CHO · Radioimmunoassay, Cyclic Amp
Clinical Chemistry · 21 CFR 862.1230 · Class 2
Overview
| Product Code | CHO |
|---|---|
| Device Name | Radioimmunoassay, Cyclic Amp |
| Regulation | 21 CFR 862.1230 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A cyclic AMP test system is a device intended to measure the level of adenosine 3′, 5′-monophosphate (cyclic AMP) in plasma, urine, and other body fluids. Cyclic AMP measurements are used in the diagnosis and treatment of endocrine disorders, including hyperparathyroidism (overactivity of the parathyroid gland). Cyclic AMP measurements may also be used in the diagnosis and treatment of Graves' disease (a disorder of the thyroid) and in the differentiation of causes of hypercalcemia (elevated levels of serum calcium.)
Classification Rationale
Class II.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K860253 | AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT) | Amersham Corp. | Mar 14, 1986 | SESE |
| K844135 | PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU | Immuno Nuclear Corp. | Mar 5, 1985 | SESE |
| K841478 | RIANEN CYCLIC-AMP RADIOIMMUNOASSAY | New England Nuclear | Jun 14, 1984 | SESE |
| K823504 | CYCLIC ADENOSINE MONOPHOSHATE BY RADIO | Immuno Nuclear Corp. | Jan 28, 1983 | SESE |
| K811746 | KING DIAGNOSTICS CHOLESTEROL-FE TEST | King Diagnostics, Inc. | Jul 10, 1981 | SESE |
| K811273 | CYCLIC AMP RADIOIMMUNOASSAY KIT [125I] | Bd Becton Dickinson Vacutainer Systems Preanalytic | May 27, 1981 | SESE |
Top Applicants
- Immuno Nuclear Corp. — 2 clearances
- New England Nuclear — 1 clearance
- King Diagnostics, Inc. — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Amersham Corp. — 1 clearance
