IGM FLEX REAGENT CARTRIDGE

K990553 · Dade Behring, Inc. · CFQ · Mar 22, 1999 · Immunology

Device Facts

• Record ID: K990553
• Device Name: IGM FLEX REAGENT CARTRIDGE
• Applicant: Dade Behring, Inc.
• Product Code: CFQ · Immunology
• Decision Date: Mar 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

The IGM Flex™ reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic test intended to quantitatively measure immunoglobulin M (IgM) in serum and plasma.

Device Story

The IGM Flex™ reagent cartridge is an in vitro diagnostic assay for the Dimension® clinical chemistry system. It measures IgM concentration in human serum or plasma samples. The principle of operation is a quantitative, turbidimetric assay; IgM reacts with polyclonal antibodies to form an immunoprecipitate, accelerated by polyethylene glycol. The system performs bichromatic endpoint measurements at 340 and 700 nm. The increase in turbidity is proportional to IgM concentration, which is calculated via a five-point calibration curve. The device is intended for use in clinical laboratory settings by trained personnel. The output provides quantitative IgM levels to assist healthcare providers in clinical decision-making regarding patient immune status.

Clinical Evidence

Clinical performance was evaluated via a split-sample comparison against the predicate Beckman Immunoglobulin M assay. Testing involved 94 clinical patient samples. Results showed a correlation coefficient of 0.943, a slope of 0.88, and an intercept of 4.92 mg/dL.

Technological Characteristics

Quantitative turbidimetric assay; utilizes polyclonal antibodies and polyethylene glycol for immunoprecipitation. Detection via bichromatic endpoint measurements at 340 and 700 nm. Designed for use on the Dimension® clinical chemistry system. Reagent cartridge format.

Indications for Use

Indicated for the quantitative measurement of immunoglobulin M (IgM) in human serum and plasma samples using the Dimension® clinical chemistry system.

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

• Beckman Array® Immunoglobulin M Method (K922273)

Submission Summary (Full Text)

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K9208553

# DADE BEHRING

DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714

### Summary of Safety and Effectiveness Information

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| Submitter's Name: | Cathy P. Craft<br>Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714-6101 |
|--------------------------|-------------------------------------------------------------------------------|
| Date of Preparation: | February 16, 1999 |
| Name of Product: | IGM Flex™ Reagent Cartridge |
| FDA Classification Name: | Immunoglobulin M Test System |
| Predicate Device: | Beckman Array® Immunoglobulin M Method (K922273) |

The IGM Flex™ reagent cartridge for the Dimension® clinical chemistry system Description: is a quantitative, turbidimetric assay based on the precipitation of IgM by its polyclonal antibodies.a

IgM from serum or plasma reacts with its polyclonal antibodies to form an immunoprecipitate. Addition of polyethylene glycol accelerates the formation of the precipitate. Turbidity created by immunoprecipitation is measured as bichromatic endpoint measurements at 340 and 700 nm. The increase in turbidity is proportional to the concentration of IgM and it is calculated from a five point calibration curve.

> PEG IgM + Antibody ------------------------> IgM-Antibody Complex

a The antibody is manufactured by Dade Behring, Marburg, Germany

Intended Use: The IgM Method is used in the Dimension® clinical chemistry system to quantitatively measure immunoglobulin M (IgM) in human serum.

#### Comparison to Predicate Device:

| Item | IGM Flex™ Reagent Cartridge | Beckman Array® IgM |
|-------------|------------------------------------------------------------|--------------------------|
| Sample Type | Serum and plasma | Serum |
| Methodology | Immunoprecipitation | Immunoprecipitation |
| Detection | Bichromatic endpoint<br>(340 and 700 nm)<br>(turbidimetry) | Nephelometry<br>(405 nm) |

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#### Comments on Substantial Equivalence:

Split sample comparison between the IGM Flex™ reagent cartridge and the Beckman Immunoglobulin M assay gave a correlation coefficient of 0.943, slope of 0.88, and an intercept of 4.92 mg/dL when tested with 94 clinical patient samples.

The IGM Flex™ reagent cartridge is substantially equivalent in principle and Conclusion: performance to the Beckman Immunoglobulin M Assay based on the split sample comparison discussed above.

C-y PCmt

Cathy P. Craft Regulatory Affairs and Compliance Manager Date: February 16, 1999

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design of three human profiles facing right, stacked on top of each other. The profiles are rendered with thick, curved lines. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

MAR 2 2 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Cathy P. Craft Regulatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, DE 19714-6101

Re: K990553 Trade Name: IgM™ Flex Reagent Cartridge Regulatory Class: II Product Code: CFQ Dated: February 16, 1999 February 22, 1999 Received:

Dear Ms. Craft:

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, Druq, 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 (QS) 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. this response to your premarket notification Please note: submission does not affect any obliqation 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.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. 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 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance 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 Manufacturers Assistance 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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## Indications For Use Statement

Device Name: IGM Flex™ Reagent Cartridge

#### Indications for Use:

The IGM Flex™ reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic test intended to quantitatively measure immunoglobulin M (IgM) in serum and plasma.

> Cathy P. Craft Regulatory Affairs and Compliance Manager

February 16, 1999

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Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-the-counter Use Prescription Use (Per 21 CFR 801.109) (Optional format 1-2-96)