510(k) · Cleared
ClearedTwin Got-Ast Ifcc/GPT-Alt Ifcc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt
Cleared on Jul 29, 1986 after an 81-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jul 29, 1986
- Review
- 81 days
- Class
- Class I
- Product code
- CKA
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK861792 Twin Got-Ast Ifcc/GPT-Alt IfccBoehringer Mannheim Corp. · 1986
- Descendant · cites it directly · 1 of its ownK981221 Aspartate Aminotransferase Activated ( Ast Activated)Abbott Laboratories · 1998
- Descendant · 2 generations on · 0 of its ownK071525 Activated Aspartate AminotransferaseAbbott Laboratories · 2008 · Recalled
- Descendant · cites it directly · 0 of its ownK983131 ASTAbbott Laboratories · 1998
- Descendant · cites it directly · 0 of its ownK980902 N-Assay L Ast/GotCrestat Diagnostics, Inc. · 1998
Most influential descendants
Showing 4 of 4 · See all- K981221Aspartate Aminotransferase Activated ( Ast Activated)Abbott Laboratories · 1998 · cites it directly1descendant
- K071525Activated Aspartate AminotransferaseAbbott Laboratories · 2008 · 2 generations on0descendants
- K983131ASTAbbott Laboratories · 1998 · cites it directly0descendants
- K980902N-Assay L Ast/GotCrestat Diagnostics, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K861792 | Twin Got-Ast Ifcc/GPT-Alt Ifcc | Boehringer Mannheim Corp. | 1986 | — |
| +1 | K981221 | Aspartate Aminotransferase Activated ( Ast Activated) | Abbott Laboratories | 1998 | — |
| +2 | K071525 | Activated Aspartate Aminotransferase | Abbott Laboratories | 2008 | 1 |
| +1 | K983131 | AST | Abbott Laboratories | 1998 | — |
| +1 | K980902 | N-Assay L Ast/Got | Crestat Diagnostics, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CKA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
What does this lineage say?
- Of its descendants, K981221 (Abbott Laboratories, 1998) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CKA devicesCKA Nadh Oxidation/Nad Reduction, Alt/Sgpt: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CKA
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · CKA
Too few CKA 510(k)s in any year since 2007 to give a median.
Recalls per year · CKA
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CKA
8in 2025
MAUDE reports naming product code CKA, 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 | — | 8 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 8 |
| 2011 | 0 | — | 0 | 39 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K861792 · printed Nov 6, 2026
Cite this page
510(k) Report. “K861792: Twin Got-Ast Ifcc/GPT-Alt Ifcc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K861792
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026