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U.S. Department of Health and Human Services

Product Classification

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Device dna-probe kit, human chromosome x and y, bmt engraftment
Regulation Description Tumor-associated antigen immunological test system.
Definition X/Y DNA probe kit is intended to detect alpha satellite sequences in the centromere of chromosome (Chr) X and satellite III DNA at Yq12 of Chr Y along with routine diagnostic cytogenetic testing. It is indicated for use as an adjunct to standard cytogenetic analysis for identifying and enumerating Chr X and Y via FISH in interphase nuclei and metaphase spreads obtained from bone marrow (BM) specimens in recipients of opposite-sex BM transplantation (BMT) for hematological disorders. It is not intended to be used as a stand alone assay for test reporting; in subjects with like-sex BMT; in diagnostic testing or screening for constitutional X and Y Chr aneuploidies.
Physical State Reagents for monitoring engraftment of sex mismatched bone marrow transplantation for hematological disorders
Technical Method fluorescence in situ hybridization (FISH)
Target Area opposite-sex bone marrow transplantation for hematological disorders
Regulation Medical Specialty Immunology
Review Panel Pathology
Product CodeOXP
Premarket Review Division of Molecular Genetics and Pathology (DMGP)
Division of Molecular Genetics and Pathology (DMGP)
Submission Type 510(k)
Regulation Number 866.6010
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