus II Assay intended for single-use or repeated testing, and how is it supplied?
The assay is explicitly supplied as a single-use reagent system, meaning each kit is intended for one test cycle. This design ensures consistency and prevents cross-contamination, aligning with standard practices for in-vitro diagnostics.
What regulatory pathway was followed for the approval of this device, and what does that mean for its use?
The IMX Tacrolimus II Assay was approved via the FDA’s Premarket Approval (PMA) process (PMA #P970007), which is required for higher-risk Class II devices. This means it underwent rigorous clinical validation to demonstrate safety and effectiveness before commercialization, ensuring its reliability for quantitative blood testing in clinical settings.
Are there specific storage instructions provided for this assay, and what should I consider when handling it?
The provided data does not specify exact storage conditions, but compliance with the manufacturer’s instructions (Abbott Laboratories) is critical for maintaining assay accuracy. Typically, such reagents require refrigeration or controlled environments to preserve stability—always refer to the included documentation for precise guidance.