510(k) · Cleared
ClearedEZ-HBT Helicobacter Blood Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Metabolic Solutions, Inc. · MSQ Test, Urea (Breath Or Blood)
Cleared on Sep 24, 1999 as substantially equivalent to K953632 (Serim Research Corp., 1995) and 1 other predicate after a 189-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Sep 24, 1999
- Review
- 189 days
- Class
- Class I
- Product code
- MSQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K953632 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK953632 Serim Pyloritek Test KitSerim Research Corp. · 1995
- This deviceK990931 EZ-HBT Helicobacter Blood TestMetabolic Solutions, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953632 | Serim Pyloritek Test Kit | Serim Research Corp. | 1995 | — |
| 0 (this device) | K990931 | EZ-HBT Helicobacter Blood Test | Metabolic Solutions, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K953632 | Serim Pyloritek Test KitSummary page 2…sification Name: Campylobacter pylori (Note: Campylobacter pylori has been renamed Helicobacter pylori.) 3. PREDICATE DEVICES e PyloriTek Test Kit Serim Research Corp. K953632 e MERETEK UBT™ Breath Test for H. pylori Meretek Diagnostics, Inc. K952220 Metabolic Solutions, Inc. 510(k) 03/15/99 Ez-HBT App… | 1995 |
| * | K952220 | Meretek Breath Test for H.Pylori Collection KitSummary page 2…renamed Helicobacter pylori.) 3. PREDICATE DEVICES e PyloriTek Test Kit Serim Research Corp. K953632 e MERETEK UBT™ Breath Test for H. pylori Meretek Diagnostics, Inc. K952220 Metabolic Solutions, Inc. 510(k) 03/15/99 Ez-HBT Appendix K-2 4. DEVICE DESCRIPTION Metabolic Solution’s Ez-HBT… | 1996 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K953632.
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 Ez-HBT™ Helicobacter Blood Test is intended for use in the qualitative detection of '>CO, in whole blood specimens, collected after the ingestion of *C-urea. Helicobacter pylori (H. pylori) organisms colonizing the lining of the human stomach, produce urease which converts BC-urea into *CO, and ammonia (NH,"). The device is indicated as an aid in the diagnosis of H. pylori infection in symptomatic adult subjects, 18 years or older. For use by health care professionals. Administer test under a physician’s supervision. Metabolic Solutions, Inc. or a qualified laboratory using Gas Isotope Ratio Mass Spectrometry or equivalent instrumentation must analyze the test samples.
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/K990931 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990931: EZ-HBT Helicobacter Blood Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990931
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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