21 CFR 862.3840 — Sirolimus Test System
Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3840
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| NRP | Sirolimus Test System | 2 | 5 | 3rd Party |
| OAV | Mycophenolic Acid Test System | 2 | 3 | 3rd Party |
| OUF | Everolimus Immunoassay | 2 | 2 |
Special Controls
NRP — Sirolimus Test System
*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.
eCFR
NRP — Sirolimus Test System
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.
Ecfr Llm
OAV — Mycophenolic Acid Test System
*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.
eCFR
OUF — Everolimus Immunoassay
*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.
eCFR
