# K974845: Bta Stat Test Prescription Home Use

- Pathway: 510(k) (Traditional)
- Applicant: Bard Diagnostic Sciences,Inc.
- Decided: Dec 8, 1998 after 355 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
Longest line of descent: 1 generation back to K964151 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964151: Bard and Bta Test, Bard Diagnostic Sciences,Inc. (1997) Summary page 1.

## Indications for use
The BTA stat test is indicated for use as an aid in the management of bladder cancer patients in conjunction with cystoscopy. This 510(k) is to expand the same indication to prescription home use of the product. The original 510(k) was K964151.

Source page: https://510kreport.com/device/K974845
Methodology: https://510kreport.com/methodology