CKG · Radioimmunoassay, Acth
Clinical Chemistry · 21 CFR 862.1025 · Class 2
Overview
| Product Code | CKG |
|---|---|
| Device Name | Radioimmunoassay, Acth |
| Regulation | 21 CFR 862.1025 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
An adrenocorticotropic hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma and serum. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 30)
Showing 20 most recent of 30 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K223867 | IDS ACTH II | Immunodiagnostic Systems Limited | Aug 18, 2023 | SESE |
| K111335 | ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 | Tosoh Bioscience, Inc. | Dec 1, 2011 | SESE |
| K060585 | ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH | Roche Diagnostics Corp. | May 3, 2006 | SESE |
| K050748 | ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 | Scantibodies Laboratory, Inc. | May 20, 2005 | SESE |
| K021032 | ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 | Scantibodies Laboratory, Inc. | Jun 3, 2002 | SESE |
| K002638 | FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT | Future Diagnostics B.V. | Jan 17, 2001 | SESE |
| K982608 | SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT | Sangui Biotech, Inc. | Aug 19, 1998 | SESE |
| K962601 | NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE | Nichols Institute Diagnostics | Dec 24, 1996 | SESE |
| K960491 | MICRO HAEMATOCRIT CENTRIFUGE | Hawksley & Sons , Ltd. | Oct 18, 1996 | SESE |
| K960066 | IMMULITE ACTH | Diagnostic Products Corp. | Feb 16, 1996 | SESE |
| K940271 | INCSTAR ACTH IRMA | Incstar Corp. | Aug 2, 1994 | SESE |
| K926396 | ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT | Nichols Institute | Jul 27, 1993 | SESE |
| K915727 | ACTH IRMA KIT II MITSUBISHI YUKA | Mitsubishi Yuka America, Inc. | Mar 2, 1992 | SESE |
| K910178 | ACTH IRMA KIT MITSUBISHI YUKA | Science Regulatory Services Intl. | May 22, 1991 | SESE |
| K900147 | MODIFIED DSL-2300 ACTH RIA | Diagnostic Systems Laboratories, Inc. | Mar 1, 1990 | SESE |
| K882741 | ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES | Nichols Institute Diagnostics | Aug 30, 1988 | SESE |
| K860311 | ACTHK-PR RIA KIT | Compagnie Oris Industrie, S.A. | Apr 7, 1986 | SESE |
| K850053 | BACI 6 -ADRENOCORTICOTROOP HORMONE | Euro-Diagnostics BV | Apr 8, 1985 | SESE |
| K850882 | ACTH II BY RADIOIMMUNOASSAY | Immuno Nuclear Corp. | Mar 21, 1985 | SESE |
| K844181 | ACTH RIA | Syncor Intl. Corp. | Nov 27, 1984 | SESE |
Top Applicants
- Diagnostic Systems Laboratories, Inc. — 3 clearances
- Nichols Institute Diagnostics — 3 clearances
- Diagnostic Products Corp. — 2 clearances
- Immuno Nuclear Corp. — 2 clearances
- Scantibodies Laboratory, Inc. — 2 clearances
