# K170548: InSure ONE

- Pathway: 510(k) (Traditional)
- Applicant: Enterix, Inc.
- Decided: Oct 5, 2017 after 223 days
- Product code: KHE (Reagent, Occult Blood)
- Device class: 2
- Regulation: 21 CFR 864.6550
- Recalls of this device: 2 (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. The FDA summary names its predicate without a number.
- (no number) InSure® FIT™ (Fecal Immunochemical Test): named in the summary without a submission number

## Recalls of this device
- Sep 17, 2025 · Class II · Z-0725-2026: InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
- Oct 8, 2020 · Class II · Z-0590-2021: Product does not meet internal testing criterion; use of the product may result in a potential false positive test result and may lead to patients undergoing unnecessary follow-up diagnostic procedure

## Indications for use
The InSure® ONE™ 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. The InSure® ONE™ test is used to aid in the detection of lower gastrointestinal bleeding.

Source page: https://510kreport.com/device/K170548
Methodology: https://510kreport.com/methodology