# K032027: Cholestech LDX Aspartate Aminotransferase (Ast)

- Pathway: 510(k) (Traditional)
- Applicant: Cholestech Corp.
- Decided: Sep 5, 2003 after 66 days
- Product code: CIS (Hydrazone Colorimetry, Ast/Sgot)
- Device class: 2
- Regulation: 21 CFR 862.1100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synchron CX AST system (Synchron CX, Beckman Coulter, Inc.): named in the summary without a submission number

## Recalls of this device
- Mar 6, 2013 · Class II · Z-1139-2013: 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 th

## Indications for use
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.

Source page: https://510kreport.com/device/K032027
Methodology: https://510kreport.com/methodology