OXP — Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment Class II

FDA Device Classification

Classification Details

Product Code
OXP
Device Class
Class II
Regulation Number
866.6010
Submission Type
Review Panel
PA
Medical Specialty
Immunology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K954214vysisCEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KITJanuary 21, 1997