DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR

K061251 · Dade Behring, Inc. · JIS · May 31, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061251
• Device Name: DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR
• Applicant: Dade Behring, Inc.
• Product Code: JIS · Clinical Chemistry
• Decision Date: May 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The TIBC Calibrator is an in vitro diagnostic product for the calibration of the Total Iron Binding Capacity (TIBC) method on the Dimension Vista™ system.

Device Story

Dimension Vista™ Total Iron Binding Capacity (TIBC) Calibrator is a liquid, bovine albumin-based product containing human transferrin. Used for calibration of TIBC method on Dimension Vista™ System. Kit includes three vials (1.0 mL each); zero level calibrator is system water provided on-board. Product prepared by adding human transferrin to base matrix via gravimetric procedures; concentration verified against NIST SRM937. Used by laboratory professionals in clinical settings to ensure accuracy of TIBC assays. Benefits patient by providing standardized calibration for iron binding capacity measurements, supporting clinical assessment of iron status.

Clinical Evidence

No clinical data. Bench testing only. Stability studies included shelf-life (up to 735 days at 4°C), freeze-thaw, stress testing, and open-vial stability. Traceability established to NIST SRM937. Donor units tested negative for HIV-1, HIV-2, HBsAg, and HCV.

Technological Characteristics

Liquid, bovine albumin-based matrix containing human transferrin. Traceable to NIST SRM937. Designed for use on the Dimension Vista™ System. Sterility/biohazard control: donor units tested for HIV-1/2, HBsAg, and HCV.

Indications for Use

Indicated for use in the calibration of the TIBC method on the Dimension Vista™ system for prescription use.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Dimension® IBCT Calibrator (k994114)

Submission Summary (Full Text)

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# 510(k) 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: | Lorraine Piestrak<br>Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714-6101 |
|---------------------------------------|----------------------------------------------------------------------------------|
| | MAY 3 1 2006 |
| Date of Preparation: | May 3, 2006 |
| Name of Product: | Dimension Vista™ Total Iron Binding Capacity<br>(TIBC) Calibrator |
| FDA Classification Name/Product Code: | Calibrator / JIS |
| Predicate Device: | Dimension® IBCT Calibrator (K994114) |

## Device Description:

The Dimension Vista™ Total Iron Binding Capacity (TIBC) Calibrator is a liquid, bovine albumin based product containing human transferrin. The kit consists of 3 vials, each containing 1.0 mL.

## Intended use:

The TIBC Calibrator is an in vitro diagnostic product for the calibration of the Total Iron Binding Capacity (TIBC) method on the Dimension Vista™ system.

## Comparison to Predicate Device:

| | Dimension Vista™<br>TIBC Calibrator | Dimension®<br>IBCT Calibrator (predicate) |
|--------------|---------------------------------------------------------|------------------------------------------------|
| Intended Use | Calibrator | Calibrator |
| Analyte | human transferrin | human transferrin |
| Matrix | bovine albumin | bovine albumin |
| Form | liquid | liquid |
| Volume | 1 mL per vial | 1 mL per vial |
| Levels | 1 level | 3 levels |
| | (Zero level is system water on board<br>the instrument) | (Zero level provided) |
| Reference | Primary standard<br>NIST Iron Standard SRM 937 | Primary standard<br>NIST Iron Standard SRM 937 |

## Comments on Substantial Equivalence:

Both the proposed Dade Behring Dimension Vista™ Total Iron Binding Capacity (TBC) Calibrator and the existing Dimension® IBCT calibrator are in vitro diagnostic products intended for calibrating Total Iron Binding Capacity assays.

#### Conclusion:

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# Conclusion:

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The Dimension Vista™ Total Iron Binding Capacity (TIBC) Calibrator is substantially equivalent to the Dimension® IBCT Calibrator based on the comparison discussed above.

Lorraine Piesta

Lorraine Piestrak Regulatory Affairs and Compliance Manager May 3, 2006

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the bird symbol. The logo is presented in black and white.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# MAY 3 1 2006

Ms. Lorraine H. Piestrak Regulatory Affairs & Compliance Manger Dade Behring, Inc. PO Box 6101, M/S 514 Newark, DE 19714-6101

Re: k061251

Trade/Device Name: Dimension Vista™ Total Iron Binding Capacity (TIBC) Calibrator Regulation Number: 21 CFR§862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIS Dated: May 3, 3006 Received: May 4, 2006

Dear Ms. Piestrak:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Gutierrez

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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#### Indications For Use Statement

Kd6125|

Device Name: Dimension Vista™ Total Iron Binding Capacity (TIBC) Calibrator

#### Indications for Use:

The Dimension Vista™ Total Iron Binding Capacity (TIBC) Calibrator is intended for use in the calibration of the TIBC method on the Dimension Vista™ system.

Prescription Use × (Part 21 CFR 801 Subpart D)

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AND/OR

Over-The-Counter Use (21 CFR 801)

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

# Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Benson
Division Sign-Off

Diagnostic
and Safety
K061251

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