510(k) K954214

CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT by Vysis — Product Code OXP

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 21, 1997
Date Received: September 7, 1995
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment
Device Class: Class II
Regulation Number: 866.6010
Review Panel: PA
Submission Type

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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K953591 — CEP 8 SPECTRUMORANGE DNA PROBE KIT (November 29, 1996)