510(k) · Cleared
ClearedInfinity Ast Reagent (Procedure NO. 51)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sigma Diagnostics, Inc. · CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
Cleared on Mar 20, 1998 as substantially equivalent to K961114 (Trace Scientific, Ltd., 1996) after a 28-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Mar 20, 1998
- Review
- 28 days
- Class
- Class II
- Product code
- CIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961114 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK961114 Ast Incorporating DSTTrace Scientific, Ltd. · 1996
- This deviceK980666 Infinity Ast Reagent (Procedure NO. 51)Sigma Diagnostics, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961114 | Ast Incorporating DST | Trace Scientific, Ltd. | 1996 | — |
| 0 (this device) | K980666 | Infinity Ast Reagent (Procedure NO. 51) | Sigma Diagnostics, Inc. | 1998 | — |
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 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? (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 |
|---|---|---|---|
| * | K961114 | Ast Incorporating DSTSummary page 1…INFINITY™ AST Reagent Kit (Procedure No. 51-uv) is substantially equivalent to, and is the same product as the TRACE Scientific AST (DST) Reagent Kit cleared by FDA as K961114. References L. Zilva JF, Pannall PR. “Plasma Enzymes in Diagnosis” in Clinical Chemistry in Diagnosis and Treatment. Lloyd-Luke… | 1996 |
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.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K961114.
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 | — |
What is it indicated for?
Sigma Diagnostics INFINITY™ AST Reagent is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) in serum. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980666 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980666: Infinity Ast Reagent (Procedure NO. 51).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980666
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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