OAV · Mycophenolic Acid Test System
Clinical Toxicology · 21 CFR 862.3840 · Class 2
Overview
| Product Code | OAV |
|---|---|
| Device Name | Mycophenolic Acid Test System |
| Regulation | 21 CFR 862.3840 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A sirolimus test system is a device intended to quantitatively determine sirolimus concentrations in whole blood. Measurements are used as an aid in management of transplant patients receiving therapy with sirolimus.
Classification Rationale
Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Sirolimus Test Systems.” See § 862.1(d) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Sirolimus Test Systems.” See § 862.1(d) for the availability of this guidance document.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K102772 | DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL) | Siemens Heatlhcare Diagnostics, Inc. | Oct 7, 2011 | SESE |
| K081083 | CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS | Thermo Fisher Scientific | Dec 19, 2008 | SESE |
| K063520 | ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS | Roche Diagnostics | Feb 16, 2007 | SESE |
Top Applicants
- Roche Diagnostics — 1 clearance
- Siemens Heatlhcare Diagnostics, Inc. — 1 clearance
- Thermo Fisher Scientific — 1 clearance
