510(k) · Cleared
ClearedAlere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alere San Diego, Incorporated · LYR Helicobacter Pylori
Cleared on Aug 12, 2015 as substantially equivalent to K024350 (ACON Laboratories, Inc., 2003) after a 29-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Aug 12, 2015
- Review
- 29 days
- Class
- Class I
- Product code
- LYR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K934863 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK934863 Flexsure HPSmithkline Diagnostics, Inc. · 1994
- 1 generation backK024350 Acon H. Pylori Rapid Test Strip and Acon H. Pylori Rapid Test DeviceACON Laboratories, Inc. · 2003
- This deviceK151935 Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H.…Alere San Diego, Incorporated · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934863 | Flexsure HP | Smithkline Diagnostics, Inc. | 1994 | — |
| −1 | K024350 | Acon H. Pylori Rapid Test Strip and Acon H. Pylori Rapid Test Device | ACON Laboratories, Inc. | 2003 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K024350 | Acon H. Pylori Rapid Test Strip and Acon H. Pylori Rapid Test DeviceSummary page 6…ori Rapid Test Strip and Test Device (k024350) Similarities Intended Use The Alere H. pylori cassette is a rapid Same… | 2003 |
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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 12.4 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All LYR devicesLYR Helicobacter Pylori: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 Signify® H. pylori cassette is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older. The Signify® H. pylori cassette is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood to aid in the diagnosis of H. pylori…
Read the full statement (166 words)
The Signify® H. pylori cassette is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.
The Signify® H. pylori cassette is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.
The Clearview® H. pylori test is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.
The Clearview® H. pylori test is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151935 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151935: Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151935
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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