Cleared Special

K212204 - 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 (FDA 510(k) Clearance)

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

K212204 · Cd Diagnostics, Inc. · Microbiology device
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Aug 2021
Decision
27d
Days
Class 2
Risk

K212204 is an FDA 510(k) clearance for the Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Def.... 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 Cleared decision on August 11, 2021 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3230 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cd Diagnostics, Inc. devices

Submission Details

510(k) Number K212204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2021
Decision Date August 11, 2021
Days to Decision 27 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 102d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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.