DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120)

K061703 · Dade Behring, Inc. · JIX · Aug 2, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061703
• Device Name: DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120)
• Applicant: Dade Behring, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Aug 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The CHEM 2 CAL is an in vitro diagnostic product for the calibration of Phosphorus (PHOS), Salicylate (SAL), and Triglycerides (TRIG) methods on the Dimension Vista™ System. For prescription use.

Device Story

CHEM 2 CAL is a liquid, multi-analyte, bovine serum albumin-based calibrator. It contains phosphorus, salicylate, and glycerol. The kit includes six vials (three of Calibrator A, three of Calibrator B), each containing 2.0 mL of ready-to-use solution. The device is used in clinical laboratories to calibrate the Dimension Vista System for specific chemistry assays. By providing known concentrations of analytes, it allows the system to establish a calibration curve, ensuring accurate measurement of patient samples. The healthcare provider uses the system output to make clinical decisions regarding patient diagnosis and monitoring.

Clinical Evidence

No clinical data. Bench testing only. Stability was validated via real-time data comparing material stored at 4°C to -20°C over 371 days, supporting a 12-month shelf life. Opened, refrigerated stability was validated over 32 days. Traceability and expected values were verified through 45 replicate measurements across multiple instruments using primary standards.

Technological Characteristics

Liquid, bovine serum albumin-based matrix. Traceability: PHOS (NIST SRM 2186I), SAL (Sodium Salicylate ACS grade), TRIG (Glycerol Anhydrous ACS grade). Two-level calibrator. No energy source or software; purely chemical calibrator material.

Indications for Use

Indicated for the calibration of Phosphorus, Salicylate, and Triglycerides diagnostic methods on the Dimension Vista System in a clinical laboratory setting.

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

• Chemistry II Calibrator (K861700)
• Salicylate Calibrator (K904307)

Submission Summary (Full Text)

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K061703

AUG 0 2 2006

# 510(k) Summary for the Dimension Vista™ System Chemistry 2 Calibrator (CHEM 2 CAL - KC120)

## A. 510(k) Number:

| B. Analytes: | Phosphorus (PHOS), Salicylate (SAL), and Triglycerides (TRIG) |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| C. Type of Test: | Calibrator Material |
| D. Applicant: | Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101<br>Victor M. Carrio, Regulatory Affairs and Compliance Manager<br>Office: [phone] Fax: [phone] |

#### E. Proprietary and Established Names:

Dimension Vista™ System Chemistry 2 Calibrator (CHEM 2 CAL - KC120)

#### F. Regulatory Information:

- 1. Regulation section: 21 CFR § 862-1150 Calibrator
- 2. Classification: Class II
- 3. Product Code: JIX Calibrator, Multi-Analyte Mixture
- 4. Panel: Clinical Chemistry
- G. Intended Use: The CHEM 2 CAL is an in vitro diagnostic product for the calibration of Phosphorus (PHOS), Salicylate (SAL), and Triglycerides (TRIG) methods on the Dimension Vista " System.

# H. Device Description:

CHEM 2 CAL is a liquid, multi-analyte, bovine serum albumin based product containing phosphorus, salicylate and glycerol. The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are ready for use (no preparation is required). The volume per vial is 2.0 mL.

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| Item | Device<br>Dimension Vista™ System<br>Chemistry 2 Calibrator | Predicates<br>Chemistry II Calibrator<br>K861700 | Predicates<br>Salicylate Calibrator<br>K904307 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CHEM 2 CAL is an in vitro diagnostic product for the calibration of Phosphorus (PHOS), Salicylate (SAL), and Triglycerides (TRIG) methods on the Dimension Vista™ System. | CHEM II Calibrator is an in vitro diagnostic product to be used to calibrate the Dimension® clinical chemistry system for the magnesium (MG), phosphorus (PHOS) and triglycerides (TRIG) methods. | The Salicylate Calibrator is an in vitro diagnostic product to be used to calibrate the Dimension® clinical chemistry system for the Salicylate (SAL) method. |
| Analytes | Phosphorus (PHOS), Salicylate (SAL), and Triglycerides (TRIG). | Phosphorus (PHOS) and Triglycerides (TRIG). | Salicylate (SAL). |
| Form | Liquid. | Liquid. | Liquid. |
| Traceability | PHOS – NIST SRM 2186I.<br>SAL – Sodium Salicylate ACS grade.<br>TRIG - Glycerol Anhydrous ACS grade. | PHOS - NIST SRM 2186I.<br>TRIG - Glycerol Anhydrous ACS grade. | SAL - Sodium Salicylate ACS grade. |
| Matrix | Bovine serum albumin based product. | Pure magnesium dissolved in a dilute solution of HCL, reagent grade potassium dihydrogen phosphate and reagent grade glycerol. | Aqueous solution of ACS grade sodium salicylate. |
| Number of<br>Levels | Two levels. | Three levels. | Three levels. |

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Substantial Equivalence Information 'I

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# J. Standard/Guidance Document Referenced:

- 1. Guidance: Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final, 02/22/1999. Guidance for Industry and FDA Staff - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use, 11/30/2004.
- 2. Standards: CEN 13640 Stability testing of In-Vitro Diagnostic Devices. ISO 14971:2000 Medical devices - Application of risk management to medical devices.

## K. Performance Characteristics:

| 1. Stability: | Target shelf life for the Dimension Vista™ Chemistry 2 Calibrator<br>is 12 months. Calibrator shelf life is determined by comparing<br>results of the product stored at 4°C with control stored at -20°C.<br>The method is calibrated from this stored material. The 4°C<br>material values are recovered versus the calibration. Recovery<br>versus time is monitored and percent change over time is<br>determined. Percent change should be less than or equal to 5%.<br>Shelf-life stability (expiration) dating assignment at<br>commercialization reflects the real-time data on file at Dade<br>Behring, Inc.<br>A vial punctured by the instrument and stored on board is stable<br>for 7 days.<br>An open vial not on instrument, but recapped and stored in a<br>refrigerator is stable for 30 days.<br><br>For testing, vials are opened /punctured on day zero. A quantity<br>sufficient for multiple calibrations is removed and the vials are<br>recapped and stored at 2 – 8 °C. Opened/punctured vials are tested<br>on days 1, 8, 15, 22, 31, and 32 versus freshly opened vials. |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Traceability: | The assigned values of the Chemistry 2 Calibrator are traceable to: |

| Constituent | Traceability |
|-------------|--------------------------------|
| PHOS | NISTa SRM 2186I |
| SAL | Sodium Salicylate ACSb grade |
| TRIG | Glycerol Anhydrous (ACS grade) |

- NIST-SRM: National Institute of Standards and Technology- Standard a. Reference Material.
- b. ACS: American Chemical Society.

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- 3. Bottle Value Assignment:
The new calibrator is made by adding weighed in aqueous solutions of potassium dihydrogen phosphate, sodium salicylate, and glycerol reference materials to a stock solution at target concentrations. The concentration is verified using an instrument calibrated with primary standards. The stock solutions are added to base matrix in appropriate concentrations and verified using an instrument calibrated with primary standards. The final bottle assignment for each level of the commercial lot is tested N = 45 replicates, with multiple reagent lots on multiple instruments.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle around the eagle.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Victor M. Carrio RA/QS Compliance Manager Dade Behring, Inc. 500 GBC Drive PO Box 6101, Mail Stop 514 Newark, DE 19714-6101

AUG 0 2 2006

Re: k061703

> Trade/Device Name: CHEM 2 CAL Regulation Number: 21 CFR§ 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: June 15, 2006 Received: June 16, 2006

Dear Mr. Carrio:

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 misbanding 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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Page 2 -

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, percoits 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 not the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 80.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolli-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

Alberto Guti

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

510(k) Number (if known): k061703

Device Name: CHEM 2 CAL

Indications For Use:

The CHEM 2 CAL is an in vitro diagnostic product for the calibration of Phosphorus (PHOS), Salicylate (SAL), and Triglycerides (TRIG) methods on the Dimension Vista™ System.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

CDRH, Office of I

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