LFX · Enzyme Linked Immunoabsorbent Assay, Rubella
Microbiology · 21 CFR 866.3510 · Class 2
Overview
| Product Code | LFX |
|---|---|
| Device Name | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Regulation | 21 CFR 866.3510 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).
Classification Rationale
Class II. The special controls for this device are:
Special Controls
*Classification.* Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards': (i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,” (ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,” (iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,” (iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and (v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,” (2) Centers for Disease Control's: (i) Low Titer Rubella Standard, (ii) Reference Panel of Well Characterized Rubella Sera, and (3) World Health Organization's International Rubella Standard.
Recent Cleared Devices (20 of 94)
Showing 20 most recent of 94 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250588 | Access Rubella IgG | Beckman Coulter, Inc. | Nov 17, 2025 | SESE |
| K243168 | Alinity i Rubella IgG | Abbott Laboratories | Jun 20, 2025 | SESE |
| K122397 | LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM | DiaSorin, Inc. | Sep 6, 2012 | SESE |
| K093101 | MAGO 4S | Diamedix Corp. | Jan 21, 2011 | SESE |
| K092587 | BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM | Bio-Rad Laboratories | Dec 3, 2010 | SESE |
| K092322 | ELECSYS RUBELLA IGM IMMUNOASSAY | Roche Diagnostics | Mar 12, 2010 | SESE |
| K080766 | VIDAS RUB IGG | bioMerieux, Inc. | Dec 23, 2008 | SESE |
| K072617 | ELECSYS RUBELLA IGG IMMUNOASSAY | Roche Diagnostics Corp. | Dec 5, 2008 | SESE |
| K073390 | DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS | DiaSorin, Inc. | Nov 21, 2008 | SESE |
| K063186 | ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM | Zeus Scientific, Inc. | Mar 21, 2007 | SESE |
| K063143 | VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS | Ortho-Clinical Diagnostics, Inc. | Dec 26, 2006 | SESE |
| K031606 | ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY | Beckman Coulter, Inc. | Jun 20, 2003 | SESE |
| K012077 | IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6 | Diagnostic Products Corp. | Jan 10, 2002 | SESE |
| K010668 | BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY | Bayer Corp. | Jul 5, 2001 | SESE |
| K003412 | ADVIA CENTAUR RUBELLA IGG ASSAY | Bayer Corp. | Apr 13, 2001 | SESE |
| K001875 | DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM | Diamedix Corp. | Aug 21, 2000 | SESE |
| K993291 | COPALIS RUBELLA IGM | DiaSorin, Inc. | Feb 10, 2000 | SESE |
| K984180 | THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM | Zeus Scientific, Inc. | Jul 20, 1999 | SESE |
| K983805 | THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO | Zeus Scientific, Inc. | May 26, 1999 | SESE |
| K981729 | IS-RUBELLA IGG TEST SYSTEM | Diamedix Corp. | Jan 28, 1999 | SESE |
Top Applicants
- Abbott Laboratories — 8 clearances
- Zeus Scientific, Inc. — 5 clearances
- Ortho Diagnostic Systems, Inc. — 5 clearances
- Labsystems, Inc. — 5 clearances
- Gull Laboratories, Inc. — 5 clearances
