510(k) · Cleared
ClearedUrine Screening Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Combact Diagnostic Systems, Ltd. · JXA Kit, Screening, Urine
Cleared on Feb 23, 1998 as substantially equivalent to K924218 (Biomerieux Vitek, Inc., 1993) after a 222-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Feb 23, 1998
- Review
- 222 days
- Class
- Class I
- Product code
- JXA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924218 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK924218 Bac-T-ScreenBiomerieux Vitek, Inc. · 1993
- This deviceK972676 Urine Screening DeviceCombact Diagnostic Systems, Ltd. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924218 | Bac-T-Screen | Biomerieux Vitek, Inc. | 1993 | — |
| 0 (this device) | K972676 | Urine Screening Device | Combact Diagnostic Systems, Ltd. | 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 JXA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K924218 | Bac-T-ScreenSummary page 1…Device classification The device is a class I device o Predicate Device: The Bactis 160US is substantially equivalent to the Bac-T-Screen, BioMerieux- Vitek Inc. 1993 (K924218) 1.1 Intended Use The Bactis 160US is an automated, computer assisted, optical imaging system intended for rapid screening anal… | 1993 |
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.
How does its category compare?
All JXA devicesJXA Kit, Screening, Urine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JXA
FDA has decided no JXA device since 2007.
Median 510(k) review, days · JXA
Too few JXA 510(k)s in any year since 2007 to give a median.
Recalls per year · JXA
No recall names JXA since 2007.
Adverse event reports per year · JXA
3in 2025
MAUDE reports naming product code JXA, 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 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 15 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Bactis 160US is indicated for rapid urine screening for the purpose of determining the occurrence of bacteriuria. Evidence of bacteriuria is an important factor for clinicians to consider in making a diagnosis of urinary tract infection.
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/K972676 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972676: Urine Screening Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972676
Report an extraction error
Are you the manufacturer?
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