510(k) · Cleared
ClearedQuickvue One-Step H. Pylori II Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corp. · LYR Helicobacter Pylori
Cleared on Aug 4, 1999 after a 75-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Aug 4, 1999
- Review
- 75 days
- Class
- Class I
- Product code
- LYR
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK991747 Quickvue One-Step H. Pylori II TestQuidel Corp. · 1999
- Descendant · cites it directly · 1 of its ownK024350 Acon H. Pylori Rapid Test Strip and Acon H. Pylori Rapid Test DeviceACON Laboratories, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK151935 Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H.…Alere San Diego, Incorporated · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991747 | Quickvue One-Step H. Pylori II Test | Quidel Corp. | 1999 | — |
| +1 | K024350 | Acon H. Pylori Rapid Test Strip and Acon H. Pylori Rapid Test Device | ACON Laboratories, Inc. | 2003 | — |
| +2 | K151935 | Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori… | Alere San Diego, Incorporated | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2015 | 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 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?
The FDA summary names no predicate by number.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024350 | Acon H. Pylori Rapid Test Strip and Acon H. Pylori Rapid Test Device | 2003 | 1 |
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?
- Of its descendants, K024350 (ACON Laboratories, Inc., 2003) has gone furthest, with 1 descendant of its own.
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 QuickVue One-Step H. pylori Il Test is intended for the rapid, qualitative detection of IgG antibodies specific to Helicobacter pylori in human serum, plasma and whole blood as an aid in the diagnosis of H. pylori infection in patients with clinical signs and symptoms of gastrointestinal disease. The test is intended for use by health care professionails.
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/K991747 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991747: Quickvue One-Step H. Pylori II Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991747
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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