ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY

K131821 · Phadia US, Inc. · MID · Dec 23, 2013 · Immunology

Device Facts

• Record ID: K131821
• Device Name: ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
• Applicant: Phadia US, Inc.
• Product Code: MID · Immunology
• Decision Date: Dec 23, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

EliA™ Cardiolipin IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to cardiolipin 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™ Cardiolipin IgA uses the EliA™ IgA method on the instruments Phadia® 100 and Phadia® 250. EliA™ APS Positive Control 100/250 is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies to cardiolipin and β2-glycoprotein I with Phadia® 100 and Phadia® 250 using the EliA IgG, IgM or IgA method. EliA™ IgG/IgM/IgA Negative Control 100/250 is intended for laboratory use in monitoring the performance of in vitro measurement of autoantibodies with Phadia® 100 and Phadia® 250 using the EliA IgG, IgM or IgA method.

Device Story

EliA Cardiolipin IgA is a fluorescence-immunoassay for detecting IgA antibodies to cardiolipin and beta2-glycoprotein I. The device uses EliA wells coated with bovine cardiolipin and bovine beta2-glycoprotein I. Patient serum or plasma samples are incubated in the wells; specific antibodies bind to the antigens. After washing, enzyme-labeled mouse anti-human IgA conjugate is added. Following further incubation and washing, a development solution is added to produce a fluorescent signal proportional to the amount of bound antibody. The assay is performed on fully automated Phadia 100 or Phadia 250 analyzers. Results are evaluated by comparing sample fluorescence to a stored calibration curve derived from WHO-standardized IgA calibrators. The system is used in clinical laboratories to assist physicians in diagnosing APS and SLE-related thrombotic disorders. The output provides semi-quantitative antibody levels, which clinicians use alongside other laboratory and clinical findings to inform diagnostic decisions.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by laboratory comparison studies between the new and predicate device, including testing of clinically defined sera and samples from apparently healthy subjects.

Technological Characteristics

Fluoroenzyme immunoassay; bovine cardiolipin and β2-glycoprotein I coated polystyrene wells. Detection via β-galactosidase labeled mouse anti-human IgA conjugate and 4-Methylumbelliferyl-βD-Galactoside substrate. Automated processing on Phadia 100/250 analyzers. Calibration traceable to WHO IRP 67/86. Reportable range 0.3 to ≥181 APL-U/mL. Storage 2-8°C.

Indications for Use

Indicated for the semi-quantitative measurement of IgA antibodies to cardiolipin in human serum and plasma to aid in the diagnosis of antiphospholipid syndrome (APS) and 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

• Quanta Lite IgA ACA (HRP) (K953366)

Submission Summary (Full Text)

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K131821

## 510(k) Summary of Safety and Effectiveness

DEC 2 3 2013

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:

September 9, 2013 Date of Summary Preparation:

Manufacturer:

Phadia AB Rapsgatan 7P P.O. Box 6460 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™ Cardiolipin IgA Immunoassay

Common Name:

Cardiolipin autoantibody immunological test system

Classification

Product Name

EliA™ Cardiolipin IgA

Class Product Code MID II

866.5660

CFR

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#### Substantial Equivalence to

Quanta Lite IgA ACA (HRP)

#### K953366

## Intended Use Statements of the New Device

EliA Cardiolipin IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to cardiolipin 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 Cardiolipin IgA uses the EliA IgA method on the instruments Phadia 100.

EliA Cardiolipin IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to cardiolipin 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 Cardiolipin IgA uses the EliA IgA method on the instruments Phadia 250.

## 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-, method-specific and general reagents that are packaged as separate units.

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#### Test Principle of the New Device

The EliA Wells are coated with the following antigen:

| Test | Antigen coated to the wells: |
|---------------------------|----------------------------------------------------------------------|
| EliA Cardiolipin IgA Well | Bovine cardiolipin antigen and bovine β2-glycoprotein I as co-factor |

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 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 inculated 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.

#### 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) as well as thrombotic disorders related to 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/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing a bird or eagle, which is a common representation of health and human services.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

December 23, 2013

PHADIA US, INC. C/O MR. MARTIN ROBERT MANN SENIOR REGULATORY AFFAIRS MANAGER 4169 COMMERCIAL AVENUE PORTAGE, MI, 49002

Re: K131821 Trade/Device Name: EliATM Cardiolipin IgA Immunoassay EliA™ APS Positive Control 100 EliA™ APS Positive Control 250 EliA™ APS IgG/IgM/IgA Negative Control 100 EliA™ APS IgG/IgM/IgA Negative Control 250

Regulation Number: CFR §866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: II Product Code: MID, JJY Dated: November 20, 2013 Received: November 21, 2013

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 your 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 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

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Page 2-Mr. Martin Robert Mann

... - - - - -

medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 regulations (21 CFR Parts 801 and 809), please contact 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/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/ReportalProblem/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Maria Mi @han -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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 ... See PRA Statement on last page.

#### 510(k) Number (if known) k 13 1821

**** **** **** ****

#### Device Name EliA™ Cardiolipin IgA

#### Indications for Use (Describe)

EliA Cardiolipin IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to cardiolipin 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 Cardiolipin IgA uses the EliA IgA method on the instruments Phadia 100.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

| | FOR FDA USE ONLY |
|------------------------------------------------------------------------------|-----------------------------------------|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
| Maria M. Chan -S | <div style="font-size: 10px;">FDA</div> |

FORM FDA 3881 (6/13)

PSC Pabliables: Scrvices [phone] P

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 -See PRA Statement on last page.

#### 510(k) Number (if known) k131821

#### Device Name EliA™ Cardiolipin IgA

#### Indications for Use (Describe)

EliA Cardiolipin IgA is intended for the in vitro seni-quantitative measurement of IgA antibilipin in human serum and plasma (heparin, EDTA, citrate) to aid in the disgnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgA uses the EliA IgA method on the instruments Phadia 250.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

#### PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

| | FOR FDA USE ONLY | |
|------------------------------------------------------------------------------|------------------|-------------------------------------------|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | | |
| | Maria M. Chan -S | |
| FORM FDA 3881 (6/13) | Page 1 of 2 | PSC Publishing Services [phone] EF |

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

#### 510(k) Number (if known) k131821

.. ....

. . .

Device Name EliATM APS Positive Control 100

#### Indications for Use (Describe)

EliA APS Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies to cardiolipin and B2-Glycoprotein I with Phadia 100 using the EliA IgG, IgM or IgA method.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

| FOR FDA USE ONLY |
|------------------|
|------------------|

| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) |
|------------------------------------------------------------------------------|
|------------------------------------------------------------------------------|

| Maria M. Chan -S |
|------------------|
|------------------|

FORM FDA 3881 (6/13)

PSC Publishing Services (30) +43-4740

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES .Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

#### 510(k) Number (if known) k 13 182 1

Device Name EliA™ APS Positive Control 250

#### Indications for Use (Describe)

EliA APS Positive Control 250 is intended for laboratory the performance of in vitro measurement of antibodies to cardiolipin and B2-Glycoprotein I with Phadia 250 using the EliA 1gG, IgM or IgA method.

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

Prescription Use (Part 21 CFR 801 Subpart D)

.. . . . . . . . . . .

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

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FOR USE ONLY " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . " . Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Maria M. Cl

FORM FDA 3881 (8/13)

Page 1 of 2

186 Trabbal Long Septace (30) 143-674)

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

#### 510(k) Number (if known) k131821

#### Device Name

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

EliA™ IgG/IgM/IgA Negative Control 100

#### Indications for Use (Describe)

EliA IgG/lgM/1gA Negalive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of autoantibodies with Phadia 100 using the EliA IgG or IgM or IgA method.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Maria M. Chan

FORM FDA 3881 (6/13)

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. --------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

#### 510(k) Number (if known) k131821

#### Device Name

EliA™ igG/igM/IgA Negative Control 250

#### Indications for Use (Describe)

EliA 1gOllgMILA Negative Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of autoantibodies with Phadia 250 using the EliA IgG or IgM or IgA method.

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

[ ] Prescription Use (Part 21 CFR 801 Subpart D)

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

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

## Maria M. Char

FORM FDA 3881 (6/13)