ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579

K994164 · Roche Diagnostics Corp. · LDJ · Apr 13, 2000 · Clinical Toxicology

Device Facts

• Record ID: K994164
• Device Name: ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579
• Applicant: Roche Diagnostics Corp.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Apr 13, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

OnTrak TesTstik 2 for Cocaine/THC is an in vitro diagnostic test intended for professional use for the qualitative detection of cocaine metabolite and cannabinoids in urine. The OnTrak TesTstik 2 for Cocaine/THC cutoff levels (300 ng/ml for cocaine and 50 ng/ml for THC) are based on the Federal Mandatory Guidelines. OnTrak TesTstik 2 for Cocaine/THC is not intended for over-the-counter sale. OnTrak TesTstik 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 confirmation 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

OnTrak TesTstik 2 is a lateral flow immunoassay for qualitative detection of cocaine metabolites and cannabinoids in urine. Device utilizes competitive microparticle capture inhibition; urine sample migrates via capillary action through a reagent strip containing blue microparticles coated with monoclonal antibodies. In absence of drug, microparticles bind to immobilized drug conjugates on membrane, forming blue bands (negative result). If drug is present, it binds to microparticles, inhibiting conjugate binding, leaving membrane white (positive result). A 'TEST VALID' band confirms reagent viability. Used in clinical settings by professionals; provides preliminary results requiring GC/MS confirmation. Benefits include rapid, point-of-care screening for drug abuse.

Clinical Evidence

Clinical evaluation compared device results against automated immunoassay screening and GC/MS confirmation. Study evaluated 70 positive specimens (including near-cutoff) and 100 negative specimens for each analyte. Results demonstrated 94% agreement for cocaine and 95% agreement for THC. Precision confirmed at >95% confidence at 150% of cutoff.

Technological Characteristics

Competitive microparticle capture inhibition assay. Components: blue dyed microparticles coated with mouse monoclonal anti-benzoylecgonine and anti-cannabinoid antibodies; drug conjugates and mouse monoclonal anti-BSA antibody immobilized on membrane. Qualitative colorimetric endpoint. Standalone, single-use test device.

Indications for Use

Indicated for professional use in the qualitative detection of cocaine metabolite and cannabinoids in human urine. Cutoff concentrations: 300 ng/ml for cocaine, 50 ng/ml for THC. Not for over-the-counter use. Requires confirmation by alternate chemical method (e.g., GC/MS).

Regulatory Classification

Identification

A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

Special Controls

*Classification.* Class II (special controls). A cannabinoid 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

• OnTrak TesTstik for Cocaine (K973075)
• OnTrak TesTstik for THC (K973075)

Reference Devices

• Abuscreen OnTrak for Cocaine
• Abuscreen OnTrak for THC

Submission Summary (Full Text)

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### APR 1 3 2000

K994164

### 510(k) Summary

According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. Roche Diagnostics Corporation 1) Submitter name, address, 9115 Hague Rd. contact Indianapolis, IN 46250 Contact Person: Jennifer Tribbett Date Prepared: March 20, 2000 2) Device Name The device name, including both the trade/proprietary name and classification name is provided below.

| Product Name | Classification<br>Name | Product<br>Code | CFR<br>Classification<br>Name | Predicate<br>Device<br>Name | Date<br>Predicate<br>Cleared | Predicate<br>510(k)<br>Number |
|-------------------------------------------|----------------------------|-----------------|-------------------------------|-----------------------------------|------------------------------|-------------------------------|
| OnTrak<br>TesTstik™ 2 for<br>Cocaine/ THC | Cocaine Test<br>System | 91DIO | 862.3250 | OnTrak<br>TesTstik for<br>Cocaine | 10/9/97 | K973075 |
| OnTrak<br>TesTstik™ 2 for<br>Cocaine/ THC | Cannabinoid<br>Test System | 91LDJ | 862.3870 | OnTrak<br>TesTstik for<br>THC | 10/9/97 | K973075 |

3) Predicate We claim substantial equivalence to the currently marketed Roche device Diagnostics OnTrak TesTstik for Cocaine(K973075) and OnTrak TesTstik for THC (K973075).

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4) Device The OnTrak TesTstik 2 Cocaine/THC assay described in this submission is an Description in vitro test intended for professional use in the qualitative detection of cocaine metabolite and cannabinoids in urine at or above a cutoff concentration of 300 ng/ml (cocaine) and 50 ng/ml (THC).

> The TesTstik assays are based on the principle of microparticle capture inhibition. The test relies on the competition between drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane.

> When the TesTstik is immersed in the urine sample, some of the sample is absorbed into the TesTstik sample pad. The absorbed sample travels through a reagent strip contained in the device by capillary action. In the reagent strip, the sample rehydrates and mobilizes antibody-coated blue microparticles. The microparticle-urine suspension continues to migrate through the reagent strip and comes in contact with the immobilized drug In the absence of drug in the urine, the antibody-coated conjugate. microparticles bind to the drug conjugates and blue bands are formed at the result window ("negative" sign).

> When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the micro-particles are inhibited from binding the drug conjugate and no blue band is formed at the result window. A positive sample caused the membrane to remain white.

> An additional antibody/antigen reaction occurs at the "TEST VALID" area. The "TEST VALID" blue band forms when antibodies, which are imbedded in the reagent membrane, bind to the antigen on the blue microparticles. The presence of the "TEST VALID" band indicates that the test has completed, the reagents in the TEST VALID area are viable, and the results are ready to interpret.

### 5. Technology Tables 1, 2 & 3 on the following pages outline the technological Characteristics characteristics (methodologies) of the OnTrak TesTstik 2 for Cocaine/THC in comparison to the predicate devices.

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### 510K Summary -Continued-

Tables 1, 2 & 3 provide the significant characteristics relied upon for a 6. Substantial Equivalence determination of substantial equivalence. This information concludes that the performance of the TesTstik 2 for Cocaine/THC is substantially equivalent to the currently marketed OnTrak TesTstik Cocaine (K973075) and OnTrak TesTstik THC (K973075).

| Item | OnTrak TesTstik 2 for<br>Cocaine/THC<br>New Device | OnTrak TesTstik for<br>Cocaine<br>Predicate | OnTrak TesTstik for<br>THC<br>Predicate |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Methodology | Competitive microparticle<br>capture inhibition | Same | Same |
| Measurement | Qualitative | Same | Same |
| Sample Type | Urine | Same | Same |
| Endpoint read | Color | Same | Same |
| Cutoff | 300 ng/ml (cocaine)<br>50 ng/ml (THC) | Same<br>300 ng/ml (cocaine) | Same<br>50 ng/ml (THC) |
| Reagent<br>(active<br>ingredients) | • Blue dyed microparticles<br>coated with mouse<br>monoclonal anti-<br>benzoylecgonine anti-body<br>and anti-cannabinoid<br>antibody. | • Blue dyed microparticles<br>coated with mouse<br>monoclonal anti-<br>benzoylecgonine antibody. | • Blue dyed<br>microparticles coated<br>with mouse monoclonal<br>anti-cannabinoid<br>antibody. |
| | • Drug conjugates immobilized<br>on a membrane | • Drug conjugates<br>immobilized on a<br>membrane | • Drug conjugates<br>immobilized on a<br>membrane |
| | • Mouse monoclonal anti-BSA<br>antibody immobilized on<br>membrane | • Mouse monoclonal anti-<br>BSA antibody immobilized<br>on a membrane | • Mouse monoclonal anti-<br>BSA antibody<br>immobilized on a<br>membrane |
| Performance:<br>Precision | >95% confidence at 150%<br>cutoff | Same | Same |

### TABLE 1

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# 510K Summary -Continued-

| Item | OnTrak TesTstik 2 for<br>Cocaine/THC | OnTrak TesTstik for Cocaine<br>Predicate |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cocaine<br>Performance:<br>Accuracy | OnTrak TesTstik 2 for<br>Cocaine/THC was evaluated<br>using clinical specimens screened<br>by an automated immunoassay<br>and confirmed positive by<br>GC/MS. Seventy (70)<br>specimens, including near cutoff<br>specimens, positive for cocaine<br>were evaluated on OnTrak<br>TesTstik 2. | OnTrak TesTstik for Cocaine<br>was evaluated using specimens<br>screened by an automated<br>immunoassay and confirmed<br>positive by GC/MS at a 150<br>ng/mL cutoff. Fifty (50) samples<br>positive for cocaine were positive<br>by OnTrak TesTstik (100%). |
| | One hundred urine specimens<br>were obtained from a clinical<br>laboratory and screened negative<br>by automated immunoassays<br>relative to a 300 ng/ml cutoff for<br>cocaine. A portion (15%) of the<br>negative specimens were also<br>confirmed negative for cocaine<br>by GC/MS. Clinical correlation<br>for all positive (including near<br>cutoff samples) and negative<br>specimens was demonstrated as<br>94% agreement. | One hundred six (106) urine<br>samples, obtained from a clinical<br>laboratory and screened negative<br>by an automated immunoassay<br>relative to a 300 ng/mL cutoff for<br>cocaine were evaluated and<br>found negative using OnTrak<br>TesTstik.<br>All positive and negative samples<br>were also assayed by, and<br>compared to, Abuscreen OnTrak<br>for Cocaine. All samples<br>demonstrated 100% agreement<br>between the two assays. |

## Table 2

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# 510K Summary --Continued-

| Item | OnTrak TesTstik 2 for<br>Cocaine/THC | OnTrak TesTstik for THC<br>Predicate |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| THC<br>Performance:<br>Accuracy | OnTrak TesTstik 2 for<br>Cocaine/THC was evaluated<br>using clinical specimens screened<br>by an automated immunoassay<br>and confirmed positive by<br>GC/MS. Seventy (70)<br>specimens, including near cutoff<br>specimens, positive for THC<br>were evaluated on OnTrak<br>TesTstik 2. | OnTrak TesTstik for THC was<br>evaluated using specimens<br>screened by an automated<br>immunoassay and confirmed<br>positive by GC/MS at a 15 ng/mL<br>cutoff. Forty five (45) samples<br>positive for THC were positive by<br>OnTrak TesTstik (100%). |
| | One hundred urine specimens<br>were obtained from a clinical<br>laboratory and screened negative<br>by automated immunoassays<br>relative to a 50 ng/ml cutoff for<br>THC. A portion (15%) of the<br>negative specimens were also<br>confirmed negative for THC by<br>GC/MS. Clinical correlation for<br>all positive (including near cutoff<br>samples) and negative specimens<br>was demonstrated as 95%<br>agreement. | One hundred six (105) urine<br>samples, obtained from a clinical<br>laboratory and screened negative<br>by an automated immunoassay<br>relative to a 50 ng/mL cutoff for<br>THC were evaluated and found<br>negative using OnTrak TesTstik.<br>All positive and negative samples<br>were also assayed by, and<br>compared to, Abuscreen OnTrak<br>for THC. All samples<br>demonstrated 100% agreement<br>between the two assays. |

### Table 3

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 3 2000

Ms. Jennifer L. Tribbett Regulatory Affairs Specialist Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis. Indiana 46250-0457

Re: K994164 Trade Name: OnTrak TesTstik™ 2 for Cocaine/THC Regulatory Class: II Product Code: LDJ, DIO Dated: March 7, 2000 Received: March 8, 2000

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

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Page 2

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" (21CFR 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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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 TesTstik™ 2 for Cocaine/THC

Indications for Use:

OnTrak TesTstik 2 for Cocaine/THC is an in vitro diagnostic test intended for professional use for the qualitative detection of cocaine metabolite and cannabinoids in urine. The OnTrak TesTstik 2 for Cocaine/THC cutoff levels (300 ng/ml for cocaine and 50 ng/ml for THC) are based on the Federal Mandatory Guidelines. OnTrak TesTstik 2 for Cocaine/THC is not intended for over-the-counter sale.

OnTrak TesTstik 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 confirmation method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lan sos
(Division Sign-Off)

Division of Clinical Laboratory De 510(k) Number JA

Prescription Use \ (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)