# K992502: Axis %CDT Turbidimetric Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Axis
- Decided: Dec 21, 1999 after 148 days
- Product code: NAO (Test, Carbohydrate Deficient Transferrin)
- Device class: 1
- Regulation: 21 CFR 862.1360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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) gamma glutamyl transferase (GGT): named in the summary without a submission number

## Most influential descendants
- K060677: N Latex CDT (2006), 1 descendant of its own
- K110169: Dimension Vista CDT Cal, Dimension Vista CDT Con L, Dimension Vista CDT Con H (2011), 0 descendants of its own

## Indications for use
The Axis ® %CDT Turbidimetric Immunoassay (TIA) is intended for the quantitative measurement of carbohydrate deficient transferrin (CDT) in human serum, as a tool to identify possible chronic heavy alcohol consumption. The Axis ® %CDT Turbidimetric Immunoassay is designed for the quantitative determination of carbohydrate deficient transferrin (CDT) in human serum. Serum transferrin is a glycoprotein with a molecular weight of about 80kD, which comprises a single polypeptide chain with two N-linked polysaccharide chains. These polysaccharide chains are branched with terminal sialic acid residues. Transferrin is an iron-transporting protein. Human transferrin occurs in isoforms with different levels of sialylation. There appear to be at least six such isoforms; penta-, tetra-, tri-, di-, mono- and asialo transferrin.

Source page: https://510kreport.com/device/K992502
Methodology: https://510kreport.com/methodology