510(k) · Cleared
ClearedCobas Reagent for Ast (Sgot)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Analytical Instruments, Inc. · CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
Cleared on Jun 20, 1980 after a 39-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jun 20, 1980
- Review
- 39 days
- Class
- Class II
- Product code
- CIT
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK801118 Cobas Reagent for Ast (Sgot)Roche Analytical Instruments, Inc. · 1980
- Descendant · cites it directly · 2 of its ownK060318 Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK102647 Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and…Elitechgroup Vital Scientific BV · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK093883 Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II…Seppim S.A.S. · 2010
Most influential descendants
Showing 3 of 3 · See all- K060318Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2006 · cites it directly2descendants
- K102647Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol II/Ast/Got 4+1…Elitechgroup Vital Scientific BV · 2011 · 2 generations on0descendants
- K093883Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model Assl-0250…Seppim S.A.S. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K801118 | Cobas Reagent for Ast (Sgot) | Roche Analytical Instruments, Inc. | 1980 | — |
| +1 | K060318 | Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry Analyzer | Horiba Abx | 2006 | 1 |
| +2 | K102647 | Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol… | Elitechgroup Vital Scientific BV | 2011 | 4 |
| +2 | K093883 | Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model… | Seppim S.A.S. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 CIT? 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? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060318 | Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry Analyzer | 2006 | 2 |
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, K060318 (Horiba Abx, 2006) has gone furthest, with 2 descendants of its own.
How does its category compare?
All CIT devicesCIT Nadh Oxidation/Nad Reduction, Ast/Sgot: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CIT
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · CIT
Too few CIT 510(k)s in any year since 2007 to give a median.
Recalls per year · CIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIT
10in 2025
MAUDE reports naming product code CIT, 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 | 2 | — | 0 | 23 |
| 2008 | 2 | — | 3 | 17 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 1 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 1 | 2 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K801118 · printed Nov 6, 2026
Cite this page
510(k) Report. “K801118: Cobas Reagent for Ast (Sgot).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K801118
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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