# K964151: Bard and Bta Test

- Pathway: 510(k) (Traditional)
- Applicant: Bard Diagnostic Sciences,Inc.
- Decided: Apr 16, 1997 after 197 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- P940018: Bard® BTA® Test. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K994356: Immunocyt (2000), 0 descendants of its own
- K974845: Bta Stat Test Prescription Home Use (1998), 0 descendants of its own
- K971402: Bard Bta Trak Test (1998), 0 descendants of its own

## Indications for use
The BTA stat test is a qualitative test indicated for use as an aid in the management of bladder cancer patients in conjunction with cystoscopy.

Source page: https://510kreport.com/device/K964151
Methodology: https://510kreport.com/methodology