# K013785: Urovysion Bladder Cancer Recurrence Kit

- Pathway: 510(k) (Abbreviated)
- Applicant: Vysis
- Decided: Feb 8, 2002 after 86 days
- Product code: MMW (System, Test, Tumor Marker, Monitoring, Bladder)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K203245: Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C (2023), 0 descendants of its own

## Recalls of this device
- Feb 19, 2004 · Not classified · Z-0640-04: Some of the control slides did not have adequate cells deposited upon their surface.

## 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/K013785
Methodology: https://510kreport.com/methodology