GOL · Antigen, Ha (Including Ha Control), Rubella
Microbiology · 21 CFR 866.3510 · Class 2
Overview
| Product Code | GOL |
|---|---|
| Device Name | Antigen, Ha (Including Ha Control), 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 21)
Showing 20 most recent of 21 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K841174 | RUBELLA ANTIBODY FLUOROIMMUNOASSAY | Intl. Diagnostic Technology | Jun 7, 1984 | SESE |
| K834032 | RUBAQUICK DIAGNOSTIC KIT | Abbott Laboratories | Apr 17, 1984 | SESE |
| K810309 | RUBELLA ANTIBODIES TEST REAGENTS | Calbiochem-Behring Corp. | Mar 11, 1981 | SESE |
| K802508 | RUBELISA IGM TEST KIT | M.A. Bioproducts | Dec 18, 1980 | SESE |
| K802339 | EIA RUBELLA-G | Beckman Instruments, Inc. | Dec 18, 1980 | SESE |
| K802102 | RUBELLA ELISA REAGENTS RUBELLA IGG ANTI | Calbiochem-Behring Corp. | Dec 18, 1980 | SESE |
| K801667 | GAMMA COAT(125 I) RUBELLA ANTIBODY | Clinical Assays, Inc. | Oct 23, 1980 | SESE |
| K801098 | ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES) | Flow Laboratories, Inc. | Sep 16, 1980 | SESE |
| K801507 | ANTIGEN CONTROL CELLS | Ortho Diagnostics, Inc. | Aug 20, 1980 | SESE |
| K800789 | RUBELLA BIO-BEAD TITRATION KIT | Litton Bionetics | Jun 30, 1980 | SESE |
| K800797 | MACRO-VUE RUBELLA CARD TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jun 20, 1980 | SESE |
| K792249 | FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD | Intl. Diagnostic Technology | Jan 23, 1980 | SESE |
| K791610 | RUBELLA BIO-BEAD SCREEN KIT | Litton Bionetics | Nov 13, 1979 | SESE |
| K790976 | RUBAZYME | Abbott Laboratories | Aug 16, 1979 | SESE |
| K790212 | CORDIA T | Cordis Corp. | Apr 12, 1979 | SESE |
| K780885 | CORDIA R | Cordis Corp. | Jan 17, 1979 | SESE |
| K771796 | RUBA-NOST TEST KITS | Behring Diagnostics, Inc. | Oct 18, 1977 | SESE |
| K770809 | MEASLES-FA LABELED PRESERUM (8-441 RNF) | Flow Laboratories, Inc. | May 20, 1977 | SESE |
| K770805 | MEASLES-FA LABELLED (8-441 RF) | Flow Laboratories, Inc. | May 20, 1977 | SESE |
| K770092 | HERPESIVIRUS TEST (TYPE L & 2) | Microbiological Research Corp. | Mar 1, 1977 | SESE |
Top Applicants
- Abbott Laboratories — 3 clearances
- Flow Laboratories, Inc. — 3 clearances
- Calbiochem-Behring Corp. — 2 clearances
- Cordis Corp. — 2 clearances
- Intl. Diagnostic Technology — 2 clearances
