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)

Class II Microbiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

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

DEN180032 is an FDA 510(k) submission (not cleared) for the Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin La.... Classified as Lateral Flow Immunochromatography Assay For Host Infection Biomarkers (product code QGN), Class II - Special Controls.

Submitted by Cd Diagnostics, Inc. (Claymont, US). The FDA issued a Not Cleared (DENG) decision on May 23, 2019 after a review of 328 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3230 - the FDA microbiology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 328 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Cd Diagnostics, Inc. devices

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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
226d slower than avg
Panel avg: 102d · This submission: 328d
Pathway characteristics

Device Classification

Product Code QGN Lateral Flow Immunochromatography Assay For Host Infection Biomarkers
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - QGN Lateral Flow Immunochromatography Assay For Host Infection Biomarkers

Devices cleared under the same product code (QGN) and FDA review panel - the closest regulatory comparables to DEN180032.
Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit
K212204 · Cd Diagnostics, Inc. · Aug 2021