# K061602: Duet System

- Pathway: 510(k) (Traditional)
- Applicant: Bioview, Ltd.
- Decided: Jan 23, 2007 after 229 days
- Product code: JOY (Device, Automated Cell-Locating)
- Device class: 2
- Regulation: 21 CFR 864.5260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K925670 (1993). 13 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 19 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.
- K043519: Ariol Her-2/Neu Fish, Applied Imaging Corp. (2005) Summary page 2.
- DEN040010: Vysis Autovysion System, Vysis (2004). Our reading of the summary gave K041875, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN040010, Vysis Autovysion System (Vysis), granted Dec 13, 2004; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- (no number) Human manual visualization of human breast cancer tissue specimens, probed by Vysis® PathVysionTM HER-2 DNA Probe Kit (Hereinafter, the Manual Method): named in the summary without a submission number

## Most influential descendants
- K101291: Scanview HER2/Neu Fish System (2010), 2 descendants of its own
- K110345: Scanview System (2011), 1 descendant of its own
- K130775: Duet System (2014), 0 descendants of its own
- K122554: Genasis Scanview System (2013), 0 descendants of its own
- K080909: Iconoscope Oncofish HER2 Test System, Model 2000 (2008), 0 descendants of its own

## 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 aiding tool 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: Detect Hematopoietic cells stained by Giemsa stain, Immunohistochemistry or ISH (with bright field and fluorescent) prepared from cell suspension. Detect amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X, Y, 13, 18 and 21). Detect cells in urine specimens, stained by FISH (using the Vysis UroVysionTM Bladder Cancer Recurrence Kit for chromosomes 3, 7, 17 and 9p2l locus), from subjects with transitional cell carcinoma of the bladder. Detect and quantify chromosome 17 and the HER-2/neit 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 visualization, to assist in determining HER-2/neu gene to chromosome 17 signal ratio.

Source page: https://510kreport.com/device/K061602
Methodology: https://510kreport.com/methodology