JKR · Radioimmunoassay, Calcitonin
Clinical Chemistry · 21 CFR 862.1140 · Class 2
Overview
| Product Code | JKR |
|---|---|
| Device Name | Radioimmunoassay, Calcitonin |
| Regulation | 21 CFR 862.1140 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thyrocalcitonin) levels in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).
Classification Rationale
Class II.
Recent Cleared Devices (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K182012 | ADVIA Centaur Calcitonin (CALCT) assay | Axis-Shield Diagnostics Limited | Dec 21, 2018 | SESE |
| K132828 | ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3 | Roche Diagnostics | Dec 4, 2013 | SESE |
| K060578 | CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION) | Scantibodies Laboratory, Inc. | Aug 30, 2006 | SESE |
| K023304 | IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL | Diagnostic Products Corp. | Dec 9, 2002 | SESE |
| K990073 | CALCITONIN | Kmi Diagnostics, Inc. | May 11, 1999 | SESE |
| K982491 | SANGUI BIOTECH, INC. CALCITONIN ELISA KIT | Sangui Biotech, Inc. | Sep 3, 1998 | SESE |
| K964635 | NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT | Nichols Institute Diagnostics | May 21, 1997 | SESE |
| K961043 | SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY) | Scantibodies Laboratory, Inc. | May 6, 1996 | SESE |
| K945961 | CALCITONIN IMMUNOASSAY KIT | Nichols Institute Diagnostics | Nov 20, 1995 | SESE |
| K951708 | ELSA-HCT | Cis-Us, Inc. | Sep 5, 1995 | SESE |
| K914429 | DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200) | Diagnostic Systems Laboratories, Inc. | Jan 15, 1992 | SESE |
| K912536 | CALCITONIN KIT MITSUBISHI YUKA | Mitsubishi Yuka America, Inc. | Jul 18, 1991 | SESE |
| K874087 | MODIFIED CALCITONIN RIA KIT DSL #1200 | Diagnostic Systems Laboratories, Inc. | Feb 2, 1988 | SESE |
| K872880 | CALCITONIN RIA KIT | Endocrine Associates, Inc. | Aug 13, 1987 | SESE |
| K861274 | DOUBLE ANTIBODY CALCITONIN RIA KIT | Diagnostic Products Corp. | Jun 25, 1986 | SESE |
| K854240 | CALCITONIN RIA KIT | Diagnostic Systems Laboratories, Inc. | Nov 22, 1985 | SESE |
| K842907 | CALCITONIN RADIOIMMUNOASSAY KIT | Nichols Institute Diagnostics | Sep 5, 1984 | SESE |
| K821675 | CALCITONIN RIA TEST KIT, DLS 1200 | Diagnostic Systems Laboratories, Inc. | Jun 22, 1982 | SESE |
| K781909 | CALCITONIN 125 | Cambridge Nuclear Radiopharmaceutical | Jan 10, 1979 | SESE |
Top Applicants
- Diagnostic Systems Laboratories, Inc. — 4 clearances
- Nichols Institute Diagnostics — 3 clearances
- Scantibodies Laboratory, Inc. — 2 clearances
- Diagnostic Products Corp. — 2 clearances
- Sangui Biotech, Inc. — 1 clearance
