510(k) · Cleared
ClearedBard Bta Trak Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bard Diagnostic Sciences,Inc. · MMW System, Test, Tumor Marker, Monitoring, Bladder
Cleared on Apr 15, 1998 as substantially equivalent to K964151 (Bard Diagnostic Sciences,Inc., 1997) after a 365-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Apr 15, 1998
- Review
- 365 days
- Class
- Class II
- Product code
- MMW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K964151 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK964151 Bard and Bta TestBard Diagnostic Sciences,Inc. · 1997
- This deviceK971402 Bard Bta Trak TestBard Diagnostic Sciences,Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964151 | Bard and Bta Test | Bard Diagnostic Sciences,Inc. | 1997 | — |
| 0 (this device) | K971402 | Bard Bta Trak Test | Bard Diagnostic Sciences,Inc. | 1998 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MMW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MMW device
- #1 K203245 Bladder EpiCheck DNA extraction kit…score 5.3 · 1 generation · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| 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…Paul Freiberg (206) 814-1520 (206) 814-1521 April 10, 1997 Bard® BTA TRAK ™ Test BTA TRAK™Test Tumor Associated Antigen Immunological Test System Bard® BTA® Test P940018 - Reclassified to Class II Bard® BTA staf™ Test K964151 Bard Diagnostic Sciences, Inc., claims substantial equivalence to the a… | |
| * | K964151 | Bard and Bta Test Cleared while this submission was under review Summary page 1…1997 Bard® BTA TRAK ™ Test BTA TRAK™Test Tumor Associated Antigen Immunological Test System Bard® BTA® Test P940018 - Reclassified to Class II Bard® BTA staf™ Test K964151 Bard Diagnostic Sciences, Inc., claims substantial equivalence to the above mentioned tests. 510(k) SUMMARY INF… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K964151.
How does its category compare?
All MMW devicesMMW System, Test, Tumor Marker, Monitoring, Bladder: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MMW
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MMW
Too few MMW 510(k)s in any year since 2007 to give a median.
Recalls per year · MMW
No recall names MMW since 2007.
Adverse event reports per year · MMW
1in 2013
MAUDE reports naming product code MMW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971402 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971402: Bard Bta Trak Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971402
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026