MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE

K063545 · Alfa Scientific Designs, Inc. · DJG · May 7, 2007 · Clinical Toxicology

Device Facts

• Record ID: K063545
• Device Name: MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE
• Applicant: Alfa Scientific Designs, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: May 7, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

The proposed test is a lateral flow, one-step immunoassay for the qualitative detection of one or more drugs or drug metabolites in urine specimens. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The BAR, BZD, TCA test will yield preliminary positive results when BAR, BZD, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, tricyclic antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level. The proposed test is for health care professional including point of care use.

Device Story

Lateral flow immunoassay for qualitative detection of drugs of abuse in human urine. Input: urine specimen. Principle: competitive binding; drug-specific antibody-coated particles compete with immobilized drug conjugate for binding sites. Output: visual burgundy line (negative) or absence of line (positive) at test region; control line indicates valid migration. Used in professional settings (clinics) and OTC (home/consumer). Operator: healthcare professional or lay user. Output interpreted visually by user to determine presence/absence of drugs at specific cutoffs. Results are preliminary; require confirmatory testing via GC/MS or HPLC for clinical decision-making. Benefits: rapid screening for potential drug abuse.

Clinical Evidence

Bench testing only. Clinical performance evaluated by comparing device results to GC/MS confirmatory data. Sensitivity (93.5%-97.6%) and specificity (98%-100%) reported across various drug analytes. Overall agreement with GC/MS ranged from 96.1% to 98.3%. Reproducibility studies conducted at multiple sites (POLs and reference labs) showed agreement rates of 96.7%-97.9%.

Technological Characteristics

Lateral flow immunochromatographic assay. Competitive binding principle. Formats: dip strip and cassette. Visual readout. No instrumentation required. Internal control line for migration validation. Analyte-specific cutoffs (e.g., 100/300 ng/mL for oxycodone).

Indications for Use

Indicated for rapid qualitative screening of drugs of abuse (Amphetamine, Barbiturates, Buprenorphine, Benzodiazepine, Cocaine, Methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Tricyclics, Marijuana, MDMA) in human urine at specified cutoff levels. For professional, point-of-care, or OTC consumer use. Provides preliminary results; requires confirmatory testing (GC/MS or HPLC).

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate 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

• Instant-View Multi-Drug of Abuse Test (k022564)
• Instant-View Amphetamine Urine Test (k994395)
• Instant-View Cocaine Urine Test (k994403)
• Instant-View Methamphetamine Urine Test (k003845)
• Instant-View Propoxyphene Urine Test (k022915)
• Instant-View TCA Urine Test (k022693)
• Instant-View MDMA Screen Urine Test (k022501)
• Instant-View BUP/NBUP Screen Urine Test (k060527)
• Oxycodone (k033047)

Submission Summary (Full Text)

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

A. 510(k) Number:
k063545

B. Purpose for Submission:
This submission is for the addition of oxycodone (with 100 and 300 ng/mL cutoffs) and to change the cutoffs for amphetamine, methamphetamine and cocaine in the previously cleared devices. In addition, the multi-analyte drug of abuse cup/cassette will be marketed as over-the-counter (OTC) and for prescription use. Oxycodone, Buprenorphine, and Norbuprenorphine will not be OTC but will remain for prescription use only.

C. Measurand:
Oxycodone, amphetamine, methamphetamine, cocaine, barbiturates, benzodiazepines, morphine, methadone, phencyclidine, tricyclic antidepressants, THC, and methylenedioxymethamphetamine (MDMA).

D. Type of Test:
Qualitative Lateral Flow Immunoassay

E. Applicant:
Alfa Scientific Designs, Inc.

F. Proprietary and Established Names:

| Instant-View Amphetamine (300) Urine Test | Instant-Verdict Amphetamine (300) Urine Test | Amphetamine (300) Urine Test |
| --- | --- | --- |
| Instant-View Cocaine (150) Urine Test | Instant-Verdict Cocaine (150) Urine Test | Cocaine (150) Urine Test |
| Instant-View Methamphetamine (300) Urine Test | Instant-Verdict Methamphetamine (300) Urine Test | Methamphetamine (300) Urine Test |
| Instant-View Oxycodone (100) Urine Test | Instant-Verdict Oxycodone (100) Urine Test | Oxycodone (100) Urine Test |
| Instant-View Oxycodone (300) Urine Test | Instant-Verdict Oxycodone (300) Urine Test | Oxycodone (300) Urine Test |
| Instant-View Multi-Drug of Abuse Urine Test | Instant-Verdict Multi-Drug of Abuse Urine Test | Multi-Drug of Abuse Urine Test |

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G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DJG | II | 862.3650, Enzyme Immunoassay, Opiates | 91 (Tox) |
| DKZ | II | 862.3100, Enzyme Immunoassay, Amphetamine | 91 (Tox) |
| DIO | II | 862.3250, Enzyme Immunoassay, Cocaine and Cocaine Metabolites | 91 (Tox) |
| DJC | II | 862.3610, Thin Layer Chromatography, Methamphetamine | 91 (Tox) |
| DIS | II | 862.3120, Enzyme immunoassay, Barbiturate | 91 (Tox) |
| NFV (JXM) | II | 862.3170, Test, Benzodiazepine, over the counter | 91 (Tox) |
| NCI (DJG) | II | 862.3640, Test, Morphine, over the counter | 91 (Tox) |
| DJR | II | 862.3620, Enzyme Immunoassay, Methadone | 91 (Tox) |
| LCM | Unclassified, 510(k) required | 862.3100, Enzyme immunoassay, phencyclidine | 91 (Tox) |
| LFG | II | 862.3910, Thin layer chromatography, tricyclic antidepressant drugs | 91 (Tox) |
| LDJ | II | 862.3870, Enzyme Immunoassay, Cannabinoids | 91 (Tox) |

H. Intended Use:

1. Intended use(s):

See indications for use section below.

2. Indication(s) for use:

The Oxycodone (300) test is a qualitative immunoassay for the rapid detection of oxycodone from human urine specimens. The calibrator for the drug is oxycodone at a cutoff concentration of 300 ng/ml. It is for health care professional use only.

This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas

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Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

The Oxycodone (100) test is a qualitative immunoassay for the rapid detection of oxycodone from human urine specimens. The calibrator for the drug is oxycodone at the cutoff concentration of 100 ng/ml. It is for health care professional use only.

This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

The Methamphetamine (300) test is a qualitative immunoassay for the rapid detection of methamphetamine from human urine specimens. The calibrator for the drug is methamphetamine at the cutoff concentration of 300 ng/ml. It is for health care professional use only.

This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

The Cocaine (150) test device is a rapid qualitative immunoassay for the rapid detection of cocaine from human urine specimens. The calibrator for the drug is benzoylecgonine at cutoff concentration of 150 ng/ml. It is for health care professional use only.

This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

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The Amphetamine (300) test is a qualitative immunoassay for the rapid detection of amphetamine from human urine specimens. The calibrator for the drug is amphetamine at cutoff concentration of 300 ng/ml. It is for health care professional use only.

This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

The multi-drug of abuse device is a rapid qualitative immunoassay for screening potential abuse of one or more drugs listed below. The device detects any combination of the drugs or drug metabolites at or above the specified cut-off levels. It is for health care professional use.

| Abbreviation | Test | Cutoff |
| --- | --- | --- |
| AMP | Amphetamine | 1000 ng/ml |
| AMP300 | Amphetamine | 300 ng/ml |
| BAR | Barbiturates | 200 ng/ml |
| BUP | Buprenorphine/Norbuprenorphine | 10 ng/ml |
| BZD | Benzodiazepine | 300 ng/ml |
| COC | Cocaine | 300 ng/ml |
| COC150 | Cocaine | 150 ng/ml |
| MET | Methamphetamine | 1000 ng/ml |
| MET500 | Methamphetamine | 500 ng/ml |
| MET300 | Methamphetamine | 300 ng/ml |
| MOR | Morphine | 2000 ng/ml |
| MOR500 | Morphine | 500 ng/ml |
| MTD | Methadone | 300 ng/ml |
| OXY100 | Oxycodone | 100 ng/ml |
| OXY300 | Oxycodone | 300 ng/ml |
| PCP | Phencyclidine | 25 ng/ml |
| PPX | Propoxyphene | 300 ng/ml |
| TCA | Tricyclics | 1000 ng/ml |
| THC | Marijuana | 50 ng/ml |
| XTC | MDMA or Ecstasy | 500 ng/ml |

The BAR, BZD, TCA test will yield preliminary positive results when BAR, BZD, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, tricyclic antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High

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Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

The multi-drug of abuse device is a rapid qualitative immunoassay for screening potential abuse of one or more drugs listed below. The device detects any combination of the drugs or drug metabolites at or above the specified cut-off levels.

| Abbreviation | Test | Cutoff |
| --- | --- | --- |
| AMP | Amphetamine | 1000 ng/ml |
| BAR | Barbiturates | 200 ng/ml |
| BZD | Benzodiazepine | 300 ng/ml |
| COC | Cocaine | 300 ng/ml |
| MET | Methamphetamine | 1000 ng/ml |
| MOR | Morphine | 2000 ng/ml |
| MTD | Methadone | 300 ng/ml |
| PCP | Phencyclidine | 25 ng/ml |
| TCA | Tricyclics | 1000 ng/ml |
| THC | Marijuana | 50 ng/ml |
| XTC | MDMA or Ecstasy | 500 ng/ml |

This test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

The BAR, BZD, TCA test will yield preliminary positive results when BAR, BZD, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, tricyclic antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

3. Special conditions for use statement(s):

This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical

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consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained. For prescription use.

For the over the counter (OTC) multi-drug of abuse test, (in addition to the statement above) the sponsor has added the following statement:

This test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

The BAR, BZD, TCA test will yield preliminary positive results when BAR, BZD, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, tricyclic antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level.

4. Special instrument requirements:

Not applicable.

I. Device Description:

The Instant-View Methamphetamine, Amphetamine, Cocaine and Oxycodone cassette kits and test strips are individually prepackaged in sets of 25 and 50 respectively. The Instant-View Multi-Drug of Abuse Urine Test has a cup and a dip card format and is available in two configurations.

The first configuration contains 12 drugs and is intended for over-the-counter use (OTC): AMP, BAR, BZD, COC, MET, MOR, MTD, PCP, PPX, TCA, THC and XTC.

The second configuration contains 14 drugs AMP, BAR, BUP/NBUP, BZD, COC, MET, MOR, MTD, OXY, PCP, PPX, TCA, THC and XTC and is intended for professional use only.

J. Substantial Equivalence Information:

| 1) Predicate Device Name | 2) Predicate 510(k) number | Analytes included |
| --- | --- | --- |
| Instant-View Multi-Drug of | k022564 | AMP, BAR, BZD, COC, |

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| Abuse Test | | MET, MOR, MTD, PCP, THC |
| --- | --- | --- |
| Instant -View Amphetamine Urine Test | k994395 | AMP |
| Instant -View Cocaine Urine Test | k994403 | COC |
| Instant -View Methamphetamine Urine Test | k003845 | MET |
| Instant -View Propoxyphene Urine Test | k022915 | PPX |
| Instant -View TCA Urine Test | k022693 | TCA |
| Instant -View MDMA Screen Urine Test | k022501 | XTC |
| Instant -View BUP/NBUP Screen Urine Test | k060527 | BUP/NBUP |
| Oxycodone | k033047 | OXY |

3. Comparison with predicate:

The device is similar or the same as the previously cleared predicate(s) in the following ways: test principles, indication for use, used in a professional and point-of-care setting, read time and sample matrix. The candidate device and the predicates are both visually-read single use devices.

The differences are the addition of oxycodone and changes to the cutoffs for AMP, MET and COC are the cutoffs. The amphetamine cutoff has been lowered from 1000 ng/ml to 300, cocaine was lowered from 300 ng/ml to 150 ng/ml, and methamphetamine has been lowered from 500 to 300 ng/ml.

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

None 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.

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M. Performance Characteristics (if/when applicable):

1. Analytical performance:

Analytical performance data (summarized in section M.1) is for the new test strips only: amphetamine (300 ng/mL), cocaine (150 ng/mL), methamphetamine (300 ng/mL), and oxycodone (100 and 300 ng/mL). Clinical performance to support OTC use of a subset of analytes is presented in Section M.2 below.

a. Precision/Reproducibility:

Precision was assessed by conducting with-in day, between day and between lot precision studies on three lots with six devices on four samples for three days. The four samples were 0, 75%, 125% and 300 or 333% of the chosen cutoff for each drug.

| Cutoffs | Conc. for Amphetamine (ng/ml) | Conc. For Cocaine (ng/ml) | Conc. For Methamphetamine (ng/ml) | Conc. For Oxycodone (ng/ml) | Conc. For Oxycodone (ng/ml) |
| --- | --- | --- | --- | --- | --- |
| 0% | 0 | 0 | 0 | 0 | 0 |
| 75% | 225 | 112.5 | 225 | 75 | 225 |
| 125% | 375 | 187.5 | 375 | 125 | 375 |
| 300 or 333% | 1000 | 450 | 1000 | 300 | 1000 |

The sponsor conducted these precision studies for both formats (dip strip and the cassette). The results of the three precision studies were the same for all of the drugs. No significant lot-to-lot or within lot variability among any of the devices was detected and the results are shown in the chart below.

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To demonstrate performance of the new test strips in a professional setting, 2 physician offices and one reference laboratory participated in a study that was conducted on both formats by a lab technician, medical assistant, and a physician. Six spiked samples (n=80), equivalent to 0, 50%, 75%, 125%, 150% and 300 or 333% of the cutoff, were prepared from a specimen and confirmed by GC/MS. The values and results are shown in the following charts below.

| Controls | | | Negative | 75% Cutoff | 125% Cutoff | 300 or 333% Cutoff | Agreement | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | | | | Within Days | Between | Between |
| Expect Results | | | 6- | 6- | 6+ | 6+ | | Days | Lots |
| Dip Strip | Lot I | Day 1 | 6- | 6- | 6+ | 6+ | 100% | 100% | 100% |
| | | Day 2 | 6- | 6- | 6+ | 6+ | 100% | | |
| | | Day 3 | 6- | 6- | 6+ | 6+ | 100% | | |
| | Lot II | Day 1 | 6- | 6- | 6+ | 6+ | 100% | 100% | |
| | | Day 2 | 6- | 6- | 6+ | 6+ | 100% | | |
| | | Day 3 | 6- | 6- | 6+ | 6+ | 100% | | |
| | Lot III | Day 1 | 6- | 6- | 6+ | 6+ | 100% | 100% | |
| | | Day 2 | 6- | 6- | 6+ | 6+ | 100% | | |
| | | Day 3 | 6- | 6- | 6+ | 6+ | 100% | | |
| Cassette | Lot I | Day 1 | 6- | 6- | 6+ | 6+ | 100% | 100% | 100% |
| | | Day 2 | 6- | 6- | 6+ | 6+ | 100% | | |
| | | Day 3 | 6- | 6- | 6+ | 6+ | 100% | | |
| | Lot II | Day 1 | 6- | 6- | 6+ | 6+ | 100% | 100% | |
| | | Day 2 | 6- | 6- | 6+ | 6+ | 100% | | |
| | | Day 3 | 6- | 6- | 6+ | 6+ | 100% | | |
| | Lot III | Day 1 | 6- | 6- | 6+ | 6+ | 100% | 100% | |
| | | Day 2 | 6- | 6- | 6+ | 6+ | 100% | | |
| | | Day 3 | 6- | 6- | 6+ | 6+ | 100% | | |
| Cutoffs | Conc. for Amphetamine (ng/ml) (c/o 300) | Conc. For Cocaine (ng/ml) (c/o 150) | Conc. For Methamp. (ng/ml) (c/o 300) | Conc. For Oxycodone (ng/ml) (c/o 100) | Conc. For Oxycodone (ng/ml) (c/o 300) | N |
| --- | --- | --- | --- | --- | --- | --- |
| Negative | 0 | 0 | 0 | 0 | 0 | 10 |
| 50% | 150 | 75 | 150 | 50 | 150 | 15 |
| 75% | 225 | 112.5 | 225 | 75 | 225 | 15 |
| 125% | 375 | 187.5 | 375 | 125 | 375 | 15 |
| 150% | 450 | 225 | 450 | 150 | 450 | 15 |
| 300/ 333 % | 1000 | 450 | 1000 | 300 | 1000 | 10 |

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| | | Site 1 | Site 2 | Site 3 |
| --- | --- | --- | --- | --- |
| Amphetamine | | | | |
| Agreement | Within Site | 96.3% | 96.3% | 100% |
| | Between Site | 97.5% | | |
| Cocaine | | | | |
| Agreement | Within Site | 97.5% | 97.5% | 98.8% |
| | Between Site | 97.9% | | |
| Methamphetamine | | | | |
| Agreement | Within Site | 96.3% | 96.3% | 98.8% |
| | Between Site | 97.1% | | |
| Oxycodone (100 ng/ml) | | | | |
| Agreement | Within Site | 96.3% | 96.3% | 97.5% |
| | Between Site | 96.7% | | |
| Oxycodone (300 ng/ml) | | | | |
| Agreement | Within Site | 97.5% | 97.5% | 97.5% |
| | Between Site | 97.5% | | |

The sponsor conducted a bridging study along with their cutoff study for each drug to show that the two formats (dip strip and cassette) are equivalent. The results demonstrated equivalency of the two formats. See cutoff section below for a summary of the data.

b. Linearity/assay reportable range:

Not applicable. The assay is intended for qualitative use.

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

This device has internal process controls. A colored line appearing in the control region confirms that sufficient sample volume has been applied and that the sample has migrated correctly on the test strip. Users are informed not to interpret the test if a colored line failed to appear in the control region. External controls are not supplied with this device.

The sponsor conducted an accelerated degradation study to assess the shelf life of the tests. The sponsor has a real-time shelf-life study ongoing.

d. Detection limit:

A cutoff study (summarized below) was conducted at six different concentrations of each new test strip and format. Each concentration was confirmed with GC/MS.

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Amphetamine

| Cassette Test | | Expected Result | Test Result | Agreement |
| --- | --- | --- | --- | --- |
| Controls (ng/ml) | 0 (negative) | 10- | 10- | 100% |
| | 150 (50% cutoff) | 15- | 15- | 100% |
| | 225 (75% cutoff) | 15- | 15- | 100% |
| | 375 (125% cutoff) | 15+ | 12+, 3- | 80% |
| | 450 (150% cutoff) | 15- | 15+ | 100% |
| | 1000 (333% cutoff) | 10+ | 10+ | 100% |
| Total | | 40-, 40+ | 43-, 37+ | 96.3% |

Cocaine

| Cassette Test | | Expected Result | Test Result | Agreement |
| --- | --- | --- | --- | --- |
| Controls (ng/ml) | 0 (negative) | 10- | 10- | 100% |
| | 75 (50% cutoff) | 15- | 15- | 100% |
| | 112.5 (75% cutoff) | 15- | 14-, 1+ | 93.3% |
| | 187.5 (125% cutoff) | 15+ | 14+, 1- | 93.3% |
| | 225 (150% cutoff) | 15+ | 15+ | 100% |
| | 450 (300% cutoff) | 10+ | 10+ | 100% |
| Total | | 40-, 40+ | 41-, 40+ | 97.5% |
| Dip Strip Test | | Expected Result | Test Result | Agreement |
| --- | --- | --- | --- | --- |
| Controls (ng/ml) | 0 (negative) | 10- | 10- | 100% |
| | 75 (50% cutoff) | 15- | 15- | 100% |
| | 112.5 (75% cutoff) | 15- | 14-, 1+ | 93.3% |
| | 187.5 (125% cutoff) | 15+ | 14+, 1- | 93.3% |
| | 225 (150% cutoff) | 15+ | 15+ | 100% |
| | 450 (300% cutoff) | 10+ | 10+ | 100% |
| Total | | 40-, 40+ | 41-, 40+ | 97.5% |

Methamphetamine

| Cassette Test | | Expected Result | Test Result | Agreement |
| --- | --- | --- | --- | --- |
| Controls (ng/ml) | 0 (negative) | 10- | 10- | 100% |
| | 150 (50% cutoff) | 15- | 15- | 1005 |
| | 225 (75% cutoff) | 15- | 15- | 100% |
| | 375 (125% cutoff) | 15+ | 13+, 2- | 86.7% |
| | 450 (150% cutoff) | 15+ | 15+ | 100% |
| | 1000 (333% cutoff) | 10+ | 10+ | 100% |
| Total | | 40-, 40+ | 42-, 38+ | 97.5% |

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| Dip Strip Test | | Expected Result | Test Result | Agreement |
| --- | --- | --- | --- | --- |
| Controls (ng/ml) | 0 (negative) | 10- | 10- | 100% |
| | 150 (50% cutoff) | 15- | 15- | 1005 |
| | 225 (75% cutoff) | 15- | 15- | 100% |
| | 375 (125% cutoff) | 15+ | 13+, 2- | 86.7% |
| | 450 (150% cutoff) | 15+ | 15+ | 100% |
| | 1000 (333% cutoff) | 10+ | 10+ | 100% |
| Total | | 40-, 40+ | 42-, 38+ | 97.5% |

Oxycodone (100 ng/ml)

| Cassette Test | | Expected Result | Test Result | Agreement |
| --- | --- | --- | --- | --- |
| Controls (ng/ml) | 0 (negative) | 10- | 10- | 100% |
| | 50 (50% cutoff) | 15- | 15- | 100% |
| | 75 (75% cutoff) | 15- | 14-, 1+ | 93.3% |
| | 125 (125% cutoff) | 15+ | 13+, 2- | 86.7% |
| | 150 (150% cutoff) | 15+ | 15+ | 100% |
| | 300 (300% cutoff) | 10+ | 10+ | 100% |
| Total | | 40-, 40+ | 41-, 39+ | 96.3% |
| Dip Strip Test | | Expected Result | Test Result | Agreement |
| --- | --- | --- | --- | --- |
| Controls (ng/ml) | 0 (negative) | 10- | 10- | 100% |
| | 50 (50% cutoff) | 15- | 15- | 100% |
| | 75 (75% cutoff) | 15- | 14-, 1+ | 93.3% |
| | 125 (125% cutoff) | 15+ | 13+, 2- | 86.7% |
| | 150 (150% cutoff) | 15+ | 15+ | 100% |
| | 300 (300% cutoff) | 10+ | 10+ | 100% |
| Total | | 40-, 40+ | 41-, 39+ | 96.3% |

Oxycodone (300 ng/ml)

| Cassette Test | | Expected Result | Test Result | Agreement |
| --- | --- | --- | --- | --- |
| Controls (ng/ml) | 0 (negative) | 10 - | 10 - | 100% |
| | 150 (50% cutoff) | 15- | 15- | 100% |
| | 225 (75% cutoff) | 15- | 14-, 1+ | 93.3% |
| | 375 (125% cutoff) | 15+ | 14+, 1- | 93.3% |
| | 450 (150% cutoff) | 15+ | 15+ | 100% |
| | 1000 (333% cutoff) | 10+ | 10+ | 100% |
| Total | | 40-, 40+ | 40-, 40+ | 97.5% |
| Dip Strip Test | | Expected Result | Test Result | Agreement |
| --- | --- | --- | --- | --- |
| Controls (ng/ml) | 0 (negative) | 10 - | 10 - | 100% |
| | 150 (50% cutoff) | 15- | 15- | 100% |
| | 225 (75% cutoff) | 15- | 14-, 1+ | 93.3% |
| | 375 (125% cutoff) | 15+ | 14+, 1- | 93.3% |
| | 450 (150% cutoff) | 15+ | 15+ | 100% |
| | 1000 (333% cutoff) | 10+ | 10+ | 100% |
| Total | | 40-, 40+ | 40-, 40+ | 97.5% |

{12}

The results support the sponsor's chosen cutoffs of 300 ng/mL for Amphetamine and methamphetamine, 150 ng/ml for cocaine and 100 and 300 ng/mL for oxycodone.

e. Analytical specificity:

Cross-reactivity for the new test strips was evaluated by spiking various concentrations of similarly structured drug compounds into a drug-free urine negative control. When a positive result was obtained, the sample was diluted to half of the concentration and tested again. The sponsor determined the concentration of the drug that produced a response approximately equivalent to the cutoff concentrations of the assays. The cross-reactivity testing results are listed below.

Amphetamine

| Chemical compounds | Concentration (ng/ml) |
| --- | --- |
| d-amphetamine | 300 |
| l-amphetamine | 20,000 |
| d,l-amphetamine | 300 |
| 3,4-methylenedioxyamphetamine | 20,000 |

Cocaine

| Chemical compounds | Concentration (ng/ml) |
| --- | --- |
| Cocaine HCl | 150 |
| Benzoylecgonine | 150 |
| Isoxsuprine | 1500 |

Methamphetamine

| Chemical compounds | Concentration (ng/ml) |
| --- | --- |
| d-methamphetamine | 300 |
| l-methamphetamine | 25,000 |
| d-amphetamine | 50,000 |
| l-amphetamine | 10,000 |
| 3,4-methylenedioxyamphetamine | 50,000 |

Oxycodone- (for both cutoffs of 100 and 300 ng/ml)

| Chemical compounds | Concentration (ng/ml) |
| --- | --- |
| Oxycodone | 100 and 300 |
| Morphine | 20,000 |
| Hydrocodone | 100,000 |
| Ethyl morphine | 100,000 |

The sponsor tested many common substances and biological materials (113) for cross-reactivity with the drug of abuse tests at a concentration of 100 µg/mL in drug-free and drug positive urines. The sponsor states that there were no deviations from the expected results. The compounds tested are listed in the table below.

13

{13}

| Chemical compounds (100μg/ml) | | |
| --- | --- | --- |
| Acetaminophen | Acetylsalicyclic acid | Aminopyrine |
| N-Acetylprocainamide | Ampicillin | Acetophenetidin |
| Amoxicillin | Apomorphine | Atropine |
| L-Ascorbic acid | Aspartame | Benzlilic acid |
| Benzoic acid | Benzphetamine | Bilirubin |
| D/L-Brompheniramine | Caffeine | Cannabidol |
| Chloralhydrate | Chloramphenicol | Chlorothiazide |
| D/L-Chloropheniramine | Chlorpromazine | Chloroquine |
| Cholesterol | Chlonidine | Cortisone |
| L-Cotinine | Creatinine | Deoxycorticosterone |
| Dextromethorphan | Diclofenac | Diflunisal |
| Digoxin | Diphenhydramine | Ecgonine methyl ester |
| L-ψ-Ephedrine | β-Estradiol | Estrone-3-sulfate |
| Ethyl-p-aminobenzoate | L(-)-Epinephrine | Erythromycin |
| Fenoprofen | Furosemide | Gentisic acid |
| Hemoglobin | Hydralazine | Hydrochlorothiazide |
| Hydrocortisone | O-Hdoryhippuric acid | p-Hydroxyamphetamine |
| p-Hydroxytyramine | Ibuprofen | Iproniazid |
| D/L-Isoproterenol | Isoxsuprine | Ketamine |
| Ketoprofen | Labetalol | Loperamide |
| Meperidine | Meprobamate | Methoxyphenamine |
| Methylphenidate | Naloxone | Nalidixic acid |
| Naproxen | Naltrexone | Nifedipine |
| Niacinamide | Norethindrone | D-Norpropoxyphene |
| Noscapine | D/L-Octopamine | Oxalic acid |
| Oxolinic acid | Oxymetazoline | Papaverine |
| Pencillin-G | Pentazocine hydrochloride | Perphenazine |
| Phenelzine | Trans-2-phenylcyclo-propylamine hydrochloride | |
| L-Phenylpropanolamine | β-Phenylethylamine | Phenylpropanolamine |
| Prednisone | D/L-Pseudoephedrine | D-Propoxyphene |
| D-Pseudoephedrine | Quinacrine | Quinine |
| Quindine | Ranitidine | Salicylic acid |
| Serotonin | Sulfamethazine | Sulindac |
| Tetrahydrocortisone 3 (β-D-glucuronide) | | Terahydrozoline |
| Thiamine | Thioridazine | D/L-Tyrosine |
| Tolbutamine | Triamterene | Trifluoperazine |
| Trimethoprim | Tryptamine | D/L-Tryptophan |
| Tyramine | Uric acid | Verapamil |
| Zomepirac | | |

The sponsor evaluated urine pH for test interference in seven pooled negative urine specimens. The specimens were adjusted to pH ranging from 3 to 9 and

{14}

divided into two groups with concentrations of 50% below and above the cutoff. The testing results are summarized in the table below and the results were the same for all the drugs. The results showed that there was no interference from urine pH ranging from 3 to 9 and that the device formats (dip strip and cassettes) gave the same result. Both cassette and dip-strip format were tested in duplicate.

| ID | PH Value | Cassette Test | | Dip-strip Test | |
| --- | --- | --- | --- | --- | --- |
| | | 50% CUTOFF | 150% CUTOFF | 50% CUTOFF | 150% CUTOFF |
| 1 | 3.0 | - | + | - | + |
| 2 | 4.0 | - | + | - | + |
| 3 | 5.0 | - | + | - | + |
| 4 | 6.0 | - | + | - | + |
| 5 | 7.0 | - | + | - | + |
| 6 | 8.0 | - | + | - | + |
| 7 | 9.0 | - | + | - | + |

The sponsor evaluated specific gravity for test interference in seven pooled negative urine specimens. The specimens were adjusted to specific gravities ranging from 1.002 to 1.035 and divided into two groups with concentrations of 50% below and above the cutoff. The testing results are summarized in the table below and the results were the same for all the drugs. The results showed that there was no interference from specific gravity ranging from 1.002 to 1.035 and that the device formats (dip strip and cassettes) gave the same result. Both cassette and dip-strip format were tested in duplicate.

| ID | SG Value | Cassette Test | | Dip-Strip Test | |
| --- | --- | --- | --- | --- | --- |
| | | 50% Cutoff | 150% Cutoff | 50% Cutoff | 150% Cutoff |
| 1 | 1.002 | - | + | - | + |
| 2 | 1.005 | - | + | - | + |
| 3 | 1.011 | - | + | - | + |
| 4 | 1.016 | - | + | - | + |
| 5 | 1.020 | - | + | - | + |
| 6 | 1.021 | - | + | - | + |
| 7 | 1.023 | - | + | - | + |
| 8 | 1.027 | - | + | - | + |
| 9 | 1.033 | - | + | - | + |
| 10 | 1.035 | - | + | - | + |

The sponsor conducted a sample volume test for the both the cassette and the dip-strip test formats. The study showed that 3 to 5 drops of specimen are required for the cassette test and that the dip-strip devices should be dipped for at least 10

15

{15}

seconds to allow for proper absorption. The sponsor has recommended 4 drops in the package insert.

The sponsor also conducted a reading time test and the study revealed that both devices can obtain results from 4 to 7 minutes after adding the specimen. The sponsor has recommended reading the test after 4 minutes and before 7 minutes.

f. Assay cut-off:

Characterization of how the devices perform analytically around the claimed cutoff concentrations appears in the precision above.

2. Comparison studies:

a. Method comparison with predicate device:

The Instant-View Methamphetamine, Amphetamine, Cocaine and Oxycodone cassette kits and test strips were compared to the GC/MS reference method. Amphetamine (n=98), cocaine (n=108), methamphetamine (n=127) and oxycodone 100 and 300 ng/ml (n=84 and 115 respectively for each level) were obtained from a clinical urine sample provider. The results of the method comparison are shown in the tables below.

Amphetamine

| Cassette Test | Proposed Device | | Total | Agreement | |
| --- | --- | --- | --- | --- | --- |
| | | Positive | | | Negative |
| GC/MS (ng/ml) | Drug-free | 0 | 30 | 30 | 100% |
| | <50% (0~150) | 0 | 4 | 4 | 100% |
| | 50%-75% (150~225) | 0 | 10 | 10 | 100% |
| | 75%-Cutoff (225~300) | 1 | 9 | 10 | 90% |
| | Cutoff-125%(300-375) | 11 | 2 | 12 | 83.6% |
| | 125-150% (375~450) | 8 | 0 | 8 | 100 |
| | Positive (>450) | 23 | 0 | 20 | 100% |
| Total | | 43 | 55 | 98 | 96.9 |
| Dip-Strip Test | Proposed Device | | Total | Agreement | |
| --- | --- | --- | --- | --- | --- |
| | | Positive | | | Negative |
| GC/MS (ng/ml) | Drug-free | 0 | 30 | 30 | 100% |
| | <50% (0~150) | 0 | 4 | 4 | 100% |
| | 50%-75% (150~225) | 0 | 10 | 10 | 100% |
| | 75%-Cutoff (225~300) | 1 | 9 | 10 | 90% |
| | Cutoff-125%(300-375) | 11 | 2 | 12 | 83.6% |
| | 125%-150% (375~450) | 8 | 0 | 8 | 100 |
| | Positive (>450) | 23 | 0 | 20 | 100% |
| Total | | 43 | 55 | 98 | 96.9% |

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Cocaine

| Cassette Test | Proposed Device | | Total | Agreement | |
| --- | --- | --- | --- | --- | --- |
| | | Positive | | | Negative |
| GC/MS (ng/ml) | Drug-free | 0 | 30 | 30 | 100% |
| | <50% (0~75) | 0 | 6 | 6 | 100% |
| | 50%-75% (75-112.5) | 0 | 8 | 8 | 100% |
| | 75%-Cutoff (112.5-150) | 1 | 11 | 12 | 91.7 |
| | Cutoff-125% (150-187.5) | 9 | 2 | 11 | 81.8% |
| | 125-150% (187.5-225) | 12 | 0 | 12 | 100 |
| | Positive (>225) | 29 | 0 | 29 | 100% |
| Total | | 51 | 57 | 108 | 97.2% |
| Dip-Strip Test | Proposed Device | | Total | Agreement | |
| --- | --- | --- | --- | --- | --- |
| | | Positive | | | Negative |
| GC/MS (ng/ml) | Drug-free | 0 | 30 | 30 | 100% |
| | <50% (0~75) | 0 | 6 | 6 | 100% |
| | 50%-75% (75-112.5) | 0 | 8 | 8 | 100% |
| | 75%-Cutoff (112.5-150) | 1 | 11 | 12 | 91.7 |
| | Cutoff-125% (150-187.5) | 9 | 2 | 11 | 81.8% |
| | 125-150% (187.5-225) | 12 | 0 | 12 | 100 |
| | Positive (>225) | 29 | 0 | 29 | 100% |
| Total | | 51 | 57 | 108 | 97.2% |

Methamphetamine

| Cassette Test | Proposed Device | | Total | Agreement | |
| --- | --- | --- | --- | --- | --- |
| | | Positive | | | Negative |
| GC/MS (ng/ml) | Drug-free | 0 | 30 | 30 | 100% |
| | <50% (0~150) | 0 | 3 | 3 | 100% |
| | 50%-75% (150~225) | 0 | 10 | 20 | 100% |
| | 75%-Cutoff (225~300) | 2 | 11 | 13 | 84.6 |
| | Cutoff-125% (300-375) | 12 | 3 | 15 | 80 |
| | 125%-150% (375~450) | 13 | 0 | 13 | 100% |
| | Positive (>450) | 40 | 0 | 40 | 100% |
| Total | | 67 | 60 | 127 | 96.4% |
| Dip-Strip Test | Proposed Device | | Total | Agreement | |
| --- | --- | --- | --- | --- | --- |
| | | Positive | | | Negative |
| GC/MS (ng/ml) | Drug-free | 0 | 30 | 30 | 100% |
| | <50% (0~150) | 0 | 3 | 3 | 100% |
| | 50%-75% (150~225) | 0 | 10 | 20 | 100% |
| | 75%-Cutoff (225~300) | 2 | 11 | 13 | 84.6% |
| | Cutoff-125% (300-375) | 12 | 3 | 15 | 80% |
| | 125%-150% (375~450) | 13 | 0 | 13 | 100% |
| | Positive (>450) | 40 | 0 | 40 | 100% |
| Total | | 67 | 60 | 127 | 100 |

Oxycodone (100 ng/ml)

{17}

| Cassette Test | Proposed Device | | Total | Agreement | |
| --- | --- | --- | --- | --- | --- |
| | | Positive | | | Negative |
| GC/MS (ng/ml) | Drug-free | 0 | 28 | 28 | 100% |
| | <75% (0~75) | 0 | 6 | 6 | 100% |
| | 75%~Cutoff (75~100) | 1 | 8 | 9 | 88.9% |
| | Cutoff~125% (100~125) | 8 | 1 | 9 | 88.9% |
| | Positive (>125) | 32 | 0 | 32 | 100% |
| Total | | 41 | 43 | 84 | 97.6% |
| Dip-Strip Test | Proposed Device | | Total | Agreement | |
| --- | --- | --- | --- | --- | --- |
| | | Positive | | | Negative |
| GC/MS (ng/ml) | Drug-free | 0 | 28 | 28 | 100% |
| | <75% (0~225) | 0 | 6 | 6 | 100% |
| | 75%~Cutoff (225~300) | 1 | 8 | 9 | 88.9% |
| | Cutoff~125% (300~375) | 8 | 1 | 9 | 88.9% |
| | Positive (>375) | 32 | 0 | 32 | 100% |
| Total | | 41 | 43 | 84 | 97.6% |

Oxycodone (300 ng/ml)

| Cassette Test | Proposed Device | | Total | Agreement | |
| --- | --- | --- | --- | --- | --- |
| | | Positive | | | Negative |
| GC/MS (ng/ml) | Drug-free | 0 | 28 | 28 | 100% |
| | <50% (0~150) | 0 | 21 | 21 | 100% |
| | 50%-75% (150~225) | 1 | 9 | 10 | 90% |
| | 75%-Cutoff (225~300) | 0 | 10 | 10 | 100% |
| | Cutoff-125%(300-375) | 9 | 1 | 10 | 90% |
| | 125%-150% (375~450) | 10 | 0 | 10 | 100% |
| | Positive (>450) | 26 | 0 | 26 | 100% |
| Total | | 46 | 69 | 115 | 98.3% |
| Dip-Strip Test | Proposed Device | | Total | Agreement | |
| --- | --- | --- | --- | --- | --- |
| | | Positive | | | Negative |
| GC/MS (ng/ml) | Drug-free | 0 | 28 | 28 | 100% |
| | <50% (0~150) | 0 | 21 | 21 | 100% |
| | 50%-75% (150~225) | 1 | 9 | 10 | 90% |
| | 75%-Cutoff (225~300) | 0 | 10 | 10 | 100% |
| | Cutoff-125%(300-375) | 9 | 1 | 10 | 90% |
| | 125%-150% (375~450) | 10 | 0 | 10 | 100% |
| | Positive (>450) | 26 | 0 | 26 | 100% |
| Total | | 46 | 69 | 115 | 98.3% |

The sponsor also conducted lay user studies at five separate sites for the OTC

{18}

version of the multi-drug urine cup and cassette formats. The panel format was evaluated in two separate studies at five sites ( 123 cassette participants and 63 cup participants) lay-users between the ages of 10 to 80 with varying education levels and a trained professional were used. All participants had proper informed consent.

| 25 | 50% | | | | | | | | | | | 150% |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 26 | 75% | | | | | | | | | | | 125% |
| 27 | 50% | 300% | 50% | 300% | 50% | 300% | 300% | 50% | 300% | 50% | 300% | 50% |
| 28 | 300% | 50% | 300% | 50% | 300% | 50% | 50% | 300% | 50% | 300% | 50% | 300% |

Study 1- Twenty-eight urine samples were prepared by spiking drug-free pooled urine with the drugs to specific concentrations. The concentrations of all the drugs were confirmed by GC/MS except for TCA, which was confirmed by HPLC. Each sample was divided into nine containers and blind-labeled $(n = 252)$ . The samples were further split into two, one for the panel test and the other for the cup. Twenty-one lay-users at three sites were given a set of four samples $(n = 252)$ from 84 GC/MS confirmed blind-labeled samples, four complete devices (with all 12 test strips) and one package insert. The lay users tested 4 samples (panel or cup) and read all 48 results. The

| Study 1 | Drug Concentrations | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | AMP | BAR | BZD | COC | MET | MOR | MTD | PCP | PPX | TCA | THC | XTC |
| 1 | 50% | 150% | 50% | 150% | 50% | 150% | 150% | 50% | 150% | 50% | 150% | 50% |
| 2 | 150% | 50% | 150% | 50% | 150% | 50% | 50% | 150% | 50% | 150% | 50% | 150% |
| 3 | 150% | 50% | | | | | | | | | | |
| 4 | 125% | 75% | | | | | | | | | | |
| 5 | | 150% | 50% | | | | | | | | | |
| 6 | | 125% | 75% | | | | | | | | | |
| 7 | | | 150% | 50% | | | | | | | | |
| 8 | | | 125% | 75% | | | | | | | | |
| 9 | | | | 150% | 50% | | | | | | | |
| 10 | | | | 125% | 75% | | | | | | | |
| 11 | | | | | 150% | 50% | | | | | | |
| 12 | | | | | 125% | 75% | | | | | | |
| 13 | | | | | | 150% | 50% | | | | | |
| 14 | | | | | | 125% | 75% | | | | | |
| 15 | | | | | | | 150% | 50% | | | | |
| 16 | | | | | | | 125% | 75% | | | | |
| 17 | | | | | | | | 150% | 50% | | | |
| 18 | | | | | | | | 125% | 75% | | | |
| 19 | | | | | | | | | 150% | 50% | | |
| 20 | | | | | | | | | 125% | 75% | | |
| 21 | | | | | | | | | | 150% | 50% | |
| 22 | | | | | | | | | | 125% | 75% | |
| 23 | | | | | | | | | | | 150% | 50% |
| 24 | | | | | | | | | | | 125% | 75% |

{19}

trained professional performed all 84 tests (both panel and cup). The subjects were asked to read the package insert and perform the test. The concentrations tested are shown in the table below.

Study 2- Eleven urine samples were prepared by spiking drug-free pooled urine specimens with the drugs to specific concentrations. The concentrations of all the drugs were confirmed by GC/MS except for TCA, which was confirmed by HPLC. Each sample was divided into sixty containers and blind-labeled (n=660). Twenty lay users at three sites were given two sets (panel A and panel B) of blind-labeled samples, devices and a package insert. Panel A is comprised of AMP100, BAR, BZD300, COC300, MET1000, MOR2000, AMP300, MET300, MOR3200, MTD, PCP and THC. Panel B is comprised of AMP500, BZD200, COC150, MET500, OXY100, BUP, KET, OXY300, PPX, TCA and XTC. Panel A samples included samples 1 to 6 and panel B samples include samples 7 to 11. The lay users tested all 11 samples and read 127 results (12 x 6=72 for panel A and 11 x 5=55 for panel B). The concentrations and panels tested are shown in the table below.

| ID | Drug Concentration (ng/ml) | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | AMP | BAR | BUP | BZD | COC | KET | MET | MOR | MTD | OXY | PCP | PPX | TCA | THC | XTC |
| 1 | | 300 | | | 450 | | | 450 | | | 37.5 | | | | |
| 2 | 150 | 800 | | 150 | 1000 | | 150 | 1000 | 150 | | 100 | | | 25 | |
| 3 | 1500 | | | 450 | | | 450 | | 450 | | | | | 75 | |
| 4 | 3000 | 100 | | 1000 | 150 | | 1500 | 150 | 1000 | | 12.5 | | | 150 | |
| 5 | 450 | | | | | | 3000 | 6000 | | | | | | | |
| 6 | | | | | | | | 3000 | | | | | | | |
| 7 | | | | | 225 | 1500 | | | | 450 | | | 1500 | | |
| 8 | 250 | | 5 | 100 | 450 | 3000 | 250 | | | 1000 | | 150 | 3000 | | 250 |
| 9 | 750 | | 15 | 300 | | | 750 | | | | | 450 | | | 750 |
| 10 | 1500 | | 30 | 800 | 75 | 500 | 1500 | | | 50 | | 1000 | 500 | | 1500 |
| 11 | | | | | | | | | | 150 | | | | | |

The combined panel results from study one and two (123 lay users) and the cup results are shown below.

{20}

Panel results:

| | | Agreement | 100% | 99% | 100% | 100% |
| --- | --- | --- | --- | --- | --- | --- |
| XTC | 500 | Positive | 0 | 0 | 86 | 69 |
| Drug | Cutoff (ng/ml) | Negative | 300 | 90Drug Concentration | | 0 |
| | | Results | Negative | 50% | Cutoff>150% | 300%Cutoff |
| | | Agreement | 100% | Cutoff | 99% | 100% |
| AMP | 1000 | Positive | 0 | 4 | 85 | 68 |
| | | Negative | 360 | 92 | 2 | 1 |
| | | Total | 360 | 96 | 87 | 69 |
| | | Agreement | 100% | 96% | 98% | 99% |
| BAR | 200 | Positive | 0 | 1 | 86 | 69 |
| | | Negative | 360 | 95 | 1 | 0 |
| | | Total | 360 | 96 | 87 | 69 |
| | | Agreement | 100% | 99% | 99% | 100% |
| BZD | 300 | Positive | 0 | 1 | 85 | 69 |
| | | Negative | 360 | 95 | 2 | 0 |
| | | Total | 360 | 96 | 87 | 69 |
| | | Agreement | 100% | 99% | 98% | 100% |
| COC | 300 | Positive | 0 | 0 | 85 | 69 |
| | | Negative | 360 | 96 | 2 | 0 |
| | | Total | 360 | 96 | 87 | 69 |
| | | Agreement | 100% | 100% | 98% | 100% |
| MET | 1000 | Positive | 0 | 2 | 85 | 69 |
| | | Negative | 360 | 94 | 2 | 0 |
| | | Total | 360 | 96 | 87 | 69 |
| | | Agreement | 100% | 98% | 98% | 100% |
| MOR | 2000 | Positive | 2 | 2 | 85 | 69 |
| | | Negative | 358 | 94 | 2 | 0 |
| | | Total | 360 | 96 | 87 | 69 |
| | | Agreement | 99% | 98% | 98% | 100% |
| MTD | 300 | Positive | 0 | 1 | 83 | 68 |
| | | Negative | 360 | 95 | 4 | 1 |
| | | Total | 360 | 96 | 87 | 69 |
| | | Agreement | 100% | 99% | 95% | 99% |
| PCP | 25 | Positive | 0 | 0 | 87 | 69 |
| | | Negative | 360 | 96 | 0 | 0 |
| | | Total | 360 | 96 | 87 | 69 |
| | | Agreement | 100% | 100% | 100% | 100% |
| THC | 50 | Positive | 0 | 2 | 85 | 69 |
| | | Negative | 360 | 94 | 2 | 0 |
| | | Total | 360 | 96 | 87 | 69 |
| | | Agreement | 100% | 98% | 98% | 100% |
| TCA | 1000 | Positive | 0 | 1 | 87 | 69 |
| | | Negative | 300 | 95 | 0 | 0 |
| | | Total | 300 | 96 | 87 | 69 |

{21}

Cup results:

| Drug | Cutoff (ng/ml) | Results | Drug Concentration | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | Negative | 50% ~ Cutoff | Cutoff ~ 150% | 300% Cutoff |
| AMP | 1000 | Positive | 0 | 1 | 25 | 9 |
| | | Negative | 180 | 35 | 2 | 0 |
| | | Total | 180 | 36 | 27 | 9 |
| | | Agreement | 100% | 97.2% | 92.6% | 100.0% |
| BAR | 200 | Positive | 0 | 0 | 26 | 9 |
| | | Negative | 180 | 36 | 1 | 0 |
| | | Total | 180 | 36 | 27 | 9 |
| | | Agreement | 100% | 100.0% | 96.3% | 100.0% |
| BZD | 300 | Positive | 0 | 1 | 25 | 9 |
| | | Negative | 180 | 35 | 2 | 0 |
| | | Total | 180 | 36 | 27 | 9 |
| | | Agreement | 100% | 97.2% | 92.6% | 100.0% |
| COC | 300 | Positive | 0 | 0 | 25 | 9 |
| | | Negative | 180 | 36 | 2 | 0 |
| | | Total | 180 | 36 | 27 | 9 |
| | | Agreement | 100% | 100% | 92.6% | 100.0% |
| MET | 1000 | Positive | 0 | 1 | 27 | 9 |
| | | Negative | 180 | 35 | 0 | 0 |
| | | Total | 180 | 36 | 27 | 9 |
| | | Agreement | 100% | 97.2% | 100.0% | 100.0% |
| MOR | 2000 | Positive | 0 | 2 | 26 | 9 |
| | | Negative | 180 | 34 | 1 | 0 |
| | | Total | 180 | 36 | 27 | 9 |
| | | Agreement | 100% | 94% | 96% | 100.0% |
| MTD | 300 | Positive | 0 | 0 | 26 | 9 |
| | | Negative | 180 | 36 | 1 | 0 |
| | | Total | 180 | 36 | 27 | 9 |
| | | Agreement | 100% | 100% | 96% | 100.0% |
| PCP | 25 | Positive | 0 | 0 | 27 | 9 |
| | | Negative | 180 | 36 | 0 | 0 |
| | | Total | 180 | 36 | 27 | 9 |
| | | Agreement | 100% | 100% | 100% | 100.0% |
| THC | 50 | Positive | 0 | 1 | 27 | 9 |
| | | Negative | 180 | 35 | 0 | 0 |
| | | Total | 180 | 36 | 27 | 9 |
| | | Agreement | 100% | 97% | 100% | 100.0% |
| TCA | 1000 | Positive | 0 | 0 | 26 | 9 |
| | | Negative | 180 | 36 | 1 | 0 |
| | | Total | 180 | 36 | 27 | 9 |
| | | Agreement | 100% | 100% | 96% | 100.0% |
| XTC | 500 | Positive | 0 | 0 | 27 | 9 |
| | | Negative | 180 | 36 | 0 | 0 |
| | | Total | 180 | 36 | 27 | 9 |
| | | Agreement | 100% | 100% | 100% | 100.0% |

{22}

The sponsor conducted an analysis of their package inserts and have stated that their package insert has received a $7^{\text{th}}$ grade Flesh-Kincaid reading score and a Flesch Reading Ease score of 63.

The sponsor conducted a questionnaire for users to evaluate the cup and cassette format of the multi-drug device. The results are shown in the tables below.

| Cassette Format | Very Easy to Understand | Easy to Understand | Understandable w/ some Difficulty | Difficult to Understand | Impossible to Understand | Total |
| --- | --- | --- | --- | --- | --- | --- |
| Explanation of intended use of the test. | 76 (61.8%) | 45 (36.6%) | 1 (0.8%) | 1 (0.8%) | 0 | 123 |
| Directions to do the test | 71 (57.7%) | 51 (41.5%) | 1 (0.8%) | 0 | 0 | 123 |
| Performing the test | 87 (70.7%) | 34 (27.6%) | 2 (1.6%) | 0 | 0 | 123 |
| Direction to interpret the result | 78 (63.4%) | 44 (35.8%) | 1 (0.8%) | 0 | 0 | 123 |
| Actual interpretation of the test result | 67 (54.5%) | 47 (38.2%) | 9 (7.3%) | 0 | 0 | 123 |
| Urine Cup Format | Very Easy to Understand | Easy to Understand | Understandable w/ some Difficulty | Difficult to Understand | Impossible to Understand | Total |
| --- | --- | --- | --- | --- | --- | --- |
| Explanation of intended use of the test. | 28 (44.4%) | 34 (54.0%) | 1 (1.6%) | 0 | 0 | 63 |
| Directions to do the test | 32 (50.8%) | 30 (47.6%) | 1 (1.6%) | 0 | 0 | 63 |
| Performing the test | 31 (49.2%) | 29 (46.0%) | 2 (3.2%) | 1 (1.6%) | 0 | 63 |
| Direction to interpret the result | 30 (47.6%) | 32 (50.8%) | 1 (1.6%) | 0 | 0 | 63 |
| Actual interpretation of the test result | 36 (57.1%) | 25 (39.7%) | 2 (3.2%) | 0 | 0 | 63 |

{23}

b. Matrix comparison:

Not applicable. The assay is intended for urine samples..

3. Clinical studies:

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 determination.