510(k) · Cleared
ClearedAcon H. Pylori Rapid Test Strip and Acon H. Pylori Rapid Test Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · LYR Helicobacter Pylori
Cleared on Apr 2, 2003 as substantially equivalent to K991747 (Quidel Corp., 1999) and 1 other predicate after a 93-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Apr 2, 2003
- Review
- 93 days
- Class
- Class I
- Product code
- LYR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K934863 (1994). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK934863 Flexsure HPSmithkline Diagnostics, Inc. · 1994
- This deviceK024350 Acon H. Pylori Rapid Test Strip and Acon H. Pylori Rapid Test DeviceACON Laboratories, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK151935 Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H.…Alere San Diego, Incorporated · 2015
Most influential descendants
Showing 1 of 1 · See all- K151935Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood…Alere San Diego, Incorporated · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934863 | Flexsure HP | Smithkline Diagnostics, Inc. | 1994 | — |
| 0 (this device) | K024350 | Acon H. Pylori Rapid Test Strip and Acon H. Pylori Rapid Test Device | ACON Laboratories, Inc. | 2003 | — |
| +1 | K151935 | Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori… | Alere San Diego, Incorporated | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K991747 | Quickvue One-Step H. Pylori II TestSummary page 3…ori Rapid Test Strip, ACON@H . pylori Rapid Test Device, and two predicate devices is shown below: ACON H. pylori Tests versus Quidel QuickVue One-Step H. pylori gII (K991747) ACON@ H. pylon Rapid ACON@ H. pylori Rapid Test Quidel QuickVue One-… | 1999 |
| * | K934863 | Flexsure HPSummary page 4…immunoassay 13 ACON H. pylon' Tests versus Beckman Coulter FlexSure HP (K934863) ACON@H. pylon Rapid ACON@H. pylori Rapid Test Beckman Coulter… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151935 | Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood… | 2015 | 0 |
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.
- Of its descendants, K151935 (Alere San Diego, Incorporated, 2015) has gone furthest, with 0 descendants 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 ACON H. pylori Rapid Test Strip and ACON H. pylori Rapid Test Device are rapid chromatographic immunoassays for the qualitative detection of antibodies specific to H. pylori in human whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older. They are intended for healthcare professionals and professionals at point of care sites only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024350 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024350: Acon H. Pylori Rapid Test Strip and Acon H. Pylori Rapid Test Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024350
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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