510(k) · Cleared
Recalled · Class II · 2013Cholestech LDX Aspartate Aminotransferase (Ast)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cholestech Corp. · CIS Hydrazone Colorimetry, Ast/Sgot
Cleared on Sep 5, 2003 after a 66-day review. The FDA summary names its predicate without a number. It has been recalled once.
- Decided
- Sep 5, 2003
- Review
- 66 days
- Class
- Class II
- Product code
- CIS
- Recalls
- 1
- Predicates
- 0
The FDA summary names its predicate without a number.
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 CIS? 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 |
|---|---|---|---|
| * | — | Synchron CX AST system (Synchron CX, Beckman Coulter, Inc.) Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 6, 2013 | Class II | Z-1139-2013 | Other | The recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT AST cassette, and it has the potential for humidity changes to impact results for certain analytes on the Alere Cholestech LDX System. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All CIS devicesCIS Hydrazone Colorimetry, Ast/Sgot: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CIS
FDA has decided no CIS device since 2007.
Median 510(k) review, days · CIS
Too few CIS 510(k)s in any year since 2007 to give a median.
Recalls per year · CIS
No recall names CIS since 2007.
Adverse event reports per year · CIS
No MAUDE report names CIS since 2007.
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 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Cholestech LDX aspartate aminotransferase (AST) test is for the in vitro quantitative determination of AST in whole blood or serum on the Cholestech LDX Analyzer.
AST measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis), and heart diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032027 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032027: Cholestech LDX Aspartate Aminotransferase (Ast).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032027
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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