QUICKSCREEN COCAINE 150 SCREENING TEST

K103295 · Phamatech, Inc. · DIO · Feb 1, 2012 · Clinical Toxicology

Device Facts

• Record ID: K103295
• Device Name: QUICKSCREEN COCAINE 150 SCREENING TEST
• Applicant: Phamatech, Inc.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Feb 1, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Indications for Use

The QuickScreen Drug Screening Test System is a rapid, qualitative immunoassay for the detection of amphetamine, barbiturates, benzodiazepines, cocaine, methadone, methamphetamines, opiates, oxycodone, phencyclidine and THC or their metabolites in urine. This assay is intended to assist in the prevention of drug abuse. The QuickScreen Drug Screening Test System is for in-vitro diagnostic use and is intended for use in point-of-care settings.

Device Story

QuickScreen Drug Screening Test System is a lateral flow immunoassay for qualitative detection of drugs of abuse in urine. Device formats include integrated cup, dip card, and cassette. Operates via immunochemical sandwich principle: antibody/target drug/antibody complexes form visible lines. Used in point-of-care settings by technicians. Provides preliminary results; requires confirmatory testing (e.g., GC/MS) for clinical decision-making. Benefits include rapid screening to assist in drug abuse diagnosis and treatment.

Clinical Evidence

Bench testing only. Precision/reproducibility studies conducted over 20 days at 4 sites using 3 operators; results showed high agreement across concentrations. Method comparison study using 160 clinical samples compared to GC/MS demonstrated 98% agreement. Additional evaluation of 80 clinical samples by typical operators confirmed 97-100% agreement across all device formats. Specificity testing confirmed no interference from pH (4.0-9.0), specific gravity (1.002-1.040), or numerous structurally related/unrelated compounds.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Formats: dip card, cassette, integrated cup. Qualitative visual readout. No electronic components or software. Storage: 15–28 °C. Shelf life: 20 months.

Indications for Use

Indicated for qualitative detection of cocaine (benzoylecgonine) and other drugs of abuse in urine for point-of-care professional use. Used in diagnosis and treatment of drug abuse. Provides preliminary results; requires GC/MS confirmation.

Regulatory Classification

Identification

A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

Special Controls

*Classification.* Class II (special controls). A cocaine and cocaine metabolite 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

• At Home Drug Test Models 9308T and 9308Z (K070009)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k103295

B. Purpose for Submission:
Device Modification: Change in the cocaine cutoff concentration from 300 ng/mL to 150 ng/mL for previously cleared devices (in single drug format and multi drug format)

C. Measurand:
Cocaine (benzoylecgonine)

D. Type of Test:
Qualitative, lateral flow immunoassay

E. Applicant:
Phamatech, Inc.

F. Proprietary and Established Names:
QuickScreen Cocaine 150 Test Dip Card Model 9050T
QuickScreen Cocaine 150 Test Cassette Model 9051
QuickScreen Multi Drug Screening Test Model 9339T
QuickScreen Drug Cup Model 9339Z

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DIO | Class II | 21 CFR § 862.3250 | Toxicology (91) |

H. Intended Use:
1. Intended use(s):
See indications for use below.

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2. Indication(s) for use:

QuickScreen Cocaine 150 Test Models 9050T, 9051

The QuickScreen Cocaine 150 Test is an in-vitro diagnostic test for the detection/presence of cocaine (benzoylecgonine) in urine. The cut-off concentration is 150 ng/mL. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. This test is intended for point-of-care testing.

This test provides only preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.

QuickScreen Multi Drug Screening Test: Model 9339T

The QuickScreen Multi Drug Screening Test is an in-vitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, barbiturates, benzodiazepines, methadone and THC in urine. Tests for barbiturates cannot distinguish between abused drugs and certain prescribed medications. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. This test is intended for point-of-care testing.

| Analyte | Calibrator | Cutoff |
| --- | --- | --- |
| Amphetamine | d amphetamine | 1000 ng/ml |
| Cocaine | Benzoylecgonine | 150 ng/mL |
| Methamphetamine | d methamphetamine | 500 ng/mL |
| Opiates | Morphine | 300 ng/mL |
| PCP | Phencyclidine | 25 ng/mL |
| Barbiturates | Secobarbital | 300 ng/mL |
| Benzodiazepines | Oxazepam | 200 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| THC | Cannabinoids | 50 ng/mL |

This test provides only preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.

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QuickScreen Drug Cup: Model 9339Z

An in-vitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, barbiturates, benzodiazepines, methadone, oxycodone and THC in urine. Tests for barbiturates cannot distinguish between abused drugs and certain prescribed medications. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. This test is intended for point-of-care testing.

| Analyte | Calibrator | Cutoff |
| --- | --- | --- |
| Amphetamine | d amphetamine | 1000 ng/ml |
| Cocaine | Benzoylecgonine | 150 ng/mL |
| Methamphetamine | d methamphetamine | 500 ng/mL |
| Opiates | Morphine | 300 ng/mL |
| PCP | Phencyclidine | 25 ng/mL |
| Barbiturates | Secobarbital | 300 ng/mL |
| Benzodiazepines | Oxazepam | 200 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| THC | Cannabinoids | 50 ng/mL |

This test provides only preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.

3. Special conditions for use statement(s):

This test provides only preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.

For prescription and point-of-care use only

4. Special instrument requirements:

Not applicable

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I. Device Description:

The single cocaine test and multi drug test device employs lateral flow immunochromatographic technology and is based on the principle of competitive binding. The device is available in the cassette, dipstick and cup formats.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Acon One Step Cocaine 150 Test Strip
Pharmatech At Home Drug Test

2. Predicate K number(s):

k032903 and k070009, respectively

3. Comparison with predicate:

| Item | Proposed Device
QuickScreen Multi
Drug Screening
Test and
QuickScreen Drug
Cup | Proposed
Device
QuickScreen
Cocaine 150
Test | Acon One
Step Cocaine
150 Test Strip | Phamatech At Home
Drug Test |
| --- | --- | --- | --- | --- |
| Intended use | Qualitative
detection of drugs
of abuse in urine | Same | Same | Same |
| Analytes | cocaine
(benzoylecgonine)
THC, opiates,
amphetamine,
methamphetamine,
benzodiazepines,
barbiturates,
methadone PCP
and OXY | cocaine | cocaine | cocaine
(benzoylecgonine)
THC, opiates,
amphetamine, ecstasy
(MDMA),
methamphetamine,
benzodiazepines,
barbiturates,
methadone PCP and
OXY |

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| Item | Proposed Device QuickScreen Multi Drug Screening Test and QuickScreen Drug Cup | Proposed Device QuickScreen Cocaine 150 Test | Acon One Step Cocaine 150 Test Strip | Phamatech At Home Drug Test |
| --- | --- | --- | --- | --- |
| Format | Integrated Cup/dip card/cassette | dip card/cassette | Dip strip | Dip card |
| Specimen | Urine | Same | Same | Same |
| Cutoff (cocaine) | 150 ng/mL | 150 ng/mL | 150 ng/mL | 300 ng/mL |
| End User | Professional | Professional | Professional | Home Use |
| Methodology | Lateral flow immunoassay | Same | Same | Same |
| Qualitative | Yes | Same | Same | Same |

# K. Standard/Guidance Document Referenced (if applicable):

None were referenced

# L. Test Principle:

The device employs lateral flow immunochromatographic technology and is based on the principle of competitive binding. Drugs, if present in concentrations below the cutoff level, will not saturate the binding sites of the antibody coated particles on the drug specific test strips. The goat-anti-rabbit IgG antibody-coated particles will then be captured by immobilized drug-specific conjugate. If the level of drug in the urine specimen is below the cutoff concentration, the T line appears as a visible burgundy line. If the level of drug in the urine specimen is above the cutoff, no T line develops. The control line (C line) serves as an internal quality control of certain testing steps. It should always appear as a burgundy-colored band regardless of the presence of the drug if enough sample volume has been added to the test and if sample has correctly migrated up the test strip.

# M. Performance Characteristics (if/when applicable):

# 1. Analytical performance:

# a. Precision/Reproducibility:

Precision studies were performed using drug-free urine spiked to the following concentrations: cutoff, $+/-25\%$ , $+/-50\%$ , $+/-75\%$ and $200\%$ of the cutoff. Also, a negative control was tested over the 20 days. The samples were aliquots, randomized and blinded. A total of 20 determinations were made at each concentration. Testing was performed once a day over 20 days by 3

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operators at 4 point of care sites. One lot number of devices for each format was used in the study. Sample concentrations were confirmed by LC/MS or GC/MS. The results are displayed in the table below:

| Conc. | Multi card | | Cup | | Cassette | |
| --- | --- | --- | --- | --- | --- | --- |
| Site 1 | Neg | Pos | Neg | Pos | Neg | Pos |
| Negative | 10 | 0 | 10 | 0 | 10 | 0 |
| -75% | 20 | 0 | 20 | 0 | 20 | 0 |
| -50% | 20 | 0 | 20 | 0 | 20 | 0 |
| -25% | 20 | 0 | 20 | 0 | 20 | 0 |
| Cutoff | 0 | 20 | 0 | 20 | 0 | 20 |
| 125% | 0 | 20 | 0 | 20 | 0 | 20 |
| 150% | 0 | 20 | 0 | 20 | 0 | 20 |
| 175% | 0 | 20 | 0 | 20 | 0 | 20 |
| 200% | 0 | 20 | 0 | 20 | 0 | 20 |
| Conc. | Multi card | | Cup | | Cassette | |
| --- | --- | --- | --- | --- | --- | --- |
| Site 2 | Neg | Pos | Neg | Pos | Neg | Pos |
| Negative | 10 | 0 | 10 | 0 | 10 | 0 |
| -75% | 20 | 0 | 20 | 0 | 20 | 0 |
| -50% | 20 | 0 | 20 | 0 | 20 | 0 |
| -25% | 20 | 0 | 20 | 0 | 20 | 0 |
| Cutoff | 7 | 13 | 13 | 7 | 10 | 10 |
| 125% | 0 | 20 | 0 | 20 | 0 | 20 |
| 150% | 0 | 20 | 0 | 20 | 0 | 20 |
| 175% | 0 | 20 | 0 | 20 | 0 | 20 |
| 200% | 0 | 20 | 0 | 20 | 0 | 20 |
| Conc. | Multi card | | Cup | | Cassette | |
| --- | --- | --- | --- | --- | --- | --- |
| Site 3 | Neg | Pos | Neg | Pos | Neg | Pos |
| Negative | 10 | 0 | 10 | 0 | 10 | 0 |
| -75% | 20 | 0 | 20 | 0 | 20 | 0 |
| -50% | 20 | 0 | 20 | 0 | 20 | 0 |
| -25% | 20 | 0 | 20 | 0 | 20 | 0 |
| Cutoff | 5 | 15 | 8 | 12 | 5 | 15 |
| 125% | 0 | 20 | 0 | 20 | 0 | 20 |
| 150% | 0 | 20 | 0 | 20 | 0 | 20 |
| 175% | 0 | 20 | 0 | 20 | 0 | 20 |
| 200% | 0 | 20 | 0 | 20 | 0 | 20 |

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| Conc. | Multi card | | Cup | | Cassette | |
| --- | --- | --- | --- | --- | --- | --- |
| Site 4 | Neg | Pos | Neg | Pos | Neg | Pos |
| Negative | 10 | 0 | 10 | 0 | 10 | 0 |
| -75% | 20 | 0 | 20 | 0 | 20 | 0 |
| -50% | 20 | 0 | 20 | 0 | 20 | 0 |
| -25% | 20 | 0 | 20 | 0 | 20 | 0 |
| Cutoff | 0 | 20 | 0 | 20 | 0 | 20 |
| 125% | 0 | 20 | 0 | 20 | 0 | 20 |
| 150% | 0 | 20 | 0 | 20 | 0 | 20 |
| 175% | 0 | 20 | 0 | 20 | 0 | 20 |
| 200% | 0 | 20 | 0 | 20 | 0 | 20 |

b. Linearity/assay reportable range:

Not applicable, the device is intended for qualitative use.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Procedural controls are included in the test strip and device. A colored line appearing in the control zone is considered as an internal procedural control. It confirms sufficient specimen volume and adequate membrane wicking. Users are informed not to interpret the test if no red line appears in the control zone.

Control standards are not supplied with these tests; however it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance. User should follow local, state and federal guidelines for testing QC material.

Accelerated and real time studies for the device have been conducted. Protocols and acceptance criteria were described and found to be acceptable. The manufacturer claims the following expiration date:

When stored at 15–28 °C product is good until expiration date which is 20 months.

Real time studies have been conducted and are on-going.

Read time Stability was performed for Quickscreen Drug Screen Dip Card, Cup and Cassette. Five urine samples containing drug at the following concentration (zero, +/-25% and +/-50% of the cutoff) were used to perform

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the study. All samples were analyzed ten times at 1-5 minute intervals from 60 sec-20 minutes. Data supports the recommended read time of 5 minutes for each device.

# d. Detection limit:

Characterization of how the device performs analytically around the claimed cutoff concentration appears in the assay cut-off section, M.1.a, above.

# e. Analytical specificity:

Cross-reactivity was established by spiking structurally related compounds into drug-free urine and diluting each to obtain various concentrations. Results are expressed as a minimum concentration of metabolite or compound required to produce a response approximately equivalent to the cutoff concentration of the assay.

Structurally related:

| Compound | Tested Concentration (ug/mL) | Response equivalent to cutoff |
| --- | --- | --- |
| Benzoylecgonine | 150 | Positive |
| Benxoylecgonine | 300 | Positive |
| Ecgonine | 100 | Negative |
| Ecgonine methyl ester | 100 | Negative |
| Ephedrine d,l | 1000 | Negative |
| Epinephrine | 1000 | Negative |
| Metoclopramide | 300 | Negative |
| Pyrilamine | 100 | Negative |

Structurally un-related:

This study was performed by spiking structurally unrelated compounds and endogenous substances at a concentration of 100 or $1000\mu \mathrm{g / mL}$ into urine samples containing drug at $+ / - 50\%$ of the drug cutoff concentrations. The following compounds showed no interference when tested at the $+ / - 50\%$ drug concentration:

| Acetaminophen | Diphenhydramine | (+) Norephedrin |
| --- | --- | --- |
| Allobarbitol | 5,5-Diphenylhydantoin | Normorphine |
| Alphenal | Doxepin | Noroxymorophine |
| Alprazolam | Doxylamine | Nortriptyline |
| Alprazolam α OH | EDDP | Nylidrin |

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| Amenoglutetimide | Erythromycin | Orphenadrine |
| --- | --- | --- |
| Amitriptyline | Ethanol | Oxazepam |
| Amobarbital | Ethylmorphine | Oxycodone |
| Amphetamine d | Fenfluramine | Oxymetazoline |
| Amphetamine l | Fentanyl | Penicillin G |
| Apomorphine | Flunitrazepam | Pentazocine |
| Ampicillin | Flurazepam | Phentobarbital |
| Amoxicillin | Griseofluvin | Phencyclidine |
| Ascorbic Acid | Hexobarbital | Phenelzine |
| Asprin | Hydrocodone | Pheniramine |
| Barbital | Hydromorphine | Phenmetrazine |
| Barbituris Acid | Hydroxyzine | Phenobarbital |
| Benztropine methane sulfonate | Ibuprofen | Phenylethylamine |
| Bilirubin | Indomethacin | Phenylproanolamine |
| Bromazepam | Isoxsuprine | Phenytoin metabolite |
| Bropheniramine | Kanamycin | Prazepam |
| Buprenorphine | Ketamine | Protriptyline |
| Butabarbital | Levallorphan | (+) Propoxyphene |
| Butalbital | Levorphanol | d-Pseudophedrine |
| Butethal | Lidocane | S.S (-) Pseudoephedrine |
| Caffine | Lorazepam | R,R (-) Pseudoephedrine |
| Cannabidol | Lysergic Acid Diethylamine | Pyridium |
| Cannabinol | MDA | Pyrilamine |
| Cannabinol Δ 9 | MDE | Quinidine |
| Chlordiazepoxide | MDEA | Ranitidine |
| Chlorpromazine | MDMA | Salicyluric Acid |
| Chlorprothixene | Medazepam | Scopolamine |
| Clemastine | Meperidine | Tabutal |
| Choripramine | Mephentermine | Temazepam |
| Chonazepam | Metanephrine | THC: 9 carboxy-11-nor Δ 8 |
| Codeine | Methadone d,l | THC: 9 carboxy-11-nor Δ 9 |
| (-)-Cotinine | Methamphetamine d | Thioridazine |
| Creatinine | Methamphetamine l | Theothixene |
| Cyclizine | Methaqualone | Tranylcypromine |
| Cyclobenzaprine | Methylephedrine | Trimterene |
| | Methylphenidate | Triazolam |
| Cyclopentobarbital | Morphine | Triazolam α-OH |
| Cycosporin A | Morphine 3 β glucuronide | Triflupromazine |
| Cyprohaptadine | Nalorphine | Trihexyphenidyl |
| Demoxepam | Naloxone | Trimipramine |
| Desalkylflurazepam | Naltrexone | Triprolidine |
| Desipramine | Naphazoline | Tyramine |
| Dextromethorphan | Nefidipine | Urea |
| Dextropropoxyphene | Netilmicin | Uric Acid |

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| Diacetylmorphine | Nitrazepam | Verapamil |
| --- | --- | --- |
| Diazepam | Norcodeine | |
| Dihydrocodine | Nordoxepin | |

Evaluation of SG and pH on test results:

To test for possible positive and/or negative interference drug free urine were adjusted to the following pH concentrations 4.0, 5.0, 6.0, 7.0, 8.0 and 9.0.

Each of these samples were divided into five aliquots: urine, containing drug at $+/-25\%$ and $+/-50\%$ of the cutoff. Each sample was assayed in triplicate. No negative or positive interference due to pH was observed.

To test for possible positive and/or negative interference from specific gravity 5 urine samples having specific gravity from 1.002-1.040 were used. These samples had GC/MS concentration at $+/-25\%$ and $+/-50\%$ of the cutoff.

Each sample was assayed in triplicate. No negative or positive interference due to specific gravity was observed.

The testing results demonstrate that varying pH's and specific gravities do not affect urine testing results around each analyte cut-off.

f. Assay cut-off:

Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section, M1.a, above.

2. Comparison studies:

a. Method comparison with predicate device:

An in-house was conducted using 160 unaltered clinical samples tested on the dipcard device and compared to the GC/MS. Results are displayed below:

| COC150 | | Negative (<50% cutoff concentration by GC/MS) | Near cutoff negative (-50% to the cutoff concentration) | Near cutoff positive (cutoff to 50%) | High Positive (>50% cutoff) | % Agreement |
| --- | --- | --- | --- | --- | --- | --- |
| | Positive | 0 | 1 | 17 | 79 | 98% |
| | Negative | 29 | 32 | 2 | 0 | 98% |
| Cutoff Value | Pharmatech | Drug/Metabolite |
| --- | --- | --- |

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| (ng/mL) | Coc150 dipcard (POS/NEG) | GC/MS value (ng/mL) |
| --- | --- | --- |
| 150 | Positive | 143 |
| 150 | Negative | 158 |
| 150 | Negative | 154 |

Performance of the Quickscreen devices (dipcard, cup and cassette) was evaluated with 3 operators who are typical operators at this site. Operators tested 80 unaltered clinical urine samples (40 negative and 40 positive). The samples were blind labeled and sufficiently randomized and compared to GC/MS results. The results are presented in the tables below:

| Quickscreen COC150 | | Negative (<50% cutoff concentration by GC/MS) | Near cutoff negative (-50% to the cutoff concentration) | Near cutoff positive (cutoff to 50%) | High Positive (>50% cutoff) | % Agreement |
| --- | --- | --- | --- | --- | --- | --- |
| Dipcard | Positive | 0 | 1 | 17 | 28 | 100% |
| | Negative | 21 | 18 | 0 | 0 | 97% |
| Cup | Positive | 0 | 1 | 17 | 28 | 100% |
| | Negative | 21 | 18 | 0 | 0 | 97% |
| Cassette | Positive | 0 | 1 | 17 | 28 | 100% |
| | Negative | 21 | 18 | 0 | 0 | 97% |
| Cutoff Value (ng/mL) | Pharmatech Coc150 (POS/NEG) | Drug/Metabolite GC/MS value (ng/mL) |
| --- | --- | --- |
| 150 | Positive (card) | 144 |
| 150 | Positive (cup) | 144 |
| 150 | Positive (cassette) | 144 |

All study participants completed questionnaires after they performed the test and recorded their results. The questionnaires covered evaluation of the package insert regarding the directions for performing the test, the ease of performing the test, directions for interpreting the results, and ease of interpretation of the results. These questionnaires demonstrated that the test instructions were easy to understand and that the testing procedure was easy to perform and the results were easy to read.

b. Matrix comparison:

Not applicable. The assay is intended for only one sample matrix, urine

3. Clinical studies:

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a. Clinical Sensitivity:
Not applicable.

b. Clinical specificity:
Not applicable.

c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable.

4. Clinical cut-off:
Not applicable.

5. Expected values/Reference range:
Not applicable.

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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