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U.S. Department of Health and Human Services

Product Classification

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Device system, mass spectrometry, multiplex genotyping, hereditary thrombophilia related mutations
Regulation Description Factor V Leiden DNA mutation detection systems.
Definition A multiplex genotying test system intended for the qualitative detection and identification of specific thrombophilia related gene mutations from genomic DNA by genomic amplification and mass spectrometry. It is intended as an aid in diagnosis of patients with suspected thrombophilia.
Physical State A qualitative multiplex amplification-based genotyping test system. Should not include any devices other than mass spectrometry-based detection systems.
Technical Method The assay uses multiplex polymerase chain reaction and allele specific single base primer extension reactions to amplify and detect specific mutations located in the Factor V and prothrombin genes. Genotyped products are resolved according to mass by mass spectrometry.
Target Area Human peripheral whole blood or other clinical samples.
Regulation Medical Specialty Hematology
Review Panel Pathology
Product CodePHJ
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Molecular Genetics and Pathology (DMGP)
Submission Type 510(k)
Regulation Number 864.7280
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 Not Third Party Eligible