LTB · Cyclosporine Radioimmunoassay
Clinical Chemistry · 21 CFR 862.1235 · Class 2
Overview
| Product Code | LTB |
|---|---|
| Device Name | Cyclosporine Radioimmunoassay |
| Regulation | 21 CFR 862.1235 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A cyclosporine test system is a device intended to quantitatively determine cyclosporine 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 cyclosporine.
Classification Rationale
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.
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K813523 | ELECTRIC SELF STERILIZATION INOCUL. LOOP | Techhnilab Instruments, Inc. | Dec 31, 1981 | SESE |
Top Applicants
- Techhnilab Instruments, Inc. — 1 clearance
