510(k) DEN180032
DEN180032 is an FDA 510(k) premarket notification submitted by Cd Diagnostics, Inc. for the device "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". The FDA issued a decision of De Novo Granted on May 23, 2019. The device falls under product code QGN (Lateral Flow Immunochromatography Assay For Host Infection Biomarkers), a Class II device regulated under 21 CFR 866.3230. Cd Diagnostics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 23, 2019
- Date Received
- June 29, 2018
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lateral Flow Immunochromatography Assay For Host Infection Biomarkers
- Device Class
- Class II
- Regulation Number
- 866.3230
- Review Panel
- MI
- Submission Type
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.