ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY

K082759 · Phadia US, Inc. · LKJ · Apr 10, 2009 · Immunology

Device Facts

• Record ID: K082759
• Device Name: ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY
• Applicant: Phadia US, Inc.
• Product Code: LKJ · Immunology
• Decision Date: Apr 10, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

EliA™ CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA™ CENP uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250. EliA™ UIRNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to UIRNP in human serum and plasma (heparin, EDTA, citrate) 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™ UIRNP uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250. EliATM Sm is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ Sm uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250. EliA™ Ro is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Ro in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Sjögren's syndrome and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ Ro uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250. EliATM La is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to La in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Siögren's syndrome and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ La uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.

Device Story

EliA immunoassays are fluorescence-based, solid-phase ELISAs for detecting specific IgG antibodies in human serum/plasma. Performed on ImmunoCAP 100/250 automated analyzers. Process: patient sample added to antigen-coated wells; specific antibodies bind; non-bound material washed away; enzyme-labeled anti-human IgG conjugate added; substrate (4-Methylumbelliferyl-BD-Galactoside) added; fluorescence measured. Output: semi-quantitative IgG concentration compared to WHO-standardized calibration curve. Used in clinical laboratories by trained personnel. Results assist clinicians in diagnosing autoimmune conditions (SLE, Sjögren's, scleroderma, MCTD).

Clinical Evidence

Comparison study between new and predicate devices, testing of clinically defined sera, and testing of samples from apparently healthy subjects.

Technological Characteristics

Fluoroenzyme immunoassay using polystyrene microwells coated with recombinant or purified human antigens. Energy source: ImmunoCAP 100/250 automated analyzer. Detection: β-Galactosidase-labeled anti-human IgG conjugate with 4-Methylumbelliferyl-β-D-galactoside substrate. Calibration: Total IgG calibration traceable to WHO IRP 67/86. Connectivity: Integrated with ImmunoCAP 100/250 systems.

Indications for Use

Indicated for semi-quantitative measurement of IgG antibodies to CENP, U1RNP, Sm, Ro, or La in human serum/plasma. Aids diagnosis of scleroderma (CREST), MCTD, SLE, or Sjögren's syndrome in conjunction with clinical findings. Prescription use only.

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 CENP Antibodies (K944171)
• Varelisa U1RNP Antibodies (K993589)
• Varelisa Sm Antibodies (K000312)
• Quanta Lite SS-A ELISA (K922830)
• Varelisa SS-B/La Antibodies (K944168)

Submission Summary (Full Text)

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KOD225-9

# 510(k) Summary of Safety and Effectiveness

# APR 1 0 2009

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: | |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary Preparation: | September 18, 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™ CENP Immunoassay<br>EliA™ U1RNP Immunoassay<br>EliA™ Sm Immunoassay<br>EliA™ Ro Immunoassay<br>EliA™ La Immunoassay |
| Common Name: | Antinuclear antibody immunological test system and<br>Control |
| Classification | |

| Product Name | Product Code | Class | CFR |
|--------------|--------------|-------|----------|
| EliATM CENP | LJM | II | 866.5100 |
| EliATM U1RNP | LJM | II | 866.5100 |
| EliATM Sm | LJM | II | 866.5100 |
| EliATM Ro | LJM | II | 866.5100 |
| EliATM La | LJM | II | 866.5100 |

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#### Substantial Equivalence to

| Varelisa CENP Antibodies | K944171 |
|-----------------------------|---------|
| Varelisa U1RNP Antibodies | K993589 |
| Varelisa Sm Antibodies | K000312 |
| Quanta Lite SS-A ELISA | K922830 |
| Varelisa SS-B/La Antibodies | K944168 |

#### Intended Use Statements of the New Devices

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

2) EliA™ UIRNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to UIRNP in human serum and plasma (heparin, EDTA, citrate) 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™ UIRNP uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.

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

4) EliA™ Ro is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Ro in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Sjögren's syndrome and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ Ro uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.

5) EliATM La is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to La in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Siögren's syndrome and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ La uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.

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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-Methylumbelliferyl-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.

#### Test Principle of the New Devices

The EliA Wells are coated with the following antigens:

| Test | Antigen coated to the wells: |
|------------|----------------------------------------------------|
| Elia CENP | human recombinant centromere protein B |
| Elia U1RNP | human recombinant RNP (RNP 70 kDa, A, C) protein |
| Elia Sm | native Sm proteins purified from bovine tissue |
| Elia Ro | human recombinant SS-A/Ro (60 kDa, 52 kDa) protein |
| Elia La | human recombinant SS-B/La 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.

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#### 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 |
|----------------------------------------|----------------------------|
| scleroderma (CREST Syndrome) | CENP |
| mixed connective tissue disease (MCTD) | U1RNP |
| systemic lupus erythematosus (SLE) | Sm, U1RNP, Ro, La |
| Sjögren's syndrome | Ro, La |

#### 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 devices
- 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/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 1 0 2009

Phadia US, Inc c/o Mr. Martin R. Mann Regulatory Affairs Manager 4169 Commercial Ave Portage, Michigan 49002

Re: k082759

Trade/Device Name: EliA™ CENP EliA™ U1RNP EliA™ Sm EliA™ Ro EliA™ La

Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: II Product Code: LJM Dated: April 3, 2009 Received: April 6, 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 ffor 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);

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#### Page 2 -- Mr. Martin Mann

labeling (21 CFR Parts 801 and 809); and good manufacturing practice 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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

mchan

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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510(k) Number (if known): K082759

EliA Sm Well Device Name:

Indication For Use:

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

Prescription Use V (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)

ia mchan

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

510(k) K082757

Page 1 of 1

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510(k) Number (if known): K082759

EliA La Well Device Name:

Indication For Use:

EliA™ La is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to La in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Sjögren's syndrome and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ La uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.

Prescription Use V (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 (OVD)

Maria M. Chan

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

510(k) K082719

Page I of 1

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510(k) Number (if known): K082759

EliA Ro Well Device Name:

Indication For Use:

EliA™ Ro is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Ro in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Sjögren's syndrome and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ Ro uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.

Prescription Use V (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 (OVD)

Maria M Chan

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

510(k) K082759

Page 1 of 1

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510(k) Number (if known): K082759

EliA U1RNP Well Device Name:

Indication For Use:

EliA™ U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (heparin, EDTA, citrate) 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™ U1RNP uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.

Prescription Use __ V_ (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 (OVD)

Marie M. Chan

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

510(k) Kof2 7√-9

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510(k) Number (if known): K082759

Device Name: EliA CENP Well

Indication For Use:

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

Prescription Use __ V_ (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 (OVD)

m. Chan

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

510(k) K082759

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