FDA product code LYR: Helicobacter Pylori
LYR is the FDA product code for helicobacter pylori. It is a Class I device, regulated under 21 CFR 866.3110 and reviewed by the Microbiology panel. FDA has cleared 91 510(k) submissions under LYR, 2 in the last five years, from 59 different applicants. The average 510(k) review took 165 days (median 137). FDA has posted 11 recalls for LYR devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Helicobacter Pylori |
| Device class | Class I |
| Regulation | 21 CFR 866.3110 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LYR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 4 | 78 |
| 2019 | 1 | 83 |
| 2020 | 1 | 164 |
| 2023 | 2 | 91 |
Compare with all 510(k) review times · Search every LYR clearance
Top LYR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meridian Bioscience, Inc. | 6 | 2023-07-03 |
| Quidel Corp. | 6 | 1999-08-04 |
| Meridian Diagnostics, Inc. | 5 | 1998-12-17 |
| Biomerica, Inc. | 3 | 2023-12-15 |
| DiaSorin, Inc. | 2 | 2018-08-31 |
54 more applicants have LYR clearances. See the full list in Caduvo.
Most recent LYR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232892 | Biomerica, Inc. | Hp Detect Stool Antigen ELISA | 2023-12-15 | 88 |
| K230901 | Meridian Bioscience, Inc. | Premier HpSA Flex (619096) | 2023-07-03 | 94 |
| K192817 | Meridian Bioscience, Inc. | Curian HpSA, Curian Analyzer | 2020-03-13 | 164 |
| K183573 | Panion & BF Biotech, Inc. | Vstrip H. pylori Antigen Rapid Test | 2019-03-14 | 83 |
| K182559 | Meridian Bioscience, Inc. | PREMIER Platinum HpSA PLUS | 2018-11-05 | 49 |
Recalls for LYR devices
11 product recalls in 7 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2022 | 3 |
| 2023 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code LYR?
LYR is the FDA product code for helicobacter pylori. It is a Class I device, regulated under 21 CFR 866.3110 and reviewed by the Microbiology panel.
What device class is LYR?
Class I, regulation 21 CFR 866.3110. Typical premarket route: 510(k).
How long does a 510(k) take for product code LYR?
Across 91 cleared submissions the average was 165 days from receipt to decision (median 137).
Which companies have the most LYR clearances?
Meridian Bioscience, Inc. (6); Quidel Corp. (6); Meridian Diagnostics, Inc. (5); Biomerica, Inc. (3); DiaSorin, Inc. (2).
Have LYR devices been recalled?
Yes: 11 product recalls across 7 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code LYR
- Run a recall and safety report across every LYR manufacturer
- Watch product code LYR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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