IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH

K133404 · Phadia AB · DGC · Feb 24, 2014 · Immunology

Device Facts

• Record ID: K133404
• Device Name: IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH
• Applicant: Phadia AB
• Product Code: DGC · Immunology
• Decision Date: Feb 24, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5510
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ImmunoCAP Total IgE assay is an in vitro quantitative assay for the measurement of total immunoglobulin E (IgE) in human serum or plasma. Measurement of total IgE is intended as an aid in the clinical diagnosis of IgE mediated allergic disorders. The assay is intended for use on Phadia 100, Phadia 250, Phadia 1000, Phadia 2500 or Phadia 5000 instruments.

Device Story

ImmunoCAP Total IgE system is an automated in vitro diagnostic assay for measuring total IgE in human serum or plasma. The device utilizes anti-IgE antibodies covalently coupled to an ImmunoCAP solid phase. Patient samples are incubated with the solid phase; after washing, enzyme-labeled anti-IgE antibodies are added to form a complex. Following further incubation and washing, a developing agent is added. The resulting fluorescence, measured by Phadia 100, 250, 1000, 2500, or 5000 instruments, is directly proportional to the IgE concentration in the sample. The instrument software automatically processes assay steps, calculates results via a calibration curve, and provides quantitative output to clinical laboratory personnel. This information assists clinicians in diagnosing IgE-mediated allergic disorders. The system includes ImmunoCAP Total IgE Control LMH for performance monitoring.

Clinical Evidence

No clinical data provided; submission relies on design control activities and verification of labeling modifications to demonstrate that the fundamental scientific technology remains unchanged from the predicate device.

Technological Characteristics

In vitro quantitative immunoassay. Components: anti-IgE covalently coupled to ImmunoCAP, enzyme-labeled anti-IgE antibodies, calibrators, and controls. Detection principle: fluorescence measurement proportional to IgE concentration. Compatible with Phadia 100, 250, 1000, 2500, and 5000 instrument platforms. Automated processing and calculation via instrument software.

Indications for Use

Indicated for the quantitative measurement of total IgE in human serum or plasma to aid in the clinical diagnosis of IgE-mediated allergic disorders in patients.

Regulatory Classification

Identification

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Predicate Devices

• UNICAP Total IgE assay/Pharmacia Total IgE Controls LMH (K964152)

Submission Summary (Full Text)

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. SCIENTIFIC

### 510(k) Summary

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.

| Premarket Notification 510(k) No: | k133404 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Date of Summary Preparation: | January 8, 2014 |
| Distributor: | Phadia US Inc.<br>4169 Commercial Avenue<br>Portage MI 49002<br>269-492-1957 |
| Manufacturer: | Phadia AB<br>Rapsgatan 7P<br>P.O. Box 6460<br>751 37 Uppsala, Sweden |
| Company Contact Person: | Martin Mann<br>Regulatory Affairs Manager<br>Phadia US Inc.<br>4165 Commercial Avenue<br>Portage, MI 49002<br>269-492-1957 |

#### Device Names:

ImmunoCAP Total IgE System, consisting of ImmunoCAP Total IgE Conjugate ImmunoCAP Total IgE Anti-IgE ImmunoCAP Total IgE Calibrators ImmunoCAP Total IgE Curve Controls ImmunoCAP Total IgE Control LMH

#### Common Name:

Automated in vitro quantitative assay for the measurement of Total IgE.

### Classification:

| Product Code | DGC |
|--------------|----------|
| Class | II |
| CFR | 866.5510 |

#### Substantial Equivalence to:

ImmunoCAP Total IgE

k964152

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SCIENTIFIC

## Indications For Use Statements

#### ImmunoCAP Total IgE system

ImmunoCAP Total IgE is an in vitro test system for the quantitative measurement of circulating total IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories. ImmunoCAP Total IgE is to be used with the instruments Phadia 250, Phadia 1000, Phadia 2500 or Phadia 5000.

#### ImmunoCAP Total IgE Control LMH

ImmunoCAP Total IqE Control LMH is used for monitoring ImmunoCAP Total IgE measurements performance in Phadia instruments.

#### Device Description

#### Reagents

ImmunoCAP Total IgE reagents and control are modular in concept and are available individually. For a complete listing of reagents needed to perform the ImmunoCAP Total IgE assay, please consult the ImmunoCAP Total IgE Directions for Use.

#### Instrument System

Phadia 100. Phadia 250. Phadia 2500 and Phadia 5000 instruments with associated software process all steps of the assay and calculate results automatically after the assay is completed.

#### ImmunoCAP Total IgE, Test Principle

Anti-IgE, covalently coupled to ImmunoCAP, reacts with the total IgE in the patient sample. After washing, enzyme labeled antibodies against IgE are added to form a complex. Following incubation, unbound enzyme-anti-IgE is washed away and the bound complex is then incubated with a developing agent. After stopping the reaction, the fluorescence of the eluate is measured. The fluorescence is directly proportional to the concentration of IgE in the sample. The higher the response, the more IgE is present in the sample. To evaluate the test results, the responses for the patient samples are transformed to concentrations with the use of a calibration curve.

#### Description of change

Three current Directions for Use have been merged to one assay specific Directions for Use. This is only a change to the format of the Directions for Use for ImmunoCAP Total IgE System, including minor editorial changes.

#### Conclusion

The change does not affect the Intended Use / Indications for Use Statement and it does not affect the safety or effectiveness of the ImmunoCAP Total IgE system, as cleared under k964152.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing or supporting another person, representing the department's mission of protecting the health of all Americans and providing essential human services.

Public Health Service

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

February 24, 2014

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

Re: k133404

Trade/Device Name: ImmunoCAP Total IgE ImmunoCAP Total IgE Control LMH Regulation Number: 21 CFR § 866.5510 Regulation Name: Immunoglobulins A, G, M, D, and E immunological test system Regulatory Class: II Product Code: DGC, JJX Dated: February 4, 2014 Received: February 5, 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 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Martin R. Mann

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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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 M. @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

510(k) Number (if known) k133404

#### Device Name

ImmunoCAP Total IgE System

#### Indications for Use (Describe)

ImmunoCAP Total IgE is an in vitro test system for the quantitative measurement of circulating total IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories. ImmunoCAP Total IgE is to be used with the instruments Phadia 100, Phadia 250, Phadia 1000, Phadia 2500 or Phadia 5000.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

:

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

FOR FOR FOR FDA USE ONLY ... .......................................................................................................................................................................... ・・・・・

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

# HEA Stafford -

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] -

"An agency may not conduct or sponsor, and a person is not respond to, a collection of information unless it displays a currently valid OMB number."

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## Indications for Use

510(k) Number (if known) k133404

#### Device Name ImmunoCAP Total IgE Control LMH

Indications for Use (Describe)

ImmunoCAP Total IgE Control LMH is used for monitoring ImmunoCAP Total IgE measurements performance in Phadia instruments.

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

🇿 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 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)

# Elizabeth AD Stafford

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

{7}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."