Who is the manufacturer of ELECSYS RUBELLA IGG IMMUNOASSAY?

Roche Diagnostics Corp. filed the 510(k) submission for ELECSYS RUBELLA IGG IMMUNOASSAY (K072617).

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

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

What are the predicate devices for ELECSYS RUBELLA IGG IMMUNOASSAY?

Zeus, Rubella IgG ELISA Test (K984180).

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

K072617 · Roche Diagnostics Corp. · LFX · Dec 5, 2008 · Microbiology

Device Facts

Record ID	K072617
Device Name	ELECSYS RUBELLA IGG IMMUNOASSAY
Applicant	Roche Diagnostics Corp.
Product Code	LFX · Microbiology
Decision Date	Dec 5, 2008
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.3510
Device Class	Class 2

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

Device Story

The Elecsys Rubella IgG Immunoassay is a two-step sandwich electrochemiluminescence immunoassay (ECLIA) used on Roche Elecsys and cobas e analyzers. It detects IgG antibodies to rubella virus in human serum or plasma (Li-heparin, K3-EDTA, sodium citrate). The system uses streptavidin-coated microparticles, biotinylated monoclonal anti-human IgG, and ruthenium-labeled anti-rubella antibody fragments. Patient sample IgG binds to rubella-specific antigens; the resulting signal count is proportional to IgG concentration. Results are calculated via a master curve and 2-point calibration. The device is used in clinical laboratories by trained personnel to assess rubella immune status. It aids clinicians in determining vaccination or exposure history, particularly for women of childbearing age. PreciControl Rubella IgG is used for quality control.

Clinical Evidence

Clinical performance was evaluated via method comparison against the predicate. Studies included routine clinical specimens, acute/recent infection samples, banked samples, outbreak samples, pregnant women (n=150), and vaccinated individuals. Agreement metrics varied by sample cohort: pregnant women showed 100% positive agreement; vaccinated individuals showed 100% agreement. Low positive samples (10-20 IU/mL) showed 95.2% positive agreement. Analytical specificity was 96.6% agreement with the predicate. No clinical data beyond method comparison provided.

Technological Characteristics

Two-step sandwich ECLIA. Components: streptavidin microparticles, biotin-labeled monoclonal anti-human IgG, ruthenium-labeled anti-rubella antibody fragment, biotin/ruthenium-labeled rubella antigens, rubella-like particles. Standardized against WHO 1st International Standard (NIBSC RUBI-1-94). Measuring range: 0.21-500 IU/mL. Automated platform (Elecsys/cobas e series). Calibration: 2-point, master curve via reagent barcode.

Indications for Use

Indicated for the quantitative determination of IgG antibodies to rubella virus in human serum and plasma to assess immune status, including 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, Rubella IgG ELISA Test (K984180)

Related Devices

K092322 — ELECSYS RUBELLA IGM IMMUNOASSAY · Roche Diagnostics · Mar 12, 2010
K954687 — ACCESS RUBELLA IGG · Bio-Rad Laboratories, Inc. · Apr 9, 1996
K961053 — SERAQUEST RUBELLA IGG · Quest Intl., Inc. · Sep 4, 1996

Submission Summary (Full Text)

{0}------------------------------------------------ K072617 ______________________________________________________________________________________________________________________________________________________________________________ # 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: SD 0.059 - 0.3.99 IU/mL 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: SD 0.076 - 0.428 IU/mL 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 | < 0.17 IU/mL | Not stated. | | Limit of Detection | < 0.21 IU/mL | Not stated. | | Analytical Specificity | 96.6 % agreement with predicate for 60 specimens representing a variety of disease states. | Not stated. | | Interferences | The assay is unaffected by icterus (bilirubin < 513 µmol/L or < 30 mg/dL), hemolysis (Hb < 3.47 mmol/L or < 5.6 g/dL), lipemia (Intralipid < 1500 mg/dL), Immunoglobulin A up to 1440 mg/dL, and biotin < 123 nmol/L or < 30 ng/mL. Criterion: Recovery of positive samples within ± 20% of initial value. No interference was observed from rheumatoid factors up to a concentration of 6210 IU/mL. Rubella-specific Immunoglobulin M may cause interference. Elevated levels of Immunoglobulin G may cause interference. There is no high dose hook effect within the assay measuring range. | No anticoagulants or preservatives should be added; avoid using hemolyzed, lipemic, or bacterially contaminated samples. | | Expected Values | | 80-90% of adult population has detectable antibodies to rubella. | | | Studies indicate that 80-90% of the adult population have detectable antibodies to rubella. According to the literature, in general, 90% of the U.S. population has either been vaccinated or exposed to rubella, with rubella IgG values greater than or equal to 10 IU/mL. In a study of 500 subjects from a United States reference laboratory, the prevalence of IgG antibodies to Rubella was shown to be 95%. Prevalence was 94.7% among women of childbearing age. | | | Method Comparison with 95% CI (Elecsys® vs Zeus Scientific Rubella IgM): | 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%) | | {3}------------------------------------------------ . {4}------------------------------------------------ {5}------------------------------------------------ : {6}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services USA. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three curved lines representing its body and wings. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Roche Diagnostics C/O Theresa A Bush, PhD, DABCC, RAC Regulatory Affairs Principal 9115 Hague Road Indianapolis, IN 46250 DEC 0 5 2008 Re: k072617 Trade/Device Name: Elecsys Rubella IgG immunoassay Elecsys Rubella IgG PreciControl Regulation Number: 21 CFR 866.3510 Regulation Name: ELISA, Rubella Regulatory Class: Class II Product Code: LFX, JJX Dated: November 13, 2008 Received: November 14, 2008 #### Dear Dr. Bush: We have reviewed vour 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice {7}------------------------------------------------ ### Page 2 - 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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Sally attigra 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 {8}------------------------------------------------ Elecsys Rubella IgG and IgM Test Systems ## Indications for Use 510(k) Number (if known): Device Name: Elecsys Rubella IgG Immunoassay Indications For 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. Prescription Use XXX (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Wie Schif Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety k072617 510(k) {9}------------------------------------------------ Elecsys Rubella IgG and IgM Test Systems ## Indications for Use 510(k) Number (if known): K072617 Device Name: Elecsys PreciControl Rubella IgG Indications For Use: Elecsys PreciControl Rubella IgG is used for quality control of the Elecsys Rubella IgG immunoassay on the Elecsys and cobas e immunoassay analyzers. Prescription Use _ XXX (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) We Schuf Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k072617

ELECSYS RUBELLA IGG IMMUNOASSAY

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Device Story

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Technological Characteristics

Indications for Use

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ELECSYS RUBELLA IGG IMMUNOASSAY

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Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Special Controls

Predicate Devices

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Submission Summary (Full Text)

Panel 1

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