CFN · Method, Nephelometric, Immunoglobulins (G, A, M)
Immunology · 21 CFR 866.5510 · Class 2
Overview
| Product Code | CFN |
|---|---|
| Device Name | Method, Nephelometric, Immunoglobulins (G, A, M) |
| Regulation | 21 CFR 866.5510 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 61)
Showing 20 most recent of 61 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233663 | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) | Siemens Healthcare Diagnostics Products GmbH | Dec 13, 2023 | SESE |
| K221114 | Immunoglobulin G (IgG) | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | Aug 2, 2023 | SESE |
| K192116 | Human IgA liquid reagent kit for Use on SPAPlus | The Binding Site Group , Ltd. | Sep 4, 2019 | SESE |
| K191985 | Optilite IgA Kit | The Binding Site Group , Ltd. | Aug 19, 2019 | SESE |
| K191635 | Optilite IgM Kit | The Binding Site Group , Ltd. | Jul 15, 2019 | SESE |
| K191465 | Human IgM Kit for use on SPAPlus | The Binding Site Group , Ltd. | Jun 27, 2019 | SESE |
| K190686 | Optilite IgM CSF Kit | The Binding Site Group , Ltd. | May 28, 2019 | SESE |
| K183151 | Optilite IgA CSF Kit | The Binding Site Group , Ltd. | Jan 23, 2019 | SESE |
| K162208 | DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent | Beckman Coulter, Inc. | Jan 9, 2017 | SESE |
| K150526 | Optilite IgG4 Kit | The Binding Site Group , Ltd. | May 30, 2015 | SESE |
| K142735 | The Optilite IgG3 kit | The Binding Site Group , Ltd. | Dec 21, 2014 | SESE |
| K130122 | BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER | Beckman Coulter, Inc. | Jan 7, 2014 | SESE |
| K120901 | HUMAN IGA CSF KIT FOR USE ON SPAPLUS | The Binding Site Group , Ltd. | May 30, 2013 | SESE |
| K120750 | HUMAN IGM CSF KIT | The Binding Site Group , Ltd. | May 17, 2013 | SESE |
| K120749 | HUMAN IGG CSF KIT | The Binding Site Group , Ltd. | May 17, 2013 | SESE |
| K113823 | HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT | The Binding Site Group , Ltd. | Mar 27, 2013 | SESE |
| K103824 | HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS | The Binding Site | Feb 27, 2012 | SESE |
| K100588 | HUMAN IGA2 KIT FOR USE ON THE SPAPLUS | The Binding Site Group , Ltd. | Aug 16, 2010 | SESE |
| K082823 | HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS | The Binding Site Group , Ltd. | Mar 1, 2010 | SESE |
| K090920 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P) | The Binding Site, Ltd. | Dec 30, 2009 | SESE |
Top Applicants
- The Binding Site Group , Ltd. — 14 clearances
- The Binding Site, Ltd. — 13 clearances
- Dade Behring, Inc. — 6 clearances
- Beckman Coulter, Inc. — 4 clearances
- Olympus America, Inc. — 3 clearances
