DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320

K061390 · Dade Behring, Inc. · JIX · Jul 5, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061390
• Device Name: DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320
• Applicant: Dade Behring, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jul 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) on the Dimension Vista™ System.

Device Story

Enzyme 2 Calibrator is a liquid, multi-analyte, bovine serum albumin-based product containing porcine heart-derived ALT and AST. Used on the Dimension Vista™ System to calibrate ALT and AST assays. Kit includes six ready-to-use vials (three of Calibrator A, three of Calibrator B). Provides traceability to ALT/AST Master pool values. Used by clinical laboratory professionals to ensure accurate instrument calibration for diagnostic testing.

Clinical Evidence

No clinical data. Bench testing only. Stability testing (12-month shelf life, 7-day on-board stability) performed per ISO 13640. Traceability verified against Master pool values on Dimension® instruments.

Technological Characteristics

Liquid, bovine serum albumin-based matrix; contains porcine heart-derived ALT and AST. Two-level calibration system. Ready-to-use. Traceable to Dimension® clinical chemistry system Master pool values. Complies with ISO 14971:2000 risk management standards.

Indications for Use

Indicated for the calibration of ALT and AST assays 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

• Dimension® Enzyme Verifier (K860021)

Submission Summary (Full Text)

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K061390

JUL - 5 2006

# 510(k) Summary for the Dimension Vista™ System Enzyme 2 Calibrator (ENZ 2 CAL - KC320)

### A. 510(k) Number:

| B. Analytes: | Alanine aminotransferase (ALT) and aspartate aminotransferase<br>(AST) |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| C. Type of Test: | Calibrator Material |
| D. Applicant: | Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101<br>Contact: Victor M. Carrio, Regulatory Affairs and Compliance<br>Manager<br>Office: [phone] Fax: [phone] |

#### E. Proprietary and Established Names:

Dimension Vista™ Enzyme 2 Calibrator (ENZ 2 Cal - KC320) - m 1-1)

### 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 Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) on the Dimension Vista™ System.

4. **Wood shingles**

### H. Device Description:

The Enzyme 2 Calibrator is a liquid, multi-analyte, bovine serum albumin based product containing alanine aminotransferase (ALT) and aspartate aminotransferase (AST) from porcine heart. 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 1.5 mL.

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### I. Substantial Equivalence Information:

- 1. Predicate Device: Dimension® Enzyme Verifier (DC19).
- 2. Predicate K Number: K860021 for Dimension® clinical chemistry system.
- 3. Comparison with Predicate:

| Item | Dimension Vista™<br>Enzyme 2 Calibrator | Dimension®<br>Enzyme Verifier |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | The Enzyme 2 Calibrator is an <i>in vitro</i> diagnostic product for the<br>calibration of alanine<br>aminotransferase (ALT) and<br>aspartate aminotransferase (AST)<br>on the Dimension Vista™<br>System. | Enzyme Verifier is an <i>in vitro</i> diagnostic<br>product to be used to verify alkaline<br>phosphatase (ALP), amylase (AMY), g-<br>glutamyl transferase (GGT), aspartame<br>aminotransferase (AST), alanine<br>aminotransferase (ALT) and lactic<br>dehydrogenase (LDH) method<br>performance on the Dimension® clinical<br>chemistry system. |
| Analytes | Alanine aminotransferase (ALT)<br>Aspartate aminotransferase (AST) | Alkaline phosphatase (ALP), Amylase<br>(AMY)<br>g-glutamyl transferase (GGT), Aspartame<br>aminotransferase (AST),<br>Alanine aminotransferase (ALT), Lactic<br>dehydrogenase (LDH) |
| Form | Liquid | Lyophilized |
| Traceability | ALT/AST Master Pool,<br>Dimension® clinical chemistry<br>system values. | ALT/AST Master Pool, Dimension®<br>clinical chemistry system values. |
| Matrix | Bovine serum and porcine heart<br>based product. | Human serum and porcine heart based<br>product |
| Levels | Two calibration levels | Three verification levels |

## J. Standard/Guidance Document Referenced:

- 1. Guidance: Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic-Galibrators; 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

# 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1

# K. Performance Characteristics:

- Calibrator shelf life for the Dimension Vista™ Enzyme 2 1. Stability: Calibrator is determined to be 12 months. Calibrator shelf life is determined by comparing results of the product stored at 4℃ with control stored at -70℃. The method is calibrated from this stored material. The 4℃ material values are recovered versus the
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calibration. Recovery versus time is monitored and percent change over time is determined where the allowable shelf life percent change should be ≤ 5 %. Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc.

A vial that is punctured (opened) by the instrument and stored on board has a seven day stability claim.

An vial that is uncapped, recapped and stored in a refrigerator, not on instrument, has a stability claim of 31 days.

Both opened and punctured vials are tested on day zero. A quantity sufficient for multiple calibrations is removed and the vials are recapped and stored at 2 - 8 °C. Opened/punctured vials are tested on days 1, 8, 15, 22, and 32 versus freshly opened vials.

- 2. Traceability: The assigned values of the Enzyme 2 Calibrator are standardized to a master pool that is assigned by the Dimension® clinical chemistry system.
- 3. Value Assignment:

To manufacture a calibrator lot, calculated quantities of a verified stock solution are added to a bovine serum albumin base at target concentrations. The concentration of each level is verified on an instrument calibrated with an approved Master Pool. The Master Pool values are assigned for each level on multiple Dimension® instruments.

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL - 5 2006

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

Re: k061390

> Trade/Device Name: Dimension Vista™ Enzyme 2 Calibrator (AST/ALT Calibrator-KC320) Regulation Number: 21 CFR§ 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: May 17, 2006 Received: May 18, 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 Foeld, Or to 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 misbaranding 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 dctermination 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 manufagturing 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, permite 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 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 Gutierrez

Alberto Guticarez, 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): CX0(390

Device Name:

Dimension Vista™ Enzyme 2 Calibrator (AST/ALT Calibrator , KC320)

Indications for Use:

The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) on the Dimension Vista™ 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) |
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Division Sign Off
Office of In Vitro Diagnostic Device
Evaluation and Safety

| 510(k) | K061320 |
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