IMX TACROLIMUS II ASSAY
Device Facts
| Record ID | P970007 |
|---|---|
| Device Name | IMX TACROLIMUS II ASSAY |
| Applicant | Abbott Laboratories |
| Product Code | MLM · Clinical Chemistry |
| Decision Date | Aug 26, 1997 |
| Decision | APRL |
| Regulation | 21 CFR 862.1678 |
| Device Class | Class 2 |
| Attributes | Expedited Review |
Regulatory Classification
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.
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.
