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U.S. Department of Health and Human Services

Product Classification

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Device severe combined immunodeficiency disorder (scid) newborn screening test system
Definition A newborn screening test for severe combined immunodeficiency (SCID) intended for the detection of T-cell receptor excision circle (TREC) genomic DNA isolated from newborn blood specimens dried on filter paper. It is intended as an aid in screening newborns for severe combined immunodeficiency (SCID).
Physical State The test consists of primers and probes to amplify and detect genomic DNA obtained from newborn peripheral blood dried on filter paper. The device includes reagents, instruments, software and consumables, and may integrate punching of a dried blood spot specimen from filter paper and may include controls and calibrators. The instrumentation enables quantitative result output based comparison between amplified specific targeted sequence relative to a standard or normalizer (e.g., alternate gene sequence). The instrumentation may also include mechanisms to store raw data.
Technical Method The test system uses primers to amplify genomic DNA obtained from newborn peripheral blood dried on filter paper and probes to detect specific DNA targets of interest.
Target Area Human peripheral blood
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodePJI
Premarket Review Division of Immunology and Hematology Devices (DIHD)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.5930
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons