# K060930: Insure II

- Pathway: 510(k) (Special)
- Applicant: Enterix, Inc.
- Decided: May 4, 2006 after 29 days
- Product code: KHE (Reagent, Occult Blood)
- Device class: 2
- Regulation: 21 CFR 864.6550
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Oct 3, 2008 · Not classified · Z-0480-2009: False readings: Reduced sensitivity could affect the test line area and/or control line on the test strips, which may lead to inaccurate results. For further information, please contact Enterix, Inc. 

## Indications for use
InSure® [ I FIT is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples. The samples will generally be collected by the test subject at home and the test developed at laboratories or professional offices. Fecal immunochemical tests are useful screening aids for detecting primarily lower gastrointestinal (g.i.) disorders that may be related to iron deficiency anemia, diverticulitis, ulcerative colitis, polyps, adenomas, colorectal cancers or other g.i. lesions that can bleed. Health professionals recommend InSure II for use as part of routine physical examinations and in screening for colorectal cancer or other sources of lower g.i. bleeding.

Source page: https://510kreport.com/device/K060930
Methodology: https://510kreport.com/methodology