Not Cleared Direct

DEN180032 - Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit (FDA 510(k) Clearance)

DEN180032 · Cd Diagnostics, Inc. · Microbiology device
May 2019
Decision
328d
Days
Class 2
Risk

DEN180032 is an FDA 510(k) submission for the Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit. This device is classified as a Lateral Flow Immunochromatography Assay For Host Infection Biomarkers (Class II - Special Controls, product code QGN).

Submitted by Cd Diagnostics, Inc. (Claymont, US). The FDA issued a Not Cleared (DENG) decision on May 23, 2019.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3230. A Device To Detect And Measure Non-microbial Analytes To Aid In The Detection And Identification Of Localized Human Infections Is Identified As An In Vitro Device Intended For The Detection And Qualitative Measurement, Quantitative Measurement, Or Both Of One Or More Non-microbial Analytes In Human Clinical Specimens To Aid In The Assessment, Identification, Or Both Of A Localized Microbial Infection When Used In Conjunction With Clinical Signs And Symptoms And Other Clinical And Laboratory Findings..

Submission Details

510(k) Number DEN180032 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 29, 2018
Decision Date May 23, 2019
Days to Decision 328 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -

Device Classification

Product Code QGN - Lateral Flow Immunochromatography Assay For Host Infection Biomarkers
Device Class Class II - Special Controls
CFR Regulation 21 CFR 866.3230
Definition A Device To Detect And Measure Non-microbial Analytes To Aid In The Detection And Identification Of Localized Human Infections Is Identified As An In Vitro Device Intended For The Detection And Qualitative Measurement, Quantitative Measurement, Or Both Of One Or More Non-microbial Analytes In Human Clinical Specimens To Aid In The Assessment, Identification, Or Both Of A Localized Microbial Infection When Used In Conjunction With Clinical Signs And Symptoms And Other Clinical And Laboratory Findings.