LYR · Helicobacter Pylori
Microbiology · 21 CFR 866.3110 · Class 1
Overview
| Product Code | LYR |
|---|---|
| Device Name | Helicobacter Pylori |
| Regulation | 21 CFR 866.3110 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Campylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases. Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.
Classification Rationale
Class I (general controls).
Recent Cleared Devices (20 of 91)
Showing 20 most recent of 91 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232892 | Hp Detect Stool Antigen ELISA | Biomerica, Inc. | Dec 15, 2023 | SESE |
| K230901 | Premier HpSA Flex (619096) | Meridian Bioscience, Inc. | Jul 3, 2023 | SESE |
| K192817 | Curian HpSA, Curian Analyzer | Meridian Bioscience, Inc. | Mar 13, 2020 | SESE |
| K183573 | Vstrip H. pylori Antigen Rapid Test | Panion & BF Biotech, Inc. | Mar 14, 2019 | SESE |
| K182559 | PREMIER Platinum HpSA PLUS | Meridian Bioscience, Inc. | Nov 5, 2018 | SESE |
| K181464 | LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set | DiaSorin, Inc. | Aug 31, 2018 | SESE |
| K181400 | H. PYLORI CHEK | Techlab, Inc. | Aug 21, 2018 | SESE |
| K181379 | H. PYLORI QUIK CHEK | Techlab, Inc. | Aug 21, 2018 | SESE |
| K161139 | LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set | DiaSorin, Inc. | Jul 22, 2016 | SESE |
| K153661 | ImmunoCard STAT! HpSA | Meridian Bioscience, Inc. | Mar 14, 2016 | SESE |
| 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 | Alere San Diego, Incorporated | Aug 12, 2015 | SESE |
| K141133 | VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II | BIOMERIEUX | Jul 9, 2015 | SESE |
| K110745 | HELICOBACTER PYLORI ELISA IGG TEST KIT | Gold Standard Diagnostics | Mar 2, 2012 | SESE |
| K110899 | GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT | Gold Standard Diagnostics | Feb 1, 2012 | SESE |
| K052716 | RAPIRUN H. PYLORI ANTIBODY DETECTION KIT | Otsuka Pharmaceutical Co., Ltd. | Nov 16, 2006 | SESE |
| K052708 | PYLO-PLUS | Arj Medical, Inc. | May 1, 2006 | SESE |
| K053335 | PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480 | Meridian Bioscience, Inc. | Mar 10, 2006 | SESE |
| K041238 | HELICOBACTER PYLORI IGG ELISA | Biohit Plc | Dec 13, 2004 | SESE |
| K032222 | IMMUNOCARDSTAT HPSA | Meridian Bioscience, Inc. | Dec 5, 2003 | SESE |
| K033067 | PYLORI IGG | Trinity Biotech USA | Nov 26, 2003 | SESE |
Top Applicants
- Meridian Bioscience, Inc. — 6 clearances
- Quidel Corp. — 6 clearances
- Meridian Diagnostics, Inc. — 5 clearances
- Biomerica, Inc. — 3 clearances
- Chemtrak, Inc. — 2 clearances
