# K971402: Bard Bta Trak Test

- Pathway: 510(k) (Traditional)
- Applicant: Bard Diagnostic Sciences,Inc.
- Decided: Apr 15, 1998 after 365 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). Cleared while this submission was under review Summary page 1.

## 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.

## Indications for use
The Bard BTA TRAK Test is indicated for the quantitative detection of bladder tumor associated antigen in urine of persons diagnosed with bladder cancer. This test an aid in the management of bladder cancer patients in conjunction with cystoscopy.

Source page: https://510kreport.com/device/K971402
Methodology: https://510kreport.com/methodology