ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01

K083117 · Phadia US, Inc. · LKO · May 28, 2009 · Immunology

Device Facts

• Record ID: K083117
• Device Name: ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01
• Applicant: Phadia US, Inc.
• Product Code: LKO · Immunology
• Decision Date: May 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

EliA™ RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ RNP70 uses the EliA™ IgG method on the instrument ImmunoCAP® 100 and ImmunoCAP® 250. EliA™ Scl-70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Scl-70 in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of scleroderma (diffuse form) in conjunction with other laboratory and clinical findings. EliA™ Scl-70 uses the EliA™ IgG method on the instrument ImmunoCAP® 100 and ImmunoCAP® 250. EliA™ Jo-1 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Jo-1 in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of polymyositis/dermatomyositis in conjunction with other laboratory and clinical findings. EliA™ Jo-1 uses the EliA™ IgG method on the instrument ImmunoCAP® 100 and ImmunoCAP® 250.

Device Story

Fluoroenzyme immunoassay (ELISA-based) for detection of IgG autoantibodies; utilizes human recombinant proteins (RNP70, Scl-70, or Jo-1) coated on polystyrene microwells. Patient serum/plasma samples are processed on ImmunoCAP 100 or 250 analyzers; automated system performs incubation, washing, and addition of enzyme-labeled anti-human IgG (β-Galactosidase). Fluorescence measured after addition of development solution; signal intensity proportional to specific IgG concentration. Results compared to stored calibration curves (total IgG calibration). Used in clinical laboratories to support diagnosis of connective tissue diseases; results interpreted by clinicians alongside other findings.

Clinical Evidence

Clinical performance evaluated using serum banks. RNP70: 145 samples (50 MCTD, 95 controls), 60% sensitivity, 97.9% specificity. Scl-70: 150 samples (50 PSS, 100 controls), 46% sensitivity, 98% specificity. Jo-1: 145 samples (45 Myositis, 100 controls), 55.6% sensitivity, 100% specificity. Method comparison studies showed high agreement with predicate ELISA kits.

Technological Characteristics

Solid-phase fluorescence immunoassay (FEIA). Reagents: EliA single wells coated with recombinant human antigens (RNP70, Scl-70, Jo-1). Conjugate: mouse anti-human IgG beta-galactosidase. Substrate: 4-Methylumbelliferyl-BD-Galactoside. Automated processing on ImmunoCAP 100/250 analyzers. Calibration: 6-point WHO-standardized IgG curve, valid for 28 days.

Indications for Use

Indicated for semi-quantitative measurement of IgG antibodies to RNP70, Scl-70, or Jo-1 in human serum/plasma to aid diagnosis of MCTD, SLE, scleroderma, or polymyositis/dermatomyositis.

Regulatory Classification

Identification

An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

Predicate Devices

• Varelisa U1RNP Antibodies (k993589)
• Varelisa Scl-70 Antibodies (k944172)
• Varelisa Jo-1 Antibodies (k944173)

Submission Summary (Full Text)

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K083117

# 510(k) Summary

MAY 28 2009

This summary 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:

| Date of Summary Preparation: | October 20, 2008 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Phadia AB<br>Rapsgatan 7<br>SE-751 37 Uppsala, Sweden |
| 510 (k) Contact Person: | Martin Mann<br>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™ RNP70 Immunoassay<br>EliA™ Scl-70 Immunoassay<br>EliA™ Jo-1 Immunoassay |
| Common Name: | Antinuclear antibody immunological test system and<br>Control |

## Classification

| Product Name | Product Code | Class | CFR |
|---------------|--------------|-------|----------|
| EliATM RNP70 | LJM | II | 866.5100 |
| EliATM Scl-70 | LJM | II | 866.5100 |
| EliATM Jo-1 | LJM | II | 866.5100 |

### Substantial Equivalence to

| Varelisa U1RNP Antibodies | K993589 |
|----------------------------|---------|
| Varelisa Scl-70 Antibodies | K944172 |
| Varelisa Jo-1 Antibodies | K944173 |

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#### Intended Use Statements of the New Devices

1) EliATM RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ RNP70 uses the EliA IgG method on the instrument ImmunoCAP® 100 and ImmunoCAP® 250.

2) EliA™ Scl-70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Scl-70 in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of scleroderma (diffuse form) in conjunction with other laboratory and clinical findings. EliA™ Sci-70 uses the EliA IgG method on the instrument ImmunoCAP® 100 and ImmunoCAP® 250.

3) EliATM Jo-1 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Jo-1 in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of polymyositis / dermatomyositis in conjunction with other laboratory and clinical findings. EliATM Jo-1 uses the EliA IgG method on the instrument ImmunoCAP® 100 and ImmunoCAP® 250.

#### Special condition for use statement

The device is for prescription use only.

#### Special instrument requirements

ImmunoCAP® 100/ImmunoCAP® 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 ImmunoCAP 100 and ImmunoCAP 250. The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbellifery|-BD-Galactoside as substrate. The total IgG calibration is based on a set of six WHOstandardized 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.

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#### Test Principle of the New Devices

The EliA Wells are coated with the following antigens:

| Test | Antigen coated to the wells: |
|-------------|----------------------------------------|
| EliA RNP70 | human recombinant RNP (70 kDa) protein |
| EliA Scl-70 | human recombinant Scl-70 protein |
| EliA Jo-1 | human recombinant Jo-1 protein |

If present in the patient's specimen, antibodies to the antigens mentioned above 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.

#### Device Comparison

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

| Disease | Detection of antibodies to |
|----------------------------------------|----------------------------|
| mixed connective tissue disease (MCTD) | RNP70 |
| systemic lupus erythematosus (SLE) | RNP70 |
| scleroderma (diffuse form) | Scl-70 |
| polymyositis / dermatomyositis | Jo-l |

#### Laboratory equivalence

The comparability of predicate device and new device 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.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

MAY 28 2009

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Phadia US Inc. c/o Mr. Martin Mann Regulatory Affairs Manager 4169 Commercial Avenue Portage, MI 49002

Re: k083117

Trade/Device Name: EliA™ RNP70, ELIA™ Scl-70 and EliA™ Jo-1 Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: LJM, LKO Dated: April 03, 2009 Received: April 06, 2009

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-indicationsfor 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice

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#### Page 2 - Mr. Martin Mann

requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

ia m. Chen

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

Enclosure

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# INDICATIONS FOR USE

510(k) Number:

k083117 -

EliA™ Jo-1

Device Name:

### Indications For Use:

EliA™ Jo-1 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Jo-1 in human serum and plasma (heparin, EDTA, citrate) as . an aid in the clinical diagnosis of polymyositis / dermatomyositis in conjunction with other laboratory and clinical findings. EliA™ Jo-1 uses the EliA IgG method on the instrument ImmunoCAP® 100 and ImmunoCAP® 250.

Prescription Use AND/OR V (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

the Thu

**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

51000 K083117

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# INDICATIONS FOR USE

510(k) Number:________________________________________________________________________________________________________________________________________________________________ k083117

Device Name: EliA™ RNP70

#### Indications For Use:

EliA™ RNP70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNP70 in human serum and plasma (heparin, EDTA) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ RNP70 uses the EliA IgG method on the instrument ImmunoCAP® 100 and ImmunoCAP® 250.

#### AND/OR Over-The-Counter Use Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

w Nh

**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k083117

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# INDICATIONS FOR USE

510(k) Number:

k083117

Device Name:

EliATM Scl-70

### Indications For Use:

EliA™ Scl-70 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Scl-70 in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of scleroderma (diffuse form) in conjunction with other laboratory and clinical findings. EliA™ Scl-70 uses the EliA IgG method on the instrument ImmunoCAP® 100 and ImmunoCAP® 250.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Tur

**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K083117

Concurrence of CDRH, Office of Device Evaluation (ODE)