Who is the manufacturer of ELECSYS RUBELLA IGM IMMUNOASSAY?

Roche Diagnostics filed the 510(k) submission for ELECSYS RUBELLA IGM IMMUNOASSAY (K092322).

What is the FDA product code for ELECSYS RUBELLA IGM IMMUNOASSAY?

LFX. It is classified under 21 CFR 866.3510 as a Class 2 device in the Microbiology panel.

What is the regulatory pathway for ELECSYS RUBELLA IGM IMMUNOASSAY?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ELECSYS RUBELLA IGM IMMUNOASSAY?

Zeus Scientific Rubella IgM ELISA Test System (K984180); Elecsys PreciControl TnT (K031990).

Who can help prepare an FDA 510(k) submission like ELECSYS RUBELLA IGM IMMUNOASSAY?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ELECSYS RUBELLA IGM IMMUNOASSAY

K092322 · Roche Diagnostics · LFX · Mar 12, 2010 · Microbiology

Device Facts

Record ID	K092322
Device Name	ELECSYS RUBELLA IGM IMMUNOASSAY
Applicant	Roche Diagnostics
Product Code	LFX · Microbiology
Decision Date	Mar 12, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.3510
Device Class	Class 2

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, including women of childbearing age. The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers. The Elecsys PreciControl Rubella IgM is used for quality control of the Elecsys Rubella IgM immunoassay on the Elecsys and cobas e immunoassay analyzers.

Device Story

The Elecsys Rubella IgM immunoassay is an automated, in vitro diagnostic test for detecting IgM antibodies to rubella virus in human serum or plasma. The device uses an electrochemiluminescence immunoassay (ECLIA) principle. Patient samples are incubated with biotinylated monoclonal anti-human IgM antibodies and rubella-specific recombinant antigens. Ruthenium-labeled rubella-specific antibodies and streptavidin-coated microparticles are added to form a sandwich complex. The reaction mixture is aspirated into a measuring cell where microparticles are magnetically captured on an electrode. Voltage application induces chemiluminescent emission, measured by a photomultiplier. Results are calculated as a Cut-off Index (COI) using a 2-point calibration curve. The device is intended for use on Roche Elecsys and cobas e immunoassay analyzers in clinical laboratory settings. It aids clinicians in diagnosing acute or recent rubella infection. The system includes quality control materials (PreciControl Rubella IgM) to ensure assay performance. The device provides qualitative results (non-reactive, indeterminate, or reactive) to support clinical decision-making.

Clinical Evidence

Method comparison study performed against predicate devices (Zeus Scientific, Abbott AxSym, DPC Immulite). Results for pregnant subjects showed 99.20% negative agreement (131/132) and 0% positive agreement (0/0). Non-pregnant subjects showed 98.90% negative agreement (364/368) and 0% positive agreement (0/1). Precision studies reported intra-assay CVs of 1.03-6.71% and inter-assay CVs of 1.86-17.07% for plasma samples.

Technological Characteristics

Two-step sandwich immunoassay; electrochemiluminescence (ECLIA) detection; streptavidin microparticles; ruthenium-labeled antibodies. Automated platform (Elecsys/cobas e analyzers). Calibrators included in kit. Matrix: human serum, Li-heparin, K3-EDTA, sodium citrate plasma.

Indications for Use

Indicated for the qualitative detection of IgM antibodies to rubella virus in human serum and plasma (Li-heparin, K3-EDTA, sodium citrate) to aid in the presumptive diagnosis of acute or recent rubella infection, particularly in women of childbearing age.

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.

Predicate Devices

Zeus Scientific Rubella IgM ELISA Test System (K984180)
Elecsys PreciControl TnT (K031990)

Related Devices

K072617 — ELECSYS RUBELLA IGG IMMUNOASSAY · Roche Diagnostics Corp. · Dec 5, 2008
K122397 — LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM · DiaSorin, Inc. · Sep 6, 2012
K012077 — IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6 · Diagnostic Products Corp. · Jan 10, 2002

Submission Summary (Full Text)

{0}------------------------------------------------ K092322 Elecsys Rubella IgM Test system ---------------------------------------------------------------------------------------------------------------------------------------------- . ... ... ... .................................................................................................................................................................. . ### 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 < 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 to 42 mg/mL and biotin < 205 nmol/L or < 50 ng/mL. Criterion: Recovery of positive samples within ± 20% of initial value. RF factor was not observed to cause any consistent bias, but RF factor levels higher than 1650 IU/mL may lead to erroneous results in some instances. Elevated levels of IgM may cause interference. There is no high dose hook effect up to a COI of 24.0. As with many μ-capture assays an interference with unspecific human IgM is observed. Increasing amounts of unspecific human IgM may lead to a decrease in the recovery of positive samples with the Elecsys Rubella IgM assay. | No anticoagulants or preservatives should be added; avoid using hemolyzed, lipemic, or bacteriallycontaminated samples. IgG antibody can cause false negative results. Epstein-Barr can cause false response, infectious mononucleosis and autoimmune disease can cause false positives. | | Method Comparison (Elecsys vs Zeus Scientific/Abbott AxSym and DPC Immulite): | 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% | のお気になる。 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . : 上 {3}------------------------------------------------ a market of the state and prospective and commends one a province of the comments of the comments of . .. יינור יי שנור מגווי ממוזי ממוזי ויינונים :一 . {4}------------------------------------------------ . : ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- - . : · 1:00 pm 1 personal program and the program and the program and the province of the province of the production of the production of the production of the province of the contr : {5}------------------------------------------------ | (2) Precicontrol Comparison | | | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Elecsys Precicontrol Rubella IgM | Predicate Elecsys Precicontrol Troponin T (K031990). | | Intended Use | Elecsys PreciControl Rubella IgM is used for quality control of the Elecsys Rubella IgM immunoassay on the Elecsys and cobas e immunoassay analyzers. | Elecsys PreciControl Troponin T is used for quality control of the Elecsys Troponin T (Cardiac T) immunoassay on the Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers. | | Levels | Two | Two | | Matrix | Human serum | Human serum | | Format | Ready to use | Lyophilized | | Stability | Unopened: up to the stated expiration date After opening at 2-8C: 8 weeks Onboard: 5 hours | Unopened: up to the stated expiration date After reconstituting: at 2- 8C: 2 weeks At -20C: 8 weeks Onboard: 5 hours | | weeks ====================================================================================================================================================================== : . i . ============================================================================================================================================================================== and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of and the more work and the comments of the first and i : : : : : : : : : : : : : : : : | : : : | : | : | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | . ነገር አርት የሚገኝ የሚያስተዋል። የአማርኛ ምሳሌ ነው። ትርጉሙ : {6}------------------------------------------------ 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 Immunoassay Elecsys 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 {7}------------------------------------------------ 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 2 {8}------------------------------------------------ # Indications for Use Form 510(k) Number (if known): k092322_____________________________________________________________________________________________________________________________________________ Device Name: Elecsys Rubella IgM Immunoassay Indications for 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 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. 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 {9}------------------------------------------------ ## 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) 3. 2. 2. 2. 2. 2. 24. 24. 1. 1. 0. 0. 1. 2. 2. 2. 2. 2. Uwe Schiff Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k 09 2322 . Page 2 of

ELECSYS RUBELLA IGM IMMUNOASSAY

Device Facts

Intended Use

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Clinical Evidence

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Indications for Use

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ELECSYS RUBELLA IGM IMMUNOASSAY

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

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Regulatory Classification

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Special Controls

Predicate Devices

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Submission Summary (Full Text)

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