# K071712: Leuko EZ Vue

- Pathway: 510(k) (Traditional)
- Applicant: Techlab Inc., Corporate Research Center
- Decided: Dec 4, 2007 after 165 days
- Product code: DEG (Lactoferrin, Antigen, Antiserum, Control)
- Device class: 1
- Regulation: 21 CFR 866.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931241 (1994). 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)
- K931241: Fast'n'flammatory Kit, Techlab, Inc. (1994) Summary page 1.
- (no number) Methylene Blue stain and Gram stain along with microscopic observation: named in the summary without a submission number

## Indications for use
The LEUKO EZ VUE™ test is an immunochromatographic test for the qualitative detection of elevated levels of fecal lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The LEUKO EZ VUE™ test detects lactoferrin in liquid, semi-solid, and solid fecal specimens. A positive test result indicates an increased level of fecal lactoferrin and warrants additional testing. FOR IN VITRO DIAGNOSTIC USE.

Source page: https://510kreport.com/device/K071712
Methodology: https://510kreport.com/methodology