510(k) · Cleared
ClearedGold Standard Diagnostics H. Pylori Elisa Iga Test Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gold Standard Diagnostics · LYR Helicobacter Pylori
Cleared on Feb 1, 2012 as substantially equivalent to K003794 (Micro Detect, Inc., 2001) after a 308-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Feb 1, 2012
- Review
- 308 days
- Class
- Class I
- Product code
- LYR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003794 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK003794 Elisa Test, SerologyMicro Detect, Inc. · 2001
- This deviceK110899 Gold Standard Diagnostics H. Pylori Elisa Iga Test KitGold Standard Diagnostics · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003794 | Elisa Test, Serology | Micro Detect, Inc. | 2001 | — |
| 0 (this device) | K110899 | Gold Standard Diagnostics H. Pylori Elisa Iga Test Kit | Gold Standard Diagnostics | 2012 | — |
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 |
|---|---|---|---|
| * | K003794 | Elisa Test, SerologySummary page 1…gA antibodies against H pylori in human serum. The test is intended as an aid in the diagnosis of infection by H pylori in patients with gastrointestinal symptoms. K003794. 4) Description of the device: The assay requires a total of 90 minutes incubation time. The test uses purified antigen coate… | 2001 |
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. 2012, 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 Helicobacter pylori (H.pylori) ELISA IgA test kit is intended for the qualitative
detection of IgA antibodies to H. pylori in human serum in the adult population.
This test is intended as a second test to aid in the diagnosis of H. pylori in
patients with gastrointestinal symptoms, in conjunction with clinical findings. It
should be performed and interpreted with another assay for detection of lgG
antibodies to H. pylon.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110899 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110899: Gold Standard Diagnostics H. Pylori Elisa Iga Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110899
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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