DHR · System, Test, Rheumatoid Factor
Immunology · 21 CFR 866.5775 · Class 2
Overview
| Product Code | DHR |
|---|---|
| Device Name | System, Test, Rheumatoid Factor |
| Regulation | 21 CFR 866.5775 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 144)
Showing 20 most recent of 144 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K192727 | K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) | Kamiya Biomedical Company | May 20, 2020 | SESE |
| K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents | Inova Diagnostics, Inc. | Apr 17, 2019 | SESE |
| K182747 | EliA RF IgM Immunoassay | Phadia AB | Dec 18, 2018 | SESE |
| K162263 | Optilite Rheumatoid Factor Kit | The Binding Site Group , Ltd. | May 3, 2017 | SESE |
| K160070 | Rheumatoid Factor (RF) Kit for use on SPAPLUS | The Binding Site Group , Ltd. | Dec 7, 2016 | SESE |
| K143736 | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA | Immco Diagnostics, Inc. | Sep 23, 2015 | SESE |
| K102673 | RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM | Phadia US, Inc. | Sep 30, 2011 | SESE |
| K100499 | ORGENTEC RHEUMATOID FACTOR EIA | Orgentec Diagnostika GmbH | Oct 27, 2010 | SESE |
| K083080 | IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM | Sqi Diagnostics Systems | Oct 29, 2009 | SESE |
| K071247 | N LATEX RF KIT | Dade Behring, Inc. | Aug 8, 2007 | SESE |
| K060201 | OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. | Olympus America, Inc. | Jun 6, 2006 | SESE |
| K041891 | MININEPH HUMAN RHEUMATOID FACTOR KIT | The Binding Site | Nov 5, 2004 | SESE |
| K041863 | VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS | Ortho-Clinical Diagnostics, Inc. | Sep 20, 2004 | SESE |
| K033802 | ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM | Zeus Scientific, Inc. | Feb 27, 2004 | SESE |
| K032535 | MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM | Roche Diagnostics Corp. | Sep 10, 2003 | SESE |
| K024067 | RHEUMATOID FACTOR (RF) | Abbott Laboratories | Jan 15, 2003 | SESE |
| K020972 | WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET | Wako Chemicals USA, Inc. | Sep 9, 2002 | SESE |
| K021394 | DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM | Diamedix Corp. | Jul 9, 2002 | SESE |
| K002609 | TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM | Roche Diagnostics Corp. | Sep 5, 2000 | SESE |
| K000534 | COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II | Roche Diagnostics Corp. | Apr 5, 2000 | SESE |
Top Applicants
- Behring Diagnostics, Inc. — 5 clearances
- Beckman Instruments, Inc. — 4 clearances
- Inova Diagnostics, Inc. — 4 clearances
- Abbott Laboratories — 3 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 3 clearances
