URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A

K033713 · Dade Behring, Inc. · DIO · Feb 9, 2004 · Clinical Toxicology

Device Facts

• Record ID: K033713
• Device Name: URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A
• Applicant: Dade Behring, Inc.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Feb 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Intended Use

The COC 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 benzoylecgonine (cocaine metabolite) in human urine using a cutoff of 150 or 300 ng/mL. Measurements obtained with the COC method are used in the diagnosis and treatment of cocainc use or overdose. The COC 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

Single-use, 8-well plastic cartridge containing polyclonal antibody, substrate, and enzyme-labeled benzoylecgonine. Used on Dimension clinical chemistry analyzers; operated by qualified laboratory personnel. Input: human urine sample. Principle: homogeneous enzyme immunoassay; drug in sample competes with enzyme-labeled drug for antibody binding sites. Unbound conjugate catalyzes G6PDH oxidation, reducing NAD+ to NADH. Analyzer measures rate of absorbance increase at 340nm. Output: qualitative or semi-quantitative benzoylecgonine concentration. Results are preliminary; require confirmation via GC/MS. Semi-quantitative output assists in sample dilution for confirmatory testing and quality control. Not for point-of-care use.

Clinical Evidence

Bench testing only. Precision evaluated per NCCLS EP5-A over 20 days. Method comparison performed on 125 urine samples against predicate and GC/MS. Qualitative agreement with GC/MS: 99% positive, 91% negative. Semi-quantitative agreement with GC/MS: 96% positive, 91% negative. Analytical sensitivity (LOD) is 35 ng/mL. Cross-reactivity and interference testing performed with various drugs and endogenous compounds.

Technological Characteristics

Plastic 8-well cartridge format. Homogeneous enzyme immunoassay (G6PDH-based). Energy source: automated clinical chemistry analyzer (optical measurement at 340nm). Connectivity: integrated with Dimension analyzer family. Sterilization: not specified.

Indications for Use

Indicated for the qualitative and semi-quantitative measurement of benzoylecgonine in human urine to aid in the diagnosis and treatment of cocaine use or overdose. Intended for use by qualified laboratory personnel.

Regulatory Classification

Identification

A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

Special Controls

*Classification.* Class II (special controls). A cocaine and cocaine metabolite 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

• Syva’s Emit II Plus Cocaine Metabolite Assay for the 30-R Biochemical System (K031512)

Submission Summary (Full Text)

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# 510(k) Summary for the Expansion of the Indications for Use to include a 150 ng/mL cutoff for the Dimension®Urine Cocaine Metabolite Screen (COC) Flex® reagent cartridge

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.

# 510(k) Number: _ KO33 713

Analyte: cocaine metabolite

Type of Test: qualitative or quantitative homogeneous enzyme immunoassay

### A. Applicant: Dade Behring Inc.

1. Submitter's Name Andrea M. Tasker Building 500, Mailbox 514 P.O.Box 6101 Newark, DE 19714-6101

2. Submission Preparation Date November 25, 2003

## B. Proprietary and Established Names: Dimension® Urine Cocaine Metabolite Screen Flex® reagent

### C. Regulatory Information:

1.Regulation section: 21CFR862.3250, Cocaine and Cocainc Metabolite test system

- 2. Classification: Class II
- 3. Product Code: 91 DIO
- Toxicology (91) 4. Panel:

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## D. Intended Use:

1. Indications for Use: The COC 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 benzoylecgonine (cocaine metabolite) in human urine using a cutoff of 150 or 300 ng/mL. Measurements obtained with the COC method are used in the diagnosis and treatment of cocaine use or overdose.

2. Special conditions for use statements: The COC 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.

# E. Device Description:

The Dade Behring Dimension® COC method is an in vitro diagnostic device that consists of prepackaged reagents in a plastic cartridge (Flex®) for use on the Dade Behring Dimension® clinical chemistry system.

# F. Substantial Equivalence Inforamtion:

- 1. Predicate Device: Syva® Emit® II Plus polyclonal Cocaine Metabolite Assay
- 2. Predicate K Number(s): K031512

3. Comparision with Predicate: Indications for use, sample type, cutoff concentration, technology and composition of reagents are similar to the predicate device. The change to the device to expand the indications for use to include a 150ng/mL cutoff includes performance claims for the correct identification of near-cutoff samples.

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# H. Device Performance Characteristics:

# 1. Method Comparison (Semi-Quantitative Results)

| | Emit® II Plus polyclonal Cocaine<br>Metabolite Assay on the SYVA®-30R<br>(Cutoff 150ng/mL) | |
|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|----|
| COC Flex® reagent cartridge<br>on the<br>Dimension® clinical chemistry system<br>(Cutoff 150ng/mL) | + | - |
| + | 69 | 2 |
| - | 2 | 52 |

| Dimension | Syva 50K | GC/MS (benzoylecgonine) |
|-----------|----------|-------------------------|
| 142 | 150 | 151 |
| 147 | 164 | 164 |
| 159 | 135 | 123 |
| 150 | 144 | 156 |

| COC Flex®<br>reagent cartridge<br>on the<br>Dimension®<br>clinical chemistry<br>system<br>(Cutoff 150ng/mL) | GC/MS<br>(cutoff 150 ng/mL) | |
|-------------------------------------------------------------------------------------------------------------|-----------------------------|----|
| | + | - |
| + | 66 | 5 |
| - | 3 | 51 |

Discrepant specimens (ng/mL): All discrepants were within +/- 25% of the cutoff. Dimension® System GC/MS (benzoylecgonine)_______________________________________________________________________________________________________________________________________________________

| ension System | GC/MS |
|---------------|-------|
| 160 | 123 |
| 183 | 123 |
| 168 | 134 |
| 151 | 140 |
| 169 | 140 |
| 143 | 151 |
| 143 | 157 |
| 147 | 164 |

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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 three stripes forming its body and wing. The eagle is facing to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB - 9 2004

Ms. Andrea M. Tasker Senior Specialist Regulatory Affairs and Compliance Dade Behring Inc. P.O. Box 6101 Newark, DE 19714-6101

Re: k033713

Trade/Device Name: Dimension® Urine Cocaine Metabolite Screen (COC) Flex reagent cartridge Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO Dated: November 25, 2003 Received: November 26, 2003

Dear Ms. Tasker:

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/dsma/dsmamain.html.

Sincerely yours.

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS, D.V.M. 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 Statement

#### Device Name:

Dimension® Urine Cocaine Metabolite Screen (COC) Flex® reagent cartridge

### Indications for Use:

The COC 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 benzoylecgonine (cocaine metabolite) in human urine using a cutoff of 150 or 300 ng/mL. Measurements obtained with the COC method are used in the diagnosis and treatment of cocainc use or overdose.

The COC 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.

See hard copy for signature page.

Andrea M. Tasker Senior Regulatory Affairs and Compliance Specialist November 25, 2003

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X
(Per 21 CFR 801.109)

Division Sign-Off

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Over-the-counter Use (Optional format 1-2-96)

Office of In Vitro Diagnostic Device Evaluation and Safety

Evaluation

KD33713

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