PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01

K991945 · Pharmacia & Upjohn Co. · DGC · Jul 28, 1999 · Immunology

Device Facts

• Record ID: K991945
• Device Name: PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01
• Applicant: Pharmacia & Upjohn Co.
• Product Code: DGC · Immunology
• Decision Date: Jul 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

Pharmacia CAP System IgE FEIA is an in vitro test system for the quantitative measurement of circulating total IgE antibodies in human blood samples.

Device Story

The Pharmacia CAP System IgE FEIA is an in vitro diagnostic assay used to measure total IgE concentration in human serum. The device utilizes a fluoroenzymeimmunoassay (FEIA) principle: patient serum is incubated with anti-IgE antibodies covalently coupled to an ImmunoCAP; after washing, enzyme-labeled anti-IgE antibodies are added to form a complex; following a second incubation and wash, a developing agent is added; the resulting fluorescence, measured by a FluoroCount 96 instrument, is directly proportional to the IgE concentration in the sample. The system supports two procedures: a standard 150-minute incubation or a rapid 30-minute 'TEMPO' procedure. The device is intended for use in clinical laboratory settings to assist in the assessment of IgE levels, which aids clinicians in diagnosing allergic conditions. The modification replaces rabbit/sheep-derived antibodies with mouse monoclonal antibodies to improve assay performance and enable the rapid procedure.

Clinical Evidence

Clinical study of 106 patient samples with varying IgE levels. Comparison of the updated device (Standard and TEMPO procedures) against the predicate device. Results showed 93% of samples tested with the updated device (Standard procedure) were within ±13% of the predicate, and 93% of samples tested with the TEMPO procedure were within ±15% of the predicate.

Technological Characteristics

Fluoroenzymeimmunoassay (FEIA) system. Reagents include ImmunoCAP (covalently coupled anti-IgE), enzyme-labeled anti-IgE, and standards. Modification: transition from rabbit/sheep antiserum to mouse monoclonal antibodies. Measurement via FluoroCount 96 fluorescence reader. Storage at +2-8°C.

Indications for Use

Indicated for the quantitative measurement of circulating total IgE antibodies in human blood samples for diagnostic purposes.

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

• Pharmacia CAP System IgE FEIA (K991945)

Submission Summary (Full Text)

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# 7/28/99

Pharmacia CAP System IgE FEIA Modified Device 510(k) Submission Section 10. Summary of Safety and Effectiveness

SUMMARY OF SAFETY AND EFFECTIVENESS 10.

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.

| Date of Summary Preparation: | May 31, 1999 | | |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|----------|
| Distributor: | Pharmacia & Upjohn<br>Diagnostics Division, US Operation<br>7425-248-1<br>7000 Portage Road<br>Kalamazoo, MI 49001 | | |
| Manufacturer: | Pharmacia & Upjohn, Diagnostics AB<br>S-751 82 Uppsala<br>Sweden | | |
| Company Contact Person: | Karen Matis<br>Regulatory Affairs Manager<br>Diagnostics Division<br>US Operation<br>7000 Portage Road<br>7425-248-01<br>Kalamazoo, MI 49001<br>[phone] (Phone)<br>[phone] (Fax) | | |
| Device Name: | Pharmacia CAP System IgE FEIA | | |
| Common Name: | In vitro quantitative assay for the measurement<br>of circulating total IgE. | | |
| Classification: | | | |
| Product Name | Product Code | Class | CFR |
| Pharmacia CAP System IgE FEIA | 82 DGC | II | 866.5510 |

pcsIsc10 06/04/99 00 00092

K9919

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# Substantial Equivalence to:

Pharmacia CAP System IgE FEIA

# Intended Use Statement:

Pharmacia CAP System IgE FEIA is an in vitro test system for the quantitative measurement of circulating total IgE antibodies in human blood samples.

# General Description

#### Reagent Description

Pharmacia CAP System IgE FEIA contains three separate units: IgE FEIA Fluoroenzymeimmuno reagents, IgE FEIA Standard reagents and Anti-IgE FEIA ImmunoCAP. The expiry date for the complete packages are stated on the outer labels and the recommended storage temperature is +2-8°C. However, each component is stable until the date stated on the respective label.

## Device Modification Description

The product update (Pharmacia CAP System IgE FEIA) consists of a modification of the antibodies in the Enzyme-Anti-IgE and Anti-IgE ImmunoCAP reagents.

In Enzyme-Anti-IgE Modification: From a mix of rabbit antiserum/mouse monoclonal to only mouse monoclonal antibodies.

In Anti-IgE ImmunoCAP Modification: From Antiserum raised in sheep to mouse monoclonal. All other reagents remain unchanged.

This modification makes it possible to use an alternative, more rapid procedure with the same reagents: The 2rd Incubation (reaction with Enzyme-Anti-IgE) time can be shortened to 30 min (the "TEMPO procedure") or the standard incubation time of 150 min can be utilized (Standard Procedure). Other test parameters remain unchanged.

# Pharmacia CAP System™ IgE FEIA, Test Principle

Anti-IgE, covalently coupled to ImmunoCAP, reacts with the total IgE in the patient serum specimen. After washing, enzyme labelled antibodies against IgE are added to form a complex. After 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 in FluoroCount 96. The fluorescence is divectly, proportional to the concentration of IgE in the blood sample.

pcsIsc10 06/04/99 00 00093

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#### Device Comparison:

The purpose of the comparison study was to show that the modified Pharmacia CAP The purpose of the compansion results compared to the predicate device, Pharmacia System IgE FEIA using both the "Standard" procedure and amore rand procedure
CAP System IgE FEIA using both the "Standard" procedure and assumples with verying CAP System Ign FEIA using oour the "Bullation of 106 patient samples with varying contents of IgE antibodies was included in the study

# Comparison Data results:

93 % of the samples tested in the updated product (Standard procedure) had a result 93 % of the samples tested in the apacticate Pharmacia CAP System IgE within £ 13 % of the samples tested utilizing the TEMPO procedure had results within ± 15 % the predicate Pharmacia CAP System IgE FEIA.

This study demonstrates that the "updated" Pharmacia CAP System IgE FEIA using both This sudy demonstrates martic "updated" " moredures gives substantially equivalent results. the Sunded to the the predicate Pharmacia CAP System IgE FEIA product.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

# JUL 28 1999

Ms. Karen Matis Manager, Regulatory Affairs and Quality Management Diagnostics Division, US Operations Pharmacia & Upjohn 7000 Portage Road 7425-248-01 Kalamazoo, Michigan 49001-0199

K991945 Re: Trade Name: Pharmacia CAP System IgE FEIA Regulatory Class: II Product Code: DGC Dated: June 8, 1999 Received: June 9, 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

#### Dear Ms. Matis:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Image /page/3/Picture/8 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three horizontal lines extending from its head, resembling feathers or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

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#### Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may Onder the Chilical Baberatory Interestion. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The PDA inding of substantial orquir 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 and If you desire specific advices for your assic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, [phone]. Praditionally, 10. queee at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your roop at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

K991945

Device Name: Pharmacia CAP System IgE FEIA is an in vitro test system for the quantitative measurement of circulating total IgE in human blood samples.

Peter E. Maleni

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

P Prescription Use

OR

Over-The-Counter Use _

(Per 21 CFR 801.109)

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