DIMENSION C4 FLEX REAGENT CARTRIDGE

K994293 · Dade Behring, Inc. · DBI · Mar 1, 2000 · Immunology

Device Facts

• Record ID: K994293
• Device Name: DIMENSION C4 FLEX REAGENT CARTRIDGE
• Applicant: Dade Behring, Inc.
• Product Code: DBI · Immunology
• Decision Date: Mar 1, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5240
• Device Class: Class 2

Intended Use

The C4 Flex® reagent cartridge for the Dimenstry system is an in vitro diagnostic test intended to quantitatively measure complement C4 (C4) in serum as an aid in the diagnosis of immunologic disorders associated with complement C4 protein.

Device Story

C4 Flex® reagent cartridge is an in vitro diagnostic assay for the Dimension® clinical chemistry system. It measures complement C4 protein levels in serum samples. The device utilizes a turbidimetric immunoprecipitation method; it relies on the precipitation of C4 by rabbit polyclonal antibodies. The system performs bichromatic endpoint detection at 340 and 700 nm. Operated by laboratory personnel in a clinical setting, the system processes the sample and provides a quantitative result. This output assists clinicians in diagnosing immunologic disorders related to C4 protein levels.

Clinical Evidence

Bench testing only. A split-sample clinical comparison was performed using 94 patient samples comparing the Dimension® C4 Flex® reagent cartridge to the Beckman Array® Complement C4 method. Results showed a correlation coefficient of 0.980, a slope of 1.01, and an intercept of 6.7 mg/dL.

Technological Characteristics

In vitro diagnostic reagent cartridge for use on the Dimension® clinical chemistry system. Methodology: turbidimetric immunoprecipitation using rabbit polyclonal antibodies. Detection: bichromatic endpoint (340 and 700 nm).

Indications for Use

Indicated for the quantitative measurement of complement C4 in serum to aid in the diagnosis of immunologic disorders associated with complement C4 protein. For prescription use.

Regulatory Classification

Identification

A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

Predicate Devices

• Beckman Array® Complement C4 Assay (K780913; K922273)

Submission Summary (Full Text)

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994293

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: | Richard M. Vaught<br>Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714-6101 |
|--------------------------|----------------------------------------------------------------------------------|
| Date of Preparation: | February 17, 2000 |
| Name of Product: | C4 Flex® Reagent Cartridge |
| FDA Classification Name: | Complement C4, Antigen, Antiserum, Control; 82CZW |
| Predicate Device: | Beckman Array® Complement C4 Assay (K780913; K922273) |

Device Description: The C4 Flex® reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay using endpoint detection, based on the precipitation of complement C4 by its polyclonal antibody.

Intended Use: The C4 Flex® reagent cartridge for the Dimenstry system is an in vitro diagnostic test intended to quantitatively measure complement C4 (C4) in serum as an aid in the diagnosis of immunologic disorders associated with complement C4 protein.

## Comparison to Predicate Device:

| Item | Dimension® C4 Flex®<br>Reagent Cartridge | Beckman<br>Complement C4 |
|-------------|------------------------------------------------------------|--------------------------|
| Sample Type | Serum | Serum |
| Methodology | Immunoprecipitation | Immunoprecipitation |
| Antibody | Rabbit polyclonal | Goat polyclonal |
| Detection | Bichromatic endpoint<br>(340 and 700 nm)<br>(turbidimetry) | Nephelometry<br>(405 nm) |

Comments on Substantial Equivalence: Split sample comparison between the Dimension® C4 Flex® reagent cartridge method and the Beckman Array® Complement C4 method gave a correlation coefficient of 0.980, slope of 1.01, and an intercept of 6.7 mg/dL when tested with 94 clinical patient samples.

Conclusion: The C4 Flex® reagent cartridge method is substantially equivalent in principle and performance to the Beckman Array® Complement C4 method based on the split sample comparison discussed above.

Rim Vaught
Richard M. Vaught

Regulatory Affairs and Compliance Manager Date: February 17, 2000

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# MAR - 1 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring, Inc. P.O. Box 6101 Newark, Delaware 19714-6101

K994293 Re:

Trade Name: C4 Flex® Reagent Cartridge Regulatory Class: II Product Code: DBI Dated: December 20, 1999 Received: December 21, 1999

Dear Mr. Vaught:

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 (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 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.

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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" (21CFR 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 Butman

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:

Dimension® C4 Flex® Reagent Cartridge

Indications for Use:

The C4 Flex® reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure complement (C4 (C4) in serum as an aid in the diagnosis of immunologic disorders associated with complement C4 protein.

Richard M. Vaught Regulatory Affairs and Compliance Manager

February 28, 2000

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Maker-

Prescription Use_ -(Per 21 CFR 801.109)

OR

Over-the-counter Use

(Optional format 1-2-96)