510(k) · Cleared
Recalled · 2007Breathtek - Ubit Ubt for H. Pylori
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meretek Diagnostics, Inc. · MSQ Test, Urea (Breath Or Blood)
Cleared on Jan 17, 2002 as substantially equivalent to K013371 (Otsuka Pharmaceutical Co., Ltd., 2001) after a 22-day review. Its family tree reaches back 2 generations to 1997. It has been recalled once.
- Decided
- Jan 17, 2002
- Review
- 22 days
- Class
- Class I
- Product code
- MSQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K974322 (1997). No later device cites it as a predicate yet.
- Root · 2 generations backK974322 Abca-NT Gas Isotope Ratio Mass Spectrometer SystemEuropa Scientific, Ltd. · 1997
- 1 generation backK013371 Ubit-IR300 Infrared Spectrometry SystemOtsuka Pharmaceutical Co., Ltd. · 2001 · Recalled
- This deviceK014225 Breathtek - Ubit Ubt for H. PyloriMeretek Diagnostics, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974322 | Abca-NT Gas Isotope Ratio Mass Spectrometer System | Europa Scientific, Ltd. | 1997 | — |
| −1 | K013371 | Ubit-IR300 Infrared Spectrometry System | Otsuka Pharmaceutical Co., Ltd. | 2001 | 1 |
| 0 (this device) | K014225 | Breathtek - Ubit Ubt for H. Pylori | Meretek Diagnostics, Inc. | 2002 | — |
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 MSQ? 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 MSQ device
- #1 K220494 BreathID Hp Lab System, BreathID Smart Systemscore 8.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K013371 | Ubit-IR300 Infrared Spectrometry System Our OCR of the scanned summary read “K013371” beside “510(k)”; FDA’s K013371 is the only number that fits it and carries the summary’s name for the device. Summary page 4…IRMS spectrometer and the bag samples using an UBiT IR spectrophotometer. The BreathTek™ - UBIiT® UBT kit will be advertised for use with the UBIT IR 300 System (510(k) #K013371). The BreathTek™ kit will be advertised for use with the ABCA-NT Gas Isotope Ratio Mass Spectrometer System and the ABCA Gas Isot… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 2, 2007 | Not classified | Z-0003-2008 | Labeling False and Misleading | Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K013371.
How does its category compare?
All MSQ devicesMSQ Test, Urea (Breath Or Blood): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSQ
3in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MSQ
121in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSQ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSQ
1in 2025
MAUDE reports naming product code MSQ, 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 | — | 1 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 2 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 3 | 121 | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BreathTek™ - UBiT® UBT for H. pylori collection kit is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients. The test may be used for monitoring treatment if used at least four weeks following completion of therapy.
For these purposes, the test utilizes the UBIT IR spectrophotometer for the measurement of the ratio of 13CO; to 12COzcontent in breath gas.
For administration by health care professionals. To be administered under a physician’s supervision.
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/K014225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014225: Breathtek - Ubit Ubt for H. Pylori.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014225
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026