# K050840: Modification to Duet System

- Pathway: 510(k) (Traditional)
- Applicant: Bioview, Ltd.
- Decided: Aug 16, 2005 after 137 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: 4 generations back to K925670 (1993). 11 ancestors in all.
7 later devices descend from it; 5 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.
- K011031: Vysis Urovysion Bladder Cancer Recurrence Kit, Vysis (2001) Summary page 2.
- K033982: Modification to Vysis Urovysion Bladder Cancer Recurrence Test, Vysis (2004) 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 urine specimen cells from subjects with transitional cell carcinoma of the bladder, probed by the UroVysion™ Kit by conventional microscope: named in the summary without a submission number

## Most influential descendants
- K061602: Duet System (2007), 5 descendants of its own
- 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

## Indications for use
The Duet™ System is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnostic usc 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 Duet™ System is intended to detect: 1. Hematopoietic cells stained by G-emsa stain, Immunohistochemistry or ISH (with bright field and fluorescent) prepared from cell suspension. 2. Amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X, Y, 13, 18 and 21>) 3. Cells in urine specimens, stained by FISH (using the Vysis UroVysion™ Bladder Cancer Recurrence Kit for chromosomes 3, 7, 17 and 9p21 locus), from subjects with transitional cell carcinoma of the bladder.

Source page: https://510kreport.com/device/K050840
Methodology: https://510kreport.com/methodology