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U.S. Department of Health and Human Services

Product Classification

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Device droplet digital pcr system
Regulation Description Instrumentation for clinical multiplex test systems.
Definition A droplet digital PCR system is an in vitro diagnostic amplification and detection test system that is intended for the amplification, detection (qualitative and quantitative), and analysis of nucleic acid samples, isolated from clinical specimens, which have been partitioned into nanoliter or smaller droplets using a water oil emulsion technique. A droplet digital PCR system is intended for use with cleared or approved in vitro diagnostic assays which specify its use.
Physical State The system may consist of separate components used for specific purposes (e.g., droplet generator and droplet reader), associated software, and consumables. Should not include real-time thermocyclers or massively parallel or high-throughput sequencers or instruments with analyzers for fluorescence.
Technical Method The nucleic acid molecules partitioned into the individual droplets are amplified using real-time PCR methods, labeled with fluorescently labeled probes or other fluorescent labeling means, and the result of each droplet reaction is counted and quantified. The fluorescence is detect using a high-power light-emitting diode (LED). Fluorescence emission is detected through the use of filters on a photodiode. The emission filters are optimized for use with specific fluorescent dyes.
Target Area Nucleic acids isolated from human clinical specimens
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodePHG
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(K) Exempt
Regulation Number 862.2570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
    Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible