DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210

K072717 · Dade Behring, Inc. · JIT · Dec 12, 2007 · Clinical Chemistry

Device Facts

• Record ID: K072717
• Device Name: DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210
• Applicant: Dade Behring, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Dec 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The BILI CAL is an in vitro diagnostic product for the calibration of the Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the Dimension Vista® System.

Device Story

BILI CAL is a two-level calibrator for the Dimension Vista® System; used to calibrate Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) assays. Level 1 consists of on-board purified system water; Level 2 is a liquid, bovine serum albumin-based material spiked with ditaurobilirubin. Traceable to NIST Standard Reference Material 916a. Used in clinical laboratory settings by laboratory technicians to ensure accuracy of bilirubin measurements. Output is used by the analyzer to establish calibration curves for patient sample testing, aiding clinicians in the diagnosis and monitoring of liver and biliary conditions.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Two-level calibrator. Level 1: purified system water. Level 2: bovine serum albumin-based liquid spiked with ditaurobilirubin. Traceable to NIST SRM 916a. Designed for use on the Dimension Vista® System.

Indications for Use

Indicated for the calibration of Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the Dimension Vista® System for in vitro diagnostic 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 Vista™ TDBIL Calibrator (k061839)

Submission Summary (Full Text)

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# 510(k) Summary for Dimension Vista® System Bilirubin Calibrator (BILI ČAL - KC210)

・

| 510 (k) Number: | K072717 | DEC 1 2 2007 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Analyte: | Bilirubin | |
| Type of Test: | Calibrator Material | |
| Applicant: | Dade Behring Inc .<br>P.O. Box 6101<br>Newark, DE 19714-6101<br>Helen M. Lee Regulatory Affairs and Compliance Manager<br>Office Phone: [phone]<br>Fax: [phone] | |
| Proprietary and Established Name: | Dimension Vista® System Bilirubin Calibrator (BILI CAL - KC210) | |
| Regulatory Information: | Regulation Section: 21 CFR § 862.1150 - Calibrator<br>Classification: Class II<br>Product Code: JIT - Calibrator, Secondary<br>Panel: Clinical Chemistry | |
| Intended Use: | The BILI CAL is an <i>in vitro</i> diagnostic product for the calibration of<br>Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the<br>Dimension Vista® System. | |
| Device Description: | The BILI calibrator is a two level calibrator. Level 1, purified system<br>water, is provided on-board the Dimension Vista® System. Level 2 is<br>a liquid, bovine serum albumin based material spiked with<br>ditaurobilirubin and traceable to NIST Standard Reference Material<br>916a. | |

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## 510(k) Summary for Dimension Vista® System Bilirubin Calibrator (BILI CAL - KC210)

### Substantial Equivalence Information:

Predicate Device: Dimension Vista™ System TBIL Flex reagent cartridge and TDBIL Calibrator (k061719).

Comparison to the Predicate Device:

| Attribute | Dimension Vista™ System<br>TDBIL Calibrator (Predicate) | Dimension Vista® System<br>BILI Calibrator (Proposed) |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The TDBIL CAL is an in vitro diagnostic product for calibration of the Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the Dimension Vista™ System. | The BILI CAL is an in vitro diagnostic product for calibration of the Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the Dimension Vista® System. |
| Analyte | Ditaurobilirubin | Ditaurobilirubin |
| Matrix | Human Serum | Bovine Serum |
| Levels | One (CAL A) | One (CAL A) |
| Bilirubin Concentration in (mg/dL) | Level 1- is on-board, purified system water | Level 1- is on-board, purified system water |
| Total (TBIL)<br>Direct (DBIL) | Level 2 (27.5)<br>Level 2 (19.25) | Level 2 (27.5)<br>Level 2 (17.5) |
| Form | Lyophilized | Liquid |
| Volume | 3 vials, 1 mL each vial (hydrated volume) | 3 vials, 2.5 mL each |
| Traceability | National Institute of Standards and Technology (NIST), Standard Reference Material (SRM) 916a. | National Institute of Standards and Technology (NIST), Standard Reference Material (SRM) 916a |

### Comments on Substantial Equivalence:

Both the proposed Dade Behring Dimension Vista® BILI Calibrator and the existing Dimension Vista® TDBIL Calibrator are in vitro diagnostic products for calibrating the DBIL and TBIL methods.

## Conclusion:

The Dimension Vista® BILI Calibrator is substantially equivalent to the Dimension Vista™ TDBIL Calibrator based upon the comparison discussed above.

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#### Public Health Service

DEC 1 2 2007

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

Dade Behring Inc. c/o Ms. Helen M. Lee. Regulatory Affairs & Compliance Manager P.O. Box 6101, Mail Box 514 Newark, DE 19714-6101

Re: k072717

> Trade Name: Dimension Vista® System Bilirubin Calibrator (BILI CAL - KC210) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: November 05, 2007 Received: November 06, 2007

Dear Ms. Lee:

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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801 and 809); 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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. 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

510(k) Number (if known): K072717

Device Name:

Dimension Vista® System BILI Calibrator (KC210)

## Indications for Use:

The BILI CAL is an in vitro diagnostic product for the calibration of the Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the Dimension Vista® System.

Prescription Use × (Per 21 CFR 801 Subpart D) 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
Sign-Off

Office of In Vitro Diagnostic Device untion and Safety ,

K072717

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