# K030704: Ibd-Quik Chek

- Pathway: 510(k) (Traditional)
- Applicant: Techlab, Inc.
- Decided: Apr 21, 2003 after 46 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
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) Leuko-Test®: named in the summary without a submission number
- (no number) Ibd-Chek™: named in the summary without a submission number

## Indications for use
The IBD-QUIK CHEK test is an immunochromatographic test for the qualitative detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to help identify patients with active inflammatory bowel disease (IBD) and rule out those with active noninflammatory irritable bowel syndrome (IBS). FOR IN VITRO DIAGNOSTIC USE.

Source page: https://510kreport.com/device/K030704
Methodology: https://510kreport.com/methodology