DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE

K062024 · Dade Behring, Inc. · LFM · Jul 28, 2006 · Clinical Toxicology

Device Facts

• Record ID: K062024
• Device Name: DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE
• Applicant: Dade Behring, Inc.
• Product Code: LFM · Clinical Toxicology
• Decision Date: Jul 28, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3300
• Device Class: Class 2

Intended Use

The DGTX method is an in vitro diagnostic test for the quantitative measurement of digitoxin in serum and plasma on the Dimension Vista™ System. Measurements of digitoxin are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy. The DIG method is an in vitro diagnostic test for the quantitative measurement of digoxin in serum and plasma on the Dimension Vista™ System. Measurements of digoxin are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy. The GENT method is an in vitro diagnostic test for the quantitative measurement of gentamicin, an aminoglycoside antibiotic, in human serum and plasma on the Dimension Vista™ System. Gentamicin measurements may be used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy. The NAPA method is an in vitro diagnostic test for the quantitative measurement of N-acetylprocainamide in serum and plasma on the Dimension Vista™ System. N-acetylprocainamide measurements may be used in therapeutic drug monitoring to maintain adequate procainamide therapy. The PTN method is an in vitro diagnostic test for the quantitative measurement of phenytoin, (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma on the Dimension Vista™ System. Phenytoin measurements may be used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy. The THEO method is an in vitro diagnostic test for the quantitative measurement of theophylline in human serum and plasma on the Dimension Vista™ System.

Device Story

The device consists of Dimension Flex reagent cartridges for Digitoxin, Digoxin, Gentamicin, N-acetylprocainamide, Phenytoin, and Theophylline. The modification involves repackaging these existing reagents for use on the Dimension Vista platform. The modification increases the number of tests per reagent pack by proportionally decreasing reagent and sample volumes while maintaining the same final sample/reagent concentration ratio in the test milieu. The device is used in clinical laboratory settings to perform diagnostic assays. The modification was validated through Failure Mode and Effect Analysis (FEMA) and verification of test performance to ensure no loss of precision or accuracy compared to the predicate Dimension platform reagents.

Clinical Evidence

Bench testing only. The sponsor performed a risk analysis (FMEA) and verification activities to confirm that the reduction in reagent and sample volumes maintained the same final concentration ratio as the predicate devices, ensuring equivalent performance.

Technological Characteristics

Reagent cartridges for clinical chemistry assays. Modification involves proportional reduction of reagent and sample volumes to increase tests per pack. Fundamental scientific technology remains consistent with previously cleared Dimension Flex reagent cartridges. No changes to detection methods or analytes.

Indications for Use

Indicated for quantitative measurement of digitoxin, digoxin, gentamicin, N-acetylprocainamide, phenytoin, or theophylline in human serum and plasma for therapeutic drug monitoring and overdose diagnosis. Prescription use only.

Regulatory Classification

Identification

A digitoxin test system is a device intended to measure digitoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.

Predicate Devices

• Dimension® DGTX Flex® reagent cartridge (K990251)
• Dimension® DGNA Flex® reagent cartridge (K946153)
• Dimension® GENT Flex® reagent cartridge (K962819)
• Dimension® NAPA Flex® reagent cartridge (K032564)
• Dimension® PTN Flex® reagent cartridge (K911056)
• Dimension® THEO Flex® reagent cartridge (K862955)

Submission Summary (Full Text)

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K062024

#### 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 |
|----------------------|------------------------------------------------------------------------------------|
| Date of Preparation: | July 17, 2006 |

JUL 2 8 2006

### Name of Products:

Dimension Vista™ Digitoxin (DGTX) Flex® reagent cartridge Dimension Vista™ Digoxin (DIG) Flex® reagent cartridge Dimension Vista™ Gentamicin (GENT) Flex® reagent cartridge Dimension VistaTM N-acetylprocainamide (NAPA) Flex® reagent cartridge Dimension Vista™ Phenytoin (PTN) Flex® reagent cartridge Dimension Vista™ Theophylline (THEO) Flex® reagent cartridge

#### FDA Classification Name:

| Classification Name: | Common/Usual Name: |
|---------------------------------------------------|-------------------------------------------|
| 862.3300 Enzyme Immunoassay, Digitoxin | Digitoxin test system |
| 862.3320 Enzyme Immunoassay, Digoxin | Digoxin test system |
| 862.3450 Enzyme Immunoassay, Gentamicin | Gentamicin test system |
| 862.3320 Enzyme Immunoassay, N-Acetylprocainamide | N-Acetylprocainamide test system |
| 862.3350 Enzyme Immunoassay, Diphenylhydantoin | Diphenylhydantoin (phenytoin) test system |
| 862.3880 Enzyme Immunoassay, Theophylline | Theophylline 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>DGTX Flex® reagent<br>cartridge | Dimension® DGTX<br>Flex® reagent<br>cartridge | K990251 | II | 862.3300 | LFM |
| Dimension Vista™<br>DIG Flex® reagent<br>cartridge | Dimension® DGNA<br>Flex® reagent cartridge | K946153 | II | 862.3320 | KXT |
| Dimension Vista™<br>GENT Flex® reagent<br>cartridge | Dimension® GENT<br>Flex® reagent cartridge | K962819 | II | 862.3450 | LCD |
| Dimension Vista™<br>NAPA Flex® reagent<br>cartridge | Dimension® NAPA<br>Flex® reagent<br>cartridge | K032564 | II | 862.3320 | LAN |

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| New Product | Predicate | Predicate<br>510(k) # | Device<br>class | Regulation | Product<br>Code |
|-----------------------------------------------------|-----------------------------------------------|-----------------------|-----------------|------------|-----------------|
| Dimension Vista™<br>PTN Flex® reagent<br>cartridge | Dimension® PTN<br>Flex® reagent<br>cartridge | K911056 | II | 862.3350 | DIP |
| Dimension Vista™<br>THEO Flex® reagent<br>cartridge | Dimension® THEO<br>Flex® reagent<br>cartridge | K862955 | II | 862.3880 | KLS |

#### Device Description:

Dade Behring Dimension VistaTM 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 VistaTM 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:

#### Digitoxin

The DGTX method is an in vitro diagnostic test for the quantitative measurement of digitoxin in serum and plasma on the Dimension Vista™ System. Measurements of digitoxin are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.

## Digoxin

The DIG method is an in vitro diagnostic test for the quantitative measurement of digoxin in serum and plasma on the Dimension Vista™ System. Measurements of digoxin are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

## Gentamicin

The GENT method is an in vitro diagnostic test for the quantitative measurement of gentamicin, an aminoglycoside antibiotic, in human serum and plasma on the Dimension Vista™ System. Gentamicin measurements may be used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

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## N-acetylprocainamide

The NAPA method is an in vitro diagnostic test for the quantitative measurement of N-acetylprocainamide in serum and plasma on the Dimension Vista™ System. N-acetylprocainamide measurements may be used in therapeutic drug monitoring to maintain adequate procainamide therapy.

#### Phenytoin

The PTN method is an in vitro diagnostic test for the quantitative measurement of phenytoin, (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma on the Dimension Vista™ System. Phenytoin measurements may be used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy.

### Theophylline

The THEO method is an in vitro diagnostic test for the quantitative measurement of theophylline 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. |

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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 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 substantially equivalent performance.

#### Conclusion:

The Flex® reagent cartridges, containing reagents for testing DGTX, DIG, GENT, NAPA, PTN, and THEO 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. Piatrak

Lorraine H Piestrak Regulatory Affairs & Compliance Manager July 17, 2006

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Profic Houte Service

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JUL 2 8 2006

Food and Drug Administrator 2098 Gammer 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

Re: k062024

| Trade/Device Name: | Dimension Vista™ Digitoxin (DGTX) Flex® reagent cartridge | |
|--------------------|--------------------------------------------------------------|--|
| | Dimension Vista™ Digoxin (DIG) Flex® reagent cartridge | |
| | Dimension Vista™ Gentamicin (GENT) Flex ® reagent cartridge | |
| | Dimension Vista™ N-acetylprocainamide (NAPA) | |
| | Flex® reagent cartridge | |
| | Dimension Vista™ Phenytoin (PTN) Flex® reagent cartridge | |
| | Dimension Vista™ Theophylline (THEO) Flex® reagent cartridge | |
| Regulation Number: | 21 CFR§862.3300 | |
| Regulation Name: | Digitoxin test system | |
| Regulatory Class: | Class II | |
| Product Code: | LFM, KXT. LCD, LAN, DIP, KLS | |
| Dated: | July 17, 2006 | |
| Received: | July 18, 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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#### 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 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):

Device Name: Dimension Vista™ Digitoxin (DGTX) Flex® reagent cartridge

Indications For Use:

The Dimension Vista™ Digitoxin (DGTX) Flex® reagent cartridge is a device intended to measure digitoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin 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)

Adipating

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K062024

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510(k) Number (if known):

Device Name: Dimension Vista™ Digoxin (DIG) Flex® reagent cartridge

Indications For Use:

The Dimension Vista™ Digoxin (DIG) Flex® reagent cartridge is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements of digoxin are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

Prescription Use × (Part 21 CFR 801 Subpart D)

and the comments of the comments of the comments of the comments of the comments of

AND/OR

Over-The-Counter Use (21 CFR 801)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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510(k) Number (if known):

Device Name: Dimension Vista™ Gentamicin (GENT) Flex® reagent cartridge

Indications For Use:

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

X Prescription Use (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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510(k) Number (if known):

Device Name: Dimension Vista™ N-acetylprocainamide (NAPA) Flex® reagent cartridge

Indications For Use:

The Dimension Vista™ N-acetylprocainamide (NAPA) Flex® reagent cartridge is a device intended to measure N-acetylprocainamide in human serum and plasma. Measurements obtained by this device maybe used in therapeutic drug monitoring to maintain adequate procainamide therapy.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801)

and the many of the many of the many of the many of the many of the many of the may be

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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510(k) Number (if known):

Device Name: D Dimension Vista™ Phenytoin (PTN) Flex® reagent cartridge

Indications For Use:

The Dimension Vista™ Phenytoin (PTN) Flex® reagent cartridge is a device intended to measure diphenylhydantoin (phenytoin), an antiepileptic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin (phenytoin) overdose and in monitoring levels of diphenylhydantoin (phenytoin) 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)

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510(k) Number (if known):

Dimension Vista™ Theophylline (THEO) Flex® reagent cartridge Device Name:

Indications For Use:

The Dimension Vista™ Theophylline (THEO) Flex® reagent cartridge is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems), in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline 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)

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