(445 days)
(1) The Elecsys Rubella IgG immunoassay is for the in vitro quantitative determination of IgG antibodies to rubella virus in human serum and Li-heparin, K3-EDTA and sodium citrate plasma.
This assay may be used as an aid in the assessment of immune status to rubella in individuals including women of childbearing age.
The electrochemiluminescence immunoassay "ECLIA" is intended for use or Elecsys and cobas e immunoassay analyzers.
(2) Elecsys PreciControl Rubella IgG is used for quality control of the Elecsys Rubella IgG immunoassay on the Elecsys and cobas e immunoassay analyzers.
(1) The Elecsys Rubella IgG Immunoassay is a two-step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. The Rubella IgG assay contains: a biotin labeled monoclonal antibody against human IgG, a ruthenium-labeled anti-Rubella antibody fragment , biotin- and ruthenium-labeled Rubella-antigens and a Rubella-like particle. A relationship exists between the concentration of the IgG antibody targets present in a patient sample and the level of signal count detected by the system. The IgG assay is quantitative and is standardized against WHO materials. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code. The test kit contains the human serum-based calibrators intended for use with the system.
(2) The Elecsys Precicontrol Rubella IgG contains two levels of human serum with Rubella IgG antibodies.
Here's an analysis of the acceptance criteria and supporting studies for the Elecsys Rubella IgG Immunoassay, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device, rather than explicit pre-defined acceptance criteria in terms of numerical thresholds for performance metrics. However, we can infer performance goals based on the presented data and the comparison to the predicate device.
| Performance Metric | Acceptance Criteria (Implied/Achieved for Substantial Equivalence) | Reported Device Performance (Elecsys Rubella IgG Immunoassay) |
|---|---|---|
| Method Comparison (vs Predicate: Zeus Scientific Rubella IgG ELISA Test System) | Agreement with predicate device demonstrating similar clinical utility. | See detailed breakdown below in "Study Details". |
| Limit of Blank (LoB) | As low as possible to ensure accurate negative results. | 5 IU/mL: CV 1.64–8.21% |
| Precision (Inter-assay) | Low variability across different assay runs. | Low Control: SD 0.118-0.319 IU/mL; High Control: CV 3.35-7.69 %; Plasma Samples 5 IU/mL: CV 2.08–9.54% |
| Analytical Specificity | High agreement in the presence of various disease states. | 96.6 % agreement with predicate for 60 specimens representing a variety of disease states. |
| Interferences | Recovery of positive samples within ± 20% of initial value. Assayed for icterus, hemolysis, lipemia, Immunoglobulin A, biotin, rheumatoid factors, and Rubella-specific Immunoglobulin M. | Unaffected by icterus ( |
§ 866.3510 Rubella virus serological reagents.
(a)
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).(b)
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.