510(k) · Cleared
ClearedBta Stat Test Prescription Home Use
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 Dec 8, 1998 as substantially equivalent to K964151 (Bard Diagnostic Sciences,Inc., 1997) after a 355-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Dec 8, 1998
- Review
- 355 days
- Class
- Class II
- Product code
- MMW
- Recalls
- None
- Predicates
- 1
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 deviceK974845 Bta Stat Test Prescription Home UseBard 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) | K974845 | Bta Stat Test Prescription Home Use | 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? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K964151 | Bard and Bta TestSummary page 1…TA stat Test Common/Usual Name: BTA stat Test Classification Name: Tumor Associated Antigen Immunological Test System C. Predicate Device Name: Trade Name: BTA stat Test K964151 Bion Diagnostic Sciences claims substantial equivalence to the above mentioned test. The new 510(k) 1s for the addition of an in… | 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 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.
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/K974845 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974845: Bta Stat Test Prescription Home Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974845
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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