ONTRAK TESTCUP-5 M2K

K990337 · Roche Diagnostics Corp. · DKZ · Feb 23, 1999 · Clinical Toxicology

Device Facts

• Record ID: K990337
• Device Name: ONTRAK TESTCUP-5 M2K
• Applicant: Roche Diagnostics Corp.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Feb 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

OnTrak TesTcup® 5 M2K is an in vitro diagnostic test intended for professional use for the qualitative detection of drug or drug metabolite in urine. OnTrak TesTcup 5 M2K simultaneously tests for the presence of multiple drugs or drug metabolites. The OnTrak TesTcup-5 M2K cutoff levels are based on the Federal Mandatory Guidelines. The OnTrak TesTcup 5 M2K profile (cutoff) consists of amphetamines (1000 ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (2000 ng/mL) and PCP (25 ng/mL). OnTrak TesTcup 5 M2K provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.

Device Story

In vitro diagnostic test for qualitative detection of drugs of abuse in urine; utilizes microparticle capture inhibition principle. Sample collected directly in cup; urine flows via capillary action through membrane containing antibody-coated microparticles and drug conjugate. Competitive binding between drug in sample and immobilized drug conjugate determines presence of blue band; absence of band indicates positive result. Used in professional clinical settings; provides preliminary results requiring confirmation by alternate chemical methods (e.g., GC/MS). Benefits include rapid, simultaneous screening for multiple drug classes.

Clinical Evidence

Bench testing only. Accuracy evaluated using 50 positive and 100 negative urine samples confirmed by GC/MS at 2000 ng/mL cutoff; 100% sensitivity and 100% specificity observed. Comparison with Abuscreen OnLine II for Opiates 2000 showed 99.3% agreement across 150 samples. Precision demonstrated >95% confidence at 150% of the cutoff.

Technological Characteristics

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

Indications for Use

Indicated for professional use in the qualitative detection of amphetamines, cocaine metabolite, THC, morphine, and PCP in human urine. 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

• OnTrak TesTcup 5 (K964355)

Reference Devices

• Abuscreen OnLine II for Opiates 2000
• Abuscreen OnTrak for Morphine

Submission Summary (Full Text)

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9/23/99

K990337

# 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 name, address, contact | Roche Diagnostics Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>[phone] | |
| | Contact Person: Jennifer Tribbett | |
| | Date Prepared: January 29, 1999 | |

#### 2) Device name

| Product Name | Classification Name | Class | CFR<br>Classification |
|-------------------------|----------------------|-------|-----------------------|
| OnTrak TesTcup®5<br>M2K | Morphine test system | II | 862.3640 |

#### We claim substantial equivalence to the currently marketed Roche 3) Predicate device Diagnostics OnTrak TesTcup 5 (K964355).

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#### 510(k) Summary, Continued

The OnTrak TesTcup-5 M2K is an in vitro diagnostic test intended for 4) Device Description professional use in the qualitative detection of amphetamines (1000ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (2000 ng/mL) and PCP (25 ng/mL). The TesTcup 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 in the test chamber. Urine is collected directly in the OnTrak TesTcup-5 M2K. After closing the cap and moving it to the "TEST" position, the sample reservoir is filled by tilting the cup. Urine then flows through a membrane by capillary action and reacts with antibody-coated microparticles and drug conjugate present on the membrane. In the absence of drug, the antibody is free to interact with the drug conjugate, causing the formation of a blue band ("negative" sign). When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the drug conjugate, and no blue band is formed. A positive sample causes the membrane to remain white ("positive" sign). An additional antibody/antigen reaction occurs at the "TEST VALID" area for all assays. The "TEST VALID" blue band forms when antibodies, which are imbedded in the membrane, interact with, and bind to, the antigen on the blue-dyed microparticles. 5. Technology Table 1 shown on the next page outlines the technological characteristics Characteristics (methodologies) of the OnTrak TesTcup-5 M2K in comparison to the predicate device. OnTrak TesTcup 5.

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## 510(k) Summary, Continued

6. Substantial Equivalence

Table 1 also provides the results of clinical and non-clinical studies performed using the OnTrak TesTcup-5 M2K. The significant performance characteristics relied upon for a determination of substantial equivalence is summarized in this chart. This information concludes that the performance of the OnTrak TesTcup 5 M2K device is substantially equivalent to the predicate device.

| Item | OnTrak TesTcup-5 M2K for<br>Morphine 2000 | OnTrak TesTcup 5 |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Methodology | Competitive microparticle capture<br>inhibition | Same |
| Measurement | Qualitative | Same |
| Sample Type | Urine | Same |
| Endpoint read | Color | Same |
| Morphine Cutoff | 2000 ng/mL | 300 ng/mL |
| Reagent (active<br>ingredients) | •Blue dyed microparticles coated<br>with mouse monoclonal anti-<br>morphine antibody | Same |
| | •Drug conjugates immobilized on a<br>membrane | |
| | •Mouse monoclonal anti-BSA<br>antibody immobilized on<br>membrane | |
| Controls | OnTrak TesTcup Positive and<br>Negative Controls | Same |
| Performance:<br>Precision | >95% confidence at 150% cutoff | Same |
| Item | OnTrak TesTcup-5 M2K for Morphine 2000 | OnTrak TesTcup 5 |
| Morphine Performance: Accuracy | OnTrak TesTcup 5 M2K was evaluated using specimens screened by an automated immunoassay and confirmed positive by GC/MS at 2000 ng/mL cutoff. All fifty (50) samples positive for morphine were positive by OnTrak TesTcup 5 M2K (100%).<br>One hundred (100) urine samples, obtained from a clinical laboratory and screened negative by an automated immunoassay relative to a 2000 ng/mL cutoff for morphine were evaluated using OnTrak TesTcup 5 M2K. All one hundred were negative for morphine by OnTrak TesTcup 5 M2K (100%).<br>All positive and negative samples were also assayed by, and compared to, Abuscreen OnLine II for Opiates 2000. One hundred fifty (150) samples tested by both OnTrak TesTcup 5 M2K and Abuscreen OnLine II for Opiates 2000 demonstrated 99.3% agreement. | OnTrak TesTcup 5 was evaluated using specimens screened by an automated immunoassay and confirmed positive by GC/MS at the 300 ng/mL cutoff. All ninety (90) samples positive for morphine were positive by OnTrak TesTcup 5 (100%).<br>Three hundred seven (307) urine samples, obtained from a clinical laboratory and screened negative by an automated immunoassay relative to a 300 ng/mL cutoff for morphine were evaluated using OnTrak TesTcup 5. Three hundred five were negative for morphine by OnTrak TesTcup 5 (>99%).<br>All positive and negative samples were also assayed by, and compared to, Abuscreen OnTrak for Morphine. Three hundred ninety seven (397) samples tested by both OnTrak TesTcup 5 and Abuscreen OnTrak for Morphine demonstrated 99.7% agreement. |

## Table 1

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# 510(k) Summary, Continued

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Public Health Service

Image /page/4/Picture/2 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem consists of a stylized caduceus symbol, with three abstract human profiles facing right, representing health and human services.

### FEB 2 3 1999

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

Re: K990337

Trade Name: OnTrak TesTcup® 5 M2K Regulatory Class: II Product Code: DKZ, DJG, DIO, LDJ, LCM Dated: January 29, 1999 Received: February 3, 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.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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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 [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/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-5 M2K for Morphine 2000

Indications for Use:

OnTrak TesTcup® 5 M2K is an in vitro diagnostic test intended for professional use for the qualitative detection of drug or drug metabolite in urine. OnTrak TesTcup 5 M2K simultaneously tests for the presence of multiple drugs or drug metabolites. The OnTrak TesTcup-5 M2K cutoff levels are based on the Federal Mandatory Guidelines.

The OnTrak TesTcup 5 M2K profile (cutoff) consists of amphetamines (1000 ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (2000 ng/mL) and PCP (25 ng/mL).

OnTrak TesTcup 5 M2K provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.

ean Cooper

(Division Sign-Off) Division of Clinical Laboratory Devices 32

Concurrence of CDRH, Office of Device Evaluation (on the of

1 Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

CONFIDENTIAL