ONTRAK TESTCUP II AND ONSITE CUPKIT

K033902 · Varian, Inc. · DKZ · Jan 20, 2004 · Clinical Toxicology

Device Facts

• Record ID: K033902
• Device Name: ONTRAK TESTCUP II AND ONSITE CUPKIT
• Applicant: Varian, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Jan 20, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

TesTcup II and CupKit products are in vitro diagnostics tests intended for professional use for the qualitative detection of drugs or drug metabolites 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: 500 ng/mL; Morphine: 300 ng/mL; Morphine (M2K): 2000 ng/mL; Phencyclidine (PCP): 25 ng/mL; Tetrahydrocannabinols (THC): 50 ng/mL. TesTcup II and CupKit products provide only a preliminary analytical test result. A more specific analytical method must be used in order to obtain a confirmed analytical result.

Device Story

OnTrak TesTcup II and OnSite CupKit are in vitro diagnostic urine drug test cups for professional use. Device utilizes microparticle capture inhibition immunoassay. Urine collected in cup; drug profile card inserted into lid. Capillary action draws urine into card, reacting with antibody-coated microparticles and drug conjugate on membrane. In absence of drug, antibody binds conjugate, forming blue band. Presence of drug inhibits binding, preventing blue band formation (preliminary positive). 'VALID' band confirms test function. Results interpreted visually by clinician. Provides preliminary screening; requires confirmatory testing (e.g., GC/MS) for clinical decision-making. Benefits include rapid, point-of-care detection of drug presence.

Clinical Evidence

Clinical evaluation performed in a SAMHSA-certified laboratory comparing device results to GC/MS reference methods and predicate devices (OnTrak TesTstik 2). Study included clinical specimens across all drug analytes. Results demonstrated high concordance with GC/MS and predicate devices, with overall percent agreement ranging from 96% to 100% across different drug classes.

Technological Characteristics

Modified strip casing configuration; attachment of strips to cap; different casing materials compared to predicate. Fundamental scientific technology unchanged.

Indications for Use

Indicated for professional use for qualitative detection of amphetamines, benzodiazepines, cocaine metabolite, methamphetamine, morphine, PCP, and THC in human urine at specified cutoff concentrations. Provides preliminary analytical results requiring confirmation by a more specific method.

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).

Submission Summary (Full Text)

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-

| 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 | Varian, Inc.<br>25200 Commercentre Drive<br>Lake Forest, CA 92630<br>[phone]<br><br>Contact: Lorna Gamboa |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | December 15, 2003 |

| 2) Device Name | Proprietary Name: OnTrak TesTcup® II and OnSite CupKit™<br><br>Panel: Toxicology |
|----------------|----------------------------------------------------------------------------------|
|----------------|----------------------------------------------------------------------------------|

| Classification Name: | Product Code | Regulation Number |
|----------------------------------------------------|--------------|-------------------|
| Enzyme Immunoassay, Amphetamine | DKZ | 862.3100 |
| Enzyme Immunoassay, Benzodiazepine | JXM | 862.3170 |
| Enzyme Immunoassay, Cocaine and Cocaine Metabolite | DIO | 862.3250 |
| Enzyme Immunoassay, Opiate | DJG | 862.3650 |
| Enzyme Immunoassay, Phencyclidine | LCM | Unclassified |
| Enzyme Immunoassay, Cannabinoids | LDJ | 862.3870 |
| Thin Layer Chromatography, Methamphetamine | DJC | 862.3610 |

| 3) Predicate Device | We claim substantial equivalence to these currently marketed devices:<br><br>OnTrak TesTcup® 501, K001421, 7/12/2000<br>OnTrak TesTcup 5 M2K, K994017, 1/27/2000<br>OnTrak TesTstik BNZ, K983174, 11/18/98<br>OnTrak TesTstik® 2 COC/THC, K994164, 4/13/2000 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 4) Device Description | The OnTrak TesTcup II and OnSite Cupkit assays contained in this submission are in vitro diagnostic tests intended for professional use for the qualitative detection of amphetamines (d,l-amphetamine 1000 ng/mL), benzodiazepines (oxazepam 200 ng/mL), cocaine metabolite (benzoylecgonine 300 ng/mL), methamphetamine (d-methamphetamine 500 ng/mL), morphine (morphine 300 ng/mL) and morphine 2000 (morphine 2000 ng/mL), PCP (phencyclidine 25 ng/mL), and THC (11-nor-Δ ⁹ -THC-9-carboxylic 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 membranc in the test chamber.

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| | Urine is collected directly in the test cup provided. The drug profile card is placed<br>in the samples by inserting it into the lid holder, then securing the lid onto the cup.<br>Urine is drawn in the profile card by capillary action and reacts with antibody-<br>coated microparticles and drug conjugate present on the membrane. In the<br>absence of drug, the antibody is free to interact with the drug conjugate, causing<br>the formation of a blue band. |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | When drug is present in the specimen, it binds to the antibody-coated<br>microparticles. If sufficient drug is present, the microparticles are inhibited from<br>binding the drug conjugate and no blue band is formed at the result window. A<br>preliminary positive ("non-negative" result is the absence of a blue band). |
| | An additional antibody/antigen reaction occurs at the "VALID" area.<br>The<br>"VALID" blue band forms when antibodies, which are imbedded in the reagent<br>membrane, interact with and bind to the antigen on the blue microparticles. |
| 5) Statement of<br>Intended Use | OnTrak TesTcup II and OnSite Cupkit assays are intended for professional use for<br>the qualitative detection of amphetamines (d,l-amphetamine 1000 ng/mL),<br>benzodiazepines (oxazepam 200 ng/mL), cocaine metabolite (benzoylecgonine<br>300 ng/mL), methamphetamine (d-methamphetamine 500 ng/mL), morphine<br>(morphine 300 ng/mL) and morphine 2000 (morphine 2000 ng/mL), PCP<br>(phencyclidine 25 ng/mL), and THC (11-nor-A9-THC-9-carboxylic acid 50<br>ng/mL). |
| 6) Technological<br>Characteristics | See "Summary of Testing" on the following pages. |
| Substantial<br>Equivalence | The TesTcup II and CupKit devices have the same intended use and incorporate<br>the same fundamental scientific technology as the predicate devices. |

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## 510(k) Summary (continued)

## Summary of testing

## Precision

The precision of TesTcup II and CupKit was determined by three operators across three different days, who tested 63 replicates on two lots using contrived specimens containing drugs or drug metabolites at various concentrations. The drug or drug metabolites were spiked into negative human urine pool and assayed by GC/MS. The results are summarized in the tables below.

All lots are required minimally to perform with a greater than 95% confidence level that negative results will be attained with drugs at 25% (1/4 X) of their respective cutoff concentrations, and a greater than 95% confidence level that positive results will be attained with drugs at 150% (1/-1/2 X) of their respective cutoff concentrations.

| Amphetamine (ng/ml) | Precision Results (%) | | | |
|---------------------|-----------------------|------|-------|------|
| Cutoff = 1000 ng/ml | Lot 1 | | Lot 2 | |
| | + | - | + | - |
| 0 | 0 | 100 | 0 | 100 |
| 250 | 0 | 100 | 0 | 100 |
| 500 | 12.7 | 87.3 | 4.8 | 95.2 |
| 750 | 93.6 | 6.4 | 88.9 | 11.1 |
| 1250 | 100 | 0 | 100 | 0 |
| 1500 | 100 | 0 | 100 | 0 |

| Morphine (ng/ml)<br>Cutoff = 2000 ng/ml | Precision Results (%) | | | |
|-----------------------------------------|-----------------------|------|-------|------|
| | Lot 1 | | Lot 2 | |
| | + | - | + | - |
| 0 | 0 | 100 | 0 | 100 |
| 500 | 0 | 100 | 0 | 100 |
| 1000 | 6.3 | 93.7 | 0 | 100 |
| 1500 | 80.9 | 19.1 | 31.7 | 68.3 |
| 2500 | 100 | 0 | 100 | 0 |
| 3000 | 100 | 0 | 100 | 0 |

| PCP (ng/ml)<br>Cutoff = 25 ng/ml | Lot 1 | | Lot 2 | |
|----------------------------------|-------|------|-------|------|
| | + | - | + | - |
| 0 | 0 | 100 | 0 | 100 |
| 6.25 | 0 | 100 | 0 | 100 |
| 12.5 | 0 | 100 | 0 | 100 |
| 18.75 | 4.7 | 95.3 | 6.3 | 93.7 |
| 31.25 | 95.2 | 4.8 | 100 | 0 |
| 37.5 | 100 | 0 | 100 | 0 |

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| Benzodiazepines (ng/ml)<br>Cutoff = 200 ng/ml | Precision Results (%) | | | |
|-----------------------------------------------|-----------------------|------|-------|------|
| | Lot 1 | | Lot 2 | |
| | + | - | + | - |
| 0 | 0 | 100 | 0 | 100 |
| 50 | 0 | 100 | 0 | 100 |
| 100 | 6.3 | 93.7 | 22.2 | 77.8 |
| 150 | 49.2 | 50.8 | 46 | 54 |
| 250 | 100 | 0 | 100 | 0 |
| 300 | 100 | 0 | 100 | 0 |

| Cocaine (ng/ml)<br>Cutoff = 300 ng/ml | Precision Results (%)<br>Lot 1 | | Lot 2 | |
|---------------------------------------|--------------------------------|------|-------|-----|
| | + | - | + | - |
| 0 | 0 | 100 | 0 | 100 |
| 75 | 0 | 100 | 0 | 100 |
| 150 | 55.6 | 44.4 | 19 | 81 |
| 225 | 100 | 0 | 93.7 | 6.3 |
| 375 | 100 | 0 | 100 | 0 |
| 450 | 100 | 0 | 100 | 0 |

| THC (ng/ml) | Precision Results (%) | | | |
|-------------------|-----------------------|-----|-------|------|
| Cutoff = 50 ng/ml | Lot 1 | | Lot 2 | |
| | + | - | + | - |
| 0 | 0 | 100 | 0 | 100 |
| 12.5 | 0 | 100 | 0 | 100 |
| 25 | 0 | 100 | 0 | 100 |
| 37.5 | 0 | 100 | 9.5 | 90.5 |
| 62.5 | 96.8 | 3.2 | 100 | 0 |
| 75 | 100 | 0 | 100 | 0 |

| Morphine (ng/ml)<br>Cutoff = 300 ng/ml | Precision Results (%) | | | |
|----------------------------------------|-----------------------|-------|-----|------|
| Lot 1 | | Lot 2 | | |
| | + | - | + | - |
| 0 | 0 | 100 | 0 | 100 |
| 75 | 0 | 100 | 0 | 100 |
| 150 | 0 | 100 | 0 | 100 |
| 225 | 17.5 | 82.5 | 1.6 | 98.4 |
| 375 | 100 | 0 | 100 | 0 |
| 450 | 100 | 0 | 100 | 0 |

:

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| Methamphetamine(ng/ml)<br>Cutoff = 500 ng/ml | Precision Results (%)<br>Lot 1 | | Lot 2 | |
|----------------------------------------------|--------------------------------|------|-------|------|
| | + | - | + | - |
| 0 | 0 | 100 | 0 | 100 |
| 125 | 0 | 100 | 0 | 100 |
| 250 | 6.3 | 93.7 | 0 | 100 |
| 375 | 79.4 | 20.6 | 66.7 | 33.3 |
| 625 | 100 | 0 | 100 | 0 |
| 750 | 100 | 0 | 100 | 0 |

## Specificity

The following structurally similar compounds for amphetamine, benzodiazepines, cocaine, methamphetamine, morphine, PCP and THC were tested for cross reactivity with TesTcup II/CupKit. memailling, its primered in normal human urine. The results are expressed as that amount of the compound capable of giving a result equivalent to the cutoff for that assay.

| Amphetamine-related Compounds | Minimum Concentration Required to give a positive result (ng/ml) |
|---------------------------------|------------------------------------------------------------------|
| d-Amphetamine | 500 |
| Methylenedioxyamphetamine (MDA) | 5000 |
| l-Amphetamine | 25,000 |
| β-Phenethylamine | 100,000 |
| d,l-Phenylpropanolamine | 100,000 |
| d,l-Methamphetamine | >100,000 |

| Benzodiazepines-related Compounds | Minimum Concentration Required to give a<br>positive result (ng/ml) |
|-----------------------------------|---------------------------------------------------------------------|
| 7-Aminoflunitrazepam | 100 |
| Bromazepam | 100 |
| Didesethylflurazepam | 100 |
| 7-Aminonitrazepam | 100 |
| α-Hydroxyalprazolam | 100 |
| α-Hydroxytriazolam | 100 |
| Norfludiazepam | 100 |
| Nordiazepam | 100 |
| Temazepam | 100 |
| Clonazepam | 250 |
| Lorazepam | 250 |
| Chlorazepate | 250 |
| Flurazepam | 250 |
| Desmethylflunitrazepam | 250 |
| Alprazolam | 250 |
| Diazepam | 250 |
| Demoxepam | 500 |

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| Triazolam | 500 |
|------------------------|------|
| Hydroxyethylflurazepam | 1000 |
| Flunitrazepam | 1000 |
| Chlordiazepoxide | 2000 |

| Cocaine-related Compounds | Minimum Concentration Required to give a<br>positive result (ng/ml) |
|---------------------------|---------------------------------------------------------------------|
| Cocaine HCl | >100,000 |

| Methamphetamine-related Compounds | Minimum Concentration Required to give a<br>positive result (ng/ml) |
|-------------------------------------------|---------------------------------------------------------------------|
| Propylhexedrine | 1000 |
| d,l-Methamphetamine | 2000 |
| 3,4-Methylenedioxymethamphetamine (MDMA) | 2000 |
| l-Methamphetamine | 3000 |
| Fenfluramine | 5000 |
| p-Hydroxymethamphetamine | 5000 |
| 3,4-Methylenedioxyethylamphetamine (MDEA) | 10,000 |
| d-Amphetamine | 25,000 |
| l-Phenylephrine | 50,000 |
| d,l-Ephedrine | 50,000 |
| Ranitidine | 50,000 |
| β-Phenethylamine | 50,000 |
| d,l-Amphetamine | 50,000 |
| 3,4-Methylenedioxyamphetamine (MDA) | 100,000 |
| l-Amphetamine | >100,000 |

| Morphine-300-related Compounds | Minimum Concentration Required to give a<br>positive result (ng/ml) |
|--------------------------------|---------------------------------------------------------------------|
| Codeine | 250 |
| Ethyl morphine HCl | 250 |
| Dihydrocodeine bitartrate | 500 |
| 6-Acetylmorphine | 500 |
| Hydrocodone bitartrate | 500 |
| Morphine-3-glucuronide | 500 |
| Hydromorphone HCl | 1000 |
| Nalorphine | 2000 |
| Thebaine | 3000 |
| Levorphanol | 25,000 |
| Rifampin | 50,000 |
| N-Norcodeine HCl | 100,000 |
| Oxycodone | 100,000 |
| Meperidine | 100,000 |
| Atropine | >100,000 |
| THC-related Compounds | Minimum Concentration Required to give a<br>positive result (ng/ml) |

11-hydroxy - Δ° THC

50,000

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| Morphine-2000-related Compounds | Minimum Concentration Required to give a positive result (ng/ml) |
|---------------------------------|------------------------------------------------------------------|
| Codeine | 2000 |
| 6-Acetylmorphine | 2000 |
| Ethyl morphine HCl | 3000 |
| Dihydrocodeine bitartrate | 3000 |
| Morphine-3-glucuronide | 3000 |
| Hydrocodone bitartrate | 10,000 |
| Hydromorphone HCl | 10,000 |
| Nalorphine | 25,000 |
| Thebaine | 50,000 |
| Levorphanol | >100,000 |
| Rifampin | >100,000 |
| Oxycodone | >100,000 |

#### Cross-Reactivity with Additional Drugs

The following compounds were tested at 100,000 ng/ml and found not to cross-react with the (OnTrak TesTcup II or Onsite CupKit) assays (except as noted).

Acetominophen Acetylsalicylic acid 6-Acetylmorphine (except morphine assay) Alprazolam (except benzodiazepine assay) 7-Aminoflunitrazepam (except benzodiazepine assay) 7-Aminonitrazepam (except benzodiazepine assay) d.l-Amphetamine (except amphetamine and methamphetamine assay) d-Amphetamine (except amphetamine and methamphetamine assay) I-Amphetamine (except amphetamine and methamphetamine assay) Atropine Benzocaine Benzphetamine Bromazepam (except benzodiazepine assay) (±) Brompheniramine Buprenorphine Bupropion Chlorazepate (except benzodiazepine assay) Chlordiazepoxide (except benzodiazepine assay) Clonazepam (except benzodiazepine assav) Cocaine HCI (except Cocaine assay) Codeine (except morphine assay) Demoxepam (except benzodiazepine assay) Desmethylflunitrazepam (except benzodiazepine assay) Dextromethorphan Dextrorphan Diazepam (except benzodiazepine assay) Didesethylflurazepam (except benzodiazepine assay) Dihydrocodeine bitartrate (except morphine assay) Diphenhydramine d, l-Methamphetamine (except methamphetamine assay)

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Doxylamine d.l-Ephedrine (except methamphetamine assay) Ethyl morphine HCI (except morphine assay) Fenfluramine (except methamphetamine assay) Fenoprofen Flunitrazepam (except benzodiazepine assay) Flurazepam (except benzodiazepine assay) Gemfibrozil Hydrochlorothiazide Hydrocodone bitartrate (except morphine assay) Hydromorphone HCl (except morphine assay) a-Hydroxyalprazolam (except benzodiazepine assay) Hydroxybupropion Hydroxyethylflurazcpam (except benzodiazepine assay) >-Hydroxymethamphetamine (except methamphetamine assay) a-Hvdroxytriazolam (except benzodiazepine assay) Ibuprofen Ketamine Lansoprazole Levorphanol (except morphine assay) Lidocaine Lorazepam (except benzodiazepine assay) MDA (except amphetamine and methamphetamine assay) MDEA (except methamphetamine assay) MDMA (except methamphetamine assay) Meperidine (except morphine assay) d-Methamphetamine (except methamphetamine assay) d, l-Methamphetamine (except amphetamine and methamphetamine assay) I-Methamphetamine (except methamphetamine assay) Methylphenidate Morphine-3-glucuronide (except morphine assay) Nalorphine (except morphine assay) Naproxen N-Norcodeine HCl (except morphine assay) Nordiazepam (except benzodiazepine assay) Norfludiazepam (except benzodiazepine assay) Oxycodone (except morphine assay) B-Phenethylamine (except amphetamine and methamphetamine assay) /-Phenvlephrine (except methamphetamine assay) d.l-Phenvlpropanolamine (except amphetamine assay) Propylhexedrine (except methamphetamine assay) Quinidine Quinine Ranitidine (except methamphetamine assay) Rifampin (except morphine assay) Temazepam (cxcept benzodiazepine assay) Thebaine (except morphine assay) 11-hydroxy - A THC (except THC assay) A THC Triazolam (except benzodiazepine assay)

{8}------------------------------------------------

## Accuracy

TesTcup II and CupKit was evaluated in a SAMHSA certified laboratory using clinical specimens. The clinical negative samples were screened negative by an automated immunoassay and reported as negative according to SAMHSA guidelines. Clinical specimens screened positive by an automated immunoassay accessible to brinners goal binnel. Some samples were diluted with negative human urine to achieve the appropriate test range. Results are summarized below.

| THC<br>Cutoff = 50<br>ng/ml | | Negative<br>Samples | Near Cutoff | | > 125% of cutoff |
|-----------------------------|---|---------------------|--------------------------|---------------------------|------------------|
| | | | 75% to 100% of<br>Cutoff | 100% to 125% of<br>cutoff | |
| | + | 0 | 13 | 6 | 31 |
| | - | 100 | 0 | 0 | 0 |

Comparison with Reference Method (GC/MS):

| Cocaine<br>Cutoff = 300<br>ng/ml | Negative<br>Samples | GC/MS Values (ng/ml) | | |
|----------------------------------|---------------------|--------------------------|---------------------------|------------------|
| | | Near Cutoff | | > 125% of cutoff |
| + | 0 | 75% to 100% of<br>Cutoff | 100% to 125% of<br>cutoff | > 125% of cutoff |
| | | 6 | 7 | 35 |
| - | 100 | 1 | 1 | 0 |

| PCP<br>Cutoff = 25<br>ng/ml | | Negative<br>Samples | GC/MS Values (ng/ml) | | > 125% of cutoff |
|-----------------------------|---|---------------------|--------------------------|---------------------------|------------------|
| | | | Near Cutoff | | |
| | + | 0 | 75% to 100% of<br>Cutoff | 100% to 125% of<br>cutoff | 37 |
| | - | 100 | 8 | 0 | 0 |

| Amphetamine<br>Cutoff = 1000<br>ng/ml | | Negative<br>Samples | GC/MS Values (ng/ml) | | |
|---------------------------------------|--|---------------------|--------------------------|---------------------------|------------------|
| | | | Near Cutoff | | |
| | | | 75% to 100% of<br>Cutoff | 100% to 125% of<br>cutoff | > 125% of cutoff |
| + | | 0 | 6 | 5 | 29 |
| - | | 100 | 8 | 0 | 2* |

*GC/MS values for these samples were 1569 ng/mL and 1776 ng/mL.

| Methamphetamine<br>Cutoff = 500<br>ng/ml | | Negative<br>Samples | GC/MS Values (ng/ml)<br>Near Cutoff | | > 125% of cutoff |
|------------------------------------------|---|---------------------|-------------------------------------|---------------------------|------------------|
| | | | 75% to 100% of<br>Cutoff | 100% to 125% of<br>cutoff | |
| | + | 0 | 3 | 5 | 48 |
| | - | 100 | 2 | 0 | 0 |

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| Morphine<br>Cutoff = 300<br>ng/ml | Negative<br>Samples | GC/MS Values (ng/ml) | | |
|-----------------------------------|---------------------|--------------------------|---------------------------|------------------|
| | | Near Cutoff | | > 125% of cutoff |
| | | 75% to 100% of<br>Cutoff | 100% to 125% of<br>cutoff | |
| + | 0 | 7 | 8 | 46 |
| - | 100 | 0 | 0 | 0 |

| Morphine<br>(M2K)<br>Cutoff = 2000<br>ng/ml | | Negative<br>Samples | GC/MS Values (ng/ml)<br>Near Cutoff | | > 125% of cutoff |
|---------------------------------------------|--|---------------------|-------------------------------------|---------------------------|------------------|
| | | | 75% to 100% of<br>Cutoff | 100% to 125% of<br>cutoff | |
| + | | 0 | 7 | 5 | 35 |
| - | | 100 | 3 | 0 | 0 |

| Benzodiazepines<br>Cutoff = 200<br>ng/ml | Negative<br>Samples | GC/MS Values (ng/ml)<br>Near Cutoff | | > 125% of cutoff |
|------------------------------------------|---------------------|-------------------------------------|---------------------------|------------------|
| | | 75% to 100% of<br>Cutoff | 100% to 125% of<br>cutoff | |
| + | 0 | 6 | 8 | 50 |
| - | 100 | 0 | 0 | 0 |

## Comparison with predicate device

All of the above clinical specimens were also tested by, and results compared to, OnTrak TesTcup and OnTrak TesTstik. Results are summarized below.

| THC | | TesTstik 2 | |
|---------------------------------|---|------------|-----|
| Overall percent agreement = 98% | | + | - |
| New Test | + | 47 | 3 |
| | - | 0 | 100 |

| Cocaine | | |
|----------------------------------|--------------|--------------|
| Overall percent agreement = 100% | | |
| New Test | TesTstik 2 + | TesTstik 2 - |
| + | 48 | 0 |
| - | 0 | 102 |

| PCP<br>Overall percent agreement = 99% | | TesTstik 2 | |
|----------------------------------------|---|------------|-----|
| | | + | - |
| New Test<br>(CupKit) | + | 41 | 1 |
| | - | 0 | 108 |

{10}------------------------------------------------

| Amphetamines | | TesTstik 2 | |
|---------------------------------|---|------------|-----|
| Overall percent agreement = 97% | | + | - |
| New Test | + | 36 | 4 |
| | - | 0 | 110 |

| Methamphetamine<br>Overall percent agreement = 100% | | TesTstik 2 | |
|-----------------------------------------------------|---|------------|-----|
| | | + | - |
| New Test | + | 56 | 0 |
| | - | 0 | 102 |

| Morphine<br>Overall percent agreement = 100% | | TesTstik 2 | |
|----------------------------------------------|---|------------|-----|
| New Test | + | + | - |
| | - | 61 | 0 |
| | | 0 | 100 |

| Morphine 2000 (M2K)<br>Overall percent agreement = 96% | | TesTstik 2 | |
|--------------------------------------------------------|---|------------|-----|
| New Test | + | + | - |
| | - | 0 | 103 |
| | + | 41 | 6 |

| Benzodiazepines<br>Overall percent agreement = 100% | | TesTstik 2 | |
|-----------------------------------------------------|---|------------|-----|
| | | + | - |
| New Test | + | 64 | 0 |
| | - | 0 | 100 |

:

:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 0 2004

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

k033902 Re:

Trade/Device Name: On Trak TesTcup® II and OnSite CupKit™ Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ Dated: January 13, 2004 Received: January 14, 2004

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 for ass suace in 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 I ou may, ateres, 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 If your device 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 r 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 or uny 1 out 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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#### Page 2

This letter will allow you to begin marketing your device as described in your Section 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 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 Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, 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,

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS, D.V.M. 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 Statement

K033902 510(k) Number:________________________________________________________________________________________________________________________________________________________________

Device Name: __ OnTrak TesTcup® II and OnSite CupKit™_________________________________________________________________________________________________________________________

## Indications for Use:

TesTcup II and CupKit products are in vitro diagnostics tests intended for professional use for t es reap if and Capitiv of drugs or drug metabolites in urine at or above the stated cutoff concentrations.

### Cutoff Concentrations:

| Amphetamines: | 1000 ng/mL | Morphine: | 300 ng/mL |
|---------------------|------------|------------------------------|------------|
| Benzodiazepines: | 200 ng/mL | Morphine (M2K): | 2000 ng/mL |
| Cocaine metabolite: | 300 ng/mL | Phencyclidine (PCP): | 25 ng/mL |
| Methamphetamine: | 500 ng/mL | Tetrahydrocannabinols (THC): | 50 ng/mL |

TesTcup II and CupKit products provide only a preliminary analytical test result. A more res reap it and Caprevical method must be used in order to obtain a confirmed analytical result.

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

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Office of In Vitro Diagnostic Device Evaluation and Safety

KO33102 510(k) _______________________________________________________________________________________________________________________________________________________________________

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use