# K042071: Ibd-Scan

- Pathway: 510(k) (Traditional)
- Applicant: Techlab, Inc.
- Decided: Oct 20, 2004 after 79 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The IBD-SCANrM test is a quantitative ELISA for measuring concentrations of fecal lactoferrin, a marker of fecal leukocytes. An elevated level is an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to distinguish patients with active inflammatory bowel disease (IBD) from those with noninflammatory irritable bowel syndrome (IBS). FOR IN VITRO DIAGNOSTIC USE.

Source page: https://510kreport.com/device/K042071
Methodology: https://510kreport.com/methodology