DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)

K061923 · Dade Behring, Inc. · JIX · Aug 25, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061923
• Device Name: DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)
• Applicant: Dade Behring, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Aug 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The ENZ 1 CAL is an in vitro diagnostic product for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIP), and Pseudocholinesterase (PCHE) methods on the Dimension Vista™ System.

Device Story

ENZ 1 CAL is a liquid, multi-analyte, bovine serum albumin-based calibrator kit; contains amylase (human saliva), GGT (bovine kidney), LDH (chicken heart), lipase (porcine pancreas), and pseudocholinesterase (horse serum). Kit includes six vials (three of Calibrator A, three of Calibrator B); ready-to-use. Used in clinical laboratory settings by trained personnel to calibrate the Dimension Vista System. Output is a set of assigned values used to establish the calibration curve for specific enzyme assays on the instrument. Enables accurate quantitative measurement of patient enzyme levels, supporting clinical diagnosis and monitoring of related metabolic or organ-specific conditions.

Clinical Evidence

No clinical data. Bench testing only. Traceability of assigned values was verified using the Dimension Vista System calibrated with an approved Master Pool. Stability testing (real-time) was conducted to support a 12-month shelf life at 4°C, with specific stability claims for on-board (1 day) and open-vial (30 days) storage.

Technological Characteristics

Liquid, multi-analyte calibrator. Matrix: Bovine serum albumin base. Analytes: Amylase (human saliva), GGT (bovine kidney), LDH (chicken heart), lipase (porcine pancreas), PCHE (horse serum). Traceability: Master Pool, Dimension clinical chemistry system. Stability: 12-month shelf life; 31-day open-vial stability (refrigerated); 7-day on-instrument stability. Complies with CEN 13640 and ISO 14971.

Indications for Use

Indicated for the calibration of Amylase, GGT, LDH, Lipase, and Pseudocholinesterase assays on the Dimension Vista System. For professional, prescription use only.

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)
• Dimension® Lipase Calibrator (K952815)
• Dimension® PCHE Verifier (K883891)

Submission Summary (Full Text)

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Kou1923

# 510(k) Summary for the Dimension Vista™ System Enzyme 1 Calibrator (ENZ 1 CAL - KC310)

AUG 2 5 2006

## A. 510(k) Number:

| B. Analytes: | Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate<br>Dehydrogenase (LDH), Lipase (LIP), and Pseudocholinesterase<br>(PCHE). |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Enzyme 1 Calibrator (ENZ 1 Cal-KC310)

## 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
- The ENZ 1 CAL is an in vitro diagnostic product for the G. Intended Use: calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIP), and Pseudocholinesterase (PCHE) methods on the Dimension Vista™ System.

## H. Device Description:

ENZ 1 CAL is a liquid, multi-analyte, bovine serum albumin based product containing amylase (human saliva), gamma-glutamyl transferase (bovine kidney), lactate dehydrogenase (chicken heart), Iipase (porcine pancreas), and pseudocholinesterase (horse serum), The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are ready for use (no preparation tis required). The volume per vial is 2.5 mL.

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| Item | Device<br>Dimension Vista™<br>System Enzyme 1<br>Calibrator | Dimension® Enzyme Verifier<br>K860021 | Predicate Devices<br>Dimension® Lipase<br>Calibrator<br>K952815 | Dimension® PCHE Verifier<br>K883891 |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The ENZ I CAL is an<br><i>in vitro</i> diagnostic<br>product for the<br>calibration of Amylase<br>(AMY), Gamma-<br>Glutamyl Transferase<br>(GGT), Lactate<br>Dehydrogenase (LDH),<br>Lipase (LIP), and<br>Pseudocholinesterase<br>(PCHE)<br>methods on the<br>Dimension Vista™<br>System. | Enzyme Verifier is an <i>in vitro</i><br>diagnostic product to be used to<br>verify Alkaline Phosphatase<br>(ALP), Amylase (AMY), G-<br>Glutamyl Transferase (GGT),<br>Aspartame Aminotransferase<br>(AST), Alanine Aminotransferase<br>(ALT) and Lactic Dehydrogenase<br>(LDH) method performance on the<br>Dimension® clinical chemistry<br>system. | The Lipase Calibrator is an <i>in<br/>vitro</i> diagnostic product to be<br>used to calibrate the<br>Dimension® clinical chemistry<br>systems for the Lipase (LIP)<br>method. | The Dimension®<br>Pseudocholinesterase Verifier is an<br><i>in vitro</i> diagnostic product to be<br>used to verify the Dimension®<br>clinical chemistry system for the<br>Pseudocholinesterase (PCHE)<br>method. |
| Analytes | Amylase (AMY)<br>Gamma-Glutamyl<br>Transferase (GGT)<br>Lactate Dehydrogenase<br>(LDH)<br>Lipase (LIP)<br>Pseudocholinesterase<br>(PCHE). | Alkaline Phosphatase (ALP)<br>Amylase (AMY)<br>Gamma-Glutamyl Transferase<br>(GGT)<br>Aspartame Aminotransferase<br>(AST)<br>Alanine Aminotransferase (ALT)<br>Lactic Dehydrogenase (LDH) | Lipase (LIP). | Pseudocholinesterase (PCHE). |
| Form | Liquid. | Lyophilized. | Lyophilized. | Lyophilized. |
| Traceability | Master Pool,<br>Dimension® clinical<br>chemistry system<br>values. | Master Pool, Dimension® clinical<br>chemistry system values. | Master Pool, Dimension® clinical<br>chemistry system values. | Master Pool, Dimension® clinical<br>chemistry system values. |
| Matrix | Bovine serum base with<br>amylase (human saliva),<br>GGT (bovine kidney) | Human serum base with amylase<br>(porcine pancreas), GGT (bovine<br>kidney) and LDH (bovine heart) | Human serum with lipase<br>(porcine pancreas). | Human serum and bovine serum<br>albumin base product. |
| Item | Device | Predicate Devices | Number of Levels | |
| Dimension Vista™<br>System Enzyme 1<br>Calibrator | LDH (chicken heart),<br>lipase (porcine<br>pancreas), and PCHE<br>(horse serum). | | Two levels. | |
| | Dimension® Enzyme Verifier<br>K860021 | | Three levels. | |
| | Dimension® Lipase<br>Calibrator<br>K952815 | | Three levels. | |
| | Dimension® PCHE Verifier<br>K883891 | | Three levels. | |

bstantial Equivalence Information

I.

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## J. Standard/Guidance Document Referenced:

medical devices

| 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 |

## K. Performance Characteristics:

| 1. Stability: | Target shelf life for the Dimension Vista™ Enzyme 1 Calibrator is<br>12 months. Calibrator shelf life is determined by comparing<br>results of the product stored at 4°C with control stored at -70°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 where the allowable shelf life percent change should be<br>≤ 7 % for lipase and ≤ 5 % for amylase, gamma-glutamyl<br>transferase, lactate dehydrogenase, and pseudocholinesterase.<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 has a seven<br>day stability claim.<br>An open vial not on instrument, but recapped and stored in a<br>refrigerator has a stability claim of 31 days.<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 3, 8, 15, 22, and 32 versus freshly opened vials. |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Traceability: | The assigned values of the Enzyme 1 Calibrator are traceable to<br>Master Pool, Dimension® clinical chemistry system. |

- 3. Bottle Value Assignment:
Bovine serum albumin (BSA) base is used as Level 1 for AMY, GGT, LDH, PCHE and LIP and stored at -70°C. AMY, GGT, LDH and PCHE are added gravimetrically to BSA base to target concentrations for levels 2 and 3 and stored at -70°C. Dimension® LIP Master Pools in human serum are used for levels 2, 3 and 4 and stored at 2 - 8°C.

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Master Pool level 1 of BSA base is assigned value 0 U/L. LIP Master Pool bottle values levels 2, 3, and 4 are assigned on multiple instruments calibrated with LIP Anchor Pool. The LIP Anchor Pool values are assigned using an external reference system (PBS/Precical®).

AMY, GGT, LDH and PCHE bottle values for levels 2 and 3 are assigned on multiple instruments using fixed coefficients. N > 40 total replicates per level. A previous Master Pool lot is used as a control.

To manufacture Enzyme 1 Calibrator, a stock solution is prepared by gravimetrically adding quantities of AMY, GGT, LDH, LIP, and PCHE to bovine serum albumin base to target concentrations. The stock solution is verified by comparing the recovery of the stock solution versus the Master Pool assigned bottle values. Calculated quantities of the stock solution are added to the bovine serum albumin base to target concentrations to produce the commercial calibrator lot. The concentration of each level is verified to be within acceptable range by using an instrument calibrated with Master Pools. The final bottle value is assigned to each level and verified on multiple instruments for N > 40 total replicates using a released commercial lot of calibrator as a control.

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features the department's name encircling a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with a single staff entwined by two snakes and topped with wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 2 5 2006

Mr. Victor M. Carrio Dade Behring, Inc. P.O. Box 6101 Newark, DE 19714

Re: k061923

> Trade/Device Name: Dimension Vista™ Enzyme 1 Calibrator (KC310) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: July 6, 2006 Received: July 7. 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 vours.

Alberto G.

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):

Device Name: K061923

Dimension Vista™ Enzyme 1 Calibrator (KC310)

#### Indications for Use:

The ENZ 1 CAL is an in vitro diagnostic product for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LPH), and Pseudocholinesterase (PCHE) methods on the Dimension Vista M 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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Carol Benson
Division Sign-Off

Office of In Vitro Dlagnostic Device Evaluation and Safety

510(K) K061923