OXP

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment

Device class

Class II (moderate risk)

Regulation

21 CFR 866.6010

Medical specialty

Immunology

Flags

Third-party review eligible

FDA 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.

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