FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Quix™ Rapid E. coli 0157 Strip Test is an immunochromatographic assay for the qualitative detection of E. coli O157 in human feces. The test is designed to be used as an aid to the diagnosis of diarrhea caused by E. coli 0157 and as an adjunct to culture methodology.

Device Description

The Quix™ Rapid E. coli 0157 Strip Test is an immunochromatographic assay.

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "Quix™ Rapid E. Coli 0157 Strip Test". It does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter acknowledges receipt of the 510(k) notification and states that the device is deemed "substantially equivalent" to predicate devices, allowing its marketing. It outlines regulatory requirements but does not delve into performance testing details.

Therefore, I cannot extract the requested information the provided text.

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K Number

K954994

Device Name

TRUST

Manufacturer

GUARDIAN SCIENTIFIC, CORP.

Date Cleared

1996-10-18

(353 days)