TOXCUP DRUG SCREEN CUP

K122633 · Branan Medical Corp. · LDJ · Feb 7, 2013 · Clinical Toxicology

Device Facts

• Record ID: K122633
• Device Name: TOXCUP DRUG SCREEN CUP
• Applicant: Branan Medical Corp.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Feb 7, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Indications for Use

The ToxCup® Drug Screen Cup is an in vitro screening test for the rapid detection of multiple drugs and drug metabolites in human urine at or above the following cutoff concentration: AMP Amphetamine 500 ng/ml BAR Secobarbital 300 ng/ml BUPG Buprenorphine Glucuronide 10 ng/ml BZO Oxazepam 300 ng/ml COC Benzoylecgonine 150 ng/ml MDMA 3,4-methylenedioxymethamphetamine 500 ng/ml MET Methamphetamine 500 ng/ml MTD Methadone 300 ng/ml OPI Morphine 300 ng/ml OXY Oxycodone 100 ng/ml PCP Phencyclidine 25 ng/ml PPX Propoxyphene 300 ng/ml TCA Nortriptyline 1000 ng/ml THC 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid 50 ng/ml These tests provide visual qualitative results and are intended for in vitro diagnostic use only. The ToxCup® Drug Screen Cup is available in single drug analyte cassette dip format and/or double drug analyte cassette dip format. It is intended for prescription point-of-care and over-the-counter consumer use. These tests provide only a preliminary test result and are the first step in a two-step process for detecting drugs of abuse in urine. The second step is confirming the results in a certified laboratory. For a quantitative result or to confirm preliminary positive results obtained by the ToxCup® Drug Screen Cup, a more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS) must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when a preliminary positive result is indicated.

Device Story

ToxCup® Drug Screen Cup is a lateral flow immunoassay for rapid, qualitative detection of up to 14 drugs/metabolites in human urine. Device consists of test strips in single or double analyte cassette dip format housed in a plastic cup. Principle of operation: competitive immunoassay where immobilized drug conjugate competes with drug in urine for limited antibody binding sites. User (consumer or clinician) observes color bands in test regions; presence of band indicates negative result, absence indicates presumptive positive. Built-in control line validates test completion. Results are preliminary; require confirmation by GC/MS in certified laboratory. Intended for point-of-care and OTC use to assist in clinical decision-making regarding drug abuse screening.

Clinical Evidence

Bench testing only. Performance evaluated via analytical studies including stability, optimal read time, precision/reproducibility, method comparison, specificity, interference, and a consumer study. Method comparison demonstrated ≥ 95% agreement with reference methods.

Technological Characteristics

Lateral flow immunoassay; competitive binding principle. Plastic housing (lid and cup base). Detects up to 14 drugs. Visual qualitative readout via color bands. No electronic components or software. Storage at 15-30°C.

Indications for Use

Indicated for rapid, qualitative, in vitro screening of multiple drugs and metabolites in human urine for prescription point-of-care or over-the-counter consumer use. Provides preliminary results requiring laboratory confirmation via GC/MS.

Regulatory Classification

Identification

A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

Special Controls

*Classification.* Class II (special controls). A cannabinoid 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

• Amedica Home Drug Test Cup (k082898)

Submission Summary (Full Text)

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

A. 510(k) Number:
k122633

B. Purpose for Submission:
New device

C. Measurand:
d-Amphetamine, Secobarbital, Buprenorphine Glucuroide, Oxazepam, Benzoylecgonine, 3,4-methylenedioxymethamphetamine, Methamphetamine, Methadone, Moprhine, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid

D. Type of Test:
Qualitative lateral flow immunoassay

E. Applicant:
Branan Medical Corporation

F. Proprietary and Established Names:
ToxCup® Drug Screen Cup

G. Regulatory Information:

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| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| LDJ | II | 862.3870 Cannabinoid test system | Toxicology (91) |
| DIO | II | 862.3250 Cocaine and cocaine metabolite test system | Toxicology (91) |
| DJG | II | 862.3650 Opiate test system | Toxicology (91) |
| DJC | II | 862.3610 Methamphetamine test system | Toxicology (91) |
| DKZ | II | 862.3100 Amphetamine test system | Toxicology (91) |
| LCM | unclassified | Enzyme immunoassay Phencyclidine | Toxicology (91) |
| JXM | II | 862.3170 Benzodiazepine test system | Toxicology (91) |
| DIS | II | 862.3150 Barbiturate test system | Toxicology (91) |
| DJR | II | 862.3620 Methadone test system | Toxicology (91) |
| LFG | II | 862.3910 Tricyclic antidepressant drugs test system | Toxicology (91) |
| JXN | II | 862.3700 Propoxyphene test system | Toxicology (91) |

H. Intended Use:

1. Intended use(s):

See indications for use below.

2. Indications(s) for use:

The ToxCup Drug Screen Cup is an in vitro screening test for the rapid detection of multiple drugs and drug metabolites in human urine at or above the following cutoff concentration:

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| Abbreviation | Analyte | Cutoff |
| --- | --- | --- |
| AMP | Amphetamine | 500 ng/mL |
| BAR | Secobarbitol | 300 ng/mL |
| BUPG | Buprenorphine Glucuronide | 10 ng/mL |
| BZO | Oxazepam | 300 ng/mL |
| COC | Benzoylecgonine | 150 ng/mL |
| MDMA | 3,4-methylenedioxymethamphetamine | 500 ng/mL |
| MET | Methamphetamine | 500 ng/mL |
| MTD | Methadone | 300 ng/mL |
| OPI | Morphine | 300 ng/mL |
| OXY | Oxycodone | 100 ng/mL |
| PCP | Phencyclidine | 25 ng/mL |
| PPX | Propoxyphene | 300 ng/mL |
| TCA | Nortriptyline | 1000 ng/mL |
| THC | 11-nor- 9-Tetrahydrocannabinol-9-carboxylic acid | 50 ng/mL |

These tests provide visual qualitative results and are intended for *in vitro* diagnostic use only. The ToxCup Drug Screen Cup is available in double drug analyte cassette dip format. It is intended for prescription point-of-care use and over-the-counter consumer use.

These tests provide only a preliminary test result and are the first step in a two-step process for detecting drugs of abuse in urine. The second step is confirming the results in a certified laboratory. For a quantitative result or to confirm preliminary positive results obtained by the ToxCup Drug Screen Cup, a more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS) must be used. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly when a preliminary positive result is indicated.

3. Special conditions for use statement(s):

For over-the counter use.

4. Special instrument requirements:

Not Applicable

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I. Device Description:

This device is to be used with human urine samples. The tests are available in the cassette dip format. The cassette format consists of the ToxCup Drug Screen Cup test strips, a plastic cassette dip and a plastic cup base. The plastic cassette dip can hold up to 7 individual test strips. Each test strip can detect up to 2 drugs.

Each test strip consists of an absorbent pad used to deliver sample to the test strip, a drug antibody-colloidal gold conjugate pad, two stripes of drug protein conjugate known as Test regions (T) and a control stripe of goat anti-rabbit IgG antibody (C).

J. Substantial Equivalence Information:

1. Predicate device name(s):
Amedica Home Drug Test Cup

2. Predicate 510(k) number(s):
k082898

3. Comparison with predicate:

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| Reagent Similarities and Differences | | |
| --- | --- | --- |
| Feature | Candidate Device: ToxCup Drug Screen Cup (k122633) | Predicate Device: Amedica Home Drug Test Cup (k082898) |
| Intended/Indications for Use | Screening Device | Same |
| Methodology | Competitive immunoassay | Same |
| Results | Qualitative | Same |
| Matrix | Human Urine | Same |
| Cut Off Value | THC: 50 ng/mL
Amphetamine: 500 ng/mL
Secobarbital: 300 ng/mL
Buprenorphine Glucuronide: 10 ng/mL
Benzoylecgonine: 150 ng/mL
MDMA: 500 ng/mL
Methamphetamine: 500ng/mL
Methadone: 300 ng/mL
Morphine: 300 ng/mL
Phencyclidine 25 ng/mL
Benzodiazepines 300 ng/mL
Nortriptyline 1000 ng/mL
Oxycodone 100 ng/mL
Propoxyphene 300 ng/mL | THC: 50 ng/mL
Amphetamine: 1000 ng/mL
Secobarbital: 300 ng/mL
Morphine: 300 ng/mL
Benzodiazepines 300 ng/mL
Methadone: 300 ng/mL
Oxycodone 100 ng/mL
MDMA: 500 ng/mL
Nortriptyline 1000 ng/mL
Phencyclidine 25 ng/mL |
| Configurations | Strip, Cassette | Card |
| Intended Use | Over the Counter and Prescription Use | Over the Counter |
| Test Strip | Tests up to 14 drugs | Tests up to 12 drugs |
| Method Comparison Total % agreement | ≥ 95% | ≥ 93% |
| Storage | Sealed Pouch at 15-30°C | Sealed pouch at 2-30°C |
| Reading Time | 5-8 minutes | 4-5 minutes |

K. Standard/ Guidance Document Referenced (if applicable):
- In Vitro Diagnostic Devices; Guidance for the Preparation of 510(k) Submission
- Premarket Submission and Labeling Recommendations for Drugs of Abuse Screening Tests, Draft Guidance

L. Test Principle:
The tests are available in the cassette dip format. Each test strip consists of an absorbent pad used to deliver sample to the test strip, a drug antibody-colloidal gold conjugate pad, two

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stripes of drug protein conjugate known as Test regions (T) and a control stripe of goat anti-rabbit IgG antibody (C).

When the absorbent end of the test device is immersed into the urine sample, the urine is absorbed into the device by capillary action, mixes with the antibody-dye conjugate, and flows across the pre-coated membrane. When sample drug levels are zero or below the target cut off (the detection sensitivity of the test), antibody-dye conjugate binds to the drug-protein conjugate immobilized in the T region of the device. This produces a colored Test line, which regardless of its intensity, indicates a negative result.

When sample drug levels are at or above the target cutoff, the free drug in the binding sample binds to the antibody-dye conjugate preventing the antibody-dye conjugate from binding to the drug-protein conjugate immobilized in the T region of the device. This prevents the development of a distinct colored band in the test region, indicating a potentially positive result.

To serve as a procedure control, a colored line will appear at the C Region, if the test has been performed properly because of the antibody-dye conjugate binding to anti-rabbit IgG immobilized in the C Region of the device.

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

### 1. Analytical performance:

#### a. Precision/Reproducibility:

The precision study was performed by taking negative urine samples and spiking these with: ± 25, 50, 75, and 100% of the different cut-off values for each drug. The study was performed at three different point-of-care sites for a minimum of 10 days. Each of the three sites had one operator perform the studies on one lot of cups for a total of three lots studied. All samples were randomized and masked three lots drug screen cups were used. A summary of the results is presented in the tables below.

11-nor-9-Tetrahydrocannabinol-9-carboxylic acid = 50 ng/mL cut-off

| Site | Negative | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | +25% Cut-off | +50% Cut-off | +75% Cut-off | + 100% Cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos |
| Site 1 | 120/0 | 15/0 | 15/0 | 14/1 | 6/9 | 2/13 | 0/15 | 0/15 | 0/15 |
| Site 2 | 120/0 | 15/0 | 15/0 | 15/0 | 7/8 | 1/14 | 0/15 | 0/15 | 0/15 |
| Site 3 | 120-0 | 15/0 | 15/0 | 15/0 | 8/7 | 1/14 | 0/15 | 0/15 | 0/15 |

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Benzoylecgonine = 150 ng/mL cut-off

| Site | Negative | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | +25% Cut-off | +50% Cut-off | +75% Cut-off | + 100% Cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos |
| Site 1 | 120/0 | 15/0 | 15/0 | 14/1 | 6/9 | 1/14 | 0/15 | 0/15 | 0/15 |
| Site 2 | 120/0 | 15/0 | 15/0 | 15/0 | 4/11 | 0/15 | 0/15 | 0/15 | 0/15 |
| Site 3 | 120/0 | 15/0 | 15/0 | 15/0 | 4/11 | 0/15 | 0/15 | 0/15 | 0/15 |

Morphine = 300 ng/mL cut-off

| Site | Negative | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | +25% Cut-off | +50% Cut-off | +75% Cut-off | + 100% Cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos |
| Site 1 | 120/0 | 15/0 | 15/0 | 13/2 | 6/9 | 1/14 | 0/15 | 0/15 | 0/15 |
| Site 2 | 120/0 | 15/0 | 15/0 | 12/3 | 4/11 | 0/15 | 0/15 | 0/15 | 0/15 |
| Site 3 | 120-0 | 15/0 | 15/0 | 14/1 | 4/11 | 0/15 | 0/15 | 0/15 | 0/15 |

Methamphetamine = 500 ng/mL cut-off

| Site | Negative | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | +25% Cut-off | +50% Cut-off | +75% Cut-off | + 100% Cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos |
| Site 1 | 105/0 | 15/0 | 15/0 | 15/0 | 7/8 | 1/14 | 0/15 | 0/15 | 0/15 |
| Site 2 | 105/0 | 15/0 | 15/0 | 15/0 | 8/7 | 1/13 | 0/15 | 0/15 | 0/15 |
| Site 3 | 105/0 | 15/0 | 15/0 | 15/0 | 10/5 | 1/14 | 0/15 | 0/15 | 0/15 |

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Amphetamine = 500 ng/mL cut-off

| Site | Negative | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | +25% Cut-off | +50% Cut-off | +75% Cut-off | + 100% Cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos |
| Site 1 | 120/0 | 15/0 | 15/0 | 13/2 | 6/9 | 1/14 | 0/15 | 0/15 | 0/15 |
| Site 2 | 120/0 | 15/0 | 15/0 | 15/0 | 5/10 | 1/14 | 0/15 | 0/15 | 0/15 |
| Site 3 | 120-0 | 15/0 | 15/0 | 15/0 | 4/11 | 2/13 | 0/15 | 0/15 | 0/15 |

Oxazepam = 300 ng/mL cut-off

| Site | Negative | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | +25% Cut-off | +50% Cut-off | +75% Cut-off | + 100% Cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos |
| Site 1 | 120/0 | 15/0 | 15/0 | 15/0 | 5/10 | 0/15 | 0/15 | 0/15 | 0/15 |
| Site 2 | 120/0 | 15/0 | 15/0 | 15/0 | 3/12 | 0/15 | 0/15 | 0/15 | 0/15 |
| Site 3 | 120/0 | 15/0 | 15/0 | 15/0 | 4/11 | 1/14 | 0/15 | 0/15 | 0/15 |

Secobarbital = 300 ng/mL cut-off

| Site | Negative | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | +25% Cut-off | +50% Cut-off | +75% Cut-off | + 100% Cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos |
| Site 1 | 120/0 | 15/0 | 15/0 | 14/1 | 6/9 | 2/13 | 0/15 | 0/15 | 0/15 |
| Site 2 | 120/0 | 15/0 | 15/0 | 15/0 | 7/8 | 1/14 | 0/15 | 0/15 | 0/15 |
| Site 3 | 120-0 | 15/0 | 15/0 | 15/0 | 8/7 | 1/14 | 0/15 | 0/15 | 0/15 |

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Methadone = 300 ng/mL cut-off

| Site | Negative | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | +25% Cut-off | +50% Cut-off | +75% Cut-off | + 100% Cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos |
| Site 1 | 120/0 | 15/0 | 15/0 | 14/1 | 6/9 | 1/14 | 0/15 | 0/15 | 0/15 |
| Site 2 | 120/0 | 15/0 | 15/0 | 15/0 | 4/11 | 0/15 | 0/15 | 0/15 | 0/15 |
| Site 3 | 120/0 | 15/0 | 15/0 | 15/0 | 4/11 | 0/15 | 0/15 | 0/15 | 0/15 |

Buprenorphine Glucoronide = 10 ng/mL cut-off

| Site | Negative | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | +25% Cut-off | +50% Cut-off | +75% Cut-off | + 100% Cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos |
| Site 1 | 120/0 | 15/0 | 15/0 | 13/2 | 6/9 | 0/15 | 0/15 | 0/15 | 0/15 |
| Site 2 | 120/0 | 15/0 | 15/0 | 12/3 | 7/8 | 0/15 | 0/15 | 0/15 | 0/15 |
| Site 3 | 120-0 | 15/0 | 15/0 | 14/1 | 9/6 | 0/15 | 0/15 | 0/15 | 0/15 |

Nortriptyline = 1000 ng/mL cut-off

| Site | Negative | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | +25% Cut-off | +50% Cut-off | +75% Cut-off | + 100% Cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos |
| Site 1 | 120/0 | 15/0 | 15/0 | 14/1 | 8/7 | 2/13 | 0/15 | 0/15 | 0/15 |
| Site 2 | 120/0 | 15/0 | 15/0 | 15/0 | 12/3 | 2/13 | 0/15 | 0/15 | 0/15 |
| Site 3 | 120/0 | 15/0 | 15/0 | 14/1 | 13/2 | 2/13 | 0/15 | 0/15 | 0/15 |

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3,4-methylenedioxymethamphetamine = 500 ng/mL cut-off

| Site | Negative | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | +25% Cut-off | +50% Cut-off | +75% Cut-off | +100% Cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos |
| Site 1 | 120/0 | 15/0 | 15/0 | 14/1 | 4/11 | 1/14 | 0/15 | 0/15 | 0/15 |
| Site 2 | 120/0 | 15/0 | 15/0 | 13/2 | 5/10 | 15/0 | 0/15 | 0/15 | 0/15 |
| Site 3 | 120-0 | 15/0 | 15/0 | 15/0 | 7/8 | 15/0 | 0/15 | 0/15 | 0/15 |

Oxycodone = 100 ng/mL cut-off

| Site | Negative | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | +25% Cut-off | +50% Cut-off | +75% Cut-off | +100% Cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos |
| Site 1 | 120/0 | 15/0 | 15/0 | 15/0 | 7/8 | 1/14 | 0/15 | 0/15 | 0/15 |
| Site 2 | 120/0 | 15/0 | 15/0 | 15/0 | 8/7 | 0/15 | 0/15 | 0/15 | 0/15 |
| Site 3 | 120/0 | 15/0 | 15/0 | 15/0 | 12/3 | 1/14 | 0/15 | 0/15 | 0/15 |

Phencyclidine = 25 ng/mL cut-off

| Site | Negative | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | +25% Cut-off | +50% Cut-off | +75% Cut-off | +100% Cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos |
| Site 1 | 120/0 | 15/0 | 15/0 | 15/0 | 9/6 | 1/14 | 0/15 | 0/15 | 0/15 |
| Site 2 | 120/0 | 15/0 | 15/0 | 15/0 | 10/5 | 2/13 | 0/15 | 0/15 | 0/15 |
| Site 3 | 120-0 | 15/0 | 15/0 | 15/0 | 10/5 | 2/13 | 0/15 | 0/15 | 0/15 |

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Propoxyphene = 300 ng/mL cut-off

| Site | Negative | -75% Cut-off | -50% Cut-off | -25% Cut-off | Cut-off | +25% Cut-off | +50% Cut-off | +75% Cut-off | +100% Cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos |
| Site 1 | 120/0 | 15/0 | 15/0 | 14/1 | 4/11 | 0/15 | 0/15 | 0/15 | 0/15 |
| Site 2 | 120/0 | 15/0 | 15/0 | 13/2 | 2/13 | 0/15 | 0/15 | 0/15 | 0/15 |
| Site 3 | 120/0 | 15/0 | 15/0 | 13/2 | 5/10 | 0/15 | 0/15 | 0/15 | 0/15 |

b. Linearity/assay reportable range:

Not Applicable, the assay is intended for qualitative use

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

Control standards are not supplied with this device; however, this device has internal process controls. A colored line appearing in the control region confirms sufficient sample volume and adequate membrane wicking. Users are informed that the test is invalid if a line fails to appear in the control region.

Professional users are informed in the labeling that external negative and positive urine controls should be used to initially test each new lot of product to ensure proper performance.

Stability

Accelerated stability studies were conducted on three lots of the ToxCup® Drug Screen Tests. Protocols and acceptance criteria were found to be acceptable. The manufacturer claims an 18 month shelf life. Real time studies are on-going.

Read time stability was performed for the ToxCup® Drug Screen Tests. A drug-free urine sample was spiked with the appropriate drug at ±25%, 50%, and +200% of the cutoff. 20 replicates per level were tested at 2-10 minute intervals from 1-60 minutes. Data supports the recommended read time of 5-8 minutes.

d. Detection limit:

Not applicable, this is a qualitative assay.

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# e. Analytical specificity:

Cross reactivity was established by spiking structurally related compounds into drug free urine and diluting each to determine the lowest concentration that produced a false positive result. Two devices were tested for each spiked urine solution. Results are expressed as the response equivalent to cutoff, which is the lowest interference concentration that produces a positive result. The percent cross-reactivity, expressed as $100^{*}$ (cutoff/response equivalent to cutoff) is also presented below:

Structurally related:

| 11-nor-9-Tetrahydrocannabinol-9-carboxylic acid (Cutoff = 50 ng/ml) | Response Equivalent to Cutoff (ng/mL) | % Cross Reactivity |
| --- | --- | --- |
| Cannabinol | 50000 | 0.1% |
| Cannabidiol | 100000 | 0.05% |
| 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid | 50 | 100% |
| 11-nor-Δ8-Tetrahydrocannabinol-9-carboxylic acid | 50 | 100% |
| 11-hydroxy-Δ9-Tetrahydrocannabinol | 2500 | 2% |
| Δ8-Tetrahydrocannabinol | 7000 | 0.71% |
| Δ9-Tetrahydrocannabinol | 10500 | 0.48% |
| Benzoylecgonine (Cutoff = 150 ng/ml) | Response Equivalent to Cutoff (ng/mL) | % Cross Reactivity |
| --- | --- | --- |
| Benzoylecgonine | 150 | 100% |
| Ecgonine | 65500 | 0.23% |

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| Morphine (Cutoff = 300 ng/ml) | Response Equivalent to Cutoff (ng/mL) | % Cross Reactivity |
| --- | --- | --- |
| 6-Acetylmorphine | 500 | 60% |
| 6-Acetylcodeine | 600 | 50% |
| Codeine | 300 | 100% |
| Dihydrocodeine | 500 | 60% |
| Ethyl Morphine | 300 | 100% |
| Heroin | 100 | 300% |
| Hydrocodone | 1000 | 30% |
| Hydromorphone | 400 | 75% |
| Morphine | 300 | 100% |
| Morphine-3-β-glururonide | 500 | 60% |
| Nalorphine | 5000 | 6% |
| Methamphetamine (Cutoff = 500 ng/ml) | Response Equivalent to Cutoff (ng/mL) | % Cross Reactivity |
| --- | --- | --- |
| Ephedrine | 10000 | 5% |
| p-hydroxymethamphetamine | 1750 | 28.57% |
| D,1-3,4-MDMA | 1000 | 50% |
| d-methamphetamine | 500 | 100% |
| l-methamphetamine | 25000 | 2% |
| Procaine | 50000 | 1% |
| d,1-3,4-MDEA | 20000 | 2.5% |
| Trimethobenzamine | 75000 | 0.67% |
| Amphetamine (Cutoff = 500 ng/ml) | Response Equivalent to Cutoff (ng/mL) | % Cross Reactivity |
| --- | --- | --- |
| 1-Amphetamine | 20000 | 2.5% |
| d-Amphetamine | 500 | 100% |
| D,1-3,4-methylenedioxyamphetamine (MDA) | 1500 | 33.3% |
| Phentermine | 1000 | 50% |
| β-phenylethylamine | 80000 | 0.63% |

{13}

| Oxazepam
Cutoff= 300 ng/ml | Response
Equivalent to
Cutoff (ng/mL) | % Cross Reactivity |
| --- | --- | --- |
| Alprazolam | 150 | 200% |
| a-hydroxyalprazolam | 50 | 600% |
| Bromazepam | 800 | 37.5 |
| Chlordiazepoxide | 3000 | 37.5% |
| Clonazepam | 4000 | 7.5% |
| Clobazam | 200 | 150% |
| Delorazepam | 6000 | 5% |
| Diazepam | 150 | 200% |
| Estazolam | 300 | 100% |
| Flunitrazepam | 1000 | 30% |
| Flurazepam | 300 | 100% |
| Lorazepam | 1500 | 20% |
| Lormetazepam | 1000 | 30% |
| Medazepam | 2000 | 15% |
| Nitrazepam | 1000 | 30% |
| Nordiazepam | 100 | 300% |
| Oxazepam | 300 | 100% |
| Phenazepam | 1000 | 30% |
| Prazepam | 1000 | 30% |
| Temazepam | 150 | 50% |
| Trazolam | 1500 | 20% |
| Secobarbital
Cutoff= 300 ng/ml) | Response
Equivalent to
Cutoff (ng/mL) | % Cross Reactivity |
| --- | --- | --- |
| Amobarbital | 1500 | 20% |
| Alphenal | 400 | 75% |
| Aprobarbital | 400 | 150% |
| Allobarbital | 1500 | 20 |
| Butabarbital | 400 | 75% |
| Butethal | 400 | 75% |
| Butalbital | 300 | 100% |
| Barbital | 400 | 75% |
| Secobarbital | 300 | 100% |
| Pentobarbital | 400 | 75% |
| Phenobarbital | 400 | 75% |

{14}

| Methadone Cutoff= 300 ng/ml | Response Equivalent to Cutoff (ng/mL) | % Cross Reactivity |
| --- | --- | --- |
| Doxylamine | 50,000 | 0.6% |
| w-Ethylidene-1,5 Dimethyl-1,3 Diphenylapyrolidine | 50,000 | 0.6% |
| Methadone | 300 | 100% |
| Pheniramine | 75,000 | 0.4% |
| Buprenorphine Glucuronide Cutoff= 10 ng/ml | Response Equivalent to Cutoff (ng/mL) | % Cross Reactivity |
| --- | --- | --- |
| Buprenorphine | 100 | 10% |
| Buprenorphine Glucuronide | 10 | 100% |
| Norbuprenorphine | 100 | 10% |
| Norbuprenorphine Glucuronide | 100 | 10% |
| Nortriptyline Cutoff= 1000 ng/ml | Response Equivalent to Cutoff (ng/mL) | % Cross Reactivity |
| --- | --- | --- |
| Amitriptyline | 1000 | 100% |
| Clomipramine | 7500 | 13.33% |
| Cyclobenzaprine | 1500 | 66.67% |
| Desipramine | 750 | 133.33% |
| Doxepin | 1000 | 100% |
| Imipramine | 750 | 133.33% |
| Nordoxepin | 1000 | 100% |
| Nortriptyline | 1000 | 100% |
| Perphenazine | 50000 | 2% |
| Promazine | 10,000 | 10 |
| Protriptyline | 350 | 285.7% |
| Trimipramine | 1500 | 66.67% |

{15}

16

| 3,4 methylenediozymethamphetamine Cutoff= 500 ng/ml | Response Equivalent to Cutoff (ng/mL) | % Cross Reactivity |
| --- | --- | --- |
| d,1-3,4-MDA | 2000 | 25% |
| d,1-3,4-MDEA | 250 | 200% |
| d,1-3,4-MDMA | 500 | 100% |
| d-Methamphetamine | 50,000 | 1% |
| Oxycodone Cutoff= 100 ng/ml | Response Equivalent to Cutoff (ng/mL) | % Cross Reactivity |
| --- | --- | --- |
| Codeine | 5000 | 2% |
| Dihydrocodeine | 2000 | 5% |
| 6-Acetylcodeine | 15,000 | 0.67% |
| Hyrdrocodone | 300 | 33.3% |
| Oxymorphone | 3000 | 3.3% |
| Oxycodone | 100 | 100% |
| Hydromorphone | 25,000 | 0.4% |
| Ethylmorphine | 5000 | 2% |
| Phencyclidine Cutoff= 25 ng/ml | Response Equivalent to Cutoff (ng/mL) | % Cross Reactivity |
| --- | --- | --- |
| 4-Hydroxy Phencyclidine | 500 | 5% |
| Metaphit | 500 | 5% |
| Phencyclidine | 25 | 100% |
| Phencyclidine Morpholine | 50,000 | 0.05% |
| Propoxyphene Cutoff= 300 ng/ml | Response Equivalent to Cutoff (ng/mL) | % Cross Reactivity |
| --- | --- | --- |
| Propoxyphene | 300 | 100% |
| Norpropoxyphene | 500 | 60% |

Structurally Un-related Compounds:

This study was performed by spiking structurally unrelated compounds and endogenous substances up to concentration of 100 µg/mL into urine samples containing drug at ± 50% of the respective drug cutoff concentrations. Testing was performed for on two devices for each urine control. The following compounds showed no interference when tested at the ± 50 % drug concentration.

{16}

17

Acetaminophen
Acetone
Albumin
Acetylsalicyclic Acid
Amoxapine
Amoxicillin
Ampicillin
Ascorbic Acid
Apomorphine
Aspartame
Atropine Sulfate
Benzilic Acid
Benzoicaine
Benzoic Acid
Bilirubin
Brompheniramine
Benzphetamine
Cholesterol
Caffeine
(+/-)-Chlorpheniramine
Chlorpromazine
Chlorquine Diphosphate
Cortisone
Cotinine
Creatinine
Creatine HCl
Deoxycorticosterone acetate
Dextromethorphan
Diphenydramine
Dopamine
4-Dimethylaminotipyrine
Ecgonine methyl ester
(-) Epinephrine
b-Estradiol
Estrone-3-sulfate
potassium salt
Ethanol
Ethyl-p-aminobenzoate
Erythromycin
Furosemide
Gentisic acid
Glutethimide
Guaiaicol Glyceryl
Ether
D-(+)-glucose
Hemoglobin
Hippuric Acid
Hydrochlorthiazide
Hydrocortisone
Ibuprofen
(+/-)-Isoproterenol
Ketamine HCl
Lidocaine
Meperidine
Methylphenamine
Methaqualone
2-Methylamine-
Propiophenone HCl
(1R,2S)-(+)-N-Methyl-
Ephedrine
Methylphenidate
Nalidixic acid
Naloxone
Naproxen
Niacinamide
S (-)-Nicotine
Norepinephrine
Norethinodrone
Oxalic Acid
Oxolinic Acid
Papaverine
Penicillin-G
Pentazocaine
Phenothiazine
Phenylephrine
Prednisone
Promethazine
d-Pseudophedrine
Pyrrolidine
Quinidine
Quinine
Ranitidine
Riboflavin
Salicylic Acid
Serotonin
Sodium Chloride
Sulfamethazine
Sulindac
Tetracycline
Thiamine
Thioridazine
Trifluoperazine
Tryptamine
d,l-Tryptophan
Tyramine
d,l-Tyrosine
Uric Acid
Verapamil
Zomepirac
Cocaine
Setraline
Ecgonine Methyl
Ester
Amitripytiline
Ephedrine
pheniramine
β-phenylethylamine
procaine

{17}

The pH of a drug-free urine pool was adjusted to pH 3, pH 3.5, pH 4, pH 4.5, pH 5, pH 5.5, pH 6, pH 6.5, pH 7, pH 7.5, pH 8, pH 8.5 or pH 9; the urine was spiked with ± 50% of the cut-off concentration for each drug and two replicates were tested for each test. Altering the pH of the urine sample did not affect the accuracy of any of the test results.

The specific gravity of a drug-free urine pool was measured by obtaining urine samples with specific gravities of 1.005, 1.010, 1.020, and 1.030 and spiking with ± 50% of the cut-off concentration of the cut-off concentration for each drug and two replicates were tested for each test. Altering the specific gravity of the urine sample did not affect the accuracy of any of the test results.

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:

The method comparison study was conducted to evaluate the performance of the device for detection of the different analytes at one point of care site using blind labeled urine samples and one lot of ToxCup Drug Screen Cups. For each drug test, at least 40 unaltered positive clinical samples and 40 unaltered negative clinical samples with known GC/MS or LC/MS values were tested. At least 10% of these samples had drug concentrations within the range of cutoff to +50% cutoff. For the phencyclidine test, four diluted urine samples were used in the study. The results of the studies are presented below:

18

{18}

| Analyte | | Negative | Low Negative by GC/MS (less than 50%) | Near Cutoff Negative by GC/MS (between 50% and cutoff) | Near Cutoff Positive by GC/MS (between cutoff and 50%) | High positive by GC/MS (greater than 40%) | Percent Agreement |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Amphetamine | Positive | 0 | 0 | 2 | 5 | 36 | 100% |
| | Negative | 36 | 1 | 2 | 0 | 0 | 95.1% |
| Oxazepam | Positive | 0 | 0 | 3 | 4 | 39 | 100% |
| | Negative | 36 | 0 | 1 | 0 | 0 | 92.5% |
| Secobarbital | Positive | 0 | 0 | 1 | 6 | 33 | 95.1% |
| | Negative | 36 | 0 | 3 | 2 | 0 | 97.5% |
| Methadone | Positive | 0 | 0 | 0 | 3 | 36 | 97.5% |
| | Negative | 36 | 0 | 4 | 1 | 0 | 100% |
| Buprenorphine Glucuronide | Positive | 0 | 0 | 1 | 4 | 38 | 97.7% |
| | Negative | 36 | 0 | 3 | 1 | 0 | 97.5% |
| Nortriptyline | Positive | 0 | 0 | 0 | 27 | 11 | 92.7% |
| | Negative | 36 | 0 | 4 | 3 | 0 | 100% |
| 3,4 methylenedioxy-Methamphetamine | Positive | 0 | 0 | 1 | 3 | 40 | 97.7% |
| | Negative | 36 | 0 | 3 | 1 | 0 | 97.5% |
| Oxycodone | Positive | 0 | 0 | 2 | 6 | 38 | 100% |
| | Negative | 36 | 0 | 4 | 0 | 0 | 95.2% |
| Phencyclidine | Positive | 0 | 0 | 0 | 3 | 36 | 95.1% |
| | Negative | 36 | 0 | 4 | 2 | 0 | 100% |
| Propoxyphene | Positive | 0 | 0 | 2 | 4 | 36 | 100% |
| | Negative | 36 | 0 | 2 | 0 | 0 | 95% |
| 11-nor-9-Tetrahydrocannabinol-9-carboxylic acid | Positive | 0 | 0 | 1 | 6 | 35 | 100% |
| | Negative | 36 | 2 | 4 | 0 | 0 | 97.7% |
| Morphine | Positive | 0 | 0 | 3 | 7 | 34 | 100% |
| | Negative | 36 | 0 | 1 | 0 | 0 | 92.5% |
| Methamphetamine | Positive | 0 | 0 | 0 | 5 | 67 | 96% |
| | Negative | 36 | 2 | 4 | 3 | 0 | 100% |
| Benzoylecgonine | Positive | 0 | 0 | 3 | 3 | 37 | 97.6% |
| | Negative | 36 | 0 | 2 | 1 | 0 | 92.7% |

{19}

The discordant results are listed in the table below.

| Cutoff value (ng/mL) | Assay (POS/NEG) | Drug Metabolite GC/MS value (ng/mL) | |
| --- | --- | --- | --- |
| | | Drug/Metabolite | GC/MS value (ng/mL) |
| THC 50 | Positive | 11-Δ9-THC-COOH | 36 |
| Cocaine 150 | Positive | Benzoylecgonine | 120 |
| Cocaine 150 | Positive | Benzoylecgonine | 138 |
| Cocaine 150 | Positive | Benzoylecgonine | 140 |
| Cocaine 150 | Negative | Benzoylecgonine | 194 |
| Opiate 300 | Positive | Morphine | 196 |
| Opiate 300 | Positive | Morphine | 251 |
| Opiate 300 | Positive | Morphine | 291 |
| Methamphetamine 500 | Negative | d-Methamphetamine | 544 |
| Methamphetamine 500 | Negative | d-Methamphetamine | 652 |
| Methamphetamine 500 | Negative | d-Methamphetamine | 677 |
| Amphetamine 500 | Positive | d-Amphetamine | 395 |
| Amphetamine 500 | Positive | d-Amphetamine | 405 |
| Benzodiazepine 300 | Positive | Oxazepam | 132 |
| Benzodiazepine 300 | Positive | Oxazepam | 224 |
| Benzodiazepine 300 | Positive | Oxazepam | 268.4 |
| Barbiturate 300 | Positive | Butalbital | 202 |
| Barbiturate 300 | Negative | Butalbital | 311 |
| Barbiturate 300 | Negative | Butalbital | 357 |
| Methadone 300 | Negative | Methadone | 304.8 |
| Buprenorphine 10 | Positive | Buprenorphine Glucuronide | 8.2 |
| Buprenorphine 10 | Negative | Buprenorphine Glucuronide | 11 |
| Tricyclic Antidepressants 1000 | Negative | Nortriptyline | 1018 |
| Tricyclic Antidepressants 1000 | Negative | Nortriptyline | 1065 |
| Tricyclic Antidepressants 1000 | Negative | Nortriptyline | 1176 |
| 3,4 methylenedioxy-Methamphetamine | Positive | 3,4 methylenedioxy-Methamphetamine | 320 |
| 3,4 methylenedioxy-Methamphetamine | Negative | 3,4 methylenedioxy-Methamphetamine | 505 |
| Oxycodone 100 | Positive | Oxycodone | 54.7 |
| Oxycodone 100 | Positive | Oxycodone | 79.3 |

{20}

| Phencyclidine 25 | Negative | Phencyclidine | 29 |
| --- | --- | --- | --- |
| Phencyclidine 25 | Negative | Phencyclidine | 31 |
| Propoxyphene 300 | Positive | Propoxyphene | 273.1 |
| Propoxyphene 300 | Positive | Propoxyphene | 278 |

A lay-user study was performed to assess the suitability of the device for home use. Seven drug-free urine sample pools were spiked to $0, \pm 25\%, \pm 50\%, \pm 75\%$ of the cutoff of target drug. These concentrations were confirmed by GC/MS and one lot of ToxCup Drug Screen Cup was tested. The testing was performed at three sites by 153 blinded consumers divided between three sites (a minimum of 45 participants per site). Each participant received the package inset, 1-3 blinded samples, and 1-3 ToxCup Drug Screen Cups. The lay persons test result was compared to the GC/MS result to demonstrate accuracy by lay-users.

The participant's ages ranged from 18-over 55 and there were slightly more males than females. They come from a variety of career and education backgrounds. All participants stated that the ToxCup Drug Screen Cup was easy to use, the test results were easy to read and the instructions for confirmation of the test were easy to understand.

Additionally, a Flesh-Kincaid reading analysis revealed that both package inserts had a reading grade level of 7.

21

{21}

The following are the results of the lay-user study pooled together from all three sites:

11-nor-9-Tetrahydrocannabinol-9-carboxylic acid

| % of Cutoff | Number of Samples | 11-nor-9-Tetrahydrocannabinol-9-carboxylic acid GS/MS Concentration (ng/mL) | Lay person results: Pos/Neg | Percentage of Correct Results |
| --- | --- | --- | --- | --- |
| Negative | 210 | 0 | 0/210 | 100 |
| -75 % Cutoff | 30 | 12.4 | 0/30 | 100 |
| -50 % Cutoff | 30 | 26.7 | 0/30 | 100 |
| -25 % Cutoff | 30 | 37.4 | 5/25 | 83.0 |
| +25% Cutoff | 30 | 62.9 | 27/3 | 90.0 |
| +50 % Cutoff | 30 | 76.5 | 30/0 | 100 |
| +75 % Cutoff | 30 | 86.4 | 30/0 | 100 |

Benzoylecgonine

| % of Cutoff | Number of Samples | Benzoylecgonine GS/MS Concentration (ng/mL) | Lay person results: Pos/Neg | Percentage of Correct Results |
| --- | --- | --- | --- | --- |
| Negative | 210 | 0 | 0/210 | 100 |
| -75 % Cutoff | 30 | 37.5 | 0/30 | 100 |
| -50 % Cutoff | 30 | 79 | 0/30 | 100 |
| -25 % Cutoff | 30 | 119 | 4/26 | 87.0 |
| +25% Cutoff | 30 | 198 | 26/4 | 87.0 |
| +50 % Cutoff | 30 | 227 | 30/0 | 100 |
| +75 % Cutoff | 30 | 236 | 30/0 | 100 |

{22}

Morphine

| % of Cutoff | Number of Samples | Morphine GS/MS Concentration (ng/mL) | Lay person results: Pos/Neg | Percentage of Correct Results |
| --- | --- | --- | --- | --- |
| Negative | 210 | 0 | 0/210 | 100 |
| -75 % Cutoff | 30 | 75 | 0/30 | 100 |
| -50 % Cutoff | 30 | 129 | 0/30 | 100 |
| -25 % Cutoff | 30 | 200 | 5/25 | 83.0 |
| +25% Cutoff | 30 | 322 | 27/3 | 90.0 |
| +50 % Cutoff | 30 | 484 | 30/0 | 100 |
| +75 % Cutoff | 30 | 475 | 30/0 | 100 |

Methamphetamine

| % of Cutoff | Number of Samples | Methamphetamine GS/MS Concentration (ng/mL) | Lay person results: Pos/Neg | Percentage of Correct Results |
| --- | --- | --- | --- | --- |
| Negative | 210 | 0 | 0/210 | 100 |
| -75 % Cutoff | 30 | 130 | 0/30 | 100 |
| -50 % Cutoff | 30 | 266 | 0/30 | 100 |
| -25 % Cutoff | 30 | 413 | 4/26 | 87.0 |
| +25% Cutoff | 30 | 586 | 26/4 | 87.0 |
| +50 % Cutoff | 30 | 811 | 30/0 | 100 |
| +75 % Cutoff | 30 | 944 | 30/0 | 100 |

23

{23}

24

Amphetamine

| % of Cutoff | Number of Samples | Amphetamine GS/MS Concentration (ng/mL) | Lay person results: Pos/Neg | Percentage of Correct Results |
| --- | --- | --- | --- | --- |
| Negative | 210 | 0 | 0/210 | 100 |
| -75 % Cutoff | 30 | 133 | 0/30 | 100 |
| -50 % Cutoff | 30 | 280 | 0/30 | 100 |
| -25 % Cutoff | 30 | 389 | 4/26 | 87.0 |
| +25% Cutoff | 30 | 663 | 26/4 | 87.0 |
| +50 % Cutoff | 30 | 740 | 30/0 | 100 |
| +75 % Cutoff | 30 | 939 | 30/0 | 100 |

Oxazepam

| % of Cutoff | Number of Samples | Oxazepam GS/MS Concentration (ng/mL) | Lay person results: Pos/Neg | Percentage of Correct Results |
| --- | --- | --- | --- | --- |
| Negative | 210 | 0 | 0/210 | 100 |
| -75 % Cutoff | 30 | 82 | 0/30 | 100 |
| -50 % Cutoff | 30 | 160 | 0/30 | 100 |
| -25 % Cutoff | 30 | 245 | 5/25 | 83.0 |
| +25% Cutoff | 30 | 403 | 26/4 | 87.0 |
| +50 % Cutoff | 30 | 465 | 30/0 | 100 |
| +75 % Cutoff | 30 | 535 | 30/0 | 100 |

{24}

Secobarbital

| % of Cutoff | Number of Samples | Secobarbital GS/MS Concentration (ng/mL) | Lay person results: Pos/Neg | Percentage of Correct Results |
| --- | --- | --- | --- | --- |
| Negative | 210 | 0 | 0/210 | 100 |
| -75 % Cutoff | 30 | 77 | 0/30 | 100 |
| -50 % Cutoff | 30 | 133 | 0/30 | 100 |
| -25 % Cutoff | 30 | 235 | 4/26 | 87.0 |
| +25% Cutoff | 30 | 333 | 26/4 | 87.0 |
| +50 % Cutoff | 30 | 448 | 30/0 | 100 |
| +75 % Cutoff | 30 | 489 | 30/0 | 100 |

Methadone

| % of Cutoff | Number of Samples | Methadone GS/MS Concentration (ng/mL) | Lay person results: Pos/Neg | Percentage of Correct Results |
| --- | --- | --- | --- | --- |
| Negative | 210 | 0 | 0/210 | 100 |
| -75 % Cutoff | 30 | 78.7 | 0/30 | 100 |
| -50 % Cutoff | 30 | 165 | 0/30 | 100 |
| -25 % Cutoff | 30 | 217 | 4/26 | 87.0 |
| +25% Cutoff | 30 | 366 | 25/5 | 83.0 |
| +50 % Cutoff | 30 | 480 | 30/0 | 100 |
| +75 % Cutoff | 30 | 547 | 30/0 | 100 |

25

{25}

Buprenorphine Glucuronide

| % of Cutoff | Number of Samples | Buprenorphine Glucuronide GS/MS Concentration (ng/mL) | Lay person results: Pos/Neg | Percentage of Correct Results |
| --- | --- | --- | --- | --- |
| Negative | 210 | 0 | 0/210 | 100 |
| -75 % Cutoff | 30 | 2.5 | 0/30 | 100 |
| -50 % Cutoff | 30 | 4.5 | 0/30 | 100 |
| -25 % Cutoff | 30 | 8 | 5/25 | 83.0 |
| +25% Cutoff | 30 | 12.3 | 29/1 | 97.0 |
| +50 % Cutoff | 30 | 14 | 30/0 | 100 |
| +75 % Cutoff | 30 | 15.3 | 30/0 | 100 |

Nortriptyline

| % of Cutoff | Number of Samples | Nortriptyline GS/MS Concentration (ng/mL) | Lay person results: Pos/Neg | Percentage of Correct Results |
| --- | --- | --- | --- | --- |
| Negative | 210 | 0 | 0/210 | 100 |
| -75 % Cutoff | 30 | 222 | 0/30 | 100 |
| -50 % Cutoff | 30 | 436 | 0/30 | 100 |
| -25 % Cutoff | 30 | 723 | 4/26 | 87.0 |
| +25% Cutoff | 30 | 1105 | 26/4 | 87.0 |
| +50 % Cutoff | 30 | 1508 | 30/0 | 100 |
| +75 % Cutoff | 30 | 1761 | 30/0 | 100 |

{26}

27

# 3,4 methylenedioxy-Methamphetamine

| % of Cutoff | Number of Samples | 3,4 methylenedioxy-Methamphetamine GS/MS Concentration (ng/mL) | Lay person results: Pos/Neg | Percentage of Correct Results |
| --- | --- | --- | --- | --- |
| Negative | 210 | 0 | 0/210 | 100 |
| -75 % Cutoff | 30 | 130 | 0/30 | 100 |
| -50 % Cutoff | 30 | 256 | 0/30 | 100 |
| -25 % Cutoff | 30 | 382 | 4/26 | 87.0 |
| +25% Cutoff | 30 | 626 | 28/2 | 93.0 |
| +50 % Cutoff | 30 | 838 | 30/0 | 100 |
| +75 % Cutoff | 30 | 917 | 30/0 | 100 |

# Oxycodone

| % of Cutoff | Number of Samples | Oxycodone GS/MS Concentration (ng/mL) | Lay person results: Pos/Neg | Percentage of Correct Results |
| --- | --- | --- | --- | --- |
| Negative | 210 | 0 | 0/210 | 100 |
| -75 % Cutoff | 30 | 27.8 | 0/30 | 100 |
| -50 % Cutoff | 30 | 51 | 0/30 | 100 |
| -25 % Cutoff | 30 | 82 | 4/26 | 80.0 |
| +25% Cutoff | 30 | 124 | 27/3 | 90.0 |
| +50 % Cutoff | 30 | 145 | 30/0 | 100 |
| +75 % Cutoff | 30 | 178 | 30/0 | 100 |

{27}

Phencyclidine

| % of Cutoff | Number of Samples | Phencyclidine GS/MS Concentration (ng/mL) | Lay person results: Pos/Neg | Percentage of Correct Results |
| --- | --- | --- | --- | --- |
| Negative | 210 | 0 | 0/210 | 100 |
| -75 % Cutoff | 30 | 6.9 | 0/30 | 100 |
| -50 % Cutoff | 30 | 13.7 | 0/30 | 100 |
| -25 % Cutoff | 30 | 17.2 | 4/26 | 87.0 |
| +25% Cutoff | 30 | 29.2 | 25/5 | 83.0 |
| +50 % Cutoff | 30 | 38.7 | 30/0 | 100 |
| +75 % Cutoff | 30 | 46.3 | 30/0 | 100 |

Propoxyphene

| % of Cutoff | Number of Samples | Propoxyphene GS/MS Concentration (ng/mL) | Lay person results: Pos/Neg | Percentage of Correct Results |
| --- | --- | --- | --- | --- |
| -100% of the Cut-off | 210 | 0 | 0/210 | 100 |
| -75 % Cutoff | 30 | 74 | 0/30 | 100 |
| -50 % Cutoff | 30 | 153 | 0/30 | 100 |
| -25 % Cutoff | 30 | 204 | 4/26 | 87.0 |
| +25% Cutoff | 30 | 337 | 28/2 | 93.0 |
| +50 % Cutoff | 30 | 424 | 30/0 | 100 |
| +75 % Cutoff | 30 | 506 | 30/0 | 100 |

{28}

The overall percent agreement between the Lay person and the GC/MS method was:

| Analyte | Overall Percent Agreement |
| --- | --- |
| 11-nor- 9-Tetrahydrocannabinol-9-carboxylic acid | 96.1% |
| Benzoylecgonine | 96.3% |
| Morphine | 96.1% |
| Methamphetamine | 96.3% |
| Amphetamine | 95.2% |
| Oxazepam | 95.7% |
| Secobarbitol | 96.3% |
| Methadone | 95.7% |
| Buprenorphine Glucuronide | 97.1% |
| Nortriptyline | 96.3% |
| 3,4-methylenedioxymethamphetamine | 97.1% |
| Oxycodone | 95.7% |
| Phencyclidine | 94.7% |
| Propoxyphene | 96.1% |

b. Matrix comparison:

Not applicable.

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

{29}

4. Clinical cut-off:
Not Applicable

5. Expected values/Reference range
Specific ranges for each analyte/methodology are listed in the package insert.

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.

30