Pharmacia CAP System IgE FEIA contains three separate units: IgE FEIA Fluoroenzymeimmuno reagents, IgE FEIA Standard reagents and Anti-IgE FEIA ImmunoCAP. 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.

AI/ML Overview

Here's an analysis of the provided text regarding the Pharmacia CAP System IgE FEIA device, structured according to your request:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Description	Acceptance Criteria	Reported Device Performance
Equivalence to Predicate Device (Standard Procedure)	Not explicitly stated but implied comparison to the predicate Pharmacia CAP System IgE FEIA using a 150-minute incubation time. The goal is to show the modified device provides "substantially equivalent results."	93% of samples tested in the updated product (Standard procedure) had a result within ±13% of the predicate Pharmacia CAP System IgE FEIA.
Equivalence to Predicate Device (TEMPO Procedure - Modified)	Not explicitly stated but implied comparison to the predicate Pharmacia CAP System IgE FEIA (presumably with the standard 150 min incubation time). The goal is to show the modified device in its faster mode provides "substantially equivalent results."	93% of samples tested utilizing the TEMPO procedure had results within ±15% of the predicate Pharmacia CAP System IgE FEIA.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 106 patient samples.
Data Provenance: Not specified, but the manufacturer is based in Sweden, so it's possible the samples are from Sweden or other European countries. The text indicates "human blood samples" in general. It is a retrospective comparison study to a predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the text. The study describes a comparison between two in vitro diagnostic devices, where the "ground truth" is essentially the measurements obtained from the predicate device.

4. Adjudication Method for the Test Set

This information is not applicable as the study compares the performance of a modified device against a predicate device, rather than requiring expert adjudication of results. The results are quantitative measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This study is for an in vitro diagnostic device, not an imaging device requiring human reader interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the study assesses the standalone performance of the modified in vitro diagnostic device (Pharmacia CAP System IgE FEIA) by comparing its quantitative measurements to those of a predicate device. There is no human interpretation component described for the test results themselves.

7. Type of Ground Truth Used

The ground truth used for comparison was the results obtained from the predicate device, Pharmacia CAP System IgE FEIA. This is a form of device-to-device comparison for substantial equivalence rather than comparison to a clinical outcome or pathological diagnosis.

8. Sample Size for the Training Set

This information is not provided in the text, and it's unlikely a traditional "training set" as understood in machine learning was used, given the nature of this in vitro diagnostic device modification and study. The description details a modification to antibodies and a comparison study to demonstrate equivalence, not a machine learning model needing a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is likely not applicable as the study design described does not involve a training set for a machine learning model.

Summary

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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 & UpjohnDiagnostics Division, US Operation7425-248-17000 Portage RoadKalamazoo, MI 49001
Manufacturer:	Pharmacia & Upjohn, Diagnostics ABS-751 82 UppsalaSweden
Company Contact Person:	Karen MatisRegulatory Affairs ManagerDiagnostics DivisionUS Operation7000 Portage Road7425-248-01Kalamazoo, MI 49001(614) 794-3324 (Phone)(614) 794-0266 (Fax)
Device Name:	Pharmacia CAP System IgE FEIA
Common Name:	In vitro quantitative assay for the measurementof 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 (770) 488-7655.

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (201) 594-4568. Praditionally, 10. queee at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

P Prescription Use

Over-The-Counter Use _

(Per 21 CFR 801.109)

00 00001

Regulation Number and Section

§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.

(a)
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.(b)
Classification. Class II (performance standards).