ONTRAK TESTCARD 9

K012396 · Roche Diagnostics Corp. · DKZ · Nov 5, 2001 · Clinical Toxicology

Device Facts

• Record ID: K012396
• Device Name: ONTRAK TESTCARD 9
• Applicant: Roche Diagnostics Corp.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Nov 5, 2001
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

The Roche Diagnostics Corporation OnTrak TesTcard 9 is an in vitro diagnostic test intended for use by health care professionals only for the qualitative detection of drug or drug metabolites in urine. OnTrak TesTcard 9 simultaneously tests for the presence of multiple drugs or drug metabolites. The OnTrak TesTcard 9 profile (cutoff) consists of amphetamines (1000 ng/ml), barbiturates (200 ng/ml), benzodiazepines (100 ng/ml), cocaine metabolite (300 ng/ml), methamphetamine (500 ng/ml), morphine (300 ng/ml), tricyclic antidepressants (TCA-1000 ng/ml) and THC (50 ng/ml). OnTrak TesTcard 9 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 test result, particularly when preliminary positive results are used.

Device Story

OnTrak TesTcard 9 is a lateral flow, in vitro diagnostic device for qualitative urine drug screening. Operated by healthcare professionals in clinical settings. Input: urine sample. Principle: competitive microparticle capture inhibition. Sample migrates via capillary action through reagent strips containing blue microparticles coated with drug-specific antibodies. In absence of drug, microparticles bind to immobilized drug conjugates on membrane, forming blue bands. In presence of drug, microparticles are inhibited from binding, leaving membrane white (positive result). 'TEST VALID' band confirms assay completion. Output: visual interpretation of blue bands. Results are preliminary; require GC/MS confirmation. Assists clinicians in identifying potential drug abuse for further diagnostic or clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Lateral flow immunoassay using competitive microparticle capture inhibition. Components: mouse monoclonal antibody-coated blue microparticles, drug conjugate-immobilized membrane, and anti-BSA control line. Qualitative visual readout. Standalone device.

Indications for Use

Indicated for health care professionals for qualitative detection of drugs or drug metabolites in urine. Targets amphetamines, barbiturates, benzodiazepines, cocaine metabolite, methamphetamine, morphine, PCP, tricyclic antidepressants, and THC. Provides preliminary results requiring confirmation by GC/MS.

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

• Triage® Panel Plus TCA (K973784)
• OnTrak TesTstik™ Methamphetamines (K000096)

Submission Summary (Full Text)

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NOV 0 5 2001

K012396

## 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 9115 Hague Rd. name, address, Indianapolis, IN 46250 contact [phone]

Contact Person: Jennifer Tribbett

Date Prepared: October 2, 2001

The device name, including both the trade/proprietary name and classification 2) Device Name name is provided below.

| Product Name | Classification<br>Name | Product<br>Code | Regulation<br>Number | Predicate Device<br>Name | Date Predicate<br>Cleared | Predicate<br>510(k) |
|-------------------|----------------------------------------------|-----------------|----------------------|--------------------------------------|---------------------------|---------------------|
| OnTrak TesTcard 9 | Amphetamines test<br>system | 91DKZ | 862.3100 | Triage® Panel | 12/03/97 | K973784 |
| OnTrak TesTcard 9 | Barbiturates test<br>system | 91DIS | 862.3150 | Triage® Panel | 12/03/97 | K973784 |
| OnTrak TesTcard 9 | Benzodiazepines<br>test systems | 91JXM | 862.3170 | Triage® Panel | 12/03/97 | K973784 |
| OnTrak TesTcard 9 | Cocaine test<br>systems | 91DIO | 862.3250 | Triage® Panel | 12/03/97 | K973784 |
| OnTrak TesTcard 9 | Methamphetamines<br>test system | 91LAF | 862.3610 | OnTrak TesTstik™<br>Methamphetamines | 04/26/00 | K000096 |
| OnTrak TesTcard 9 | Morphine test<br>systems | 91DJJ | 862.3640 | Triage® Panel | 12/03/97 | K973784 |
| OnTrak TesTcard 9 | PCP test systems | 91LCM | Not<br>Assigned | Triage® Panel | 12/03/97 | K973784 |
| OnTrak TesTcard 9 | Tricyclic<br>antidepressants test<br>systems | 91LFG | 862.3910 | Triage® Panel | 12/03/97 | K973784 |
| OnTrak TesTcard 9 | Cannabinoid test<br>systems | 91LDJ | 862.3870 | Triage® Panel | 12/03/97 | K973784 |

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We claim substantial equivalence to the currently marketed Biosite 3) Predicate Diagnostics Triage® Panel Plus TCA (K973784) and the Roche Diagnostics device Corporation, OnTrak TesTstikTM Methamphetamines (K000096).

The OnTrak TesTcard 9 is an in vitro test intended for use by health care 4) Device professionals only for the qualitative detection of drug or drug metabolites in Description urine. The OnTrak TesTcard 9 profile (cutoff) consists of amphetamines (1000 ng/ml), barbiturates (200 ng/ml), benzodiazepines (100 ng/ml), cocaine metabolite (300 ng/ml), methamphetamine (500 ng/ml), morphine (300 ng/ml), PCP (25 ng/ml), tricyclic antidepressants (1000 ng/ml) and THC (50 ng/ml).

> The TesTcard 9 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.

> When the TesTcard 9 contacts the urine sample, the sample is absorbed into the TesTcard 9 sample pad. The absorbed sample travels through the reagent strips 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 conjugates and blue bands are formed in the result areas.

> When drugs are present in the specimen, they bind to the respective antibodycoated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the appropriate drug conjugate and no blue band is formed in the result area below the drug name. A positive sample causes the membrane to remain white.

> An additional antibody/antigen reaction occurs at the "TEST VALID" area. The "TEST VALID" blue band forms when antibodies, 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 valid, and the results are ready to interpret.

The TesTcard 9 assays are based on the principle of microparticle capture 5. Technology Characteristics 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.

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## OnTrak TesTcard 9 is substantially equivalent to the currently marketed 6. Substantial Equivalence Biosite Diagnostics Triage® Panel Plus TCA (K973784) and the Roche Diagnostics Corporation, OnTrak TesTstik™ Methamphetamines (K000096). The following table describes the similarities and differences between the devices.

| Item | OnTrak TesTcard 9 | Triage® Panel | OnTrak TesTstik<br>Methamphetamine |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Methodology | Competitive microparticle<br>capture inhibition | Competitive binding immunoassay | Same as TesTcard 9 |
| Measurement | Qualitative | Same as TesTcard 9 | Same as TesTcard 9 |
| Sample Type | Urine | Same as TesTcard 9 | Same as TesTcard 9 |
| Cutoff | Amphetamines: 1000 ng/ml<br>Barbiturates: 200 ng/ml<br>Benzodiazepines: 100 ng/ml<br>Cocaine metabolite: 300 ng/ml<br>Methamphetamine: 500 ng/ml<br>Morphine: 300 ng/ml<br>PCP: 25 ng/ml<br>TCA: 1000 ng/ml<br>THC: 50 ng/ml | Amphetamines: 1000 ng/ml<br>Barbiturates: 300 ng/ml<br>Benzodiazepines: 300 ng/ml<br>Cocaine: 300 ng/ml<br>Opiates (Morphine): 300 ng/ml<br>PCP: 25 ng/ml<br>TCA: 1000 ng/ml<br>THC: 50 ng/ml | Methamphetamine: 500 ng/ml |
| Reagent<br>(active<br>ingredients) | •Microparticles coated with<br>mouse monoclonal anti-<br>amphetamine and anti-<br>barbiturate analogs,<br>anti-benzoylecgonine,<br>anti-methamphetamine,<br>anti-morphine, anti-<br>phencylidine, anti-TCA and<br>anti-cannabinoid, sheep<br>polyclonal anti-benzodiazepine<br>analog and BSA in a buffered<br>solution containing<br>preservative and dried on a<br>membrane.<br><br>•Drug or drug analog<br>conjugates immobilized on a<br>membrane<br><br>•Mouse monoclonal anti-BSA<br>immobilized on membrane | • Mouse monoclonal antibodies<br>against phencyclidine,<br>benzodiazepine metabolites,<br>benzoylecgonine, amphetamines,<br>THC, morphine, barbiturates and<br>tricyclic antidepressants<br>immobilized on a membrane<br><br>• Mouse monoclonal antibodies<br>against phencyclidine,<br>benzodiazepine metabolites,<br>benzoylecgonine, amphetamines,<br>THC, morphine, barbiturates and<br>tricyclic antidepressants lyophilized<br>in a protein matrix containing<br><0.01% sodium azide<br><br>• Drugs and drug derivatives<br>conjugated to colloidal gold,<br>lyophilized in a protein matrix<br>containing <0.01% sodium azide<br><br>• Lyophilized buffer | • Microparticles coated with<br>mouse monoclonal<br>anti-methamphetamine<br>antibody, and BSA in a<br>buffered solution containing<br>preservative and dried on a<br>membrane.<br><br>• Drug conjugates<br>immobilized on a membrane.<br><br>• Mouse monoclonal anti-<br>BSA immobilized on a<br>membrane. |

ﭘﻨ

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 0 5 2001

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

Re: k012396

Trade/Device Name: Roche Diagnostics Corporation, OnTrak TesTcard 9 Regulation Number: 21 CFR 862.3100; 21 CFR 862.3150; 21 CFR 862.3170; 21 CFR 862.3250; 21 CFR 862.3610; 21 CFR 862.3640; Not Assigned; 21 CFR 862.3910; 21 CFR 862 3870 Regulation Name: Amphetamines test system; Barbiturates test system; Benzodiazepines test systems; Cocaine test systems; Methamphetamines test system; Morphine test systems; PCP test systems; Tricyclic antiepressants test Systems; Cannabinoid test systems Regulatory Class: Class II; Class II; Class II; Class II; Class II; Class II; Class II; Class II: Class II Product Code: DKZ; DIS; JXM; DIO; LAF; DJJ; LCM; LFG; LDJ Dated: October 3, 2001 Received: October 4, 2001

Dear Ms. Tribbett:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast be advised that I Dr o lessantes over device complies with other requirements of the Act that I DA has made a active regulations administered by other Federal agencies. You must of any I cacal statutes and regerments, including, but not limited to: registration and listing (21 Comply with an the For 8 requirements) and manufacturing practice requirements as set CFN in the quality systems (DF CFR Part 820); and if applicable, the electronic form in the quality by stations (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will anow yourse organ finding of substantial equivalence of your device to a legally premated predicated 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 11 you desire specific ad 1809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF It F 4- - 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general misters, International and Consumer 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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## NOV 0 5 2001

510(k) Number (if known): Ko12396 Device Name: Roche Diagnostics Corporation, OnTrak TesTcard 9

Indications for Use:

The Roche Diagnostics Corporation OnTrak TesTcard 9 is an in vitro diagnostic test intended for use by health care professionals only for the qualitative detection of drug or drug metabolites in urine. OnTrak TesTcard 9 simultaneously tests for the presence of multiple drugs or drug metabolites. The OnTrak TesTcard 9 profile (cutoff) consists of amphetamines (1000 ng/ml), barbiturates (200 ng/ml), benzodiazepines (100 ng/ml), cocaine metabolite (300 ng/ml), methamphetamine (500 ng/ml), morphine (300 ng/ml), tricyclic antidepressants (TCA-1000 ng/ml) and THC (50 ng/ml).

OnTrak TesTcard 9 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 test result, particularly when preliminary positive results are used.

Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K012396

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)

CONFIDENTIAL