ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY

K112414 · Phadia US, Inc. · MSV · Jun 22, 2012 · Immunology

Device Facts

• Record ID: K112414
• Device Name: ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
• Applicant: Phadia US, Inc.
• Product Code: MSV · Immunology
• Decision Date: Jun 22, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

EliA™ β2-Glycoprotein I IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to β2-Glycoprotein I in human serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ β2-Glycoprotein I IgA uses the EliA IgA method on the instruments Phadia® 100 and Phadia® 250.

Device Story

The EliA™ β2-Glycoprotein I IgA is an automated semi-quantitative immunofluorescence assay for detecting IgA antibodies to β2-Glycoprotein I in human serum or plasma. The device utilizes microwells coated with purified human β2-glycoprotein I antigen. Patient samples are processed on Phadia® 100 or Phadia® 250 automated analyzers; patient antibodies bind to the antigen; enzyme-labeled anti-IgA conjugate is added; after washing, a development solution is added to produce a fluorescent signal. The instrument measures fluorescence intensity, which is proportional to the concentration of bound IgA antibodies. Results are compared against a calibration curve to provide a semi-quantitative value. The device is intended for use in clinical laboratories by trained personnel to aid in the diagnosis of APS and SLE-related thrombotic disorders. The output assists clinicians in confirming clinical findings and managing patient care.

Clinical Evidence

Clinical performance was evaluated using 424 serum samples from patients with APS (n=124), SLE (n=100), and various other conditions (infections, MCTD, RA, cancer). Sensitivity for APS was 44.4% (equivocal as negative) to 53.2% (equivocal as positive), with specificity of 96.5% to 94.5%. For SLE, sensitivity was 13.0% to 30.0% with similar specificity. Method comparison against the predicate showed total percent agreement of 88.9%–89.7%.

Technological Characteristics

Semi-quantitative immunofluorescence assay. Components: β2-glycoprotein I coated microwells, β-galactosidase labeled anti-IgA conjugate, calibrators, and controls. Instrumentation: Phadia® 100/250 automated analyzers. Detection: Fluorescence. Measuring range: 0.3–183 U/mL. Calibration: Traceable to WHO IRP 67/86. Software: Automated processing and result calculation. Sterilization: Not applicable (reagents).

Indications for Use

Indicated for patients suspected of having antiphospholipid syndrome (APS) or thrombotic disorders related to systemic lupus erythematosus (SLE). 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

• Varelisa β2-Glycoprotein I IgA Antibodies (k040450)

Submission Summary (Full Text)

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K112414

# 510(k) Summary of Safety and Effectiveness

JUN 2 2 2012

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: May 29, 2012

Manufacturer:

Phadia AB Rapsgatan 7 SE-751 37 Uppsala, Sweden

510 (k) Contact Person:

Martin Mann Regulatory Affairs Manager Phadia US Inc. 4169 Commercial Avenue Portage, Mi 49002, USA +1 (-269-492) -1957 (Phone) +1 (-269-492) -7541 (Fax) [e-mail]

Device Name:

EliA™ ß2-Glycoprotein I IgA Immunoassay

Common Name:

B2-Glycoprotein I autoantibody immunological test system

### Classification

| Product Name | Product Code | Class | CFR |
|----------------------------|--------------|-------|----------|
| EliA β2-Glycoprotein I IgA | MSV | II | 866.5660 |

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# Substantial Equivalence to

Varelisa ß2-Glycoprotein I IgA Antibodies

K040450

### Intended Use Statement of the New Device

EliA ß2-Glycoprotein I IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to ß2-Glycoprotein I in human serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA ß2-Glycoprotein 1 IgA uses the EliA IgA method on the instruments Phadia 100 and Phadia 250.

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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 Device

The new device belongs 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 IgA method is mouse anti-human IgA beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate.

The total IgA calibration is based on a set of six WHO-standardized IgA 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-specific, method-specific and general reagents that are packaged as separate units.

#### Test Principle of the New Device

The EliA Wells are coated with the following antigen:

| Test | Antigen coated to the wells: |
|---------------------------------|---------------------------------|
| EliA β2-Glycoprotein I IgA Well | Human β2-Glycoprotein I antigen |

If present in the patient's specimen, antibodies to the antigen mentioned above bind to their specific antigen. After washing away non-bound antibodies, enzyme-labeled antibodies against human IgA antibodies (EliA IgA 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 higher the amount of antibody bound and detected in the sample tested. 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 device both represent non-competitive solid phase ELISAs. Both IVDs are used as an aid in the diagnosis of antiphospholipid syndrome (APS) and to evaluate the thrombotic risk in patients with systemic lupus erythematosus (SLE).

## 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 device is substantially equivalent to the predicate device.

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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.

#### Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Phadia AB c/o Martin Mann Regulatory Affairs Manager 4169 Commercial Avenue Portage, MI 49002, USA

JUN 2 2 2012

#### Re: k112414

Trade/Device Name: EliA™ ß2-Glycoprotein I IgA Immunoassay Regulation Number: 21 CFR §866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MSV Dated: June 20, 2012 Received: June 21, 2012

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). and Cosmetic Pro (110) 1100 (110) 1100) 110 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 class II (Special Controls), it may be subject to such n your device is elabilities 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 I lease be advised that I Dr. interestion that your device complies with other requirements of the Act that I Drimas intatutes and regulations administered by other Federal agencies. You must of uny I outral 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 CI K Par 807), laboration adverse events) (21 CFR 803); and good manufacturing practice medical device related adverted on the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as bet formarketing your device as described in your Section 510(k) premarket

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Page 2 - Mr. Martin Mann

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 Parts 801 and 809), 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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Reena Philip

Maria M. Chan, Ph.D. Director Division 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 (if known):

k 112414

Device Name:

### EliA™ ß2-Glycoprotein I IgA

Indications For Use:

EliA ß2-Glycoprotein I IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to B2-Glycoprotein I in human serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA ß2-Glycoprotein I IgA uses the EliA IgA method on the instruments Phadia 100 and Phadia 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)

Riene Philip

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

510(k) k 1/24/14