ON TRAK TESTCARD

K051235 · Varian, Inc. · DKZ · Jun 8, 2005 · Clinical Toxicology

Device Facts

• Record ID: K051235
• Device Name: ON TRAK TESTCARD
• Applicant: Varian, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Jun 8, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

The OnTrak TesTcard menus are various combinations of the different drugs that are listed below. The TesTcard products are in vitro diagnostic tests for the qualitative detection of drug or drug metabolite in urine. The TesTcard devices simultaneously test for the presence of multiple drugs or drug metabolites. The TesTcard profile (cutoff) consists of the following: Amphetamines (d,l-amphetamine 1000 ng/mL), Barbiturates (secobarbital 200 ng/mL), Benzodiazepines (oxazepam 100 ng/mL), Cocaine metabolite (benzoylecgonine 300 ng/mL), Methamphetamine (d-methamphetamine 500 ng/mL), Morphine (morphine 300 ng/mL), PCP (phencyclidine 25 ng/mL), Tricyclic Antidepressants (TCA) (imipramine 1000 ng/mL) and THC (11-nor-Δ9-THC-9-carboxylic acid 50 ng/mL). TesTcard products provide only preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.

Device Story

OnTrak TesTcard is an in vitro diagnostic device for qualitative drug screening in urine. Device utilizes microparticle capture inhibition; urine sample is absorbed into a pad and migrates via capillary action through reagent strips. Strips contain antibody-coated blue microparticles and immobilized drug conjugates. In absence of drug, microparticles bind to conjugates, forming blue bands. In presence of drug, microparticles bind to drug in sample, preventing band formation (negative result). A 'TEST VALID' band confirms proper test completion. Device is intended for professional use to provide preliminary results; positive results require confirmation by alternate chemical methods. Benefits include rapid, simultaneous multi-drug screening.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and performance of the previously cleared drug test strips.

Technological Characteristics

Microparticle capture inhibition assay. Device consists of reagent strips with antibody-coated blue microparticles and immobilized drug conjugates on a membrane. Form factor is a test card. No electronic components, software, or external energy sources required. Qualitative visual readout.

Indications for Use

Indicated for the qualitative detection of various combinations of 9 drugs using test strips.

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

• On Trak TesTcard 9 (K051235)

Submission Summary (Full Text)

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# JUN 8 - 2005

### 510(k) Summary

K051235
page 1 of 2

According to the requirements of 21 CFR 807.92, the following Introduction According to the requirements detail to understand the basis for a determination of substantial equivalence.

1) Submitter name, address, contact

Varian, Inc. 25200 Commercentre Drive Lake Forest, CA 92630 [phone]

Contact: Lorna Gamboa

Date Prepared: May 11, 2005

Proprietary Name: OnTrak TesTcard 2) Device Name

Panel: Toxicology

| Panel: Toxicology | | | |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|----------------------|
| | Classification Name: | Product<br>Code | Regulation<br>Number |
| | Enzyme Immunoassay, Amphetamine | DKZ | 862.3100 |
| | Enzyme Immunoassay, Barbiturate | DIS | 862.3150 |
| | Enzyme Immunoassay, Benzodiazepines | JXM | 862.3170 |
| | Enzyme Immunoassay, Cocaine and Cocaine<br>Metabolite | DIO | 862.3250 |
| | Fluorometry, Morphine | DJJ | 862.3640 |
| | Enzyme Immunoassay, Phencyclidine | LCM | Unclassified |
| | Enzyme Immunoassay, Cannabinoids | LDJ | 862.3870 |
| | Gas Chromatography, Methamphetamine | LAF | 862.3610 |
| | Radioimmunoassay, Tricyclic Antidepressant<br>Drugs | LFG | 862.3910 |
| 3) Predicate<br>Device | We claim substantial equivalence to this currently marketed device:<br>On Trak TesTcard 9, K012396, 11/05/2001<br>On Trak TesTcard 9, K050321, 04/18/2005 | | |
| 4) Device<br>Description | The OnTrak TesTcard assays contained in this submission are in vitro<br>diagnostic tests intended for the qualitative detection of drug or drug<br>metabolite in urine. The TesTcard devices simultaneously test for the<br>presence of multiple drugs or drug metabolites. The TesTcard profile<br>(cutoff) consists of amphetamines (d,l-amphetamine 1000 ng/mL),<br>barbiturates (secobarbital 200 ng/mL), benzodiazepines (oxazepam 100 | | |

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K051235
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(benzoylecgonine cocaine metabolite ng/mL). methamphetamine (d-methamphetamine 500 ng/mL), morphine (morphine 300 ng/mL), PCP (phencyclidine 25 ng/mL), tricyclic antidepressants (TCA) (imipramine 1000 ng/mL) and THC (11-nor-A-THC-9-carboxylic acid 50 ng/mL).

The TesTcard 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 contacts the urine sample, the sample is absorbed into the TesTcard 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 conjugates. In the absence of drugs 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 antibody-coated 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 specimen causes the membrane to remain white.

An additional antibody/antigen reaction occurs at the "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.

#### All drug test strips contained in the TesTcard products have been 5) Technological previously reviewed by FDA under the 510(k) numbers indicated in Characteristics Section 3 of this summary.

Like the predicate device, TesTcard devices utilize microparticle capture inhibition.

### 6) Substantial Equivalence

The TesTcard devices have the same intended use and incorporate the same fundamental scientific technology as the predicate device.

| | Testcard | Predicate |
|-----------------------|-----------------------------------------|-----------|
| Intended Use | Qualitative detection of drugs in urine | Same |
| Scientific Technology | Microparticle capture inhibition | Same |
| Sample Matrix | Urine | Same |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure, composed of three curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 8 - 2005

Ms. Lorna Gamboa RA/QA Manager Varian, Inc. 25200 Commercentre Drive Lake Forest, CA 92630

Re: k051235

Trade/Device Name: OnTrak TesTcard™ Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Regulatory Class: Class II
Product Code: DKZ, DIS, JXM, DIO, LAF, DJJ, LCM, LFG, LDJ Dated: May 11, 2005 Received: May 13, 2005

Dear Ms. Gamboa:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) premaince is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) is regars analysis and the Medical Device American Comments, or to commence program to May 20, 1978, the eccordance with the provisions of the Federal Food, Drug, devices that have been reclassified in accessfired in a premarket approval application (PMA). alle Costlictic Act (71ct) that do not required to the general controls provisions of the Act. The 1 ou may, merceroro, manov as act include requirements for annual registration, listing of general connols provisions of ractice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (bee acover) in s. Existing major regulations affecting your device It inay be subject to Such additional comiser - Marts 800 to 895. In addition, FDA can be louing in Title 21, Coursements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease of advised mat I Dri 3 issualled or wouldevice complies with other requirements of the Act that I Dri has made a associations administered by other Federal agencies. You must or any Federal statutes and regulations adminities or of not limited to: registration and listing (21 comply with an the Free STequirements 801 and 809); and good manufacturing practice and requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will allow you to begin naketing your actrice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of yo premarket notification. "The I DA miding of our device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, If you destic specific information and advertising of your device, please contact the Office of In or questions on the promotion and Safety at [phone]. Also, please note the Vitro Diagnostic Dovec Dranation and Bases to premarket notification" (21CFR Part \$07.97). regulation entitled, "Misoranant of Frience on your responsibilities under the Act from the You may ootan other general information on Joan Copyrer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benem

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

| 510(k) Number: | K051233 |
|----------------|---------|
|----------------|---------|

Device Name: __OnTrak TesTcard™

### Indications for Use:

The OnTrak TesTcard menus are various combinations of the different drugs hat are listed The On Frax TesTcard menus are various collegnostic tests for the qualitative detection of drug below. The Tes Icard products are in viro diagnoste the resence of multiple drugs or drug of the fictabolite in article (cutoff) consists of the following:

| | Cutoff Concentrations |
|----------------------------------------------|-----------------------|
| Amphetamines (d,I-amphetamine): | 1000 ng/mL |
| Barbiturates (secobarbital): | 200 ng/mL |
| Benzodiazepines (oxazepam): | 100 ng/mL |
| Cocaine metabolite (benzoylecgonine): | 300 ng/mL |
| Methamphetamine (d-methamphetamine): | 500 ng/mL |
| Morphine (morphine): | 300 ng/mL |
| PCP (phencyclidine): | 25 ng/mL |
| Tricyclic Antidepressants (TCA)(Imipramine): | 1000 ng/mL |
| THC (11-nor-Δ9-THC-9-carboxylic acid): | 50 ng/mL |

AND/OR

TesTcard products provide only preliminary analytical test result. A more specific alternate rest card products provide only porder to obtain a confirmed analytical result.

Prescription Use V (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Shutt Clam

Page 1 of 1

Division Sign-Off

Office of In Vitro Diagno Device Evaluation and

510(k) K051235

CONFIDENTIAL