AMPHETAMINES II

K083764 · Roche Diagnostics Corp. · DKZ · Feb 3, 2010 · Clinical Toxicology

Device Facts

• Record ID: K083764
• Device Name: AMPHETAMINES II
• Applicant: Roche Diagnostics Corp.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Feb 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

Amphetamines II (AMPII) is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamines and methamphetamines on automated clinical chemistry analyzers at cutoff concentrations of 300 ng/mL, 500 ng/mL and 1000 ng/mL when calibrated with d-methamphetamine. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Semiquantitative assays are intended to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/mass spectrometry (GC/MS). Amphetamines II 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. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Device Story

In vitro diagnostic immunoassay for detection of amphetamines and methamphetamines in urine; utilizes Kinetic Interaction of Microparticles in Solution (KIMS) technology; performed on automated clinical chemistry analyzers (Roche/Hitachi 917). Reagents include conjugated drug derivatives and anti-drug monoclonal antibody-coated microparticles. Principle: drug in sample competes with drug-polymer conjugates for antibody binding sites on microparticles; inhibition of particle aggregation measured by changes in light transmission. Output: qualitative or semi-quantitative concentration relative to 300, 500, or 1000 ng/mL cutoffs. Used in clinical laboratories to screen for drug abuse; results require confirmation by GC/MS. Benefits: rapid preliminary screening to guide confirmatory testing.

Clinical Evidence

No clinical data provided. Substantial equivalence established via bench testing comparing performance characteristics, including cutoff concentrations and analytical sensitivity, against predicate devices.

Technological Characteristics

KIMS (Kinetic Interaction of Microparticles in Solution) immunoassay. Reagents: mouse monoclonal anti-drug antibodies, drug-polymer conjugates, bovine serum albumin, 0.09% sodium azide. Energy source: optical (light transmission measurement). Form factor: liquid reagent solutions for automated clinical chemistry analyzers. Storage: 2-8°C. Software: embedded firmware for analyzer control and data processing.

Indications for Use

Indicated for the qualitative and semiquantitative detection of amphetamines and methamphetamines in human urine. For prescription use only. Provides preliminary analytical results; requires confirmation by GC/MS.

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

• Abuscreen ONLINE Amphetamines assay (K983699)
• Abbott Amphetamine/Methamphetamine (K012998)

Submission Summary (Full Text)

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## 510(k) Summary: Amphetamines II Assay, Hitachi 917

·

| Introduction | According to the requirements of 21 CFR 807.92, the following<br>information provides sufficient detail to understand the basis for a<br>determination of substantial equivalence. | |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Submitter<br>Name, Address,<br>Contact | Roche Diagnostics<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>317-521-3742 | FEB - 3 201 |
| | Contact Person: Michelle Neff | |
| Device Name | Proprietary name: Amphetamines II | |
| | Common name: Amphetamine metabolite test system | |
| | Classification name:<br>Enzyme Immunoassay, Amphetamine<br>Gas Chromatography, Methamphetamine | |
| | Product Code: DKZ, LAF | |
| Device<br>Description | The Amphetamines II assay is based on the kinetic interaction of<br>microparticles in a solution (KIMS) as measured by changes in light<br>transmission. In the absence of sample drug, soluble drug-polymer<br>conjugates bind to antibody-bound microparticles, causing the<br>formation of particle aggregates. As the aggregation reaction<br>proceeds in the absence of sample, the absorbance increases. | |
| | When a urine sample contains the drug in question, this drug competes<br>with the conjugate-bound drug derivative for microparticle-bound<br>antibody. Antibody bound to sample drug is no longer available to<br>promote particle aggregation, and subsequent particle lattice formation<br>is inhibited. | |
| | The presence of sample drug diminishes the increasing absorbance in<br>proportion to the concentration of drug in the sample. Sample drug<br>content is determined relative to the value obtained for a known cutoff<br>concentration of drug. | |

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## 510(k) Summary: Amphetamines II Assay, Hitachi 917

Intended Use

Amphetamines II (AMPII) is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamines and methamphetamines on automated clinical chemistry analyzers at cutoff concentrations of 300 ng/mL, 500 ng/mL and 1000 ng/mL when calibrated with d-methamphetamine. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Semiquantitative assays are intended to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/mass spectrometry (GC/MS).

Amphetamines II 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.1 Clinical consideration and professional iudgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

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## 510(k) Summary: Amphetamines II Assay, Hitachi 917

Comparison to the Predicate Device

The ONLINE Amphetamines II assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, we claim substantial equivalence to the currently marketed Abuscreen ONLINE Amphetamines assay (K983699).

The ONLINE Amphetamines II assay contains an in vitro diagnostic reagent system intended for use on the Roche/Hitachi 917 analyzer for the semi-quantitative and qualitative detection of amphetamines in human urine at cutoff concentrations of 300, 500, and 1000 ng/mL.

The Roche ONLINE Amphetamines II assay utilizes a modified KIMS technology relative to the currently marketed Abuscreen OnLine Amphetamines assay. Differences between this application and the cleared assay include:

- 1. use of amphetamine and methamphetamine, and monoclonal antibodies attached to microparticles in solution
- 2. a soluble drug-polymer conjugate
- 3. increased sensitivity to "designer drugs" and their metabolites, and
- 4. addition of 300 and 500 ng/mL cutoff concentrations.

The recommended calibrators to be used with the proposed ONLINE Amphetamines II assay are the Preciset DAT Plus I, Preciset DAT Plus II and Cfas DAT Qualitative Plus Calibrators (K060645).

The recommended controls to be used with the proposed ONLINE Amphetamines II assay are the Control Set DAT I, Control Set DAT II, Control Set DAT III (K080183).

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510 Summary: Amphetamines II Assay, Hitachi 917

| Feature | Roche Amphetamines II Assay | Predicate Device: ONLINE Amphetamines<br>(K983699) |
|---------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Methodology | Same | KIMS, Kinetic interaction of microparticles in<br>solution |
| Sample Type | Same | Urine |
| Intended Use | Qualitative and semi-quantitative detection of<br>amphetamine and methamphetamine | Qualitative and semi-quantitative detection of<br>amphetamine and methamphetamine and their<br>metabolites |
| Cutoff | 300, 500, 1000 ng/mL | 1000 ng/mL |
| Calibrator/Control Matrix | Same | Human urine |

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510 Summary: Amphetamines II Assay, Hitachi 917
-

| Feature | Roche Amphetamines II Assay | Predicate Device: Abbott<br>Amphetamine/Methamphetamine (K012998) |
|---------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Methodology | KIMS, Kinetic interaction of microparticles in solution | Homogenous enzyme immunoassay |
| Sample Type | Same | Urine |
| Intended Use | Qualitative and semi-quantitative detection of amphetamine and methamphetamine | Qualitative detection of amphetamine/methamphetamine |
| Cutoff | 300, 500, 1000 ng/mL | 1000 ng/mL |
| Calibrator/Control Matrix | Same | Human urine |

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Roche Diagnostics Corporation c/o Ms. Michelle Neff Regulatory Principal 9115 Hague Road Indianapolis, IN 46250

FEB - 3 2010

Re: k083764

> Trade Name: ONLINE DAT II Amphetamines II Regulation Number: 21 CFR §862.3100 Regulation Name: Enzyme Immunoassay, Amphetamine Regulatory Class: Class II Product Codes: DKZ, LAF Dated: December 02, 2009 Received: December 03, 2009

Dear Ms. Neff:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

CA

Courtney C. Harper, 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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## Indication for Use

510(k) Number (if known):

Device Name: ONLINE DAT II Amphetamines II

Indication For Use:

Amphetamines II (AMPII) is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamines and methamphetamines on automated clinical chemistry analyzers at cutoff concentrations of 300 ng/mL, 500 ng/mL and 1000 ng/mL when calibrated with d-methamphetamine. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Semiquantitative assays are intended to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/mass spectrometry (GC/MS).

Amphetamines II 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.4 Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Prescription Use XXX (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use __ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol (Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K083764