DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE

K061238 · Dade Behring, Inc. · KHS · May 25, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061238
• Device Name: DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE
• Applicant: Dade Behring, Inc.
• Product Code: KHS · Clinical Chemistry
• Decision Date: May 25, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1160
• Device Class: Class 2

Intended Use

Dimension Vista™ Carbon Dioxide (CO2) Flex® reagent cartridge: The CO2 method is an in vitro diagnostic test for the quantitative measurement of carbon dioxide in human serum and plasma on the Dimension Vista 100 System. Dimension VistaTM Creatinine (CREA) Flex® reagent cartridge: The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vista 100 System. Dimension Vista™ Lactate dehydrogenase (LDH) Flex® reagent cartridge: The LDH method is an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista 100 System.

Device Story

Modification of existing clinical chemistry analyzer platform (Vista) to support carbon dioxide, creatinine, and lactate dehydrogenase assays; previously cleared on Dimension platform. Modification involves optimization of reagent and sample volumes to increase test capacity per reagent pack. Device operates in clinical laboratory settings; used by laboratory technicians. Output consists of quantitative analyte concentrations; assists clinicians in diagnostic assessment of metabolic and organ function. Fundamental scientific technology remains unchanged from predicate.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures (21 CFR 820.30) to confirm that modifications to reagent and sample volumes for carbon dioxide, creatinine, and lactate dehydrogenase assays met predetermined acceptance criteria.

Technological Characteristics

Prepackaged 12-well plastic reagent cartridges. Automated, microprocessor-controlled integrated instrument system. Reagents are identical to those in predicate Dimension® systems. Calibration intervals range from 30 to 90 days depending on the method.

Indications for Use

Indicated for quantitative measurement of CO2 in human serum/plasma for diagnosis/treatment of acid-base balance disorders; creatinine in human serum, plasma, and urine for diagnosis/treatment of renal disease and monitoring dialysis; and LDH in human serum/plasma for diagnosis/treatment of liver diseases (e.g., hepatitis, cirrhosis, carcinoma), cardiac diseases (e.g., myocardial infarction), and lung/kidney tumors. Prescription use only.

Regulatory Classification

Identification

A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

Predicate Devices

• Dimension® ECO2 Flex® reagent cartridge (K010206)
• Dimension® CREA Flex® reagent cartridge (K925668)
• Dimension® LDH Flex® reagent cartridge (K860021)

Submission Summary (Full Text)

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K061238

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

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 | MAY 2 5 2006 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Date of Preparation: | May 2, 2005 | |
| Name of Product: | Dimension Vista™ Carbon Dioxide (CO2) Flex® reagent cartridge<br>Dimension Vista™ Creatinine (CREA) Flex® reagent cartridge<br>Dimension Vista™ Lactate dehydrogenase (LDH) Flex® reagent cartridge | |
| FDA Classification Name: | Methods (Class II); Bicarbonate/Carbon Dioxide,<br>Creatinine, Lactate dehydrogenase test systems | |

#### Predicate Device:

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

| New Product | Predicate | Predicate<br>510(k) # | Device<br>class | Regulation | Product<br>Code |
|-----------------------------------------------|-----------------------------------------|-----------------------|-----------------|------------|-----------------|
| Dimension Vista™ CO2 Flex® reagent cartridge | Dimension® ECO2 Flex® reagent cartridge | K010206 | II | 862.1160 | KHS |
| Dimension Vista™ CREA Flex® reagent cartridge | Dimension® CREA Flex® reagent cartridge | K925668 | II | 862.1125 | CGX |
| Dimension Vista™ LDH Flex® reagent cartridge | Dimension® LDH Flex® reagent cartridge | K860021 | II | 862.1440* | CFJ |

* Not exempt from premarket notification per 862.9(c)(3)

#### 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.

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The CO2. CREA, and LDH 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™ Carbon Dioxide (CO2) Flex® reagent cartridge: The CO2 method is an in vitro diagnostic test for the quantitative measurement of carbon dioxide in human serum and plasma on the Dimension Vista 100 System.

Dimension VistaTM Creatinine (CREA) Flex® reagent cartridge: The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vista 100 System.

Dimension Vista™ Lactate dehydrogenase (LDH) Flex® reagent cartridge: The LDH method is an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista 100 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. |

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#### 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.

The CO2, CREA, and LDH 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 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 CO2, CREA, and LDH 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 May 2, 2006

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

MAY 2 5 2006

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

k061238 Re:

Trade/Device Name: Dimension Vista™ Carbon Dioxide (CO2) Flex® reagent cartridge Dimension Vista™ Creatinine (CREA) Flex® reagent cartridge Dimension Vista™ Lactate dehydrogenase (LDH) Flex® reagent cartridge Regulation Number: 21 CFR§862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: Class II Product Code: KHS, CGX, CFJ Dated: May 2, 2006 Received: May 3, 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 (OS) 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 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

510(k) Number (if known): K061238

Dimension Vista™ Carbon Dioxide (CO2) Flex® reagent cartridge Device Name:

Indications For Use:

The Dimension Vista™ Carbon Dioxide (CO2) Flex® reagent cartridge is a device intended to measure carbon dioxide in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

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)

Division Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

5100k061238

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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## Indications for Use

510(k) Number (if known): k061238

Dimension Vista™ Creatinine (CREA) Flex® reagent cartridge Device Name:

Indications For Use:

The Dimension Vista™ Creatinine (CREA) Flex® reagent cartridge is a device intended to measure creatinine levels in serum, plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

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

Office of In Vitro Diagnostic Device Evaluation and Safety

100(k) /k061238

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# Indications for Use

510(k) Number (if known): | K061238

Device Name: Dimension Vista™ Lactate dehydrogenase (LDH) Flex® reagent cartridge

Indications For Use:

The Dimension Vista™ Lactate dehydrogenase (LDH) Flex® reagent cartridge is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum and plasma. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung 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)

Page I of

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety