TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE

K994115 · Dade Behring, Inc. · JMO · Jan 28, 2000 · Clinical Chemistry

Device Facts

• Record ID: K994115
• Device Name: TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE
• Applicant: Dade Behring, Inc.
• Product Code: JMO · Clinical Chemistry
• Decision Date: Jan 28, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1415
• Device Class: Class 1

Intended Use

The Total Iron Binding Capacity (IBCT) Flex® reagent cartridge is used in the Dimension® clinical chemistry system to quantitatively measure total iron binding capacity in human serum and plasma.

Device Story

The IBCT Flex® reagent cartridge is an in vitro diagnostic assay for the Dimension® clinical chemistry system. It measures total iron binding capacity (TIBC) in human serum or plasma. The process involves mixing the sample with a ferric iron solution to saturate transferrin binding sites at pH 8.6; excess iron is reduced by ascorbic acid to form a blue complex with Ferene®. Subsequent acidification to pH 4.5 releases transferrin-bound iron, which is then reduced and complexed with Ferene®. The system measures the increase in absorbance at 600 and 700 nm. This automated photometric measurement allows clinicians to assess iron status, aiding in the diagnosis and management of iron deficiency anemia and chronic inflammatory disorders.

Clinical Evidence

Clinical evidence consists of a split-sample method comparison study. 137 clinical patient samples (range 59-469 ug/dL TIBC) were tested using both the subject IBCT Flex® reagent cartridge and the predicate TIBC Flex® reagent cartridge on the Dimension® clinical chemistry system. Results showed a correlation coefficient of 0.971, a slope of 1.14, and an intercept of -22.4 ug/dL.

Technological Characteristics

Automated in vitro diagnostic reagent cartridge for use on the Dimension® clinical chemistry system. Employs a photometric, bichromatic endpoint detection method (600 nm and 700 nm). Reagents include ferric iron solution, ascorbic acid, and Ferene®. Designed for quantitative analysis of human serum and plasma.

Indications for Use

Indicated for quantitative measurement of total iron binding capacity in human serum and plasma to aid in diagnosis and treatment of iron deficiency anemia and chronic inflammatory disorders.

Regulatory Classification

Identification

An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

Predicate Devices

• Dimension® Total Iron Binding Capacity (TIBC) Flex® reagent cartridge (K864230)

Submission Summary (Full Text)

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### JAN 2 8 2000

# 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: | Robin O. Norris |
|--------------------------|---------------------------------------------------------------------------------|
| | Dade Behring Inc. |
| | P.O. Box 6101 |
| | Newark, DE 19714-6101 |
| Date of Preparation: | December 2, 1999 |
| Name of Product: | Total Iron Binding Capacity (IBCT) Flex® reagent cartridge |
| FDA Classification Name: | Iron Binding Capacity Test System |
| Predicate Device: | Dimension® Total Iron Binding Capacity (TIBC) Flex® reagent cartridge (K864230) |

Device Description: The IBCT method for the Dimension® clinical chemistry system is a fully automated assay in which serum or plasma is mixed with a ferric iron solution, to saturate all available iron-binding sites of transferrin in the sample. Under non-acidic conditions (pH 8.6), only unbound, excess saturating iron is available to be reduced to ferrous iron by ascorbic acid and to form a blue complex with Ferene®. Subsequent addition of acid (final pH of 4.5) releases the iron bound to transferrin; this additional iron is reduced to ferrous iron by ascorbic acid and forms an increased amount of blue complex with Ferene®. The increase in absorbance upon shifting from pH 8.6 to pH 4.5, measured using a bicromatic (600,700 nm) endpoint technique, is proportional to the concentration of transferrin-bound iron, and thus to the iron binding capacity (total) of the serum or plasma sample.

Intended Use: The Total Iron Binding Capacity (1BCT) Flex® reagent cartridge is used in the Dimension® clinical chemistry system to quantitatively measure total iron binding capacity in human serum and plasma.

#### Comparison to Predicate Device:

| Item | IBCT Flex® reagent cartridge | TIBC Flex® reagent cartridge |
|-------------|------------------------------------------|-----------------------------------------------------------|
| Sample Type | serum and plasma | serum |
| Methodology | Photometric measurement | Pretreatment step, followed by<br>Photometric measurement |
| Detection | Bichromatic endpoint<br>(600 and 700 nm) | Bichromatic endpoint<br>(600 and 700 nm) |

Comments on Substantial Equivalence: Split sample comparison between the IBCT Flex® reagent cartridge and TIBC Flex® reagent cartridges on the Dimension® clinical chemistry system gave a correlation coefficient of 0.971, slope of 1.14, and an intercept of -22.4 ug/dL when tested with 137 clinical patient samples ranging from 59 to 469 ug/dL TIBC.

The IBCT Flex® reagent cartridge is substantially equivalent in principle and performance to the TIBC Conclusion: Flex® reagent cartridge based on the comparison discussed abo

Robin Orner

Robin O. Norris Manager, Quality Assurance and Compliance December 2, 1999

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JAN 2 8 2000

Ms. Robin O. Norris Manager, Quality Assurance and Compliance Dade Behring, Inc. Building 500, Mailbox 514 P.O. Box 6101 Newark, Delaware 19714-6101

- Re: K994115
Trade Name: Total Iron Binding Capacity Flex® Reagent Cartridge Regulatory Class: I reserved Product Code: JMO Dated: December 2, 1999 Received: December 6, 1999

Dear Ms. Norris:

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 Autman

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: Total Iron Binding Capacity Flex® reagent cartridge

#### Indications for Use:

The Total Iron Binding Capacity (IBCT) Flex® reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure total iron binding capacity in human serum and plasma. Measurements of total iron binding capacity are used in the diagnosis and treatment of iron deficiency anemia and chronic inflammatory disorders.

Jean Cooger
(Division Sign-Off)

510(k) Number

Robin O'nomis

Robin O. Norris Manager, Quality Assurance and Compliance

December 2, 1999

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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OR

Over-the-counter Use

(Optional format 1-2-96)