DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109

K053337 · Dade Behring, Inc. · DKZ · May 19, 2006 · Clinical Toxicology

Device Facts

• Record ID: K053337
• Device Name: DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109
• Applicant: Dade Behring, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: May 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

The EXTC Flex® reagent cartridge used on the Dimension® clinical chemistry system provides reagents for an in vitro diagnostic test intended for the qualitative and semiquantitative determination of methylenedioxymethamphetamine (MDMA) and closely related drugs in human urine using a cutoff of either 300 or 500 ng/mL. Measurements obtained with the EXTC method are used in the diagnosis and treatment of ecstasy use or overdose. The EXTC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Device Story

The EXTC Flex® reagent cartridge is an in vitro diagnostic device for use on automated clinical chemistry analyzers (e.g., Dimension® RxL, Xpand®). It utilizes a homogeneous enzyme immunoassay based on the competition for antibody binding sites between drug in the urine sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH). The device measures the rate of increasing absorbance at 340 nm as unbound conjugate catalyzes the oxidation of glucose-6-phosphate, reducing NAD+ to NADH. The rate is mathematically related to drug concentration. The device is operated by laboratory professionals in clinical settings. Results are preliminary and require confirmation by a more specific method like GC/MS. The assay aids in the diagnosis and treatment of ecstasy use or overdose and assists in sample dilution preparation for further analysis.

Clinical Evidence

Method comparison studies were conducted comparing the EXTC Flex® reagent cartridge on the Dimension® clinical chemistry system against a GC/MS reference method. At the 300 ng/mL cutoff, the device showed 92% agreement. At the 500 ng/mL cutoff, the device showed 91.2% agreement.

Technological Characteristics

In vitro diagnostic enzyme immunoassay; prepackaged reagents in an eight-well plastic cartridge; designed for use on the Dimension® clinical chemistry system; qualitative and semiquantitative detection of MDMA in urine.

Indications for Use

Indicated for the qualitative and semiquantitative determination of MDMA and related drugs in human urine for the diagnosis and treatment of ecstasy use or overdose. Intended for use with 300 or 500 ng/mL cutoffs. Requires confirmatory testing via GC/MS or other chemical methods.

Regulatory Classification

Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Predicate Devices

• Emit® II Plus Ecstasy Assay (k043028)

Submission Summary (Full Text)

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Dade Behring Inc. 510(k) Premarket Notification - Dimension® Urine Ecstasy Screen Flex® reagent cartridge

## 510(k) Summary EXTC Flex® reagent cartridge

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

The assigned 510(k) number is:

K053337

### 1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation

Manufacturer:

Dade Behring Inc. P.O. Box 6101 Newark, DE 19714

Contact Information:

| Dade Behring Inc. |
|----------------------|
| P.O. Box 6101 |
| Newark, DE 19714 |
| Attn: Yuk-Ting Lewis |
| Tel: [phone] |

Date of Preparation:

Nov. 29, 2005

#### 2. Device Name / Classification

Dimension® Urine Ecstasy Screen Flex® reagent cartridge / Amphetamine Test System Classification: Class II (862.3100)

### 3. Identification of the Predicate Device

Emit® II Plus Ecstasy Assay, K043028

#### 4. Device Description

The Dimension® Urine Ecstasy Screen Flex® reagent cartridge is an in vitro diagnostic device that consists of prepackaged reagents in a plastic eight-well cartridge for use on the Dade Behring Dimension® clinical chemistry system.

a conc

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Dade Behring Inc. Date Deming int.

#### 5. Device Intended Use

The EXTC Flex® reagent cartridge used on the Dimension® clinical chemistry system provides reagents for an in vitro diagnostic test intended for the qualitative and semiquantitative determination of methylenedioxymethamphetamine (MDMA) and closely related drugs in human urine using a cutoff of either 300 or 500 ng/mL. Measurements obtained with the EXTC method are used in the diagnosis and treatment of ecstasy use or overdose.

The EXTC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

### Medical device to which equivalence is claimed and comparison information Q.

The EXTC Flex® reagent cartridge is substantially equivalent in intended use and methodology to the Emit® II Plus Ecstasy Assay (K043028). Both devices are enzyme immunoassays intended for use in the qualitative and semiquantitative determination of ecstasy drugs in human urine. Both assays have two cutoffs: 300 ng/mL and 500 ng/mL.

Method comparison studies were conducted with the EXTC Flex® reagent cartridge on the Dimension® clinical chemistry system vs. a reference method (GC/MS). Results are summarized in the 2 x 2 concordance tables below.

### Comparison to GC/MS at the 300 ng/mL cutoff

| | Reference Method GC/MS | | |
|--------------------------------------------------------------------------------|------------------------|----------|----|
| | Positive | Negative | |
| EXTC Flex® reagent cartridge<br>on the Dimension® clinical<br>chemistry system | Positive | 73 | 0 |
| | Negative | 11 | 54 |

% agreement = 92%

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# Comparison to GC/MS at the 500 ng/mL cutoff

| | | Reference Method GC/MS | |
|--------------------------------------------------------------------------------|----------|------------------------|----------|
| | | Positive | Negative |
| EXTC Flex® reagent cartridge<br>on the Dimension® clinical<br>chemistry system | Positive | 58 | 0 |
| | Negative | 11 | 56 |

and the same of the second

% agreement = 91.2%

.

.

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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, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged around the upper portion of the circle.

### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

MAY 1 9 2006

Re: k053337

Trade/Device Name: Dimension® Urine Ecstasy Screen Flex® reagent cartridge Regulation Number: 21 CFR§862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ Dated: May 8. 2006 Received: May 9, 2006

Dear Ms. Lewis:

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. Iisting 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 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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Dade Behring Inc. 510(k) Premarket Notification - Dimension® Urine Ecstasy Screen Flex® reagent cartridee

# Indications for Use

510(k) Number (if known):

): K053337

Device Name:

Dimension® Urine Ecstasy Screen Flex® reagent cartridge

Indications For Use:

The EXTC Flex® reagent cartridge used on the Dimension® clinical chemistry system provides reagents for an in vitro diagnostic test intended for the qualitative and semi-quantitative determination of methylenedioxymethamphetamine (MDMA) and closely related drugs in human urine using a cutoff of either 300 or 500 ng/mL. Measurements obtained with the EXTC method are used in the diagnosis and treatment of ecstasy use or overdose.

The EXTC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

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

Over-The-Counter Use (21 CFR 801)

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