DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI

K061792 · Dade Behring, Inc. · DIC · Jul 18, 2006 · Clinical Toxicology

Device Facts

• Record ID: K061792
• Device Name: DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI
• Applicant: Dade Behring, Inc.
• Product Code: DIC · Clinical Toxicology
• Decision Date: Jul 18, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3040
• Device Class: Class 2

Intended Use

Alcohol (Ethyl) The ALC method is an in vitro diagnostic test for the measurement of ethyl alcohol in serum on the Dimension Vista™ System. Ethyl alcohol test results may be used in the diagnosis and treatment of alcohol intoxication and poisoning. Alkaline Phosphatase The ALP method is an in vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma the Dimension Vista™ System. Calcium The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in serum, plasma, and urine on the Dimension Vista™ System.

Device Story

Repackaged reagent cartridges for Dimension Vista Integrated System; modification involves reduction in sample and reagent volumes while maintaining original ratio; enables increased test capacity per pack; intended for clinical laboratory use; provides quantitative analysis of Ethyl Alcohol, Alkaline Phosphatase, Calcium, Lactic Acid, and Lithium.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the identical chemical formulation and assay technology compared to previously cleared predicate devices.

Technological Characteristics

Reagent cartridges for automated clinical chemistry analysis. Modification involves volume reduction of reagents and samples; maintains original ratio. Operates on Dimension Vista Integrated System. No change to fundamental scientific technology or detection methods.

Indications for Use

Indicated for measurement of ethyl alcohol (serum), alkaline phosphatase (serum/plasma), calcium (serum/plasma/urine), lactic acid (plasma), and lithium (serum/plasma) to aid in diagnosis/treatment of alcohol intoxication, liver/bone/parathyroid/intestinal diseases, parathyroid/bone/renal diseases, lactic acidosis, and bipolar disorder.

Regulatory Classification

Identification

An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.

Predicate Devices

• Dimension® ALC Flex® reagent cartridge (K904302)
• Dimension® ALP Flex® reagent cartridge (K860021)
• Dimension® CA Flex® reagent cartridge (K860021)
• Dimension® LA Flex® reagent cartridge (K914508)
• Dimension® LI Flex® reagent cartridge (K011033)

Submission Summary (Full Text)

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K061792

# 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 | JUL 1 8 2006 |
|----------------------|------------------------------------------------------------------------------------|--------------|
| Date of Preparation: | June 23, 2006 | |

# Name of Products:

Dimension Vista™ Ethyl Alcohol (ALC) Flex® reagent cartridge Dimension Vista™ Alkaline phosphatase (ALP) Flex® reagent cartridge Dimension Vista™ Calcium (CA) Flex® reagent cartridge Dimension Vista™ Lactic Acid (LA) Flex® reagent cartridge Dimension Vista™ Lithium (LI) Flex® reagent cartridge

# FDA Classification Name:

| Classification Name: | Common/Usual Name: |
|-------------------------------------------------------------------------------|----------------------------------|
| 862.3040 Alcohol Dehyrdogenase, specific reagent for<br>Ethanol Enzyme method | Alcohol test system |
| 862.1050 Alkaline phosphatase | Alkaline phosphatase test system |
| 862.1145 Calcium | Calcium test system |
| 862.1450 Lactic acid | Lactic acid test system |
| 862.3560 Lithium | Lithium test system |

# 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™<br>ALC Flex® reagent<br>cartridge | Dimension® ALC<br>Flex® reagent cartridge | K904302 | II | 862.3040 | DIC |
| Dimension Vista™<br>ALP Flex® reagent<br>cartridge | Dimension® ALP<br>Flex® reagent<br>cartridge | K860021 | II | 862.1050 | CJE |
| Dimension Vista™<br>CA Flex® reagent<br>cartridge | Dimension® CA<br>Flex® reagent<br>cartridge | K860021 | II | 862.1145 | CIC |

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| New Product | Predicate | Predicate<br>510(k) # | Device<br>Class | Regulation | Product<br>Code |
|---------------------------------------------------|---------------------------------------------|-----------------------|-----------------|------------|-----------------|
| Dimension Vista™<br>LA Flex® reagent<br>cartridge | Dimension® LA<br>Flex® reagent<br>cartridge | K914508 | I* | 862.1450 | KHP |
| Dimension Vista™<br>LI Flex® reagent<br>cartridge | Dimension® LI Flex®<br>reagent cartridge | K011033 | II | 862.3560 | JIH |

* Not exempt from premarket notification per 862.9 or per Reserved Medical Devices list

# 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 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:

## Alcohol (Ethyl)

The ALC method is an in vitro diagnostic test for the measurement of ethyl alcohol in serum on the Dimension Vista™ System. Ethyl alcohol test results may be used in the diagnosis and treatment of alcohol intoxication and poisoning.

## Alkaline Phosphatase

The ALP method is an in vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma the Dimension Vista™ System.

## Calcium

The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in serum, plasma, and urine on the Dimension Vista™ System.

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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

JUL 1 8 2006

Re: k061792

Trade/Device Name: Dimension Vista™ Ethyl Alcohol (ALC) Flex® reagent cartridge Dimension Vista™ Alkaline phoshatase (ALP) Flex® reagent cartridge Dimension Vista™ Calcium (CA) Flex® reagent cartridge Dimension Vista™ Lactic Acid (LA) Flex® reagent cartridge Dimension Vista™ Lithium (LI) Flex® reagent cartridge Regulation Number: 21 CFR§862.3040 Regulation Name: Alcohol test system Regulatory Class: Class II Product Code: DIC, CJE, CJE, JIH, KHP Dated: June 23, 2006 Received: June 26, 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 Guti

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): K061792

Dimension Vista™ Ethyl Alcohol (ALC) Flex® reagent cartridge Device Name:

Indications For Use:

The Dimension Vista™ Ethyl Alcohol (ALC) Flex® reagent cartridge is a device intended to measure ethyl alcohol in human serum. Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.

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

Carol Benson

Division Sign-Off

310(k) K061792

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510(k) Number (if known): K061792

Dimension Vista™ Alkaline phosphatase (ALP) Flex® reagent cartridge Device Name:

Indications For Use:

The Dimension Vista™ Alkaline phosphatase (ALP) Flex® reagent cartridge is a device intended to measure alkaline phosphatase in serum and plasma. Measurements of alkaline phosphatase are used primarily in the diagnosis and treatment of liver, bone, parathyroid and intestinal 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)

Carol Benson

Division Sign-Off

512(K) K061792

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510(k) Number (if known): K061792

Dimension Vista™ Calcium (CA) Flex® reagent cartridge Device Name:

Indications For Use:

The Dimension Vista™ Calcium (CA) Flex® reagent cartridge is a device intended to measure the total calcium level in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

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)

Carol C Benson

Division Sign-

K061792

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# Indications for Use 510(k) Number (if known): KOlo1792

Dimension Vista™ Lactic Acid (LA) Flex® reagent cartridge Device Name:

Indications For Use:

The Dimension Vista™ Lactic Acid (LA) Flex® reagent cartridge is a device intended to measure lactic acid in plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

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)

Carol Benam

Division Sign-Off

) k061792

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510(k) Number (if known): K061792

Dimension Vista™ Lithium (LI) Flex® reagent cartridge Device Name:

Indications For Use:

The Dimension Vista™ Lithium (LI) Flex® reagent cartridge is a device intended to measure lithium in serum and plasma. Measurements of lithium are used to assure the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

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)

Carol Benam
Division Sign-Off

K061792

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