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.

Elecsys PreciControl Rubella IgM is used for quality control of the Elecsys Rubella IgM immunoassay on the Elecsys and cobas e immunoassay analyzers.

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.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text for the Elecsys Rubella IgM Test system.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. Instead, it presents performance data (e.g., agreement percentages) as part of the method comparison with predicate devices.

Metric (Type of Agreement)	Acceptance Criteria (Not explicitly stated as criteria in document)	Reported Device Performance (Elecsys vs. Predicate)	Notes
Pregnant Subjects			Against Zeus Scientific/Abbott AxSym and DPC Immulite
Negative Agreement	N/A	99.20% (131/132) [95.90%-99.98% CI]	Very high agreement for negative cases
Positive Agreement	N/A	0.00% (0/0) [0%-100% CI]	No positive rubella IgM cases found in pregnant subjects within this specific comparison
Non-Pregnant Subjects			Against Zeus Scientific/Abbott AxSym and DPC Immulite
Negative Agreement	N/A	98.90% (364/368) [97.20-99.70% CI]	Very high agreement for negative cases
Positive Agreement	N/A	0.00% (0/1) [0.00-97.5% CI]	Only one positive rubella IgM case found, and the Elecsys device did not agree. The wide CI reflects the small sample size.
Analytical Specificity (against predicate)	N/A	77.6% agreement with predicate for 60 specimens representing a variety of disease states	This indicates how well the assay differentiates Rubella IgM from other conditions.
Precision			Various CVs (Coefficient of Variation) are reported for intra-assay and inter-assay precision for different control levels and plasma samples. The predicate also reports CVs. These are performance characteristics rather than explicit acceptance criteria.

2. Sample Sizes Used for the Test Set and Data Provenance

Test Set Sample Sizes:
- Method Comparison (Elecsys vs. Zeus Scientific/Abbott AxSym and DPC Immulite):
  - Pregnant Subjects: 132 (131 negative, 0 positive)
  - Non-Pregnant Subjects: 369 (368 negative, 1 positive)
  - This totals 501 samples for the method comparison.
- Analytical Specificity: 60 specimens.
Data Provenance: The document does not explicitly state the country of origin of the data. It also does not explicitly state if the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not provide information regarding the number of experts used to establish ground truth or their qualifications. The "ground truth" for the method comparison appears to be established by the results of the predicate devices (Zeus Scientific Rubella IgM ELISA Test System, Abbott AxSym, and DPC Immulite).

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1). The comparison is directly made against the results of the predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not mentioned or conducted. This device is an in-vitro diagnostic (IVD) immunoassay, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance data presented (e.g., method comparison, analytical specificity, precision) represents the standalone performance of the Elecsys Rubella IgM Immunoassay system. Since it's an automated immunoassay, its performance is inherently "standalone" without direct human-in-the-loop interaction in the diagnostic step (though human operators initiate and interpret the results).

7. The Type of Ground Truth Used

The primary "ground truth" used for evaluating the Elecsys Rubella IgM Immunoassay appears to be:

Predicate Device Results: For the method comparison, the results from the legally marketed predicate devices (Zeus Scientific Rubella IgM ELISA Test System, Abbott AxSym, and DPC Immulite) served as the reference for determining agreement.
The document also implies other laboratory methods were used for the "analytical specificity" though more detail is not provided.

8. The Sample Size for the Training Set

The document does not provide information regarding a "training set" size. As an immunoassay, the device is developed and validated through analytical studies and clinical comparisons, rather than a machine learning approach that typically involves distinct training and test sets.

9. How the Ground Truth for the Training Set Was Established

Since a "training set" is not mentioned in the context of this immunoassay's development, the document does not describe how ground truth for a training set was established. The development of such assays typically involves optimizing reagents and protocols to achieve desired analytical performance and then validating that performance against established methods and clinical samples.

Summary

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K092322

Elecsys Rubella IgM Test system ----------------------------------------------------------------------------------------------------------------------------------------------

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510(k) Summary

MAR ] 2 2010

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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 Diagnostics9115 Hague RoadIndianapolis, IN 46250(317) 521 - 3723Contact Person: Theresa A. BushDate prepared: March 12, 2010
Device Name	Proprietary name: (1) Elecsys Rubella IgM Immunoassay(2) Elecsys Rubella IgM PreciControlCommon name: (1) Rubella IgM Immunoassay(2) Rubella IgM PreciControlClassification 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.

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510(k) Summary, Continued

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Intended use	(1) The Elecsys Rubella IgM immunoassay is for the in vitro qualitativedetermination of IgM antibodies to rubella virus in human serum and Li-heparin, K3-EDTA, and sodium citrate plasma. This assay may be used as anaid in the presumptive diagnosis of an acute or recent rubella infection inindividuals, including women of childbearing age. Theelectrochemiluminescence immunoassay "ECLIA" is intended for use on theElecsys and cobas e immunoassay analyzers. NOTE: This assay has not beencleared/approved by the FDA for blood/plasma donor screening.(2) Elecsys PreciControl Rubella IgM is used for quality control of theElecsys Rubella IgM immunoassay on the Elecsys and cobas e immunoassayanalyzers.
Indications forUse	(1)The Elecsys Rubella IgM assay may be used as an aid in the presumptivediagnosis of an acute or recent rubella infection, particularly in women ofchildbearing age.
Substantialequivalence	ContinuedThe Elecsys Rubella IgM Test system is substantially equivalent to otherdevices legally marketed in the United States.(1) Elecsys Rubella IgM Immunoassay is equivalent to the Zeus ScientificRubella IgM ELISA Test System cleared in K984180(2) Elecsys PreciControl Rubella IgM is equivalent to the ElecsysPreciControl TnT (K031990)The devices are compared to their predicates in the tables below.

Intended use

(1) The Elecsys Rubella IgM immunoassay is for the in vitro qualitativedetermination of IgM antibodies to rubella virus in human serum and Li-heparin, K3-EDTA, and sodium citrate plasma. This assay may be used as anaid in the presumptive diagnosis of an acute or recent rubella infection inindividuals, including women of childbearing age. Theelectrochemiluminescence immunoassay "ECLIA" is intended for use on theElecsys and cobas e immunoassay analyzers. NOTE: This assay has not beencleared/approved by the FDA for blood/plasma donor screening.(2) Elecsys PreciControl Rubella IgM is used for quality control of theElecsys Rubella IgM immunoassay on the Elecsys and cobas e immunoassayanalyzers.

Indications forUse

(1)The Elecsys Rubella IgM assay may be used as an aid in the presumptivediagnosis of an acute or recent rubella infection, particularly in women ofchildbearing age.

Substantialequivalence

ContinuedThe Elecsys Rubella IgM Test system is substantially equivalent to otherdevices legally marketed in the United States.(1) Elecsys Rubella IgM Immunoassay is equivalent to the Zeus ScientificRubella IgM ELISA Test System cleared in K984180(2) Elecsys PreciControl Rubella IgM is equivalent to the ElecsysPreciControl TnT (K031990)The devices are compared to their predicates in the tables below.

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510(k) Summary, Continued

	(1) Rubella IgM Immunoassay Comparison
Feature	Elecsys Rubella IgMImmunoassay	Predicate Device: Zeus ScientificRubella IgM ELISA Test System(K984180)
Intended Use	The Elecsys Rubella IgMimmunoassay is for the in vitroqualitative determination of IgMantibodies to rubella virus inhuman serum and Li-heparin, K3-EDTA and sodium citrate plasma.This assay may be used as an aidin the presumptive diagnosis of anacute or recent rubella infection,particularly in women ofchildbearing age. Theelectrochemiluminescenceimmunoassay "ECLIA" isintended for use on the Elecsysand cobas e immunoassayanalyzers.Note: This assay has not beencleared/approved by the FDA forblood/plasma donor screening.	The Zeus Scientific, Inc. LaboratoriesRubella IgM ELISA Test System isdesigned for the qualitative detectionof IgM antibodies to rubella virus inhuman serum. The test system isintended to be used to evaluateserological evidence of acute or recentinfection with rubella virus and is forin vitro diagnostic use
Indication forUse	aid in the presumptive diagnosis ofan acute or recent rubellainfection, particularly in women ofchildbearing age.	is intended to be used to evaluateserological evidence of acute or recentinfection with rubella virus and is forin vitro diagnostic use
Assay Protocol	ElectrochemiluminescentImmunoassay	ELISA
Sample Type	Human serum. lithium heparinplasma, potassium (K3) EDTAplasma and sodium citrate plasma	Serum
InstrumentPlatform	Roche Elecsys 2010 andMODULAR ANALYTICS E170(Elecsys module) and cobas eimmunoassay analyzers.	No automated instrument platform.ELISA equipment/ microwell platereader needed. No specific modelrequired.
Calibrator	Included in kit	Included in kit
Calibrator levels	Two	One
Format	Human serum	Human serum
CalibratorStability	After opening at 2-8°C: 8 weeksOn Elecsys 2010/ cobas e 411: upto 5 hoursOn E170/ cobas e 601: use onlyonce	Store between 2-8 °C.
Calibrationfrequency	Once per reagent lot and• After 1 month when usingsame reagent lot• After 7 days when usingsame reagent kit• As required per QCfindings or pertinentregulations	Each time the assay is run.
Controls	PreciControl Rubella IgM (soldseparately)	Positive and negative control includedin kit.
Traceability	Roche standard with arbitraryunits	Recovery of WHO ReferenceStandard is shown.
Reagent Stability	Unopened 2-8°C - up to expirationOpened 2-8°C - 12 weeksOnboard- 2 weeks or 12 weeks(stored alternately in refrigeratorand on the analyzer- ambienttemperature 20-25°C; up to 84hours opened in total.)	Unopened kit: Store at 2-8°C.Coated microwell strips: 2-8°C shouldbe immediately resealed withdessicant ; stable 60 days providedindicator on dessicant pouch remainsblue.Conjugate, Control, Calibrator, TMB,and Diluent: 2-8°CWash buffer and Stop Solution: 2-25°CDiluted wash buffer: stable at roomtemperature 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%
AnalyticalSpecificity	77.6% agreement with predicatefor 60 specimens representing avariety of disease states	Not stated.

Interferences	The assay is unaffected by icterus(bilirubin < 428 µmol/L or < 25 mg/dL), hemolysis (Hb < 1.49 mmol/L or < 2.4 g/dL), lipemia(Intralipid < 1500 mg/dL),Immunoglobulin A up to 9.6 mg/mL. Immunoglobulin G up to42 mg/mL and biotin < 205 nmol/L or < 50 ng/mL.Criterion: Recovery of positivesamples within ± 20% of initialvalue.RF factor was not observed tocause any consistent bias, but RFfactor levels higher than 1650IU/mL may lead to erroneousresults in some instances.Elevated levels of IgM may causeinterference. There is no high dosehook effect up to a COI of 24.0.As with many μ-capture assays aninterference with unspecifichuman IgM is observed.Increasing amounts of unspecifichuman IgM may lead to a decreasein the recovery of positive sampleswith the Elecsys Rubella IgMassay.	No anticoagulants or preservativesshould be added; avoid usinghemolyzed, lipemic, or bacteriallycontaminated samples. IgG antibodycan cause false negative results.Epstein-Barr can cause false response,infectious mononucleosis andautoimmune disease can cause falsepositives.
MethodComparison(Elecsys vs ZeusScientific/AbbottAxSym and DPCImmulite):	Pregnant Subjects:Negative Agreement:Positive Agreement:Non-Pregnant Subjects:Negative Agreement:Positive Agreement:	99.20% (131/132) 95.90%-99.98%0.00% (0/0) 0%-100%98.90% (364/368) 97.20-99.70%0.00% (0/1) 0.00-97.5%

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(2) Precicontrol Comparison
Feature	Elecsys PrecicontrolRubella IgM	PredicateElecsys PrecicontrolTroponin T (K031990).
Intended Use	Elecsys PreciControlRubella IgM is used forquality control of theElecsys Rubella IgMimmunoassay on theElecsys and cobas eimmunoassay analyzers.	Elecsys PreciControlTroponin T is used forquality control of theElecsys Troponin T(Cardiac T) immunoassayon the Elecsys 2010 andMODULARANALYTICS E170(Elecsys module)immunoassay analyzers.
Levels	Two	Two
Matrix	Human serum	Human serum
Format	Ready to use	Lyophilized
Stability	Unopened: up to thestated expiration dateAfter opening at 2-8C: 8weeksOnboard: 5 hours	Unopened: up to the statedexpiration dateAfter reconstituting: at 2-8C: 2 weeksAt -20C: 8 weeksOnboard: 5 hours

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black against a white background.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002

Roche Diagnostics c/o Theresa A Bush Regulatory Affairs Program Manager 9115 Hague Road Indianapolis, IN, 46250-3831

K092322 Re:

Trade/Device Name:	Elecsys Rubella IgM ImmunoassayElecsys PreciControl Rubella IgM
Regulation Number:	21CFR §866.3510
Regulation Name:	Rubella virus serological reagents
Regulatory Class:	Class II
Product Code:	LFX
	JJX
Dated:	March 5, 2010
Received:	March 9, 2010

Dear Ms. Bush:

We have reviewed your Section 510/k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

MAR 1 2 2010

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): k092322_____________________________________________________________________________________________________________________________________________

Device Name: Elecsys Rubella IgM Immunoassay

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

ייני מיני מיני מקומע היינונג באינגע באונגע באונג

Uke Schief

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k 092322

Page 1 of 2

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Indications for Use Form - - - - - -

510(k) Number (if known): K092322

Device Name: PreciControl Rubella IgM

Elecsys PreciControl Rubella IgM is used for quality control of the Elecsys Rubella IgM immunoassay on the Elecsys and cobas e immunoassay analyzers.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE ... .. .. .......... .. ......................................................................................................................................................

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Uwe Schiff

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k 09 2322 .

Page 2 of

Regulation Number and Section

§ 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.