DeviceClearance

Product code OXP— Immunology

CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT

Classification name
Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment
Device class
Class 2
Regulation
21 CFR 866.6010
Advisory panel
Immunology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OXP under 21 CFR 866.6010, via openFDA

Market context for product code OXP

FDA has cleared 1 device under product code OXP, all in 1997, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OXP

Recent clearances under product code OXP

Data sourced from openFDA. This site is unofficial and independent of the FDA.