510(k) · Cleared
ClearedAccustat H. Pylori One Step Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · LYR Helicobacter Pylori
Cleared on Mar 3, 1998 as substantially equivalent to K953686 (Cortecs, Ltd., 1996) after a 167-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Mar 3, 1998
- Review
- 167 days
- Class
- Class I
- Product code
- LYR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953686 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK953686 Helisal Rapid Blood TestCortecs, Ltd. · 1996
- This deviceK973523 Accustat H. Pylori One Step TestBoehringer Mannheim Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953686 | Helisal Rapid Blood Test | Cortecs, Ltd. | 1996 | — |
| 0 (this device) | K973523 | Accustat H. Pylori One Step Test | Boehringer Mannheim Corp. | 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 LYR? 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 LYR device
- #1 K232892 Hp Detect™ Stool Antigen ELISAscore 7.1 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K953686 | Helisal Rapid Blood TestSummary page 1…in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Cortecs Helisal Rapid Blood Test (510(k) file #k953686). The AccuStat H. pylori One Step Test is also substantially equivalent to Smith Kline FlexSure HP and Quidel QuickVue One-Step H… | 1996 |
| * | — | Smith Kline FlexSure HP Named without a submission number | |
| * | — | Quidel QuickVue One-Step H. pylori test Named without a submission number |
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 LYR devicesLYR Helicobacter Pylori: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYR
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LYR
86in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYR
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYR
2in 2023
MAUDE reports naming product code LYR, 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 | — | 2 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 2 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 4 | 86 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 2 | — | 1 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 2 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AccuStat™ H. pylori One Step test is a qualitative immunochemical membrane assay for the detection of antibodies to Helicobacter pylori (H. pylori) in whole blood and serum by visual interpretation. The test is for use as an aid in the diagnosis of H. pylori infection in symptomatic patients.
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/K973523 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973523: Accustat H. Pylori One Step Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973523
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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