(415 days)
The Duet™ System is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnostic use as an aid to the pathologist in the detection, classification and counting of cells of interest based on color, intensity, size, pattern and shape.
The Duet™ System is intended to:
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Detect Hematopoietic cells stained by Giemsa stain, Immunohistochemistry or ISH (with brightfield and fluorescent) prepared from cell suspension.
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Detect Amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X. Y. 13, 18 and 21).
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Detect Aneuploidy for chromosomes 3,7. 17 and loss of the 9p21 locus via FISH in Urine specimens from subjects with transitional cell carcinoma of the bladder, probed by the Vysis Urovysion Bladder Cancer Kit.
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Detect and quantify chromosome 17 and the HER-2/neu gene via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens, probed by the Vysis® Path Vysion™ HER-2 DNA Probe Kit. The Duet™ is to be used as an adjunctive automated enumeration tool, in conjunction with manual review of the digital image, to assist in determining HER-2/neu gene to chromosome 17 signal ratio.
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Qualitatively detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalinfixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens, probed with the Vysis ® ALK Break Apart FISH Probe Kit. The Duer™ is to be used as an adjunctive autonated enumeration with manual review of the digital image. Note: The pathologist should verify the image analysis software application score.
The Duet™ System is a fully integrated imaging and scanning platform that automates time-consuming and difficult laboratory tasks of slide scanning.
The Duet™ System workstation integrates a microscope, CCD camera, motorized stage / slide-loader, computer, keyboard, mouse, joystick, monitor and a dedicated software program.
The Duet™ System is software controlled and includes features such as: acquisition of images, views, editing, relocation, enhancement capabilities, automatic/manual counting and classification, printing, export of images and backups.
The Duet™ System scans in high resolution cell samples at high speed both in bright light illumination and in fluorescent illumination.
The Duet™ System suggests classification of the cells according to their morphological features, their staining (Giemsa, IHC) and fluorescent signals, and allows the user to quickly examine the results, correct them as needed and generate a report summarizing the sample's data. The Duet™ system allows combined presentation of morphological and specific staining information of the same cell, for all the cells of the sample.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Coefficient of Variation, CV) | Reported Device Performance (Mean %CV Range for Individuals Slides) | Reported Device Performance (Overall %CV derived from Random Model) |
|---|---|---|
| Positive samples: CV 10%) | Below specified goals | |
| Negative samples, with mean percentage below 4%: CV ≤ 180% | Within-run: 0.0% - 86.6% (for negative slides with mean |
§ 866.4700 Automated fluorescence
in situ hybridization (FISH) enumeration systems.(a)
Identification. An automated FISH enumeration system is a device that consists of an automated scanning microscope, image analysis system, and customized software applications for FISH assays. This device is intended for in vitro diagnostic use with FISH assays as an aid in the detection, counting and classification of cells based on recognition of cellular color, size, and shape, and in the detection and enumeration of FISH signals in interphase nuclei of formalin-fixed, paraffin-embedded human tissue specimens.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Automated Fluorescencein situ Hybridization (FISH) Enumeration Systems.” See § 866.1(e) for the availability of this guidance document.