21 CFR 862.1235 — Cyclosporine Radioimmunoassay
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1235
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LTB | Cyclosporine Radioimmunoassay | 2 | 1 | 3rd Party |
| MAR | Cyclosporine And Metabolites Serum Assay | 2 | 0 | 3rd Party |
| MGS | High Performance Liquid Chromatography For Cyclosporine | 2 | 1 | 3rd Party |
| MGU | Fluorescence Polarization Immunoassay For Cyclosporine | 2 | 1 | 3rd Party |
| MGV | Radioimmunoassay For Cyclosporine | 2 | 1 | 3rd Party |
| MKW | Cyclosporine | 2 | 10 | 3rd Party |
Special Controls
LTB — Cyclosporine Radioimmunoassay
*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.
eCFR
LTB — Cyclosporine Radioimmunoassay
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.
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MAR — Cyclosporine And Metabolites Serum Assay
*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.
eCFR
MGS — High Performance Liquid Chromatography For Cyclosporine
*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.
eCFR
MGU — Fluorescence Polarization Immunoassay For Cyclosporine
*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.
eCFR
MGV — Radioimmunoassay For Cyclosporine
*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.
eCFR
MKW — Cyclosporine
*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.
eCFR
