# K033982: Modification to Vysis Urovysion Bladder Cancer Recurrence Test

- Pathway: 510(k) (Special)
- Applicant: Vysis
- Decided: Jan 22, 2004 after 30 days
- Product code: MMW (System, Test, Tumor Marker, Monitoring, Bladder)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bard® (Bion) BTAstat™ Test: named in the summary without a submission number

## Most influential descendants
- K050840: Modification to Duet System (2005), 7 descendants of its own
- 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

## Indications for use
The UroVysion Bladder Cancer Recurrence Kit (UroVysion Kit) is designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from subjects with transitional cell carcinoma of the bladder. Results from the UroVysion Kit are intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer.

Source page: https://510kreport.com/device/K033982
Methodology: https://510kreport.com/methodology