DIMENSION TRNF FLEX REAGENT CARTRIDGE

K994294 · Dade Behring, Inc. · DDG · Feb 4, 2000 · Immunology

Device Facts

• Record ID: K994294
• Device Name: DIMENSION TRNF FLEX REAGENT CARTRIDGE
• Applicant: Dade Behring, Inc.
• Product Code: DDG · Immunology
• Decision Date: Feb 4, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5880
• Device Class: Class 2

Intended Use

The TRNF Flex® reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic device used to measure by immunochemical techniques the transferrin in human serum and heparinized plasma. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

Device Story

TRNF Flex® reagent cartridge is an in vitro diagnostic component for the Dimension® clinical chemistry system; used by laboratory professionals in clinical settings. Input: human serum or heparinized plasma samples. Principle: quantitative, turbidimetric assay using endpoint detection; relies on immunoprecipitation of transferrin by rabbit polyclonal antibodies. System performs bichromatic endpoint detection at 340 and 700 nm. Output: quantitative transferrin concentration. Results assist clinicians in diagnosing malnutrition, acute inflammation, infection, and red blood cell disorders (e.g., iron deficiency anemia).

Clinical Evidence

Bench testing only. A split-sample comparison was conducted between the TRNF Flex® reagent cartridge and the predicate Beckman Array® TRF method using 95 clinical patient samples. The study yielded a correlation coefficient of 0.984, a slope of 0.90, and an intercept of 7.9 mg/dL.

Technological Characteristics

Quantitative, turbidimetric assay; utilizes rabbit polyclonal antibodies for immunoprecipitation. Detection via bichromatic endpoint (340 and 700 nm). Designed for use on the Dimension® clinical chemistry system. Sample types: human serum and heparinized plasma.

Indications for Use

Indicated for patients requiring assessment of transferrin levels to aid in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia. For use with human serum and heparinized plasma.

Regulatory Classification

Identification

A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

Predicate Devices

• Beckman Array® Transferrin (TRF) method (K780913; K922273)

Submission Summary (Full Text)

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4 2000 FEB

## DADE BEHRI

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: | December 20, 1999 | |
| Name of Product: | TRNF Flex® Reagent Cartridge | |
| FDA Classification Name: | Transferrin, Antigen, Antiserum, Control; 82DDG | |
| Predicate Device: | Beckman Array® Transferrin (TRF) method (K780913; K922273) | |

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

Intended Use: The TRNF Flex® reagent cartridge is used in the Dimension® clinical chemistry system to quantitatively measure TRNF in human serum and heparinized plasma.

## Comparison to Predicate Device:

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

Comments on Substantial Equivalence: Split sample comparison between the TRNF Flex® reagent cartridge method and the Beckman Array® TRF method gave a correlation coefficient of 0.984, slope of 0.90, and an intercept of 7.9 mg/dL when tested with 95 clinical patient samples.

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

R m Vaught
Richard M. Vaught

Regulatory Affairs and Compliance Manager Date: December 20, 1999

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FEB 4 2000 Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring Inc. Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714-6101

Re: K994294 Trade Name: Dimension® TRNF Flex® Reagent Cartridge Regulatory Class: II Product Code: DDG 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

K994294

Device Name:

Dimension® TRNF Flex® Reagent Cartridge

Indications for Use:

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The TRNF Flex® reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic device used to measure by immunochemical techniques the transferrin in human serum and heparinized plasma. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

R M. Van

Richard M. Vaught Regulatory Affairs and Compliance Manager

December 20, 1999

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Maxim

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(Division Sign-Off) Division of Clinical Labora

ﺎ Prescription Use (Per 21 CFR 801.109)

OR

Over-the-counter Use

(Optional format 1-2-96)