LQN · Latex Agglutination Assay, Rubella
Microbiology · 21 CFR 866.3510 · Class 2
Overview
| Product Code | LQN |
|---|---|
| Device Name | Latex Agglutination 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 (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K031490 | RUBELLACOL | Immunostics Inc., | Jul 16, 2003 | SESE |
| K970931 | COPALIS TORC TOTAL ANTIBODY ASSAY | Sienna Biotech, Inc. | Apr 24, 1997 | SESE |
| K961784 | COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS | Sienna Biotech, Inc. | Oct 31, 1996 | SESE |
| K954920 | MUREX RUB-EX | Murex Diagnostics, Inc. | Aug 21, 1996 | SESE |
| K952544 | COLORSLIDER RUBELLA | Seradyn, Inc. | Jan 17, 1996 | SESE |
| K912391 | RUBALEX, MODIFICATION | Orion Corp. | May 4, 1992 | SESE |
| K901637 | RESUBMITTED MODIFIED RUBALEX | Orion Corp. | Apr 26, 1990 | SESE |
| K896433 | MODIFIED RUBAGEN | Biokit USA, Inc. | Nov 29, 1989 | SESE |
| K893755 | RUBAGEN | Biokit USA, Inc. | Aug 21, 1989 | SESE |
| K861881 | RUBALEX (REVISED VERSION) | Orion Corp. | Jun 4, 1986 | SESE |
| K852788 | RUBALEX | Orion Corp. | Mar 12, 1986 | SESE |
| K844436 | VIROGEN RUBELLA MICROTITER TEST | Armkel, LLC | May 21, 1985 | SESE |
| K844435 | VIROGEN RUBELLA SLIDE TEST | Armkel, LLC | May 20, 1985 | SESE |
Top Applicants
- Orion Corp. — 4 clearances
- Armkel, LLC — 2 clearances
- Biokit USA, Inc. — 2 clearances
- Sienna Biotech, Inc. — 2 clearances
- Immunostics Inc., — 1 clearance
