# K991834: Cholestech LDX Alanine Aminotransferase (Alt), Model 11-772

- Pathway: 510(k) (Traditional)
- Applicant: Cholestech Corp.
- Decided: Sep 9, 1999 after 104 days
- Product code: CKD (Hydrazone Colorimetry, Alt/Sgpt)
- Device class: 1
- Regulation: 21 CFR 862.1030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K864082 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864082: Reflotron (R) Alt (GPT), Boehringer Mannheim Corp. (1986) Summary page 2.

## 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 L-D-X Alanine aminotransferase Test (ALT) is for the in vitro quantitative determination of alanine aminotransferase (ALT) in whole blood or serum on the Cholestech L-D-X Analyzer. Alanine aminotransferase 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/K991834
Methodology: https://510kreport.com/methodology