ONTRAK TESTCUP 5, CAT. 07 6481 7

K994030 · Roche Diagnostics Corp. · LCM · Jan 27, 2000 · TX

Device Facts

• Record ID: K994030
• Device Name: ONTRAK TESTCUP 5, CAT. 07 6481 7
• Applicant: Roche Diagnostics Corp.
• Product Code: LCM · TX
• Decision Date: Jan 27, 2000
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

OnTrak TesTcup® 5 is an in vitro diagnostic test intended for professional use for the qualitative detection of drug or drug metabolite in urine. OnTrak TesTcup 5 simultaneously tests for the presence of multiple drugs or drug metabolites. The OnTrak TesTcup 5 profile (cutoff) consists of amphetamines (1000 ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (300 ng/mL) and PCP (25 ng/mL). OnTrak TesTcup 5 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 abuse result, particularly when preliminary positive results are used.

Device Story

OnTrak TesTcup-5 is a point-of-care, professional-use, in vitro diagnostic device for qualitative urine drug screening. Device utilizes competitive microparticle capture inhibition principle. User collects urine directly into cup; tilts cup to fill reservoir; sample flows via capillary action across membrane containing antibody-coated microparticles and drug conjugates. In absence of drug, antibodies bind drug conjugate, forming blue band (negative). In presence of drug, drug binds antibodies, inhibiting conjugate binding, leaving membrane white (positive). Test valid band confirms assay integrity. Provides preliminary results for clinical decision-making; requires GC/MS confirmation for definitive diagnosis. Benefits include rapid, simultaneous multi-drug screening in clinical settings.

Clinical Evidence

Bench testing only. Accuracy evaluated using 397 clinical urine samples compared against GC/MS confirmation and Abuscreen OnLine. Results showed 100% agreement for PCP detection at 25 ng/mL cutoff (90 positive samples, 307 negative samples). Precision demonstrated >95% confidence at 150% of the cutoff concentration.

Technological Characteristics

Competitive microparticle capture inhibition assay. Components: blue-dyed microparticles coated with mouse monoclonal anti-phencyclidine, drug conjugates immobilized on membrane, mouse monoclonal anti-BSA antibody. Qualitative colorimetric endpoint. Standalone, single-use cup form factor. No energy source required.

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 requiring confirmation by alternate chemical methods like GC/MS.

Predicate Devices

• OnTrak TesTcup 5 (K964355)

Reference Devices

• Abuscreen OnLine for PCP

Submission Summary (Full Text)

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(JAN 2 7 2000

K994030

## 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><br>Contact Person: Jennifer Tribbett<br><br>Date Prepared: November 24, 1999 |

#### 2) Device name

| Product Name | Classification<br>Name | Product Code | CFR<br>Classification |
|------------------|-----------------------------------------|--------------|-----------------------|
| OnTrak TesTcup-5 | Enzyme<br>Immunoassay,<br>Phencyclidine | 91LCM | Unassigned |

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

ﺗ

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#### 510(k) Summary, Continued

The OnTrak TesTcup-5 is an in vitro diagnostic test intended for professional 4) Device Description use in the qualitative detection of amphetamines (1000ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL), morphine (300 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 . 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. Table 1 shown on the next page outlines the technological characteristics 5. Technology Characteristics (methodologies) of the modified OnTrak TesTcup-5 in comparison to the predicate OnTrak TesTcup 5.

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### 510(k) Summary, Continued

Table 1 also provides the results of evaluation studies performed using the 6. Substantial modified OnTrak TesTcup-5 . The significant performance characteristics Equivalence relied upon for a determination of substantial equivalence is summarized in this chart. This information concludes that the performance of the modified OnTrak TesTcup-5 device is substantially equivalent to the predicate device.

## Table 1

| Item | OnTrak TesTcup-5<br>New PCP Monoclonal Antibody | OnTrak TesTcup 5<br>Predicate |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Methodology | Competitive microparticle capture<br>inhibition | Same |
| Measurement | Qualitative | Same |
| Sample Type | Urine | Same |
| Endpoint read | Color | Same |
| PCP Cutoff | 25 ng/mL | Same |
| Reagent<br>(active<br>ingredients) | • Blue dyed microparticles coated<br>with mouse monoclonal<br>antiphencyclidine.<br><br>• Drug conjugates immobilized on a<br>membrane<br><br>• Mouse monoclonal anti-BSA<br>antibody immobilized on membrane | • Blue dyed microparticles<br>coated with rabbit polyclonal<br>antiphencyclidine.<br><br>• Drug conjugates immobilized<br>on a membrane<br><br>• Mouse monoclonal anti-BSA<br>antibody immobilized on a<br>membrane |
| Controls | OnTrak TesTcup Positive and<br>Negative Controls | Same |
| Performance:<br>Precision | >95% confidence at 150% cutoff | Same |

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## Table 1 (Continued)

| Item | OnTrak TesTcup-5<br>New PCP Monoclonal<br>Antibody | OnTrak TesTcup 5<br>Predicate |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PCP<br>Performance:<br>Accuracy | OnTrak TesTcup 5 was evaluated<br>using specimens screened by an<br>automated immunoassay and<br>confirmed positive by GC/MS at<br>the 25 ng/mL cutoff. All ninety<br>(90) of the PCP positive samples<br>(100%) were positive by OnTrak<br>TesTcup 5. | OnTrak TesTcup 5 was evaluated<br>using specimens screened by an<br>automated immunoassay and<br>confirmed positive by GC/MS at<br>the 25 ng/mL cutoff. All ninety<br>(90) of the PCP positive samples<br>(100%) were positive by OnTrak<br>TesTcup 5. |
| | Three hundred seven (307) urine<br>samples, obtained from a clinical<br>laboratory and screened negative<br>by an automated immunoassay<br>relative to a 25 ng/mL cutoff for<br>PCP were evaluated using<br>OnTrak TesTcup 5. All three<br>hundred seven (307) were<br>negative for PCP (100%) | Three hundred seven (307) urine<br>samples, obtained from a clinical<br>laboratory and screened negative<br>by an automated immunoassay<br>relative to a 25 ng/mL cutoff for<br>PCP were evaluated using<br>OnTrak TesTcup 5. All three<br>hundred seven (307) were<br>negative for PCP (100%) |
| | All positive and negative samples<br>were also assayed by, and<br>compared to, Abuscreen OnLine<br>for PCP. Three hundred ninety<br>seven (397) samples tested by<br>both OnTrak TesTcup 5 and<br>Abuscreen OnLine for PCP<br>demonstrated 100% | All positive and negative samples<br>were also assayed by, and<br>compared to, Abuscreen OnTrak<br>for PCP. Three hundred ninety<br>seven (397) samples tested by<br>both OnTrak TesTcup 5 and<br>Abuscreen OnTrak for PCP<br>demonstrated 100% agreement. |

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# Jan 2 7 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K994030 Re: Trade Name: OnTrak TesTcup-5 Regulatory Class: II Product Code: LCM Dated: November 24 1999 Received: November 26, 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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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/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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

Enclosure

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510(k) Number (if known): Device Name: Roche Diagnostics Corporation, OnTrak TesTcup-5

Indications for Use:

OnTrak TesTcup® 5 is an in vitro diagnostic test intended for professional use for the qualitative detection of drug or drug metabolite in urine. OnTrak TesTcup 5 simultaneously tests for the presence of multiple drugs or drug metabolites.

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

OnTrak TesTcup 5 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 abuse result, particularly when preliminary positive results are used.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ocan Coazer

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K994030

Prescription Use ﻟﻌﺴﺮ (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)