CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT

• K Number: K954214
• Device Name: CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT
• Manufacturer: VYSIS
• Date Cleared: 1997-01-21 ( 502 days)
• Product Code: OXP , KIR
• Regulation Number: 866.6010
• Type: Traditional
• Panel: PA
• Reference & Predicate Devices: N/A

Intended Use

This assay is designed to provide a reliable method for the simultaneous detection and enumeration of X and Y chromosomes in interphase nuclei and metaphase spreads in bone marrow by fluorescence in situ hybridization (FISH).

Device Description

The CEP X/Y probe is a combination of CEP X SpectrumOrange and CEP Y SpectrumGreen continuous DNA probes for the centromeric region of chromosome X and the satellite III DNA at the Yq12 region of chromosome Y.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the CEP X SpectrumOrange/Y SpectrumGreen DNA Probe Kit, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Hybridization Efficiency:

Regulation Number and Section

§ 866.6010 Tumor-associated antigen immunological test system.

(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.