ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON

K973075 · Roche Diagnostic Systems, Inc. · DKZ · Oct 9, 1997 · Clinical Toxicology

Device Facts

• Record ID: K973075
• Device Name: ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON
• Applicant: Roche Diagnostic Systems, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Oct 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

The 5 ONTRAK TESTSTIK Assays contained in this submission are in vitro diagnostic tests intended for professional use for the qualitative detection of drug or drug metabolite in urine. They are the ONTRAK TESTSTIK for Amphetamines (1000 ng/mL cutoff), the ONTRAK TESTSTIK for Cocaine (300 ng/mL cutoff), the ONTRAK TESTSTIK for THC (50 ng/mL cutoff), the ONTRAK TESTSTIK for Morphine (300 ng/mL cutoff) and the ONTRAK TESTSTIK for PCP (25 ng/mL cutoff).

Device Story

ONTRAK TESTSTIK assays are lateral flow, competitive microparticle capture inhibition tests for professional use. Device consists of a reagent strip with antibody-coated blue microparticles and immobilized drug conjugate on a membrane. Urine sample is absorbed into a pad and migrates via capillary action. In the absence of drug, antibody-coated microparticles bind to the immobilized drug conjugate, forming a blue band (negative result). If drug is present, it binds to the microparticles, inhibiting binding to the conjugate, resulting in no blue band (positive result). A 'TEST VALID' band confirms proper flow. Results are visually interpreted by a clinician to aid in drug screening. Benefits include rapid, qualitative detection of specific drugs of abuse in urine samples.

Clinical Evidence

Bench testing only. Performance evaluated by comparing TESTSTIK results to GC/MS reference methods. Precision reported as >95% confidence at 150% of cutoff. Accuracy studies showed high concordance with GC/MS across all five drug analytes.

Technological Characteristics

Lateral flow immunoassay using competitive microparticle capture inhibition. Reagents: blue dyed microparticles coated with mouse monoclonal or rabbit polyclonal antibodies, drug conjugates immobilized on a membrane, and mouse monoclonal anti-BSA antibody. Qualitative colorimetric endpoint read. Sample type: urine.

Indications for Use

Indicated for professional in vitro diagnostic qualitative detection of amphetamines (1000 ng/mL), cocaine metabolite (300 ng/mL), morphine (300 ng/mL), phencyclidine (25 ng/mL), or cannabinoids (50 ng/mL) in human urine.

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 ONTRAK for Amphetamines (K881817/A)
• Abuscreen ONTRAK for Cocaine (K881815)
• Abuscreen ONTRAK for Morphine (K882496)
• Abuscreen ONTRAK for PCP (K895906)
• Abuscreen ONTRAK for THC (K904856)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the word "Roche" in bold, white letters against a black, hexagon-shaped background. The hexagon is oriented horizontally, with the word "Roche" centered within it. The font is sans-serif and appears to be a simple, clean design.

# Roche Diagnostic Systems

A Member of the Roche Group

Roche Diagnostic Systems, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

Direct Dial Fax

K973075

# 510(k) Summary

## ONTRAK TESTSTIK Assays

In accordance with the Safe Medical Devices Act of 1990, a 510(k) summary is provided as outlined in 21 CFR 807.92.

#### Identification of 510(k) Sponsor: I.

Roche Diagnostic Systems, Inc. a subsidiary of Hoffmann-La Roche, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

510(k) Submission dated August 15, 1997

James W. Haynes Contact: Regulatory Affairs Associate Phone: [phone] Fax: [phone]

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#### II. Device Name:

The device name, including both the trade/proprietary name and the classification name are provided in the table below.

| Proprietary Name | Classification Name | Regulation Number |
|------------------------|---------------------------|-------------------|
| ONTRAK TESTSTIK for... | | |
| Amphetamines | Amphetamines test system | 862.3100 |
| Cocaine | Cocaine test system | 862.3250 |
| Morphine | Morphine test system | 862.3640 |
| PCP | Phencyclidine test system | NA |
| THC | Cannabinoid test system | 862.3870 |

Table 1

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### Identification of the legally marketed device to which the 510(k) sponsor claims III. equivalence:

The following table identifies the legally marketed devices to which Roche Diagnostic Systems, Inc. claims equivalence.

| Proprietary Name | Predicate Product Name | K number | Date of substantial<br>equivalence |
|------------------------|-----------------------------------|-----------|------------------------------------|
| ONTRAK TESTSTIK for... | | | |
| Amphetamines | Abuscreen ONTRAK for Amphetamines | K881817/A | 7/29/88 |
| Cocaine | Abuscreen ONTRAK for Cocaine | K881815 | 7/29/88 |
| Morphine | Abuscreen ONTRAK for Morphine | K882496 | 9/2/88 |
| PCP | Abuscreen ONTRAK for PCP | K895906 | 1/26/90 |
| THC | Abuscreen ONTRAK for THC | K904856 | 12/13/90 |

## Table 2

#### IV. Description of the Device/Statement of Intended Use:

The 5 ONTRAK TESTSTIK Assays contained in this submission are in vitro diagnostic tests intended for professional use for the qualitative detection of drug or drug metabolite in urine. They are the ONTRAK TESTSTIK for Amphetamines (1000 ng/mL cutoff), the ONTRAK TESTSTIK for Cocaine (300 ng/mL cutoff), the ONTRAK TESTSTIK for THC (50 ng/mL cutoff), the ONTRAK TESTSTIK for Morphine (300 ng/mL cutoff) and the ONTRAK TESTSTIK for PCP (25 ng/mL cutoff).

The ONTRAK TESTSTIK Assays are based on the principle of microparticle capture inhibition. These tests rely on the competition between the specific drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane test chamber.

When an ONTRAK 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 conjugate. In the absence of drug in the urine, the antibody-coated microparticles bind to the drug conjugate and a blue band is formed at the result window ("negative" sign).

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When drug is present in the specimen. it binds to the antibody-coated particles, the microparticles are inhibited from binding the drug conjugate and no blue band is formed at the result window. Therefore, a positive sample causes the membrane to remain white ("positive" sign).

An additional antibody/antigen reaction occurs at the "TEST VALID" area. The "TEST VALID" blue band forms when antibodies, which are embedded in the reagent membrane, bind to the antigen on the blue microparticles.

### Summary of the technological characteristics of the new device in comparison to V. those of the predicate.

Tables 3-7 outline the technological characteristics (methodologies) of the ONTRAK TESTSTIK Assays in comparison to those of legally marketed predicate products.

### VI. Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence:

Tables 3-7 demonstrate the results of clinical and nonclinical studies performed using the ONTRAK TESTSTIK Assays. The significant performance characteristics relied upon for a determination of substantial equivalence are summarized in this information concludes that the performance of these devices are essentially equivalent to other legally marketed devices of a similar kind.

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-

| Table 3 - ONTRAK TESTSTIK for Amphetamines | | |
|--------------------------------------------|--|--|
|--------------------------------------------|--|--|

| | ONTRAK TESTSTIK<br>for Amphetamines | Abuscreen ONTRAK for<br>Amphetamines |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Methodology | Competitive microparticle capture<br>inhibition | Competitive latex agglutination<br>inhibition |
| Measurement | Qualitative | Qualitative |
| Sample type | urine | urine |
| Endpoint read | color | agglutination pattern |
| Cutoff(s) | 1000 ng/mL | 1000 ng/mL |
| Reagent (active<br>ingredients) | 1. Blue dyed microparticles coated<br>with mouse monoclonal anti-<br>amphetamine analogue<br>2. Drug conjugates immobilized on a<br>membrane<br>3. Mouse monoclonal anti-BSA<br>antibody immobilized on a<br>membrane | 1. Sheep anti-amphetamine<br>antibody in a buffered<br>solution<br>2. Reaction buffer<br>3. Latex-amphetamine<br>conjugate in a buffered<br>solution |
| Controls | ONTRAK TESTCUP Positive & Negative<br>Controls | Abuscreen ONTRAK for<br>Amphetamines Negative Control |
| Performance Characteristics: | | |
| Precision | > 95% confidence at 150% cutoff | > 99% confidence at 200% of<br>cutoff |
| Accuracy:<br>Positive Samples | TesTstik | GC/MS |
| + | 50 | 45 |
| - | 0 | 1 |

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# Table 4 - ONTRAK TESTSTIK for Cocaine

| | ONTRAK TESTSTIK<br>for Cocaine | | Abuscreen ONTRAK for<br>Cocaine |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Methodology | Competitive microparticle capture<br>inhibition | | Competitive latex agglutination<br>inhibition |
| Measurement | Qualitative | | Qualitative |
| Sample type | urine | | urine |
| Endpoint read | color | | agglutination pattern |
| Cutoff(s) | 300 ng/mL | | 300 ng/mL |
| Reagent (active<br>ingredients) | 1. Blue dyed microparticles coated<br>with mouse monoclonal anti-<br>benzoylecgonine antibody<br>2. Drug conjugates immobilized on a<br>membrane<br>3. Mouse monoclonal anti-BSA<br>antibody immobilized on a<br>membrane | | 1. Mouse monoclonal anti-<br>benzoylecgonine antibody in<br>a buffered solution<br>2. Reaction buffer<br>3. Latex- benzoylecgonine<br>conjugate in a buffered<br>solution |
| Controls | ONTRAK TESTCUP Positive & Negative<br>Controls | | Abuscreen ONTRAK for Cocaine<br>Negative Control |
| Performance Characteristics: | | | |
| Precision | > 95% confidence at 150% cutoff | | > 99% confidence at 200% of<br>cutoff |
| Accuracy:<br>Positive Samples | | TESTSTIK<br>ONTRAK | GC/MS<br>GC/MS |
| | + | 50<br>50 | 49<br>0 |
| | - | 0<br>0 | 0<br>0 |

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| | ONTRAK TESTSTIK<br>for Morphine | | Abuscreen ONTRAK for<br>Morphine |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Methodology | Competitive microparticle capture<br>inhibition | | Competitive latex agglutination<br>inhibition |
| Measurement | Qualitative | | Qualitative |
| Sample type | urine | | urine |
| Endpoint read | color | | agglutination pattern |
| Cutoff(s) | 300 ng/mL | | 300 ng/mL |
| Reagent (active<br>ingredients) | 1. Blue dyed microparticles coated<br>with mouse monoclonal anti-<br>morphine antibody<br>2. Drug conjugates immobilized on a<br>membrane<br>3. Mouse monoclonal anti-BSA<br>antibody immobilized on a<br>membrane | | 1. Mouse anti- morphine<br>antibody in a buffered<br>solution<br>2. Reaction buffer<br>3. Latex-morphine conjugate in<br>a buffered solution |
| Controls | ONTRAK TESTCUP Positive & Negative<br>Controls | | Abuscreen ONTRAK for<br>Morphine Negative Control |
| Performance Characteristics: | | | |
| Precision | > 95% confidence at 150% cutoff | | > 99% confidence at 200% of<br>cutoff |
| Accuracy:<br>Positive Samples | | TESTSTIK<br>49 | ONTRAK GC/MS<br>50 GC/MS<br>54 |

0

l

-

0

0

## Table 5 - ONTRAK TESTSTIK for Morphine

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## Table 6 - ONTRAK TESTSTIK for PCP

| | ONTRAK TESTSTIK<br>for PCP | | Abuscreen ONTRAK for PCP | | |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------|-------|
| Methodology | Competitive microparticle capture inhibition | | Competitive latex agglutination inhibition | | |
| Measurement | Qualitative | | Qualitative | | |
| Sample type | urine | | urine | | |
| Endpoint read | color | | agglutination pattern | | |
| Cutoff(s) | 25 ng/mL | | 25 ng/mL | | |
| Reagent (active ingredients) | 1. Blue dyed microparticles coated with rabbit polyclonal anti-phencyclidine antibody<br>2. Drug conjugates immobilized on a membrane<br>3. Mouse monoclonal anti-BSA antibody immobilized on a membrane | | 1. Rabbit anti- phencyclidine antibody in a buffered solution<br>2. Reaction buffer<br>3. Latex- phencyclidine conjugate in a buffered solution | | |
| Controls | ONTRAK TESTCUP Positive & Negative Controls | | Abuscreen ONTRAK for PCP Negative Control | | |
| Performance Characteristics: | | | | | |
| Precision | > 95% confidence at 150% cutoff | | > 99% confidence at 200% of cutoff | | |
| Accuracy:<br>Positive Samples | | TESTSTIK | ONTRAK | GC/MS | GC/MS |
| | + | 50 | 50 | 50 | 52 |
| | - | 0 | 0 | 0 | 1 |

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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | ONTRAK TESTSTIK<br>for THC | Abuscreen ONTRAK for THC | | | |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|-------|----|
| Methodology | Competitive microparticle capture<br>inhibition | Competitive latex agglutination<br>inhibition | | | |
| Measurement | Qualitative | Qualitative | | | |
| Sample type | urine | urine | | | |
| Endpoint read | color | agglutination pattern | | | |
| Cutoff(s) | 50 ng/mL | 50 ng/mL | | | |
| Reagent (active<br>ingredients) | 1. Blue dyed microparticles coated<br>with mouse monoclonal anti-<br>cannabinoid antibody<br>2. Drug conjugates immobilized on a<br>membrane<br>3. Mouse monoclonal anti-BSA<br>antibody immobilized on a<br>membrane | 1. Mouse monoclonal anti-<br>cannabinoid in a buffered<br>solution<br>2. Reaction buffer<br>3. Latex-tetrahydrocannabinoid<br>conjugate in a buffered<br>solution | | | |
| Controls | ONTRAK TESTCUP Positive & Negative<br>Controls | Abuscreen ONTRAK for THC<br>Negative Control | | | |
| Performance Characteristics: | | | | | |
| Precision | > 95% confidence at 150% cutoff | > 99% confidence at 200% of<br>cutoff | | | |
| Accuracy:<br>Positive Samples | TESTSTIK | ONTRAK | GC/MS | GC/MS | |
| | + | 45 | 45 | 45 | 50 |
| | - | 0 | 0 | 0 | 0 |

## Table 7 - ONTRAK TESTSTIK for THC

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Image /page/9/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. James W. Haynes Regulatory Affairs Associate Roche Diagnostic Systems, Inc. a subsidiary of Hoffmann-La Roche, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

OCT - 9 1997

Re: K973075 Trade Name: OnTrak TesTstik Assays Requlatory Class: II Product Code: DKZ Dated: Auqust 15, 1997 Received: August 18, 1997

Dear Mr. Haynes:

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 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 requlations 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 requirement, 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 Druq 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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Page 2

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 qeneral 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 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) Jan 9730 73

ONTRAK TESTSTIK for Amphetamines Device Name: ONTRAK TESTSTIK for Cocaine ONTRAK TESTSTIK for Morphine ONTRAK TESTSTIK for PCP ONTRAK TESTSTIK for THC

Indications for Use:

- 1. The ONTRAK TESTSTIK for Amphetamines is an in vitro diagnostic test intended for professional use for the qualitative detection of amphetamines in urine at or above a cutoff concentration of 1000 ng/mL.
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:

- 2. The ONTRAK TESTSTIK for Cocaine is an in vitro diagnostic test intended for professional use for the qualitative detection of cocaine metabolite in urine at or above a cutoff concentration of 300 ng/mL.
- 3. The ONTRAK TESTSTIK for Morphine is an in vitro diagnostic test intended for professional use for the qualitative detection of morphine in urine at or above a cutoff concentration of 300 ng/mL
- 4. The ONTRAK TESTSTIK for PCP is an in vitro diagnostic test intended for professional use for the qualitative detection of phencyclidine in urine at or above a cutoff concentration of 25 ng/mL.
- 5. The ONTRAK TESTSTIK for THC is an in vitro diagnostic test intended for professional use for the qualitative detection of cannabinoids in urine at or above a cutoff concentration of 50 ng/mL.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | |

| Prescription Use<br>(Per 21 CFR 801,109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
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