ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8

K990399 · Roche Diagnostics Corp. · DKZ · Apr 15, 1999 · Clinical Toxicology

Device Facts

• Record ID: K990399
• Device Name: ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8
• Applicant: Roche Diagnostics Corp.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Apr 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

OnTrak TesTcup® M2K is an in vitro test intended for professional use for the qualitative detection of drug or drug metabolite in urine. OnTrak TesTcup M2K simultaneously tests for the presence of multiple drugs or drug metabolites. The OnTrak TesTcup M2K cutoff levels are based on the Federal Mandatory Guidelines. The OnTrak TesTcup M2K profile (cutoff) consists of d,l-amphetamines (1000 ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL) and morphine (2000 ng/mL). OnTrak TesTcup M2K provides only a preliminary analytical test result. A more specific. alternate chemical method must be used in order to obtain a configures and presult.

Device Story

OnTrak TesTstik/TesTcup M2K is an in vitro diagnostic device for professional use; detects morphine and other drugs in urine via competitive microparticle capture inhibition. Device consists of reagent strip with antibody-coated blue microparticles and immobilized drug conjugate on a membrane. Operation: device immersed in urine; sample absorbed into pad and migrates via capillary action; sample rehydrates/mobilizes microparticles. In absence of drug, microparticles bind to immobilized conjugate, forming blue band (negative). If drug present, it binds microparticles, inhibiting conjugate binding; membrane remains white (positive). Additional 'TEST VALID' band confirms reagent viability and test completion. Provides preliminary qualitative results; requires confirmatory testing (e.g., GC/MS) for clinical decision-making. Benefits include rapid, point-of-care screening for drug presence.

Clinical Evidence

Bench testing only. Evaluated 150 clinical urine samples (50 positive, 100 negative) against GC/MS confirmation and the predicate device. Demonstrated 100% agreement with GC/MS and 100% agreement with the predicate device. Precision testing showed >95% confidence at 150% of the 2000 ng/mL cutoff.

Technological Characteristics

Competitive microparticle capture inhibition assay. Components: Azo-blue dyed microparticles coated with mouse monoclonal anti-morphine antibody, BSA, sodium azide; drug conjugates and anti-BSA antibody immobilized on membrane. Form factor: reagent strip/cup. Qualitative colorimetric readout. Standalone device.

Indications for Use

Indicated for professional use in the qualitative detection of morphine, d,l-amphetamines, cocaine metabolite, and THC in human urine at specified cutoff concentrations. Provides preliminary analytical results; requires confirmation by alternate 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

• Abuscreen Online II for Opiates 300/2000 (K974840)

Submission Summary (Full Text)

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K990399

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## 510(k) Summary

Introduction According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

1) Submitter Roche Diagnostics Corporation name, address, 9115 Hague Rd. contact Indianapolis, IN 46250 [phone]

control control consideration in

Contact Person: Jennifer Tribbett

Date Prepared: March 22, 1999

- 2) Device Name The device name, including both the trade/proprietary name and classification name is provided below.

| Product<br>Name | Classification<br>Name | Class | CFR<br>Classification<br>Name | Predicate<br>Device Name | Date<br>Predicate<br>Cleared | Predicate<br>510(k)<br>Number |
|--------------------------------------------------|-------------------------|-------|-------------------------------|---------------------------------------------------|------------------------------|-------------------------------|
| OnTrak<br>TesTstik for<br>Morphine<br>2000 (M2K) | Morphine<br>test system | II | 862.3640 | Abuscreen<br>Online II for<br>Opiates<br>300/2000 | 04/24/98 | K974840 |

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

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3) Predicate We claim substantial equivalence to the currently marketed Roche device Diagnostics Abuscreen OnLine II for Opiates 300/2000 (K974840).

. . . .

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| 4) Device<br>Description | The OnTrak TesTstik Morphine 2000 assay contained in this submission is an<br>in vitro test intended for professional use in the qualitative detection of<br>morphine in urine at or above a cutoff concentration of 2000 ng/mL. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The TesTstik assays are based on the principle of microparticle capture<br>inhibition. The test relies on the competition between drug, which may be<br>present in the urine being tested, and drug conjugate immobilized on a<br>membrane. |
| | When the TesTstik is immersed in the urine sample, some of the sample is<br>absorbed into the TesTstik sample pad. The absorbed sample travels through<br>a reagent strip contained in the device by capillary action. In the reagent<br>strip, the sample rehydrates and mobilizes antibody-coated blue<br>microparticles. The microparticle-urine suspension continues to migrate<br>through the reagent strip and comes in contact with the immobilized drug<br>conjugate. In the absence of drug in the urine, the antibody-coated<br>microparticles bind to the drug conjugate and a blue band is formed at the<br>result window ("negative" sign). |
| | When drug is present in the specimen, it binds to the antibody-coated<br>microparticles. If sufficient drug is present, the micro-particles are inhibited<br>from binding the drug conjugate and no blue band is formed at the result<br>window. A positive sample caused the membrane to remain white ("positive"<br>sign). |
| | An additional antibody/antigen reaction occurs at the "TEST VALID" area.<br>The "TEST VALID" blue band forms when antibodies, which are imbedded<br>in the reagent membrane, bind to the antigen on the blue microparticles. The<br>presence of the "TEST VALID" band indicates that the test has completed,<br>the reagents are viable, and the results are ready to interpret. |
| 5. Technology<br>Characteristics | Table 1 on the next pages outlines the technological characteristics<br>(methodologies) of the OnTrak TesTstik for Morphine 2000 (M2K) in<br>comparison to the Abuscreen OnLine II for Opiates 300/2000. |
| 6. Substantial<br>Equivalence | Table 1 provides the significant performance characteristics relied upon for a<br>determination of substantial equivalence. This information concludes that the<br>performance of the TesTstik Morphine 2000 device is substantially equivalent<br>to the currently marketed Abuscreen OnLine II for Opiates 300/2000<br>(K974840). |
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# 510K Summary -Continued-

| Item | OnTrak TesTstik for Morphine 2000 (M2K) | Abuscreen Online for Opiates 2000 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Methodology | Competitive microparticle capture inhibition | Kinetic interaction of microparticles |
| Measurement | Qualitative | Qualitative and Semi-Quantitative |
| Sample Type | Urine | Urine |
| Endpoint read | Color | Absorbance change |
| Cutoff | 2000 ng/mL | 2000 ng/mL |
| Reagent (active ingredients) | •Azo-blue dyed microparticles coated with mouse monoclonal anti-morphine antibody in a buffered solution with BSA and sodium azide.<br>•Drug conjugates immobilized on a membrane<br>•Mouse monoclonal anti-BSA antibody immobilized on membrane | •Microparticles coated with mouse monoclonal morphine antibody .<br>•Morphine conjugated derivative in a buffer with BSA and sodium azide. |
| Controls | OnTrak TesTcup Positive and Negative Controls | Abuscreen OnLine Positive and Negative Controls |
| Performance: Precision | >95% confidence at 150% cutoff<br>When one hundred (100) replicates of urine standards containing different concentrations of drug were tested with OnTrak TesTstik, the following results were found: | >95% confidence at 1.2 x (2400ng/mL) cutoff |
| | Standard (ng/mL) $Morphine 2000 Assay$ | |
| | = + | |
| | 0 100 0 | |
| | 500 100 0 | |
| | 1000 76 24 | |
| | 1500 11 89 | |
| | 2500 0 100 | |
| | 3000 0 100 | |
| Performance:<br>Accuracy | | |
| OnTrak TesTstik for Morphine 2000<br>(M2K) was evaluated using<br>specimens screened by an automated<br>immunoassay and confirmed<br>positive by GC/MS at the 2000<br>ng/mL cutoff. Fifty (50) samples<br>positive for morphine were positive<br>by OnTrak TesTstik M2K (100%).<br><br>One hundred (100) urine samples,<br>obtained from a clinical laboratory<br>and screened negative by an<br>automated immunoassay relative to<br>a 2000 ng/mL cutoff for morphine<br>were evaluated using OnTrak<br>TesTstik M2K. One hundred (100)<br>were negative for morphine by<br>OnTrak TesTstik for Morphine 2000<br>(100%). | Forty-two (42) samples shown<br>to contain morphine and/or<br>codeine by GC/MS above 2000<br>ng/mL were also positive in the<br>Abuscreen OnLine II relative to<br>the 2000 ng/mL cutoff (100%<br>agreement)<br><br>One hundred (100) urine<br>samples, obtained from a<br>clinical laboratory where they<br>screened negative in a drug test<br>panel, were evaluated with the<br>Abuscreen OnLine II for<br>Opiates 300/2000. All 100<br>samples were negative at both<br>the 300 ng/mL and 2000 ng/mL<br>cutoffs (100%) | |
| All positive and negative samples<br>were also assayed by, and compared<br>to, Abuscreen OnLine II for Opiates<br>2000. One hundred fifty (150)<br>samples, tested by both OnTrak<br>TesTstik M2K and Abuscreen<br>OnLine II for Opiates 2000,<br>demonstrated 100% agreement. | | |

### TABLE 1

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# Table 1 -continued-

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Image /page/4/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, arranged in a way that they resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

APR 15 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jennifer L. Tribbett Regulatory Affairs Specialist Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46250-0457

K990399 Re: Trade Name: OnTrak TesTcup M2K Regulatory Class: II Product Code: DKZ, DIO, DJJ, LDJ Dated: February 5, 1999 Received: February 9, 1999

Dear Ms. Tribbett:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Device Name: Roche Diagnostics Corporation, OnTrak TesTcup® M2K for Morphine 2000

Indications for Use:

……

OnTrak TesTcup® M2K is an in vitro test intended for professional use for the qualitative detection of drug or drug metabolite in urine. OnTrak TesTcup M2K simultaneously tests for the presence of multiple drugs or drug metabolites. The OnTrak TesTcup M2K cutoff levels are based on the Federal Mandatory Guidelines.

The OnTrak TesTcup M2K profile (cutoff) consists of d,l-amphetamines (1000 ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL) and morphine (2000 ng/mL).

OnTrak TesTcup M2K provides only a preliminary analytical test result. A more specific. alternate chemical method must be used in order to obtain a configures and presult. Division of Clinical Laboratory Devices

510(k) Number_ x 990 399

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)