(445 days)
Not Found
No
The description details a standard immunoassay technology and does not mention any AI or ML components. The results are determined using a calibration curve, which is a traditional method, not indicative of AI/ML.
No.
The device is an in vitro diagnostic immunoassay used to determine IgG antibodies for rubella virus. It is used as an aid in assessing immune status, not for treating a condition or disease.
Yes
The device quantitatively determines IgG antibodies to rubella virus, which can "aid in the assessment of immune status to rubella." This information is used for diagnostic purposes.
No
The device is an in vitro diagnostic immunoassay kit, which includes reagents and calibrators, and is intended for use on specific immunoassay analyzers. This involves physical components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the in vitro quantitative determination of IgG antibodies to rubella virus in human serum and Li-heparin, K3-EDTA and sodium citrate plasma." The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The description details a laboratory-based immunoassay that analyzes biological samples (serum and plasma) to detect and quantify specific antibodies.
- Performance Studies: The performance studies involve testing human samples and comparing the results to a predicate device, which is typical for IVD validation.
- Predicate Device: The mention of a predicate device (Zeus Scientific Rubella IgG ELISA Test System) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for new IVDs.
N/A
Intended Use / Indications for Use
(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.
Product codes (comma separated list FDA assigned to the subject device)
LFX, JJX
Device Description
(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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
individuals including women of childbearing age.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
US Routine Clinical Specimens and Acute/Recent Infection:
Negative Agreement: 64.0% (16/25) 42.5 - 82.0%
Positive Agreement: 98.1% (466/475) 96.4-99.1%
Banked Samples:
Negative Agreement: 96.6% (140/145) 92.1-98.9%
Positive Agreement: 84.0% (168/200) 78.2-88.8%
Samples Collected During a Rubella Outbreak:
Negative Agreement: 100% (10/10) 69.1-100.0%
Positive Agreement: 82.0% (50/61) 70.02-90.6%
Pregnant Women
Serum samples were collected from 150 pregnant women in the US and tested on the Elecsys and the reference assay. The Elecsys Rubella IgG showed 100 % agreement (95% CI: 97.57- 100%), with 150/150 positive tests..
Vaccinated Individuals:
Commercially available vaccination follow-up panels comprising 15 samples from 13 subjects were also tested. The final specimen from each panel yielded 100 % agreement (95% CI: 75.29%~100%) between the methods, with 13/13 positive test results.
Testing of Low Positive Samples
84 serum samples that gave low positive (10-20 IU/mL) on the reference assay were tested with the Elecsys Rubella IgG assay. The positive agreement was 80/84 or 95.2%. (88.25 - 98.69%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) Summary
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
| Submitter name, address, contact | Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46250
(317) 521 - 3723
Contact Person: Theresa A. Bush
Date Prepared: November 21, 2008 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Proprietary name: (1) Elecsys Rubella IgG Immunoassay
(2) Elecsys Rubella IgG PreciControl
Common name: (1) Rubella IgG Immunoassay
(2) Rubella IgG PreciControl |
| Device Description | Classification name: (1) Rubella Virus serological reagents
(2) Single (specified) analyte controls (assayed and unassayed)
(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. |
1
| Intended use | (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. |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Elecsys Rubella IgG assay may be used as an aid in the assessment of
immune status to rubella in individuals including women of childbearing age. |
| Substantial
equivalence | The Elecsys Rubella IgG Test System is substantially equivalent to other
devices legally marketed in the United States.
Elecsys Rubella IgG Immunoassay is equivalent to the Zeus Scientific
Rubella IgG ELISA Test System cleared in K983805 |
:
2
510(k) Summary, Continued
Substantial equivalence – similarities
| (1) Rubella IgG Immunoassay Comparison | ||
|---|---|---|
| Feature | Elecsys Rubella IgG | |
| Immunoassay | Predicate Device: Zeus Scientific | |
| Rubella IgG ELISA Test System | ||
| (K984180) | ||
| Intended Use | 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 on Elecsys and cobas e | ||
| immunoassay analyzers. | The Zeus Scientific, Inc. Laboratories | |
| Rubella IgG ELISA Test System is | ||
| designed for the qualitative and/or | ||
| quantitative detection of IgG antibodies | ||
| to rubella virus in human serum. The | ||
| test system is intended to be used to | ||
| evaluate single sera for immune status | ||
| or paired sera to demonstrate | ||
| seroconversion, and is for in vitro | ||
| diagnostic use. | ||
| Indication for | ||
| Use | This assay may be used as an aid in | |
| the assessment of immune status to | ||
| rubella in individuals including | ||
| women of childbearing age. | The test system is intended to be used | |
| to evaluate single sera for immune | ||
| status or paired sera to demonstrate | ||
| seroconversion, and is for in vitro | ||
| diagnostic use. | ||
| Assay Protocol | Electrochemiluminescent | |
| Immunoassay | ELISA | |
| Sample Type | Human serum, lithium heparin | |
| plasma, potassium EDTA plasma | ||
| and sodium citrate plasma | Serum | |
| Instrument | ||
| Platform | Roche Elecsys 2010/ cobas e 411 | |
| and MODULAR ANALYTICS | ||
| E170 (Elecsys module)/ cobas e | ||
| 601 analyzers. | No automated instrument platform. | |
| ELISA equipment/ microwell plate | ||
| reader needed. No specific model | ||
| required. | ||
| Calibrator | Included in kit | Included in kit |
| Calibrator levels | Two | One |
| Format | Human serum | Human serum |
| Calibrator | ||
| Stability | After opening at 2-8°C: 8 weeks | |
| On Elecsys 2010/ cobas e 411: up | ||
| to 5 hours | ||
| On E170/ cobas e 601: use only | ||
| once | Store between 2-8 °C. | |
| Calibration | ||
| frequency | Once per reagent lot and | |
| • After 1 month when using | ||
| same reagent lot | ||
| • After 7 days when using | ||
| same reagent kit | ||
| • As required per QC findings | ||
| or pertinent regulations | Each time the assay is run. | |
| Controls | PreciControl Rubella IgG (sold | |
| separately) | Positive and negative control included | |
| in kit. | ||
| Traceability | 1st International Standard for Anti- | |
| Rubella Immunoglobulin, human, | ||
| NIBSC RUBI-1-94; formerly | ||
| referred to as proposed 3rd WHO | ||
| Reference Standard Preparation | Recovery of WHO Reference Standard | |
| is shown. | ||
| Reagent Stability | Unopened 2-8°C - up to expiration | |
| Opened 2-8°C - 12 weeks | ||
| Onboard- 2 weeks or 12 weeks | ||
| (stored alternately in refrigerator | ||
| and on the analyzer- ambient | ||
| temperature 20-25°C; up to 84 hours | ||
| opened in total.) | Unopened kit: Store at 2-8°C. | |
| Coated microwell strips: 2-8°C should | ||
| be immediately resealed with | ||
| dessicant, stable 60 days provided | ||
| indicator on dessicant pouch remains | ||
| blue. | ||
| Conjugate, Control, Calibrator, TMB, | ||
| and Diluent: 2-8°C | ||
| Wash buffer and Stop Solution: 2-25°C | ||
| Diluted wash buffer: stable at room | ||
| temperature 7 days or 30 days at 2-8°C | ||
| Measuring | 0.21 - 500 IU/mL | 0-20 IU/mL |
| Precision | ||
| Intrassay: (range of values) | ||
| Low Control: SD 0.075-0.176 IU/mL | ||
| High Control: CV 1.20-6.79 % | ||
| Plasma Samples 5 IU/mL: | ||
| CV 1.64 – 8.21% |
Inter-assay:
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% | Intraassay:
Low: 5.1-6.2%
Medium: 6.8-13.2%
High: 4.4-8.96%
Inter-assay:
Low:6.3 %
Medium:5.8%
High:8.7% |
| Limit of Blank |