RUBELLACOL
Device Facts
| Record ID | K031490 |
|---|---|
| Device Name | RUBELLACOL |
| Applicant | Immunostics Inc., |
| Product Code | LQN · Microbiology |
| Decision Date | Jul 16, 2003 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3510 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K031490 · Jul 16, 2003 | RUBELLACOL | Immunostics Inc., | Retrospective human serum specimens from donor centers; Hospital research sample bank | Retrospective clinical serum samples were used to conduct method comparison studies against a predicate device to establish performance characteristics. | Retrospective study; Method comparison; Clinical serum specimens |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Retrospective method comparison | 545 human serum specimens (positive, borderline, negative); Sample Size: 545; Number of Sites: 1 | Commercially available latex agglutination test | Positive and negative agreement |
| Retrospective method comparison | 200 human serum specimens (positive, borderline, negative); Sample Size: 200; Number of Sites: 1 | Commercially available latex agglutination test | Positive and negative agreement |
| Method comparison | 200 human serum specimens with unknown Rubella titers; Sample Size: 200; Number of Sites: 1 | Commercially available latex agglutination (LA) test | Positive and negative agreement |
Indications for Use
The RUBELLACOL™ TEST is to be used as an aid in the detection of anti-rubella virus antibodies in serum. This test is "For Professional Use Only".
Device Story
Rubellacol is a color-enhanced latex agglutination slide test for detecting rubella virus antibodies in human serum. The device utilizes polystyrene latex particles coated with purified K2S antigen extract from Rubella HPV-77 virus (grown in African Green Monkey Kidney Vero cells). The suspension buffer contains compatible dyes to facilitate visual observation of the antigen-antibody reaction. The test is performed manually by professional laboratory personnel. The presence of agglutination indicates a positive result, while the absence indicates a negative result. The test provides qualitative and semi-quantitative results to assist clinicians in assessing patient immune status or identifying recent/active infection. It is not intended for prenatal or newborn screening.
Clinical Evidence
Performance validated through three retrospective/prospective comparison studies and a CDC panel. Study 1 (n=545) showed 98.5% total agreement. Study 2 (n=200) showed 99% total agreement. Study 3 (n=200) showed 98% total agreement. CDC panel (n=50) demonstrated 100% agreement with positive and negative specimens. Analytical performance includes >92% reproducibility and no prozone effect up to 1600 IU/ml. Assay cut-off is 10 IU/ml.
Technological Characteristics
Latex particle agglutination assay. Reagent consists of deeply colored polystyrene latex particles coated with purified K2S antigen extract from Rubella HPV-77 virus (Vero cell line). Employs color-enhanced visual observation of antigen-antibody reaction. Manual slide-based test format. Traceable to WHO standards.
Indications for Use
Indicated for the detection of anti-rubella virus antibodies in serum to aid in the diagnosis of recent or active rubella infection and determination of immune status. For professional use only.
Regulatory Classification
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).
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.
