510(k) · Cleared
ClearedActh Immunoradiometric (Irma) Diagnostic Assay Kit, Model #3KG100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scantibodies Laboratory, Inc. · CKG Radioimmunoassay, Acth
Cleared on Jun 3, 2002 after a 66-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 3, 2002
- Review
- 66 days
- Class
- Class II
- Product code
- CKG
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CKG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CKG device
- #1 K223867 Ids Acth IIscore 7.4 · 6 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All CKG devicesCKG Radioimmunoassay, Acth: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CKG
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CKG
Too few CKG 510(k)s in any year since 2007 to give a median.
Recalls per year · CKG
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CKG
4in 2025
MAUDE reports naming product code CKG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 1 | 2 |
| 2019 | 0 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 3 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Scantibodies Laboratory, Inc. Adrenocorticotropic Hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma. 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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K021032 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021032: Acth Immunoradiometric (Irma) Diagnostic Assay Kit, Model #3KG100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021032
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026