(220 days)
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No
The description details a standard immunoassay technology and analysis based on a fixed cut-off value, with no mention of AI or ML algorithms for data processing or interpretation.
No
This device is an in vitro diagnostic immunoassay used to detect antibodies for diagnosis, not to treat a condition.
Yes
The Elecsys Rubella IgM immunoassay is an aid in the presumptive diagnosis of an acute or recent rubella infection, which falls under the definition of a diagnostic device.
No
The device is an in vitro diagnostic immunoassay kit that includes reagents and controls, intended for use on specific immunoassay analyzers. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Elecsys Rubella IgM immunoassay is "for the in vitro qualitative determination of IgM 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.
- Sample Type: The assay uses human serum and plasma, which are biological specimens tested outside of the body.
- Purpose: The assay is used as an "aid in the presumptive diagnosis of an acute or recent rubella infection," which is a diagnostic purpose.
- Device Description: The description details a laboratory-based immunoassay system designed to analyze biological samples.
- Quality Control: The mention of "Elecsys PreciControl Rubella IgM" for quality control further supports its use in a clinical laboratory setting for diagnostic testing.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
(1) The Elecsys Rubella IgM immunoassay is for the in vitro qualitative determination of IgM 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 presumptive diagnosis of an acute or recent rubella infection in individuals, including women of childbearing age. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers. NOTE: This assay has not been cleared/approved by the FDA for blood/plasma donor screening.
(2) Elecsys PreciControl Rubella IgM is used for quality control of the Elecsys Rubella IgM 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 IgM Immunoassay is a two-step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. The Rubella IgM is composed of a biotin-labeled monoclonal antibody-against-human IgM, a Rubella-like particle and a ruthenium-labeled anti-Rubella antibody. A relationship exists between the concentration of the IgM antibody targets present in a patient sample and the level of signal count detected by the system. The IgM assay is a qualitative test based on a cut-off formula dependent on the negative and positive calibrators. Cut-off index (COI) is based on the ratio of assay signal to cut-off signal (also abbreviated s/co). COI values equal to or greater than 1.0 are considered positive for the presence of anti-Rubella IgM antibody. Results are determined using a 2 point calibration. The test system contains the human serum-based calibrators intended for use with the system.
(2) The Elecsys PreciControl Rubella igM contains two levels of human serum. The positive control contains native, inactivated Rubella IgM antibodies.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison (Elecsys vs Zeus Scientific/Abbott AxSym and DPC Immulite):
Pregnant Subjects:
Negative Agreement: 99.20% (131/132) 95.90%-99.98%
Positive Agreement: 0.00% (0/0) 0%-100%
Non-Pregnant Subjects:
Negative Agreement: 98.90% (364/368) 97.20-99.70%
Positive Agreement: 0.00% (0/1) 0.00-97.5%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical Specificity: 77.6% agreement with predicate for 60 specimens representing a variety of disease states
Precision:
Intrassay: (range of values)
Low Control: CV 1.38 - 5.74%
High Control: CV 1.14 - 4.83%
Plasma Samples: CV 1.03 - 6.71%
Inter-assay:
Low Control: CV 2.04 - 10.52%
High Control: CV 2.77 - 10.43%
Plasma Sample: 1.86 - 17.07 %
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.
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Elecsys Rubella IgM Test system ----------------------------------------------------------------------------------------------------------------------------------------------
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510(k) Summary
MAR ] 2 2010
. ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Introduction | 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: March 12, 2010 |
| Device Name | Proprietary name: (1) Elecsys Rubella IgM Immunoassay
(2) Elecsys Rubella IgM PreciControl
Common name: (1) Rubella IgM Immunoassay
(2) Rubella IgM PreciControl
Classification name: (1) Rubella Virus serological reagents
(2) Single (specified) analyte controls (assayed and unassayed) |
| Device Description | (1) The Elecsys Rubella IgM Immunoassay is a two-step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. The Rubella IgM is composed of a biotin-labeled monoclonal antibody-against-human IgM, a Rubella-like particle and a ruthenium-labeled anti-Rubella antibody. A relationship exists between the concentration of the IgM antibody targets present in a patient sample and the level of signal count detected by the system. The IgM assay is a qualitative test based on a cut-off formula dependent on the negative and positive calibrators. Cut-off index (COI) is based on the ratio of assay signal to cut-off signal (also abbreviated s/co). COI values equal to or greater than 1.0 are considered positive for the presence of anti-Rubella IgM antibody. Results are determined using a 2 point calibration. The test system contains the human serum-based calibrators intended for use with the system: |
calibrators intended for use with the system: · · · · · · · · · · · · ·
(2) The Elecsys PreciControl Rubella igM contains two levels of human serum. The positive control contains native, inactivated Rubella IgM antibodies.
ー・
1
510(k) Summary, Continued
with the state of the program and the country of the county of the
| Intended use | (1) The Elecsys Rubella IgM immunoassay is for the in vitro qualitative
determination of IgM 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 presumptive diagnosis of an acute or recent rubella infection in
individuals, including women of childbearing age. The
electrochemiluminescence immunoassay "ECLIA" is intended for use on the
Elecsys and cobas e immunoassay analyzers. NOTE: This assay has not been
cleared/approved by the FDA for blood/plasma donor screening.
(2) Elecsys PreciControl Rubella IgM is used for quality control of the
Elecsys Rubella IgM immunoassay on the Elecsys and cobas e immunoassay
analyzers. |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | (1)The Elecsys Rubella IgM assay may be used as an aid in the presumptive
diagnosis of an acute or recent rubella infection, particularly in women of
childbearing age. |
| Substantial
equivalence | Continued
The Elecsys Rubella IgM Test system is substantially equivalent to other
devices legally marketed in the United States.
(1) Elecsys Rubella IgM Immunoassay is equivalent to the Zeus Scientific
Rubella IgM ELISA Test System cleared in K984180
(2) Elecsys PreciControl Rubella IgM is equivalent to the Elecsys
PreciControl TnT (K031990)
The devices are compared to their predicates in the tables below. |
in a pipe to treating and the comment of the province of the comments of . t...
ﺎ ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... 1
2
510(k) Summary, Continued
| (1) Rubella IgM Immunoassay Comparison | ||
|---|---|---|
| Feature | Elecsys Rubella IgM | |
| Immunoassay | Predicate Device: Zeus Scientific | |
| Rubella IgM ELISA Test System | ||
| (K984180) | ||
| Intended Use | The Elecsys Rubella IgM | |
| immunoassay is for the in vitro | ||
| qualitative determination of IgM | ||
| 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 presumptive diagnosis of an | ||
| acute or recent rubella infection, | ||
| particularly in women of | ||
| childbearing age. The | ||
| electrochemiluminescence | ||
| immunoassay "ECLIA" is | ||
| intended for use on the Elecsys | ||
| and cobas e immunoassay | ||
| analyzers. | ||
| Note: This assay has not been | ||
| cleared/approved by the FDA for | ||
| blood/plasma donor screening. | The Zeus Scientific, Inc. Laboratories | |
| Rubella IgM ELISA Test System is | ||
| designed for the qualitative detection | ||
| of IgM antibodies to rubella virus in | ||
| human serum. The test system is | ||
| intended to be used to evaluate | ||
| serological evidence of acute or recent | ||
| infection with rubella virus and is for | ||
| in vitro diagnostic use | ||
| Indication for | ||
| Use | aid in the presumptive diagnosis of | |
| an acute or recent rubella | ||
| infection, particularly in women of | ||
| childbearing age. | is intended to be used to evaluate | |
| serological evidence of acute or recent | ||
| infection with rubella virus and is for | ||
| in vitro diagnostic use | ||
| Assay Protocol | Electrochemiluminescent | |
| Immunoassay | ELISA | |
| Sample Type | Human serum. lithium heparin | |
| plasma, potassium (K3) EDTA | ||
| plasma and sodium citrate plasma | Serum | |
| Instrument | ||
| Platform | Roche Elecsys 2010 and | |
| MODULAR ANALYTICS E170 | ||
| (Elecsys module) and cobas e | ||
| immunoassay 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 IgM (sold | |
| separately) | Positive and negative control included | |
| in kit. | ||
| Traceability | Roche standard with arbitrary | |
| units | 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 | ||
| Precision | Intrassay: (range of values) | |
| Low Control: CV 1.38 - 5.74% | ||
| High Control: CV 1.14 - 4.83% | ||
| Plasma Samples: CV 1.03 - 6.71% |
Inter-assay:
Low Control: CV 2.04 - 10.52%
High Control: CV 2.77 - 10.43%
Plasma Sample: 1.86 - 17.07 % | Intraassay:
Negative: 27-60%
Negative close to equivocal: 3.1-7.1%
Equivocal: 1.2-10.1%
High Positive: 3.4-9.3%
Low Positive: 3.2-5.4%
Inter-assay:
Negative: 48%
Negative close to equivocal: 16.4%
Equivocal: 3.5%
High Positive 5.7%
Low Positive: 4.1% |
| Analytical
Specificity | 77.6% agreement with predicate
for 60 specimens representing a
variety of disease states | Not stated. |
| | | |
| Interferences | The assay is unaffected by icterus
(bilirubin