DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110

K061838 · Dade Behring, Inc. · JIX · Aug 21, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061838
• Device Name: DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110
• Applicant: Dade Behring, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Aug 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (URCA) methods on the Dimension VistaTM System.

Device Story

Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL) is a liquid, multi-analyte, bovine serum albumin-based product; used to calibrate clinical chemistry assays on the Dimension Vista System. Kit contains six vials (three of Calibrator A, three of Calibrator B). Device provides reference values for CA, CHOL, CREA, GLU, LA, MG, T4, TU, BUN, and URCA. Used by laboratory professionals in clinical settings to ensure accuracy of patient sample testing. Healthcare providers use the resulting calibrated instrument output to diagnose and monitor patient metabolic and endocrine health. Benefits include standardized, reliable diagnostic measurements.

Clinical Evidence

Bench testing only. Stability testing performed per CEN 13640; shelf life established at 12 months at 4°C. Assigned values verified against Master Pools using N=45 replicates across multiple instruments. Traceability established to NIST SRMs (912, 915, 914, 917, 929A, 913), CDC Abell-Kendall method, USP, and A-Grade lithium salt.

Technological Characteristics

Liquid, multi-analyte, bovine serum albumin-based calibrator. Two-level concentration. Traceable to NIST SRMs, USP, and reference methods. Stability: 12-month shelf life; 1-day on-board stability; 30-day open-vial refrigerated stability. Standards: CEN 13640, ISO 14971:2000.

Indications for Use

Indicated for the calibration of clinical chemistry methods (CA, CHOL, CREA, GLU, LA, MG, T4, TU, BUN, URCA) on the Dimension Vista System for professional 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

• CHEM I Calibrator (k860021)
• URCA (k862359)
• Chemistry II Calibrator (k861700)
• Cholesterol Calibrator (k861700)
• Thyroxine Calibrator (k862359)
• Thyronine Uptake Calibrator (k862359)

Submission Summary (Full Text)

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## 510(k) Summary for the Dimension Vista™ System Chemistry 1 Calibrator (CHEM 1 CAL - KC110)

A. 510(k) Number:

B. Analytes:

K061838

Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN)4 and Uric Acid (URCA).

AUG 2 1 2006

- C. Type of Test: Calibrator Material
D. Applicant: Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101 Victor M. Carrio, Regulatory Affairs and Compliance Manager Office: [phone] Fax: [phone]

### E. Proprietary and Established Names:

Dimension Vista™ System Chemistry 1 Calibrator (CHEM 1 CAL-KC110)

### 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

### H. Device Description:

CHEM 1 CAL is a liquid, multi-analyte, bovine serum albumin based product containing calcium, cholesterol, creatinine, glucose.

G. Intended Use: The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN) 1 and Uric Acid (URCA) methods on the Dimension Vista™ System.

¹ The Dimension Vista™ System Chemistry 1 Calibrator was previously cleared for the calibration of blood urea nitrogen (BUN) in the Dimension Vista™ System under K051087.

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lactic acid, magnesium, thyroxine, urea nitrogen and uric acid. 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 2.5 mL. This same product, the Dimension Vista™ System Chemistry 1 Calibrator (KC110), was previously cleared (K051087) for the calibration of the Blood Urea Nitrogen (BUN) method on the Dimension Vista™ system.

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ostantial Equivalence Informatio I

| Item | Device | Predicate Devices | | | | |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | Dimension Vista™<br>System Chemistry 1<br>Calibrator² | CHEM I<br>Calibrator<br>K860021<br>(URCA-K862359) | Chemistry II<br>Calibrator<br>K861700 | Cholesterol<br>Calibrator<br>K861700 | Thyroxine<br>Calibrator<br>K862359 | Thyronine Uptake<br>Calibrator<br>K862359 |
| | The CHEM 1 CAL is an<br>in vitro diagnostic<br>product for the calibration<br>of Calcium (CA),<br>Cholesterol (CHOL),<br>Creatinine (CREA),<br>Glucose (GLU), Lactic<br>Acid (LA), Magnesium<br>(MG), Thyroxine (T4),<br>Thyronine Uptake (TU),<br>Blood Urea Nitrogen<br>(BUN)² and Uric Acid<br>(URCA) methods on the<br>Dimension Vista™<br>System. | The Dimension®<br>Chemistry I<br>Calibrator is an in<br>vitro diagnostic<br>product to be used to<br>calibrate the<br>Dimension® clinical<br>chemistry system for<br>the Calcium (CA),<br>Creatinine (CREA),<br>Glucose<br>(GLU/GLUC), Lactic<br>Acid (LA), Urea<br>Nitrogen (BUN) and<br>Uric Acid (URCA)<br>methods. | CHEM II Calibrator<br>is an in vitro<br>diagnostic product to<br>be used to calibrate<br>the Dimension®<br>clinical chemistry<br>system for the<br>magnesium (MG),<br>phosphorus (PHOS)<br>and triglycerides<br>(TRIG) methods. | The Dimension®<br>Cholesterol Calibrator<br>is an in vitro<br>diagnostic product to<br>be used to calibrate the<br>Dimension® clinical<br>chemistry system for<br>the Cholesterol<br>(CHOL) method. | The Dimension®<br>Thyroxine Calibrator<br>is an in vitro<br>diagnostic product to<br>be used to calibrate the<br>Dimension® clinical<br>chemistry system for<br>the Thyroxine (T4)<br>method. | The Dimension®<br>Thyronine Uptake is<br>an in vitro diagnostic<br>product to be used to<br>calibrate the<br>Dimension® clinical<br>chemistry system for<br>the Thyronine Uptake<br>method. |
| Analytes | Calcium (CA),<br>Cholesterol (CHOL),<br>Creatinine (CREA),<br>Glucose (GLU), Lactic<br>Acid (LA), Magnesium<br>(MG), Thyroxine (T4),<br>Thyronine Uptake (TU),<br>Blood Urea Nitrogen<br>(BUN)² and Uric Acid<br>(URCA) | Calcium (CA),<br>Creatinine (CREA),<br>Glucose (GLU),<br>Lactic Acid (LA),<br>Urea Nitrogen (BUN)<br>and Uric Acid<br>(URCA). | Magnesium (MG). | Cholesterol (CHOL). | Thyroxyne (T4). | Thyronine Uptake<br>(TU). |
| Item | Device | Predicate Devices | | | | |
| | Dimension Vista™<br>System Chemistry 1<br>Calibrator² | CHEM I<br>Calibrator<br>K860021<br>(URCA–K862359) | Chemistry II<br>Calibrator<br>K861700 | Cholesterol<br>Calibrator<br>K861700 | Thyroxine<br>Calibrator<br>K862359 | Thyronine Uptake<br>Calibrator<br>K862359 |
| Form | Liquid. | Lyophilized. | Liquid. | Lyophilized. | Lyophilized. | Lyophilized. |
| Traceability | BUN – NIST SRM 912²<br>CA – NIST SRM 915.<br>CHOL – Abell-Kendall<br>(CDC-NCEP).<br>CREA – NIST SRM 914.<br>GLU – NIST SRM 917.<br>LA – Lactic acid – lithium<br>salt A-Grade.<br>MG – NIST SRM 929A.<br>T4 – USP.<br>TU – Calculated value.<br>URCA – NIST SRM 913. | BUN – NIST SRM<br>912<br>CA – NIST SRM 915.<br>CREA – NIST SRM<br>914.<br>GLU – NIST SRM<br>917.<br>LA – Lactic acid –<br>lithium salt A-Grade.<br>URCA – NIST SRM<br>913. | MG – NIST SRM<br>929A. | CHOL – NIST SRM<br>911. | T4 – Thyroxine Master<br>Pool. | TU – Thyronine<br>Uptake Master Pool. |
| Matrix | Bovine serum albumin<br>based product. | Bovine serum<br>albumin based<br>product. | Pure magnesium<br>dissolved in a dilute<br>solution of HCL,<br>reagent grade<br>potassium<br>dihydrogen<br>phosphate and<br>reagent grade<br>glycerol. | Bovine serum albumin<br>based product. | Human serum based<br>product. | Human serum based<br>product. |
| Number of<br>Levels | Two levels. | Three levels. | Three levels. | Three levels. | Five levels. | Five levels. |

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² The Dinansion Vista™ System Chemistry 1 Calbrator was previously cleared for the calbration of blood ura nimogen (BUN) in the Dimension Vista™ System
under K051087.

.

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# J. Standard/Guidance Document Referenced:

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

### K. Performance Characteristics:

- 1. Stability: Target shelf life for the Dimension Vista™ Chemistry 1 Calibrator is 12 months. Calibrator shelf life is determined by comparing results of the product stored at 4°C with control stored at -20°C. The method is calibrated from this stored material. The 4°C material values are recovered versus the calibration. Recovery versus time is monitored and percent change over time is determined where the allowable shelf life percent change should be less than or equal to:

| Analyte | Allowable Shelf life percent change |
|------------------|-------------------------------------|
| Urea Nitrogen3 | ≤ 5%. |
| Calcium | ≤ 5 % |
| Cholesterol | ≤ 3% |
| Creatinine | ≤ 5% |
| Glucose | ≤ 5% |
| Lactic Acid | ≤ 5% |
| Magnesium | ≤ 3% |
| Thyroxine | ≤ 6% |
| Thyroxine Uptake | ≤ 6% |
| Uric Acid | ≤ 5% |

Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc.

A vial punctured by the instrument and stored on board has a stability claim of one day.

An open vial not on instrument, but recapped and stored in a refrigerator has a stability claim of 30 days.

For testing, vials are opened /punctured on day zero. A quantity sufficient for multiple calibrations is removed and the vials are

³ The Dimension Vista™ System Chemistry 1 Calibrator was previously cleared for the calibration of blood urea nitrogen (BUN) in the Dimension Vista™ System under K051087.

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recapped and stored at 2 - 8 °C. Opened/punctured vials are tested on days 0, 8 hrs, 2, 8, 31 versus freshly opened vials.

- The assigned values of the Chemistry 1 Calibrator are standardized 2. Traceability: to the enclosed table of assigned values:

| Constituent | Traceability |
|-------------|-------------------------------------------------------|
| BUN4 | NIST SRMa 912 |
| CA | NIST SRM 915 |
| CHOL | NIST SRM 911<br>(CDCb) Abell-Kendall reference method |
| CREA | NIST SRM 914 |
| GLU | NIST SRM 917 |
| LA | Lactic acid- lithium salt (A- Grade) |
| MG | NIST SRM 929 A |
| T4 | USPc |
| TU | Calculated value |
| URCA | NIST SRM 913 |

4 National Institute of Standards and Technology - Standard Reference Material. 6 Centers for Disease Control.

C United States Pharmacopeia.

- 3. Bottle Value Assignment:
Urea Nitrogen, calcium carbonate, creatinine, cholesterol. glucose, lactic acid, magnesium gluconate, uric acid, and thyroxine reference materials are weighed appropriate aqueous solutions or human serum traced to primary standard material. Master Pool and standards are stored frozen for each analyte. The verification of the Master Pool/Standard values are compared against previously approved Master Pool/Standard values. The stock solution is made by adding reference materials gravimetrically to stock solution at target concentrations. The stock solution values are verified versus previously approved Master Pool/Standard values. The commercial lot is made by adding calculated quantities of stock solution to base matrix in appropriate concentrations for two calibrator levels. The concentration of each level is verified by using an instrument calibrated with Master Pools. The final bottle values for each level of the commercial lot is assigned and verified using multiple instruments by testing N = 45 replicates.

⁴ The Dimension Vista™ System Chemistry 1 Calibrator was previously cleared for the calibration of blood urea nitrogen (BUN) in the Dimension Vista™ System under K051087.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Victor M. Carrio RA/OS Compliance Manager Dade Behring, Inc. P.O. Box 6101 Newark, DE 19714-6101

AUG 2 1 2006

Re: k061838

Trade/Device Name: Dimension Vista™ Chemistry 1 Calibrator (KC110) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: June 28, 2006 Received: June 29, 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 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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### 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, 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 Guts

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

510(k) Number (if known): K061838

Device Name:

Dimension Vista™ Chemistry 1 Calibrator (KC110)

### Indications for Use:

The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (URCA) methods on the Dimension VistaTM System

Prescription Use X (Per 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)

Carl Benson
Division Sign-Off

Division Sign-On

ce of In Vitro Diagnost Evaluation and Safety

510(k) K061838