ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO

K140225 · Phadia US, Inc. · MOB · Oct 27, 2014 · Immunology

Device Facts

• Record ID: K140225
• Device Name: ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
• Applicant: Phadia US, Inc.
• Product Code: MOB · Immunology
• Decision Date: Oct 27, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

EliA PR3s is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to proteinase 3 (PR3) in human serum and plasma (heparin, EDTA, citrate) to aid in the clinical diagnosis of Granulomatosis with Polyangiitis (GPA; formerly known as Wegener's granulomatosis) in conjunction with other laboratory and clinical findings. EliA PR3 uses the EliA IgG method on the instruments Phadia 100 and Phadia 250. EliA MPO is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to myeloperoxidase (MPO) in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of microscopic polyangiitis (MPA) in conjunction with other laboratory and clinical findings. EliA MPO uses the EliA IgG method on the instruments Phadia 100 and Phadia 250. EliA GBM is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to a.3 chain of collagen IV in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Goodpasture syndrome in conjunction with other laboratory and clinical findings. EliA GBM uses the EliA IgG method on the instruments Phadia 100 and Phadia 250. EliA ANCA/GBM Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of ANCA/GBM antibodies with Phadia 100 using the EliA IgG method. EliA ANCA/GBM Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of ANCA/GBM antibodies with Phadia 250 using the EliA IgG method.

Device Story

EliA immunoassays utilize antigen-coated wells to detect specific IgG antibodies in human serum/plasma samples. Input: patient specimen; process: non-competitive solid-phase ELISA; patient antibodies bind to coated antigens (PR3, MPO, or collagen IV alpha3 chain); enzyme-labeled anti-human IgG conjugate added; fluorescence measured after development solution reaction. Output: semi-quantitative IgG concentration. Used in clinical laboratories on Phadia 100/250 automated analyzers. Results interpreted by clinicians alongside other findings to aid diagnosis of autoimmune vasculitis or Goodpasture syndrome. Benefits: standardized, automated diagnostic support for specific autoimmune conditions.

Clinical Evidence

Clinical validation included 455 samples for PR3, 425 for MPO, and 460 for GBM. Sensitivity/specificity for GPA (PR3): 83.0%/95.8%. Sensitivity/specificity for MPA (MPO): 58.8%/92.2%. Sensitivity/specificity for Goodpasture syndrome (GBM): 98.6%/99.5%. Method comparison against predicate ELISAs showed high agreement. Analytical performance included precision (CVs generally <15%), linearity, and lack of interference from bilirubin, hemoglobin, lipids, or rheumatoid factor.

Technological Characteristics

Polystyrene wells coated with human PR3, MPO, or recombinant alpha3 chain of collagen IV. Detection via beta-galactosidase labeled mouse monoclonal anti-IgG conjugate and MUG substrate. Fluorescence signal measured on Phadia 100/250 instruments. Automated, 37°C controlled reaction. Calibrated against WHO-standardized IgG calibrators. Sample matrix: serum, Li-heparin, EDTA, or citrate plasma.

Indications for Use

Indicated for semi-quantitative measurement of IgG antibodies to PR3, MPO, or alpha3 chain of collagen IV in human serum/plasma to aid diagnosis of Granulomatosis with Polyangiitis, microscopic polyangiitis, or Goodpasture syndrome, respectively. For prescription use only.

Regulatory Classification

Identification

A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

Predicate Devices

• Quanta Lite PR-3 Elisa, INOVA (K981328)
• Quanta Lite MPO IgG Elisa, INOVA (K981330)
• Wielisa GBM, Wieslab AB (K974169)

Submission Summary (Full Text)

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

October 27, 2014

PHADIA US, INC MR. MARTIN ROBERT MANN REGULATORY AFFAIRS MANAGER 4169 COMMERCIAL AVE. PORTAGE, MI 49002

Re: K140225 Trade/Device Name: EliA™ PR38 Immunoassay EliA™ MPOS Immunoassay EliA™ GBM Immunoassay EliA™ ANCA/GBM Positive Control 100 EliA™ ANCA/GBM Positive Control 250 Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MOB, MVJ, JJY Dated: September 19, 2014 Received: September 24, 2014

Dear Mr. Mann:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Maria M. Chan -S

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K140225

#### Device Name

EliA(TM) PR3s, EliA(TM) MPOs, EliA(TM) GBM, EliA(TM) ANCA/GBM Positive Control 100, EliA ANCA/GBM Positive Control 250

#### Indications for Use (Describe)

EliA PR3s is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to proteinase 3 (PR3) in human serum and plasma (heparin, EDTA, citrate) to aid in the clinical diagnosis of Granulomatosis with Polyangiitis (GPA; formerly known as Wegener's granulomatosis) in conjunction with other laboratory and clinical findings. EliA PR3s uses the EliA IgG method on the instrument Phadia 100.

EliA PR3s is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to proteinase 3 (PR3) in human serum and plasma (heparin, EDTA, citrate) to aid in the clinical diagnosis of Granulomatosis with Polyangitis (GPA; formerly known as Wegener's granulomatosis) in conjunction with other laboratory and clinical findings. EliA PR3s uses the EliA IgG method on the instrument Phadia 250.

EliA MPOs is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to myeloperoxidase (MPO) in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of microscopic polyangitis (MPA) in conjunction with other laboratory and clinical findings. EliA IgG method on the instrument Phadia 100.

EliA MPOs is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to myeloperoxidase (MPO) in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of microscopic polyangitis (MPA) in conjunction with other laboratory and clinical findings. EliA IgG method on the instrument Phadia 250.

EliA GBM is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to alpha3 chain of collagen IV in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Goodpasture syndrome in conjunction with other laboratory and clinical findings. EliA GBM uses the EliA IgG method on the instrument Phadia 100.

EliA GBM is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to alpha3 chain of collagen IV in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Goodpasture syndrome in conjunction with other laboratory and clinical findings. EliA GBM uses the EliA IgG method on the instrument Phadia 250.

EliA ANCA/GBM Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of ANCA/GBM antibodies with Phadia 100 using the EliA IgG method.

EliA ANCA/GBM Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of ANCA/GBM antibodies with Phadia 250 using the EliA IgG method.

Type of Use (Select one or both, as applicable)

| <span style="font-family: sans-serif;"> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> <path d="M2,2 L14,14 M14,2 L2,14" stroke="black" stroke-width="2"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: sans-serif;"> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> </svg> </span> Over The Counter Use (21 CFR 801 Subpart C) |
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| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness information is being submitted in accordance with the requirements of The Safety Medical Devices Act of 1990 (SMDA 1990) and 21 CFR Part 807.92.

| Assigned 510(k) Number: | K140225 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary Preparation: | October 24, 2014 |
| Manufacturer: | Phadia AB<br>Rapsgatan 7P<br>P.O. Box 6460<br>SE-751 37 Uppsala, Sweden |
| 510 (k) Contact Person: | Martin Mann<br>Senior Regulatory Affairs Manager<br>Phadia US Inc.<br>4169 Commercial Avenue<br>Portage, MI 49002, USA<br>+1 (-269-492) -1957 (Phone)<br>+1 (-269-492) -7541 (Fax)<br>[e-mail] |
| Device Name: | EliA™ PR3s Immunoassay<br>EliA™ MPOs Immunoassay<br>EliA™ GBM Immunoassay<br>EliA™ ANCA/GBM Positive Control 100<br>EliA™ ANCA/GBM Positive Control 250 |
| Common Name: | Test system, antineutrophil cytoplasmic antibodies (ANCA)<br>Devices, antibodies to glomerular basement membrane (GBM) |

# Classification

| Product Name | Product Code | Class | CFR |
|---------------------------------|--------------|-------|----------|
| EliA™ PR3ˢ | MOB | II | 866.5660 |
| EliA™ MPOˢ | MOB | II | 866.5660 |
| EliA™ GBM | MVJ | II | 866.5660 |
| EliA™ ANCA/GBM Positive Control | JJY | I | 862.1660 |

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# Predicate Devices:

| Quanta Lite PR-3 Elisa, INOVA | K981328 |
|----------------------------------|---------|
| Quanta Lite MPO IgG Elisa, INOVA | K981330 |
| Wielisa GBM, Wieslab AB | K974169 |

### Intended Use Statements of the New Devices

1) EliA PR38 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to proteinase 3 (PR3) in human serum and plasma (heparin, EDTA, citrate) to aid in the clinical diagnosis of Granulomatosis with Polyangiitis (GPA; formerly known as Wegener's granulomatosis) in conjunction with other laboratory and clinical findings. EliA PR3 uses the EliA IgG method on the instruments Phadia 100 and Phadia 250.

2) EliA MPO is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to myeloperoxidase (MPO) in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of microscopic polyangiitis (MPA) in conjunction with other laboratory and clinical findings. EliA MPO° uses the EliA IgG method on the instruments Phadia 100 and Phadia 250.

3) EliA GBM is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to a.3 chain of collagen IV in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Goodpasture syndrome in conjunction with other laboratory and clinical findings. EliA GBM uses the EliA IgG method on the instruments Phadia 100 and Phadia 250.

4) EliA ANCA/GBM Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of ANCA/GBM antibodies with Phadia 100 using the EliA IgG method.

5) EliA ANCA/GBM Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of ANCA/GBM antibodies with Phadia 250 using the EliA IgG method.

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### Special condition for use statement

The device is for prescription use only.

# Special instrument requirements

Phadia® 100/Phadia® 250 are fully automated immunoassay analyzers, which include software for evaluation of test results.

# General Description of the New Devices

The new devices belong to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments Phadia 100 and Phadia 250.

The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-ß-D-Galactoside as substrate.

The total IgG calibration is based on a set of six WHO-standardized IgG Calibrators derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method-specific and general reagents that are packaged as separate units.

### Test Principle of the New Devices

The EliA Wells are coated with the following antigens:

| Test | Antigen coated to the wells: |
|-----------|-------------------------------------------|
| EliA PR3s | Human PR3 protein |
| EliA MPOs | Human MPO protein |
| EliA GBM | Human recombinant α3 chain of collagen IV |

If present in the patient's specimen, antibodies to these proteins bind to their specific antigen. After washing away non-bound antibodies, enzyme-labeled antibodies against human IgG antibodies (EliA IgG Conjugate) are added to form an antibody-conjugate complex. After incubation, non-bound conjugate is washed away and the bound complex is incubated with a Development Solution. After stopping the reaction, the fluorescence in the reaction mixture is measured. The higher the response value, the more specific IgG is present in the specimen. To evaluate test results, the response for patient samples is compared directly to the response for calibrators.

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# Device Comparison

The new and the predicate devices both represent non-competitive solid phase ELISAs. The IVDs are used as an aid in the diagnosis of the following diseases:

| Disease | Detection of antibodies to |
|------------------------------------------------------------------------------------------|----------------------------|
| Granulomatosis with Polyangiitis (GPA;<br>formerly known as Wegener's<br>granulomatosis) | PR3 |
| Microscopic polyangiitis (MPA) | MPO |
| Goodpasture syndrome | GBM |

# Laboratory equivalence

The comparability of the predicate devices and new devices is supported by a data set including

- results obtained within a comparison study between new and predicate device
- results obtained for clinically defined sera
- · results obtained for samples from apparently healthy subjects (normal population).

In summary, all available data support that the new devices are substantially equivalent to the predicate devices.