Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment
OXP · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.6010
Classification
FDA Product Code
OXP
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.6010
Review panel
PA
Medical specialty
Immunology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.