# K060677: N Latex CDT

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Aug 25, 2006 after 164 days
- Product code: NAO (Test, Carbohydrate Deficient Transferrin)
- Device class: 1
- Regulation: 21 CFR 862.1360
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K992502 (1999). 1 ancestor in all.
1 later device descends 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)
- K992502: Axis %CDT Turbidimetric Immunoassay, Axis (1999) Summary page 1.

## Most influential descendants
- K110169: Dimension Vista CDT Cal, Dimension Vista CDT Con L, Dimension Vista CDT Con H (2011), 0 descendants of its own

## Recalls of this device
- Mar 2, 2020 · Class II · Z-1790-2020: Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed to occur after 15 months based on shelf life monitoring
- May 31, 2018 · Class II · Z-2931-2018: Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transferrin (CDT) measurement when using the affected N Latex CDT lots in comparison to the HPLC method. CDT 

## Indications for use
In vitro diagnostic for the quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum by means of particle-enhanced immunonephelometry using the BNTM IIand BN ProSpec® System. The N Latex CDT assay must be run concurrently with the N Antisera to Human Transferrin assay so that the result can be expressed as a relative ratio, i.e., %CDT of the total transferrin. The calculation of %CDT can be used as a tool to identify possible chronic heavy alcohol consumption.

Source page: https://510kreport.com/device/K060677
Methodology: https://510kreport.com/methodology