← Back to catalogue

InSure ONE

FDA 510(k)

Class II (US FDA 510(k))

510(k) K170548

by Enterix Inc.

Identifiers

510(k) Number
K170548 FDA 510(k)
FDA Product Code
KHE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.6550 FDA 510(k)
Regulation Number
864.6550 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

InSure ONE is a Class II medical device that functions as a reagent for detecting occult blood in fecal samples using a lateral flow chromatographic immunoassay to measure human hemoglobin (hHb). It is designed for fecal sample collection and analysis in hematology applications.

The device is supplied as a single-use product and is regulated under FDA 510(k) clearance with product code KHE. It is stored at room temperature and is not indicated for MRI safety. The device has received FDA clearance as substantially equivalent for the purpose of modifying the fecal sample collection procedure.

Frequently asked questions

What is the purpose of the InSure ONE device?

InSure ONE is a Class II medical device designed as a reagent for detecting occult blood in fecal samples using lateral flow chromatographic immunoassay technology to measure human hemoglobin (hHb) in hematology applications.

How is the InSure ONE device supplied and is it reusable?

The InSure ONE device is supplied as a single-use product and is not intended for reuse. It is designed for one-time fecal sample collection and analysis to ensure accurate test results and prevent cross-contamination between samples.

What are the storage requirements for the InSure ONE device?

The InSure ONE device should be stored at room temperature. No special storage conditions are required beyond maintaining ambient room temperature, making it convenient for clinical settings without refrigeration needs.

What regulatory clearance has the InSure ONE device received?

The InSure ONE device has received FDA 510(k) clearance with product code KHE and is classified as substantially equivalent for the purpose of modifying the fecal sample collection procedure. It is regulated under FDA 510(k) clearance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Contact • InSure One, InSure ONE (K170548) — FDA 510(k) | Innolitics, InSure® ONE™ — FDA Class II Medical Device | MedEquip Directory, InSure® ONE™ 01 InSure® ONE™ Collection Kit… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Enterix Inc.
FDA Applicant
Enterix, Inc.

Sources (1)

  • FDA 510(k) K170548 24 fields · synced Sep 26, 2026