510(k) · Cleared
Recalled · Class II · 2018ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tosoh Bioscience, Inc. · CKG Radioimmunoassay, Acth
Cleared on Dec 1, 2011 as substantially equivalent to K060585 (Roche Diagnostics Corp., 2006) after a 203-day review. Its family tree reaches back 6 generations to 1993. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Dec 1, 2011
- Review
- 203 days
- Class
- Class II
- Product code
- CKG
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 6 generations to K931172 (1993). 11 ancestors in all, the oldest K924863 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 5 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- 4 generations backK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
- 3 generations backK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
- 2 generations backK031990 Elecsys Precicontrol Troponin TRoche Diagnostics Corp. · 2003
- 1 generation backK060585 Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol ActhRoche Diagnostics Corp. · 2006
- This deviceK111335 ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221…Tosoh Bioscience, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK143296 AIA-PACK C-Peptide Control SetTosoh Bioscience, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K143296AIA-PACK C-Peptide Control SetTosoh Bioscience, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| −5 | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| −4 | K962575 | Elecsys Precicontrol Cardiac | Boehringer Mannheim Corp. | 1996 | — |
| −3 | K983492 | Boehringer Mannheim Elecsys Presicontrol Cardiac | Boehringer Mannheim Corp. | 1998 | — |
| −2 | K031990 | Elecsys Precicontrol Troponin T | Roche Diagnostics Corp. | 2003 | — |
| −1 | K060585 | Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol Acth | Roche Diagnostics Corp. | 2006 | — |
| 0 (this device) | K111335 | ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321 | Tosoh Bioscience, Inc. | 2011 | — |
| +1 | K143296 | AIA-PACK C-Peptide Control Set | Tosoh Bioscience, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060585 | Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol ActhSummary page 1…LIX Clinical Chemistry 21 CFR 862.1660 Predicate Device: k 060585 Roche Diagnostics Elecsys ACTH Imnmunoassay… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143296 | AIA-PACK C-Peptide Control Set | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 30, 2018 | Class II | Z-0676-2019 | Device Design | |
| Jun 5, 2018 | Class III | Z-2827-2018 | Error in labeling | Distribution of unapproved product labeling |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K143296 (Tosoh Bioscience, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K060585.
How does its category compare?
All CKG devicesCKG Radioimmunoassay, Acth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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?
ST AlA-PACK ACTH is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of adrenocorticotropic hormone (ACTH) in human EDTA plasma. Measurements of ACTH 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.
ST AlA-PACK ACTH Calibrator Set is designed for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AlA-PACK ACTH assay on Tosoh AlA System Analyzers
ST ALA-PACK ACTH Control Set is designed for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AlA-PACK ACTH assay on Tosoh AlA System Analyzers
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111335 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111335: ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111335
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026