ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES

K983174 · Roche Diagnostic Systems, Inc. · JXM · Nov 18, 1998 · Clinical Toxicology

Device Facts

• Record ID: K983174
• Device Name: ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES
• Applicant: Roche Diagnostic Systems, Inc.
• Product Code: JXM · Clinical Toxicology
• Decision Date: Nov 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3170
• Device Class: Class 2

Intended Use

1. The ONTRAK TESTSTIK for Barbiturates is an in vitro diagnostic test intended for professional use for the qualitative detection of barbiturates in urine at or above a cutoff concentration of 200 ng/mL. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose. 2. The ONTRAK TESTSTIK for Benzodiazepines is an in vitro diagnostic test intended for professional use for the qualitative detection of benzodiazepines in urine at or above a cutoff concentration of 200 ng/mL. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose.

Device Story

ONTRAK TESTSTIK assays are in vitro diagnostic devices for qualitative drug detection in urine. Device utilizes microparticle capture inhibition principle. Urine sample absorbed into sample pad; migrates via capillary action through reagent strip. Reagent strip contains antibody-coated blue microparticles; these mobilize upon rehydration. In absence of drug, microparticles bind to immobilized drug conjugate on membrane, forming blue band (negative result). If drug present, it binds microparticles, inhibiting binding to conjugate; no blue band forms (positive result). Additional 'TEST VALID' area confirms assay function via antibody-antigen reaction. Used in clinical settings by professionals. Provides rapid visual qualitative result to assist in diagnosis and treatment of drug use or overdose.

Clinical Evidence

Bench testing only. Comparison of ONTRAK TESTSTIK against GC/MS and predicate devices. Accuracy studies performed on 50 positive samples for each assay; results showed 100% agreement with GC/MS. Precision reported as >95% confidence at 150% of cutoff.

Technological Characteristics

Competitive microparticle capture inhibition assay. Reagents: blue dyed microparticles coated with monoclonal/polyclonal antibodies, drug conjugates immobilized on membrane, anti-BSA antibody on membrane. Qualitative colorimetric endpoint. Sample type: urine. Cutoff: 200 ng/mL. Manual test strip format.

Indications for Use

Indicated for professional use for qualitative detection of barbiturates or benzodiazepines in human urine at or above 200 ng/mL cutoff. Used for diagnosis and treatment of drug use or overdose.

Regulatory Classification

Identification

A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A benzodiazepine 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 Barbiturates (K881816/A)
• Abuscreen OnTrak for Benzodiazepines (K910590)

Submission Summary (Full Text)

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K983174

# 510(k) Summary

# ONTRAK TESTSTIK Assays for Barbiturates & Benzodiazepines

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 September 9, 1998

Contact: Maria Feijoo Manager, Regulatory Affairs Phone: [phone] [phone] Fax:

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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.

| Product Name | Classification Name | Regulatory Class | CFR Classification Number |
|----------------------------------------|--------------------------------|------------------|---------------------------|
| ONTRAK TESTSTIK for<br>Barbiturates | Barbiturates test<br>system | Class II | 862.3150 |
| ONTRAK TESTSTIK for<br>Benzodiazepines | Benzodiazepines<br>test system | Class II | 862.3170 |

## 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.

| Product Name | Predicate Product<br>Name | Date<br>Predicate<br>Cleared | Predicate<br>510(k)<br>Number |
|----------------------------------------|-----------------------------------------|------------------------------|-------------------------------|
| ONTRAK TESTSTIK for<br>Barbiturates | Abuscreen OnTrak for<br>Barbiturates | 7/28/88 | K881816/A |
| ONTRAK TESTSTIK for<br>Benzodiazepines | Abuscreen OnTrak for<br>Benzodiazepines | 4/05/91 | K910590 |

| 2<br>7<br>able<br>শ | પ |
|---------------------|---|
|---------------------|---|

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

The ONTRAK TESTSTIK Assays for Barbiturates and Benzodiazepines are in vitro diagnostic tests intended for professional use for the qualitative detection of drug in urine at or above a cutoff of 200 ng/mL.

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).

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).

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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.

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

Tables 3-4 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 3-4 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 chart. 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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،

| | ONTRAK TESTSTIK<br>for Barbiturates | | | Abuscreen ONTRAK for<br>Barbiturates | |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|--------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| 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) | 200 ng/mL | | | 200 ng/mL | |
| Reagent (active<br>ingredients) | 1. Blue dyed microparticles coated<br>with mouse monoclonal anti-<br>barbiturates<br>2. Drug conjugates immobilized on a<br>membrane<br>3. Mouse monoclonal anti-BSA<br>antibody immobilized on a<br>membrane | | | 1. Rabbit anti-barbiturate<br>antibody in a buffered<br>solution<br>2. Reaction buffer<br>3. Latex-barbiturate conjugate<br>in a buffered solution | |
| Precision | > 95% confidence at 150% cutoff | | | | > 99% confidence at 200% of<br>cutoff |
| Accuracy:<br>Positive Samples | | TesTstik | ONTRAK | GC/MS | GC/MS |
| | + | 50 | 50 | 50 | 48 |
| | - | 0 | 0 | 0 | 0 |

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| | ONTRAK TESTSTIK<br>for Benzodiazepines | | | Abuscreen ONTRAK for<br>Benzodiazepines | |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| 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) | 200 ng/mL | | | 200 ng/mL | |
| Reagent (active<br>ingredients) | 1. Blue dyed microparticles coated<br>with sheep polyclonal anti-<br>benzodiazepine analogue<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>benzodiazepine antibody in a<br>buffered solution<br>2. Reaction buffer<br>3. Latex- benzodiazepine<br>conjugate in a buffered<br>solution | |
| 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 |
| | + | 50 | 50 | 50 | 66 |
| | - | 0 | 0 | 0 | 1 |

# Table 4 - ONTRAK TESTSTIK for Benzodiazepines

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Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the eagle in a circular fashion. The logo is black and white.

# NOV 1 8 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Maria Feijoo Manager, Regulatory Affairs Roche Diagnostic System, Inc. 1080 U.S. Highway 202 Somerville, NJ 08876-3771

Re: K983174 Trade Name: OnTrak TesTstik for Barbiturates and OnTrak TesTstik for Benzodiazepines Regulatory Class: II, II Product Code: DIS, JXM Dated: September 9, 1998 Received: September 10, 1998

Dear Ms. Feijoo:

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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## 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 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 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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Page 1 of 1

K 983174 510(k) Number (if known)

Device Name: ONTRAK TESTSTIK FOR BARBITURATES ONTRAK TESTSTIK FOR BENZODIAZEPINES

Indications for Use:

- 1. The ONTRAK TESTSTIK for Barbiturates is an in vitro diagnostic test intended for professional use for the qualitative detection of barbiturates in urine at or above a cutoff concentration of 200 ng/mL.
Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose.

- 2. The ONTRAK TESTSTIK for Benzodiazepines is an in vitro diagnostic test intended for professional use for the qualitative detection of benzodiazepines in urine at or above a cutoff concentration of 200 ng/mL.
Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose.

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

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)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number: K983174