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U.S. Department of Health and Human Services

Product Classification

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Device inherited nucleotide repeat disorder dna test
Definition An inherited nucleotide repeat disorder DNA test is a prescription in vitro diagnostic test that is intended to detect and identify the number of nucleotide repeats in a gene using genomic DNA isolated from post-natal patient specimens. It is solely intended as an aid for carrier testing and as an aid for the diagnosis of inherited nucleotide repeat-associated disorders. Assay results are solely intended to be used in conjunction with other clinical and diagnostic findings. These tests do not include those indicated for use for fetal diagnostic testing or newborn screening.
Physical State Gene region specific amplification test system.
Technical Method Uses polymerase chain reaction (PCR) and amplicon fragment sizing on a DNA genetic analyzer or capillary electrophoresis platform to determine the number of triplet repeats.
Target Area Peripheral human whole blood or human tissue.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeOYV
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.5970
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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