# K130775: Duet System

- Pathway: 510(k) (Traditional)
- Applicant: Bioview, Ltd.
- Decided: May 9, 2014 after 415 days
- Product code: NTH (System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays)
- Device class: 2
- Regulation: 21 CFR 866.4700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K925670 (1993). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030192: Duet System, Bioview, Ltd. (2003) Summary page 2.
- K040591: Duet System, Bioview, Ltd. (2004) Summary page 2.
- K050840: Modification to Duet System, Bioview, Ltd. (2005) Summary page 2.
- K061602: Duet System, Bioview, Ltd. (2007) Summary page 2.
- (no number) Human manual visualization of formalin-fixed paraffin-embedded human lung cancer tissue specimens, probed by Vysis ALK Break Apart FISH Probe Kit: named in the summary without a submission number

## Indications for use
The DuetTM 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 DuetTM System is intended to: 1. Detect Hematopoietic cells stained by Giemsa stain, Immunohistochemistry or ISH (with brightfield and fluorescent) prepared from cell suspension. 2. Detect Amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X,Y,13, 18 and 21). 3. 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. 4. 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® PathVysionTM HER-2 DNA Probe Kit. The DuetTM 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. 5. Qualitatively detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens, probed with the Vysis® ALK Break Apart FISH Probe Kit. The DuetTM is to be used as an adjunctive automated enumeration tool, in conjunction with manual review of the digital image. Note: The pathologist should verify the image analysis software application score.

Source page: https://510kreport.com/device/K130775
Methodology: https://510kreport.com/methodology