Radioimmunoassay, Acth
The Radioimmunoassay, ACTH test system (product code CKG) is an in-vitro diagnostic device used in clinical chemistry to measure adrenocorticotropic hormone (ACTH) levels in plasma using a radioimmunoassay method, supporting the diagnosis and differential evaluation of pituitary and adrenal disorders including Cushing's disease and Addison's disease. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1025 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
Basic Information
- Product Code
- CKG
- Device Class
- FDA class 2
- Regulation Number
- 862.1025
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 30 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K223867 | IDS ACTH II | Aug 18, 2023 | Substantially Equivalent | Immunodiagnostic Systems Limited |
| K111335 | ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 | Dec 01, 2011 | Substantially Equivalent | Tosoh BioScience, Inc. |
| K060585 | ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH | May 03, 2006 | Substantially Equivalent | ROCHE DIAGNOSTICS CORP. |
| K050748 | ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 | May 20, 2005 | Substantially Equivalent | SCANTIBODIES LABORATORY, INC. |
| K021032 | ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 | Jun 03, 2002 | Substantially Equivalent | SCANTIBODIES LABORATORY, INC. |
| K002638 | FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT | Jan 17, 2001 | Substantially Equivalent | FUTURE DIAGNOSTICS B.V. |
| K982608 | SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT | Aug 19, 1998 | Substantially Equivalent | SANGUI BIOTECH, INC. |
| K962601 | NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE | Dec 24, 1996 | Substantially Equivalent | NICHOLS INSTITUTE DIAGNOSTICS |
| K960491 | MICRO HAEMATOCRIT CENTRIFUGE | Oct 18, 1996 | Substantially Equivalent | HAWKSLEY & SONS LTD. |
| K960066 | IMMULITE ACTH | Feb 16, 1996 | Substantially Equivalent | DIAGNOSTIC PRODUCTS CORP. |
| K940271 | INCSTAR ACTH IRMA | Aug 02, 1994 | Substantially Equivalent | INCSTAR CORP. |
| K926396 | ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT | Jul 27, 1993 | Substantially Equivalent | NICHOLS INSTITUTE |
| K915727 | ACTH IRMA KIT II MITSUBISHI YUKA | Mar 02, 1992 | Substantially Equivalent | MITSUBISHI YUKA AMERICA, INC. |
| K910178 | ACTH IRMA KIT MITSUBISHI YUKA | May 22, 1991 | Substantially Equivalent | SCIENCE REGULATORY SERVICES INTL. |
| K900147 | MODIFIED DSL-2300 ACTH RIA | Mar 01, 1990 | Substantially Equivalent | DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K882741 | ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES | Aug 30, 1988 | Substantially Equivalent | NICHOLS INSTITUTE DIAGNOSTICS |
| K860311 | ACTHK-PR RIA KIT | Apr 07, 1986 | Substantially Equivalent | COMPAGNIE ORIS INDUSTRIE, S.A. |
| K850053 | BACI 6 -ADRENOCORTICOTROOP HORMONE | Apr 08, 1985 | Substantially Equivalent | EURO-DIAGNOSTICS BV |
| K850882 | ACTH II BY RADIOIMMUNOASSAY | Mar 21, 1985 | Substantially Equivalent | IMMUNO NUCLEAR CORP. |
| K844181 | ACTH RIA | Nov 27, 1984 | Substantially Equivalent | SYNCOR INTL. CORP. |
| K842249 | ACTH NORMAL RANGE | Aug 15, 1984 | Substantially Equivalent | DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K833934 | ADRENOCORTICOTROPIC HORMONE TEST | Apr 04, 1984 | Substantially Equivalent | CLINETICS CORP. |
| K840018 | DPC ACTH KIT | Mar 23, 1984 | Substantially Equivalent | DIAGNOSTIC PRODUCTS CORP. |
| K833849 | ACTH RIA | Jan 30, 1984 | Substantially Equivalent | SYNCOR INTL. CORP. |
| K833471 | ADRENOCOR TICOTROPIC HORMONE RADIOIMM | Jan 11, 1984 | Substantially Equivalent | NICHOLS INSTITUTE DIAGNOSTICS |
| K831855 | HATCH KIT | Jul 28, 1983 | Substantially Equivalent | RADIOASSAY SYSTEMS LABORATORIES, INC. |
| K831826 | ADRENOCORTICOTROPIN RADIO-IMMUNOASSAY | Jul 18, 1983 | Substantially Equivalent | DAMON CORP. |
| K830893 | ACTH RIA SYSTEM-DSI 2300 | Apr 27, 1983 | Substantially Equivalent | DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
| K822115 | SERAGAN ACTH125 I-RIA KIT | Oct 18, 1982 | Substantially Equivalent | SERAGEN DIAGNOSTICS, INC. |
| K811565 | ACTH RADIOIMMUNOASSAY KIT | Jun 25, 1981 | Substantially Equivalent | IMMUNO NUCLEAR CORP. |
FEI Numbers
This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.