MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT

K060896 · Varian, Inc. · DJC · Jun 9, 2006 · Clinical Toxicology

Device Facts

• Record ID: K060896
• Device Name: MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT
• Applicant: Varian, Inc.
• Product Code: DJC · Clinical Toxicology
• Decision Date: Jun 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3610
• Device Class: Class 2

Intended Use

TesTcup II and OnSite CupKit products are in vitro diagnostics tests intended for professional use for the qualitative detection of drug or drug metabolite in urine at or above the stated cutoff concentrations. Cutoff Concentrations: Amphetamines: 1000 ng/mL Benzodiazepines: 200 ng/mL Cocaine metabolite: 300 ng/mL Methamphetamine: 300 ng/mL Methamphetamine: 500 ng/mL Morphine: 300 ng/mL Morphine (M2K): 2000 ng/mL Phencyclidine (PCP): 25 ng/mL Tetrahydrocannabinols: 50 ng/mL

Device Story

In vitro diagnostic test for qualitative detection of drugs of abuse in urine; utilizes immunochromatographic assay with microparticle capture inhibition. Urine collected in test cup; drug profile card inserted into lid holder; capillary action draws urine into card. Competition occurs between drug in urine and immobilized drug conjugate on membrane; absence of drug allows antibody-coated microparticles to bind conjugate, forming blue band. Presence of drug inhibits binding, resulting in absence of blue band (preliminary positive). Used in professional settings; visually read by operator. Provides preliminary results requiring confirmation by specific alternate chemical method. Benefits include rapid, point-of-care screening for drug presence.

Clinical Evidence

Bench testing only. Method comparison study performed using 100 negative and 50 positive clinical urine specimens. Negative samples confirmed by GC/MS. Positive samples evaluated against GC/MS values, including samples near the 300 ng/mL cutoff (75-125%). Precision study conducted with 378 devices across 6 concentrations (0-450 ng/mL) over 3 days. Analytical specificity tested against various methamphetamine-related compounds to determine cross-reactivity thresholds.

Technological Characteristics

Microparticle capture inhibition assay. Components: urine collection cup, drug profile card, antibody-coated microparticles, drug conjugate membrane. Visual readout via blue band formation. Standalone, non-electronic, manual test.

Indications for Use

Indicated for professional use for qualitative detection of drugs/metabolites in human urine. Target analytes: amphetamines, benzodiazepines, cocaine metabolite, methamphetamine, morphine, phencyclidine (PCP), and tetrahydrocannabinols (THC) at specified cutoff concentrations. Provides preliminary results requiring confirmation by alternate chemical methods.

Regulatory Classification

Identification

A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

Special Controls

*Classification.* Class II (special controls). A methamphetamine 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® II and OnSite CupKit™ (k033902)

Submission Summary (Full Text)

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JUN - 9 2006

K060896

### 510(k) Summary

According to the requirements of 21 CFR 807.92, the following Introduction information provides sufficient detail to understand the basis for a determination of substantial equivalence. Varian, Inc. 1) Submitter 25200 Commercentre Drive name, address, Lake Forest, CA 92630 contact [phone] Contact: Lorna Gamboa Date Prepared: March 24, 2006 Proprietary Name: OnTrak TesTcup® II and 2) Device Name OnSite CupKit Panel: Toxicology Product Regulation Code Number Classification Name: 862.3100 Enzyme Immunoassay, Amphetamines DKZ Enzyme Immunoassay, Benzodiazepines 862.3170 JXM Enzyme Immunoassay, Cocaine and Cocaine 862.3250 DIO Metabolite Enzyme Immunoassay, Opiate DIG 862.3650 Enzyme Immunoassay, Phencyclidine Unclassified LCM Enzyme Immunoassay, Cannabinoids LDJ 862.3870 Thin Layer Chromatography, Methamphetamine DIC 862.3610 We claim substantial equivalence to these legally marketed devices: 3) Predicate Device OnTrak TesTcup® II and OnSite CupKit™ , K033902, 01/20/2004 The OnTrak TesTcup II and OnSite Cupkit assays contained in this 4) Device submission are in vitro diagnostic tests intended for professional use in the Description qualitative detection of amphetamines (d,1-amphetamine 1000 ng/mL), benzodiazepines (oxazepam 200 ng/mL), cocaine metabolite (benzoylecgonine 300 ng/mL), methamphetamine (d-methamphetamine 500 ng/mL), and methamphetamine (d-methamphetamine 300 ng/mL), morphine (morphine 300 ng/mL), and morphine (morphine 2000 ng/mL), PCP (phencyclidine 25 ng/mL) and THC (11-nor-Δ'-THC-9-carboxylic

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acid 50 ng/mL).

The 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 test cup provided. The drug profile card is placed in the samples by inserting it into the lid holder, then securing the lid onto the cup. Urine is drawn in the profile card by capillary action and reacts with antibody-coated microparticles and drug conjugate present on the membrance. In the absence of drug, the antibody is free to interact with the drug conjugate, causing the formation of a blue band.

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 at the result window. A preliminary positive ("non-negative") result is the absence of a blue band.

An additional antibody/antigen reaction occurs at the "VALID" area. The "VALID" blue band forms when antibodies, which are imbedded in the reagent membrane, interact with and bind to the antigen on the blue microparticles.

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

Like the predicate devices, the modified TesTcup II and CupKit utilize microparticle capture inhibition.

#### 6) Substantial Equivalence

The modified TesTcup II and CupKit devices have the same intended use and incorporate the same fundamental scientific technology as the predicate devices.

| | TesTcup II and CupKit | Predicates |
|--------------------------|--------------------------------------------|------------|
| Intended Use | Qualitative detection of<br>drugs in urine | Same |
| Scientific<br>Technology | Microparticle capture<br>inhibition | Same |
| Sample<br>Matrix | Urine | Urine |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Lorna Gamboa Regulatory Affairs Manager Varian, Inc. Consumable Products 25200 Commercentre Drive Lake Forest, CA 92630

JUN - 9 2006

k060896 Re:

Trade/Device Name: OnTrak TesTcup® II and OnSite CupKit™ Regulation Number: 21 CFR§862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: DJC, DKZ, JXM, DIO, DNK, LCM, LDJ Dated: March 24, 2006 Received: April 3, 2006

Dear Ms. Gamboa:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice 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 510(k) This loter with and w Job he FDA finding of substantial equivalence of your device to a legally promation notification ' ' device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In of quotions on the promie Evaluation and Safety at [phone]. Also, please note the vial Diagnoutied "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may other bants gearch generational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Alberto Gutierrez, Ph.D.

Alberto Gutierrez, Ph.D. 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 (if known): ری 668 96

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

TesTcup II and CupKit products are in vitro diagnostics tests mended for professional use for the qualitative detection of drug or drug metabolite in urine at or above the stated cutoff concentrations:

Cutoff Concentrations:

- Amphetamines: Benzodiazepines: Cocaine metabolite: Methamphetamine: Methamphetamine:
1000 ng/mL 200 ng/mL 300 ng/mL 500 ng/mL 300 ng/mL

Morphine: Morphine (M2K): Phencyclidine (PCP): Tetrahydrocannabinols:

300 ng/mL 2000 ng/mL 25 ng/mL 50 ng/mL

TesTcup II and CupKit products provide only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Carol C Benson
Division Sign Off

**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

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