DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE

K061020 · Dade Behring, Inc. · CKA · May 10, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061020
• Device Name: DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE
• Applicant: Dade Behring, Inc.
• Product Code: CKA · Clinical Chemistry
• Decision Date: May 10, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1030
• Device Class: Class 1

Intended Use

Dimension Vista™ Albumin (ALB) Flex® reagent cartridge: The ALB method is an in vitro diagnostic test for the quantitative measurement of albumin in human serum and plasma on the Dimension Vista™ System. Dimension Vista™ Aspartate amino transferase (AST) Flex® reagent cartridge: The AST method is an in vitro diagnostic test for the quantitative measurement of aspartate aminotransferase in human serum and plasma on the Dimension Vista™ System. Dimension Vista™ Carbamazepine (CRBM) Flex® reagent cartridge: The CRBM method is an in vitro diagnostic test for the quantitative measurement of carbamazepine in human serum and plasma on the Dimension Vista™ System. Carbamazepine measurements may be used in the diagnosis and treatment of carbamazepine overdose and in therapeutic drug monitoring. Dimension Vista™ Alanine amino transferase (ALT) Flex® reagent cartridge: The ALT method is an in vitro diagnostic test for the quantitative measurement of alanine aminotransferase in human serum and plasma on the Dimension Vista™ System. Dimension Vista™ Total Iron-binding capacity (TIBC) Flex® reagent cartridge: The TIBC method is an in vitro diagnostic test for the quantitative measurement of total iron binding capacity in human serum and plasma on the Dimension Vista™ System.

Device Story

Prepackaged in-vitro diagnostic Flex® reagent cartridges for use on the automated, microprocessor-controlled Dimension Vista™ Integrated system. Cartridges contain reagents for quantitative measurement of ALB, AST, CRBM, ALT, and TIBC in human serum and plasma. System automates sample processing and analysis; results provided to clinicians for diagnosis and therapeutic monitoring of liver, kidney, heart, and hematological conditions. Packaging modification allows use of previously cleared reagents on the Vista™ platform; fundamental scientific technology remains unchanged from predicate Dimension® systems.

Clinical Evidence

Bench testing only. Submitter provided design control documentation, risk analysis, and verification/validation results confirming that repackaging did not impact reagent performance or safety compared to the predicate devices.

Technological Characteristics

Prepackaged 12-well flexible plastic reagent cartridges. Automated, microprocessor-controlled integrated instrument system. Reagents identical to those used in Dimension® clinical chemistry systems. Calibration interval 30-90 days.

Indications for Use

Indicated for use as in vitro diagnostic reagents for the quantitative determination of specific analytes (AST, ALB, ALT, CRBM, TIBC) in human serum or plasma samples on the Dimension Vista system.

Regulatory Classification

Identification

An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

Predicate Devices

• Dimension® ALB Flex® reagent cartridge (K861700)
• Dimension® AST Flex® reagent cartridge (K860021)
• Dimension® CRBM Flex® reagent cartridge (K962820)
• Dimension® ALT Flex® reagent cartridge (K862359)
• Dimension® IBCT Flex® reagent cartridge (K994115)

Submission Summary (Full Text)

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Kocloro

#### 510(k) Summary of Safety and Effectiveness Information

NAY 10 2005

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| Submitter's Name: | Lorraine H Piestrak<br>Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714-6101 |
|-------------------|------------------------------------------------------------------------------------|
|-------------------|------------------------------------------------------------------------------------|

Date of Preparation: April 12, 2005

#### Name of Product:

Dimension Vista™ Albumin (ALB) Flex® reagent cartridge Dimension Vista™ Aspartate amino transferase (AST) Flex® reagent cartridge Dimension Vista™ Carbamazepine (CRBM) Flex® reagent cartridge Dimension Vista™ Alanine amino transferase (ALT) Flex® reagent cartridge Dimension Vista™ Total Iron-binding capacity (TIBC) Flex® reagent cartridge

#### FDA Classification Name:

Methods (Class II) Albumin, Aspartate amino transferase, and Carbamazepine test systems.

Methods (Class I) Alanine amino transferase and Iron-binding capacity test systems

#### Predicate Device:

The following table describes the predicate devices, device classification, regulation and product code associated with this pre-market notification:

| Product | Dade Behring<br>Predicate | Predicate<br>510(k) # | Device<br>class | Regulation | Product<br>Code |
|----------------------------------------------------|----------------------------------------------|-----------------------|-----------------|------------|-----------------|
| Dimension Vista™<br>ALB Flex® reagent<br>cartridge | Dimension® ALB<br>Flex® reagent<br>cartridge | K861700 | II | 862.1035 | CJW |
| Dimension Vista™<br>AST Flex® reagent<br>cartridge | Dimension® AST<br>Flex® reagent<br>cartridge | K860021 | II | 862.1100 | CIT |

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| Dimension Vista™<br>CRBM Flex® reagent<br>cartridge | Dimension®<br>CRBM Flex®<br>reagent cartridge | K962820 | II | 862.3645 | KLT |
|-----------------------------------------------------|-----------------------------------------------|---------|----|----------|-----|
| Dimension Vista™<br>ALT Flex® reagent<br>cartridge | Dimension® ALT<br>Flex® reagent<br>cartridge | K862359 | I* | 862.1030 | CKA |
| Dimension Vista™<br>TIBC Flex® reagent<br>cartridge | Dimension®<br>IBCT Flex®<br>reagent cartridge | K994115 | I | 862.1415 | JMO |

* Not exempt when indications include diagnosis of cardiovascular (heart) diseases

## Device Description:

Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Dade Behring Dimension Vista™ Integrated system, a floor model, fully automated, microprocessor-controlled, integrated instrument system. The Dimension Vista™ system was previously cleared with seven associated test methods (K 051087).

This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic devices that have been cleared under the 510(k) process for use on Dimension® clinical chemistry systems. The packaging change is to allow use on the Dimension Vista™ system.

The ALB, AST, CRBM, ALT, and TIBC reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modification, does not affect the intended use of the devices, nor does it alter the fundamental scientific technology of the devices.

## Intended Use:

Dimension Vista™ Albumin (ALB) Flex® reagent cartridge: The ALB method is an in vitro diagnostic test for the quantitative measurement of albumin in human serum and plasma on the Dimension Vista™ System.

Dimension Vista™ Aspartate amino transferase (AST) Flex® reagent cartridge: The AST method is an in vitro diagnostic test for the quantitative measurement of aspartate aminotransferase in human serum and plasma on the Dimension Vista™ System.

Dimension Vista™ Carbamazepine (CRBM) Flex® reagent cartridge: The CRBM method is an in vitro diagnostic test for the quantitative measurement of carbamazepine in human serum and plasma on the Dimension Vista™ System. Carbamazepine measurements may be used in the diagnosis and treatment of carbamazepine overdose and in therapeutic drug monitoring.

Dimension Vista™ Alanine amino transferase (ALT) Flex® reagent cartridge:

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The ALT method is an in vitro diagnostic test for the quantitative measurement of alanine aminotransferase in human serum and plasma on the Dimension Vista™ System.

Dimension Vista™ Total Iron-binding capacity (TIBC) Flex® reagent cartridge: The TIBC method is an in vitro diagnostic test for the quantitative measurement of total iron binding capacity in human serum and plasma on the Dimension Vista™ System.

### Comparison to Predicate Device:

Both the Dimension Vista™ Flex® reagent cartridges and the predicate Dimension® Flex® reagent cartridges contain prepackaged reagents in flexible plastic, cartridges. A comparison of the important similarities and differences between the two Flex® cartridges is provided in the following table:

| Feature | Dimension Vista™<br>Flex® reagent cartridge | Dimension® Analyzer<br>Flex® reagent cartridge |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Reagents | Prepackaged, 12-well plastic, Dade<br>Behring Flex® reagent cartridges | Prepackaged, 6 & 8 well plastic, Dade<br>Behring Flex® reagent cartridges |
| Intended Use | in vitro diagnostic use | in vitro diagnostic use |
| Indications for Use | Same as Dimension® analyzer | As described in 510(k)s for each<br>previously cleared method. |
| Final concentration<br>of sample/reagent<br>ratio in test milieu | Same as Dimension® analyzer | As described in 510(k)s for each<br>previously cleared method |
| Tablet Sizes | 7/32" | 7/32" & 9/32" |
| Total tests contained<br>in each Flex®<br>cartridge | Approximately three times more<br>than contained in Dimension®<br>Flex® reagent cartridges | As described in 510(k)s for each<br>previously cleared method. |
| Calibration | 30 to 90 days<br>(determined for each method) | 30 to 90 days<br>As described in 510(k)s for each<br>previously cleared method. |

## Comments on Substantial Equivalence:

The Dade Behring Dimension Vista™ Flex® reagent cartridges and the Dimension® Flex® reagent cartridges are designed similarly for the same purpose. Both contain prepackaged reagents for in-vitro diagnostic tests that are processed on microprocessorcontrolled, integrated instrument systems to analyze a variety of analytes in human specimens.

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The ALB, AST, CRBM, ALT, and TIBC reagents contained in the Dimension VistaTM Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modifications, do not affect the intended use of the devices, nor do they alter the fundamental scientific technology of the devices.

Comparative testing described in the protocol included in this submission demonstrates equivalent performance.

#### Conclusion:

The Flex® reagent cartridges, containing reagents for testing ALB, AST, ALT, CRBM, and TIBC on the Dimension® Vista™ Integrated system are substantially equivalent in design, principle, and performance to the Dimension® system Flex® reagent cartridges. They have the same intended use and indications for use. Comparative testing also demonstrates substantially equivalent performance.

Lorraine H Piestrak Regulatory Affairs & Compliance Manager April 27, 2006

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the bird in a circular fashion.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Lorraine Piestrak Regulatory Affairs & Compliance Manager Dade Behring, Inc. PO Box 6101, M/S 514 Newark, DE 19714-6101

MAY 10 2006

Re: k061020

Trade/Device Name: Dimension Vista™ Albumin (ALB) Flex® reagent cartridge Dimension Vista™ Aspartate amino transferase (AST) Flex reagent cartridge Dimension Vista™ Carbarmazepine (CRBM) Flex® reagent cartridge Dimension Vista™ Alanine amino transferase (ALT) Flex® reagent cartridge Dimension Vista™ Total Iron-binding capacity (TIBC) Flex® reagent cartridge

Regulation Number: 21 CFR§ 862.1035 Regulation Name: Albumin test system Regulatory Class: Class II Product Code: CJW, CIT, KLT, CKA, JMO Dated: April 12, 2006 Received: April 13, 2006

Dear Ms. Piestrak:

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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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 Gutz

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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510(k) Number (if known):

K061020

Dimension Vista™ Albumin (ALB) Flex® reagent cartridge Device Name:

Indications For Use:

The Dimension Vista™ Albumin Flex® reagent cartridge (ALB) is a device intended to measure the albumin concentration in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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)

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Division Sign-Off

K061020

003

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510(k) Number (if known):

Device Name: Dimension Vista™ Aspartate amino transferase (AST) Flex® reagent cartridge

K061020

Indications For Use:

The Dimension Vista™ Aspartate amino transferase (AST) Flex® reagent cartridge is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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)

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Division Sign-Off

(k) 1061020

005

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510(k) Number (if known):

K061020

Device Name:

Dimension Vista™ Carbamazepine (CRBM) Flex® reagent cartridge

Indications For Use:

The Dimension Vista™ Carbamazepine (CRBM) Flex® reagent cartridge is a device intended to measure carbamazepine, an anticonvulsant drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to ensure appropriate therapy.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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)

Page 1 of 1

Division Sign-Off

006

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510(k) Number: (if known): K061020

Device Name: Dimension Vista™ Alanine amino transferase (ALT) Flex® reagent cartridge

Indications For Use:

The Dimension Vista™ Alanine amino transferase (ALT) Flex® reagent cartridge is intended to measure the activity of the enzyme pyruvic transaminase (ALT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g. viral hepatitis and cirrhosis) and heart diseases.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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)

Page 1 of _l

Division Sign-Off

/061020

007

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510(k) Number: (if known):

K061020

Device Name: Dimension Vista™ Total Iron-binding capacity (TIBC) Flex® reagent cartridge

Indications For Use:

The Dimension Vista™ Total Iron-binding capacity (TIBC) Flex® reagent cartridge is intended to quantitatively measure total iron binding capacity in human serum and plasma. Measurements of total iron binding capacity are used in the diagnosis and treatment of iron deficiency anemia and chronic inflammatory disorders.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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)

Page 1 of

CACL

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