← Product Code [DKZ](/productcode/DKZ) · K050394

# SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS (K050394)

_Medtox Diagnostics, Inc. · DKZ · Oct 25, 2005 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K050394

## Device Facts

- **Applicant:** Medtox Diagnostics, Inc.
- **Product Code:** [DKZ](/productcode/DKZ.md)
- **Decision Date:** Oct 25, 2005
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3100
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Indications for Use

The SURE-SCREEN Drugs of Abuse Test System uses immunochromatographic test strips for the rapid, qualitative detection of one or more of the following: Amphetamines, Benzodiazepines, Cocaine, Methamphetamine, Methadone, Opiates, Phencyclidine and THC (Cannabinoids) in human urine. It is intended for prescription point-of-care use including workplace settings, criminal justice or forensic settings, drug rehabilitation clinics, physician offices and laboratory settings. SURE-SCREEN is not for over-the-counter sale.

## Device Story

Sure-Screen is an immunochromatographic test system for qualitative detection of drugs of abuse in human urine. Device utilizes test strips to detect specific drug classes at defined cutoff concentrations; results are preliminary and require confirmation via GC/MS or LC/MS/MS. Intended for point-of-care use in workplace, forensic, and clinical settings by trained operators (minimum high school education). Operators must complete a certification program including written examination and technique demonstration. Output is visual interpretation of test strips; healthcare providers use results for preliminary screening, necessitating clinical judgment and confirmatory testing for definitive diagnosis. Benefits include rapid, on-site screening for drug presence.

## Clinical Evidence

No clinical data provided. The document describes the device as an analytical test system requiring confirmatory methods (GC/MS or LC/MS/MS) for definitive results. Performance characteristics regarding sensitivity and cutoff concentrations are provided, noting that many tests are positive at levels below claimed cutoffs, which may increase false positive rates.

## Technological Characteristics

Single-use test cup; immunochromatographic lateral flow strips; competitive immunoassay principle. Mouse monoclonal antibodies conjugated to colloidal gold; drug-protein conjugate immobilized on nitrocellulose membrane. Visually read; no instrumentation required. Includes internal procedural control line. Non-medical adulteration checks and temperature strip included but not reviewed.

## Regulatory Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

## Special Controls

*Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

## Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
K050394

B. Purpose for Submission:
New 510(k)

C. Measurand:
- Amphetamines (d-Amphetamine)
- Benzodiazepines (Nordiazepam)
- Cocaine (Benzoylecgonine)
- Methamphetamine (d-Methamphetamine)
- Methadone (Methadone)
- Opiates (Codeine/Morphine)
- Phencyclidine (Phencyclidine)
- Cannabinoids (11-nor-9-carboxy-Δ9-THC)

D. Type of Test:
Qualitative visually read immunochromatographic test for drugs in urine

E. Applicant:
Medtox Diagnostics, Inc.

F. Proprietary and Established Names:
Sure-Screen

G. Regulatory Information:
1. Regulation section:
- 862.3100, Enzyme Immunoassay, Amphetamine
- 862.3170, Enzyme Immunoassay, Benzodiazepine
- 862.3870, Enzyme Immunoassay, Cannabinoids
- 862.3250, Enzyme Immunoassay, Cocaine and Cocaine Metabolites
- 862.3620, Enzyme Immunoassay, Methadone
- 862.3610, Thin Layer Chromatography, Methamphetamine
- 862.3650, Enzyme Immunoassay, Opiates
- 862.3100, Enzyme Immunoassay, Amphetamine - Phencyclidine

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2. Classification:

Class II

3. Product code:
DKZ, JXM, LDJ, DIO, DJR, DJC, DJG, LCM, respectively

4. Panel:
91 (Toxicology)

H. Intended Use:

1. Intended use(s):
See indications for use.

2. Indication(s) for use:
The SURE-SCREEN Drugs of Abuse Test System uses immunochromatographic test strips for the rapid, qualitative detection of one or more of the following: Amphetamines, Benzodiazepines, Cocaine, Methamphetamine, Methadone, Opiates, Phencyclidine and THC (Cannabinoids) in human urine. It is intended for prescription point-of-care use including workplace settings, criminal justice or forensic settings, drug rehabilitation clinics, physician offices and laboratory settings. SURE-SCREEN is not for over-the-counter sale.

Operators that may use this device are defined as individuals with a minimum of a high school education with no formal laboratory training or experience. Individuals should also satisfy the following training and certification guidelines: (1) Training should be conducted by a qualified professional and include a demonstration of the SURE-SCREEN test system and (2) the use of quality assurance samples for monitoring and confirming the performance of the test system. Trainers should observe and confirm that the operator (3) uses proper technique when running a test sample and quality assurance samples, (4) has a basic understanding of test results, including a the potential for false positive and false negative results, (5) knows how to prepare a sample for shipment to the laboratory for confirmation testing, (6) has reviewed the information contained in the MEDTOX SURE-SCREEN Training and Certification Program (available at www.medtox.com and that the operator (7) minimally achieves a score of 80% on the written exam provided by MEDTOX.

Operators achieving a score of 80% will be provided with a certificate of training participation. Quality assurance samples appropriate for training are available from MEDTOX Laboratories Inc. Additionally, MEDTOX Technical Support will provide access to assistance from individuals who are experienced in the

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interpretation of drug testing results.

Sure-Screen detects drug classes at the following cutoff concentrations:

|  (AMP) Amphetamines (d-Amphetamine) | 300 ng/mL  |
| --- | --- |
|  (BZO) Benzodiazepines (Nordiazepam) | 200 ng/mL  |
|  (COC) Cocaine (Benzoylecgonine) | 100 ng/mL  |
|  (MAMP) Methamphetamine (d-Methamphetamine) | 300 ng/mL  |
|  (MTD) Methadone (Methadone) | 200 ng/mL  |
|  (OPI) Opiates (Morphine) | 100 ng/mL  |
|  (PCP) Phencyclidine (Phencyclidine) | 25 ng/mL  |
|  (THC) Cannabinoids (11-nor-9-carboxy-Δ⁹-THC) | 40 ng/mL  |

Many of the cutoff concentrations for these tests are below those recommended by SAMHSA. Additionally, many of these tests are positive at levels significantly below the claimed cutoff concentration. The rate of false positive results with tests having sensitivities this low has not been studied. However, the rate of false positives generally increases as the cutoff concentration of the test is lowered. See the Precision/Sensitivity section for more information.

The SURE-SCREEN drugs of abuse test system provides only a preliminary analytical test 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 liquid chromatography/tandem mass spectrometry (LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result.

It is the responsibility of those organizations required to follow Department of Transportation (DOT) or Substance Abuse Mental Health Services Administration (SAMHSA) Workplace Drug Testing Guidelines to determine that use of this product satisfies the criteria for workplace testing established under DOT and SAMHSA authority.

3. Special conditions for use statement(s):

The device is for in vitro diagnostic prescription use.

4. Special instrument requirements:

Not applicable. The device is a visually read single-use device.

I. Device Description:

The device consists of a single-use test cup with a specialized lid. The lid contains individual test strips for each of the drugs being tested. When the cup is tipped, the urine comes into contact with the bottom of each test strip, thereby initiating the

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reaction. Users determine the result by visually determining the presence or absence of a line. Each strip includes an internal process control.

This device is a one-step immunochromatographic test intended for the detection of amphetamines, benzodiazepines, cocaine, methamphetamine/MDMA, methadone, opiates, phencyclidine and cannabinoids in human urine. The principle of the test relies upon the competitive binding of unbound drug and drug bound to protein (applied as a test line on the nitrocellulose) with the specific antibody (absorbed to colloidal gold) targeted to the drug.

The device includes adulteration checks, the Lateral Flow Adulterant Strip, or LFAS. There is also a temperature check on the cup. Because these are not medical devices, they are not included in the review and do not appear in the indications for use.

The sponsor indicates the test does not contain any human source material.

The training guide and certification, including a 17 question quiz is included with the submission.

## J. Substantial Equivalence Information:

1. Predicate device name(s):

PROFILE II and PROFILE-ER

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

k982211 and k002331

3. Comparison with predicate:

Both devices are qualitative immunochromatographic visually read single-use tests for measurement of the same analyte(s) in the same matrix. Both are competitive immunoassays.

The cutoff concentrations vary, with the candidate device having lower cutoffs in all but one of the assays, i.e., PCP. The candidate device has also been modified to a cup-type configuration.

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

The sponsor did not reference any guidance documents or standards.

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L. Test Principle:

Each test strip contains antibody colloidal gold, a drug conjugate and a control line. Mouse monoclonal antibodies are mixed with colloidal gold and applied to the sample well pads of the strip. Drug is conjugated to protein and immobilized at the test line. Strips have an anti-mouse immunoglobulin antibody immobilized at the control line. The anti-mouse antibody binds the mouse antibodies coated on the colloidal gold.

When the test cup is tipped over, urine flows into the sample well of the device, the dried antibody-colloidal gold on the sample pad dissolves and the urine wicks up the white test strips carrying the red antibody-colloidal gold with it.

Interpretation of Results

Negative: When no drug is present in the urine sample, the red antibody-colloidal gold migrates up the test strip and binds to the drug conjugate immobilized on the membrane. The binding of the antibody-colloidal gold to the drug conjugate generates a line at the test line.

Non-negative: When a drug is present in the sample the antibody-colloidal gold binds the drug before it migrates up the test strip. However, when the antibody-colloidal gold binds the drug in the urine, the antibody-colloidal gold can not bind to the drug conjugate immobilized on the test strip. When the drug concentrating is at or above the cutoff concentration, the majority of the antibody colloidal gold is bound to the drug from the urine. Therefore, as drug bound antibody-colloidal gold migrates up the test strip it is unable to bind to the drug conjugate immobilized on the membrane. Therefore no line is generated at the "T" location on the device.

Control Line: Each test strip has an internal procedural control. A control line forms when the antibody-colloidal gold binds to the anti-mouse immunoglobulin antibody immobilized on the membrane at the "C" location on the device. A line must form at the control "C" location on the device to indicate that there was an adequate volume of sample, the reagents migrated properly, and that the test strip is intact.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Performance around the cutoff concentration for each drug was evaluated by testing drug-free urines spiked with standard solutions. Drug-free urines were also tested. Testing was performed in triplicate on 5 different occasions by 3 Medtox employees. Results were read at five minutes.

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Data from this study is pooled and presented, below. There were significant differences between results read by different operators. However, most often this occurred below the claimed cutoff concentration, and may not be as significant. Many positive results are observed significantly below the cutoff concentration. There are also negative results occurring at and above the cutoff. The sponsor has no explanation for these inconsistencies other than operator error.

|  Amphetamine (d-Amphetamine) Cutoff = 300 ng/mL  |   |   |   |
| --- | --- | --- | --- |
|  Conc. (ng/mL) | Number Tested | Positive | Negative  |
|  0 | 540 | 0 | 540  |
|  75 | 45 | 0 | 45  |
|  150 | 45 | 13 | 32  |
|  225 | 45 | 38 | 7  |
|  300 | 45 | 44 | 1  |
|  375 | 45 | 44 | 1  |
|  450 | 45 | 44 | 1  |
|  Benzodiazepines (Nordiazepam) Cutoff = 200 ng/mL  |   |   |   |
| --- | --- | --- | --- |
|  Conc. (ng/mL) | Number Tested | Positive | Negative  |
|  Negative | 540 | 0 | 540  |
|  50 | 45 | 30 | 15  |
|  100 | 45 | 40 | 5  |
|  150 | 45 | 45 | 0  |
|  200 | 45 | 45 | 0  |
|  250 | 45 | 44 | 1  |
|  300 | 45 | 45 | 0  |
|  Cocaine (Benzoylecgonine) Cutoff = 100 ng/mL  |   |   |   |
| --- | --- | --- | --- |
|  Conc. (ng/mL) | Number Tested | Positive | Negative  |
|  Negative | 540 | 0 | 540  |
|  25 | 45 | 0 | 45  |
|  50 | 45 | 19 | 26  |
|  75 | 45 | 25 | 20  |
|  100 | 45 | 35 | 10  |
|  125 | 45 | 44 | 1  |
|  150 | 45 | 41 | 4  |

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|  Methamphetamine (d-Methamphetamine) Cutoff = 300 ng/mL  |   |   |   |
| --- | --- | --- | --- |
|  Conc. (ng/mL) | Number Tested | Positive | Negative  |
|  Negative | 540 | 0 | 540  |
|  75 | 45 | 1 | 44  |
|  150 | 45 | 18 | 27  |
|  225 | 45 | 44 | 1  |
|  300 | 45 | 45 | 0  |
|  375 | 45 | 45 | 0  |
|  450 | 45 | 45 | 0  |
|  Methadone (Methadone) Cutoff = 200 ng/mL  |   |   |   |
| --- | --- | --- | --- |
|  Conc. (ng/mL) | Number Tested | Positive | Negative  |
|  Negative | 405 | 0 | 405  |
|  50 | 45 | 4 | 41  |
|  100 | 45 | 37 | 8  |
|  150 | 45 | 44 | 1  |
|  200 | 45 | 45 | 0  |
|  250 | 45 | 44 | 1  |
|  300 | 45 | 45 | 0  |
|  Opiate (Morphine) Cutoff = 100 ng/mL  |   |   |   |
| --- | --- | --- | --- |
|  Conc. (ng/mL) | Number Tested | Positive | Negative  |
|  Negative | 540 | 0 | 540  |
|  25 | 45 | 20 | 25  |
|  50 | 45 | 38 | 7  |
|  75 | 45 | 44 | 1  |
|  100 | 45 | 45 | 0  |
|  125 | 45 | 44 | 1  |
|  150 | 45 | 43 | 2  |
|  Phencyclidine (Phencyclidine) Cutoff = 25 ng/mL  |   |   |   |
| --- | --- | --- | --- |
|  Conc. (ng/mL) | Number Tested | Positive | Negative  |
|  Negative | 540 | 0 | 540  |
|  6.25 | 45 | 1 | 44  |
|  12.50 | 45 | 0 | 45  |
|  18.75 | 45 | 17 | 28  |
|  25.00 | 45 | 43 | 2  |
|  31.25 | 45 | 43 | 2  |
|  37.50 | 45 | 44 | 1  |

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|  Cannabinoids (11-nor-9-carboxy-Δ⁹-THC) Cutoff = 40 ng/mL  |   |   |   |
| --- | --- | --- | --- |
|  Conc. (ng/mL) | Number Tested | Positive | Negative  |
|  Negative | 105 | 0 | 105  |
|  10 | 45 | 0 | 45  |
|  20 | 45 | 0 | 45  |
|  30 | 45 | 1 | 44  |
|  40 | 45 | 45 | 0  |
|  50 | 45 | 40 | 5  |
|  60 | 45 | 45 | 0  |

## POC Studies

Precision studies were performed by 3 POC operators. Operators were trained and educated in a similar manner to those participating in the method comparison study. Samples were drug-free urines, the majority of which were spiked with multiple drugs to concentrations that were 25% above the cutoff, at the cutoff, 50% below the cutoff, and 75% below the cutoff concentrations. Results appear below.

|  Amphetamine (d-Amphetamine) Cutoff = 300 ng/mL  |   |   |   |
| --- | --- | --- | --- |
|  Conc. (ng/mL) | Number Tested | Positive | Negative  |
|  Negative | 135 | 0 | 135  |
|  75 | 45 | 4 | 41  |
|  150 | 45 | 35 | 10  |
|  300 | 45 | 45 | 0  |
|  375 | 45 | 45 | 0  |
|  Benzodiazepines (Nordiazepam) Cutoff = 200 ng/mL  |   |   |   |
| --- | --- | --- | --- |
|  Conc. (ng/mL) | Number Tested | Positive | Negative  |
|  Negative | 135 | 0 | 135  |
|  50 | 45 | 1 | 44  |
|  100 | 45 | 4 | 41  |
|  200 | 45 | 9 | 36  |
|  250 | 45 | 45 | 0  |
|  Cocaine (Benzoylecgonine) Cutoff = 100 ng/mL  |   |   |   |
| --- | --- | --- | --- |
|  Conc. (ng/mL) | Number Tested | Positive | Negative  |
|  Negative | 135 | 0 | 135  |
|  25 | 45 | 0 | 45  |
|  50 | 45 | 6 | 39  |
|  100 | 45 | 26 | 19  |
|  125 | 45 | 45 | 0  |

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|  Methamphetamine (d-Methamphetamine) Cutoff = 300 ng/mL  |   |   |   |
| --- | --- | --- | --- |
|  Conc. (ng/mL) | Number Tested | Positive | Negative  |
|  Negative | 135 | 0 | 135  |
|  75 | 45 | 1 | 44  |
|  150 | 45 | 11 | 34  |
|  300 | 45 | 25 | 20  |
|  375 | 45 | 45 | 0  |
|  Methadone (Methadone) Cutoff = 200 ng/mL  |   |   |   |
| --- | --- | --- | --- |
|  Conc. (ng/mL) | Number Tested | Positive | Negative  |
|  Negative | 135 | 0 | 135  |
|  50 | 45 | 4 | 41  |
|  100 | 45 | 22 | 23  |
|  200 | 45 | 25 | 20  |
|  250 | 45 | 45 | 0  |
|  Opiate (Morphine) Cutoff = 100 ng/mL  |   |   |   |
| --- | --- | --- | --- |
|  Conc. (ng/mL) | Number Tested | Positive | Negative  |
|  Negative | 135 | 0 | 135  |
|  25 | 45 | 0 | 45  |
|  50 | 45 | 0 | 45  |
|  100 | 45 | 7 | 38  |
|  125 | 45 | 43 | 2  |
|  Phencyclidine (Phencyclidine) Cutoff = 25 ng/mL  |   |   |   |
| --- | --- | --- | --- |
|  Conc. (ng/mL) | Number Tested | Positive | Negative  |
|  Negative | 135 | 0 | 135  |
|  6.25 | 45 | 1 | 44  |
|  12.5 | 45 | 34 | 11  |
|  25.0 | 45 | 44 | 1  |
|  31.25 | 45 | 45 | 0  |
|  Cannabinoids (11-nor-9-carboxy-Δ⁹-THC) Cutoff = 40 ng/mL  |   |   |   |
| --- | --- | --- | --- |
|  Conc. (ng/mL) | Number Tested | Positive | Negative  |
|  Negative | 135 | 0 | 135  |
|  10 | 45 | 2 | 43  |
|  20 | 45 | 14 | 31  |
|  40 | 45 | 25 | 20  |
|  50 | 45 | 45 | 0  |

Results are similar in this POC study to those observed in the professional study.

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b. Linearity/assay reportable range:

Not applicable. The assay is intended for qualitative use.

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

The sponsor did not indicate any degree of traceability for their devices.

Control materials are required but are not specifically identified in the labeling.

No calibrators are required. The device is calibrated during the manufacturing process.

## Product Stability:

Stability studies depend on readouts from an instrument (BioDot). The BioDot reader takes a picture of a test line, and converts it to a number which is proportional to the line intensity. Readings less than 0.6 are typically read as positive (absence of a line) and those above 1.1 are typically read as negative (a line is present). Those between 0.6 and 1.1 are visually interpreted as borderline results. The sponsor provided the following in support of these conclusions.

Artificial Test Strips were used to simulate lines on a test strip. Numerous Test Strips were read by 29 operators. The BioDot range of readings are compared to the visual observations of the readers.

Data to Support Equivalence Between BioDot Readings and Visually Read Results

|  BioDot Range | Positive Results Read Visually | Negative Results Read Visually | Rate  |
| --- | --- | --- | --- |
|  ≥ 2.0 | 19 | 3287 | 99% Negative  |
|  1.1-1.9 | 75 | 389 | 83% Negative  |
|  0.7- 1.0 | 156 | 163 | 51% Negative  |
|  ≤ 0.6 | 423 | 12 | 97% positive  |

## Stability Protocol:

Drug tests are stored at 2 - 8°C and room temperature.

Drug tests are assayed at 3, 6, 12, 18 and 25 months intervals.

Twenty samples are run on each of three different lots of each of each drug test.

The twenty replicates consist of the following:

- 5 replicates of a positive urine (containing drug at a concentration of 50% above the cutoff)
- 15 replicates of a drug-free urine

Readings are recorded and averaged for each lot.

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Acceptance Criteria for the Study:
Drug-free urine should have a BioDot reading of 2.5 reading or greater.
Individual test line intensities should be 2.0 or greater.
Urine spiked with drug 50% above the cutoff should have an average
BioDot test line intensity of 0.6 or less. Individual test line intensities
should be 0.8 or less.

Calculations used to estimate shelf life are:
At 20K Cal/mole; 12 months (365 days) at 25° C is equivalent to 44 days
at 45°C; 15 months at 25° C is equivalent to 55 days at 45°C. 24 months at
25°C is equivalent to 88 days at 45°C.

Users are instructed to follow federal, state, and local guidelines
concerning QC practices.

d. Detection limit:
Sensitivity of qualitative assays may be characterized by validating
performance around the claimed cutoff concentration of the assay, and
demonstrating the lowest concentration of drug that is capable of or
consistently producing a positive result. This information appears in the
precision section, above.

Most tests render positive results well below the claimed cutoff
concentration.

e. Analytical specificity:

Cross-Reactivity
The following metabolites and compounds were initially dissolved in appropriate
solvents and then added at varying concentrations to drug-free urine for evaluation.
Samples were evaluated in triplicate by in-house operators. Results are expressed as the
minimum concentration of metabolite or compound required to produce a positive test
result. Percent cross reactivity of a compound is calculated by dividing the cutoff
concentration by the minimum concentration required to obtain a positive result and then
multiplying by 100%.

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|  Benzodiazepines
(Nordiazepam, cutoff = 200 ng/mL) | Result
Positive at 200 ng/mL | % Cross-Reactivity
100%  |
| --- | --- | --- |
|  Alprazolam | Positive at 25 ng/mL | 800%  |
|  Alprazolam, 1-Hydroxy | Positive at 500 ng/mL | 40%  |
|  7-Amino-clonazepam | Negative at 100,000 ng/mL | < 1%  |
|  7-Amino-flunitrazepam | Negative at 100,000 ng/mL | < 1%  |
|  Chlordiazepoxide | Negative at 100,000 ng/mL | < 1%  |
|  Clobazam | Positive at 25 ng/mL | 800%  |
|  Clonazepam | Positive at 125 ng/mL | 160%  |
|  Clorazepate | Positive at 50 ng/mL | 400%  |
|  Desalkylflurazepam | Positive at 100 ng/mL | 200%  |
|  Desmethyl-chlordiazepoxide | Positive at 250 ng/mL | 80%  |
|  Desmethylflunitrazepam | Positive at 50 ng/mL | 400%  |
|  Diazepam | Positive at 50 ng/mL | 400%  |
|  Flunitrazepam | Positive at 50 ng/mL | 400%  |
|  Flurazepam | Negative at 100,000 ng/mL | < 1%  |
|  Lorazepam | Positive at 2500 ng/mL | 8%  |
|  Lorazepam glucuronide | Positive at 25 ng/mL | 800%  |
|  Lysergic acid | Positive at 25,000 ng/mL | < 1%  |
|  Midazolam | Negative at 100,000 ng/mL | < 1%.  |
|  Nitrazepam | Positive at 50 ng/mL | 400%  |
|  Oxazepam | Positive at 25 ng/mL | 800%  |
|  Oxazepam glucuronide | Positive at 750 ng/mL | 27%  |
|  Pyrilamine | Positive at 10,000 ng/mL | 2%  |
|  Sidenfil | Positive at 10,000 ng/mL | 2%  |
|  Sulindac | Positive at 10,000 ng/mL | 2%  |
|  Temazepam | Positive at 50 ng/mL | 400%  |
|  Temazepam glucuronide | Positive at 250 ng/mL | 80%  |
|  Triazolam | Positive at 75 ng/mL | 267%  |
|  Amphetamine
(d-amphetamine, cutoff = 300 ng/mL) | Result
Positive at 300 ng/mL | % Cross-Reactivity
100%  |
| --- | --- | --- |
|  l-Amphetamine | Positive at 100,000 ng/mL | < 1%  |
|  Ephedrine | Negative at 100,000 ng/mL | < 1%  |
|  MDA | Positive at 750 ng/mL | 40%  |
|  MDE (MDEA) | Negative at 100,000 ng/mL | < 1%  |
|  MDMA | Negative at 100,000 ng/mL | < 1%  |
|  d-Methamphetamine | Negative at 100,000 ng/mL | < 1%  |
|  l-Methamphetamine | Negative at 100,000 ng/mL | < 1%  |
|  Phenethylamine | Negative at 100,000 ng/mL | < 1%  |
|  Phentermine | Positive at 1,000 ng/mL | 33%  |
|  Tyramine | Negative at 100,000 ng/mL | < 1%  |

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|  Benzodiazepines
(Nordiazepam, cutoff = 200 ng/mL) | Result
Positive at 200 ng/mL | % Cross-Reactivity
100%  |
| --- | --- | --- |
|  Triazolam, 1-hydroxy | Negative at 10,000 ng/mL | < 1%  |
|  Cocaine
(Benzoylecgonine, cutoff = 100 ng/mL) | Result
Positive at 100 ng/mL | % Cross-Reactivity
100%  |
| --- | --- | --- |
|  Cocaine | Positive at 300 ng/mL | 33%  |
|  Ecgonine | Positive at 100,000 ng/mL | < 1%  |
|  Ecgonine Methyl Ester | Negative at 100,000 ng/mL | < 1%  |
|  Methamphetamine
(d-Methamphetamine, cutoff = 300 ng/mL) | Result
Positive at 300 ng/mL | % Cross-Reactivity
100%  |
| --- | --- | --- |
|  d-Amphetamine | Positive at 75,000 ng/mL | < 1%  |
|  l-Amphetamine | Negative at 100,000 ng/mL | < 1%  |
|  Ephedrine | Positive at 75,000 ng/mL | < 1%  |
|  Fenfluramine | Positive at 10,000 ng/mL | 3%  |
|  MDA | Negative at 100,000 ng/mL | < 1%  |
|  MDE (MDEA) | Positive at 25,000 ng/mL | 1.2%  |
|  MDMA | Positive at 1000 ng/mL | 33%  |
|  l-Methamphetamine | Positive at 2500 ng/mL | 12%  |
|  Methcathinone | Positive at 25,000 ng/mL | 1.2%  |
|  Methadone
(Methadone, cutoff = 200 ng/mL) | Result
Positive at 200 ng/mL | % Cross-Reactivity
100%  |
| --- | --- | --- |
|  EDDP | Negative at 100,000 ng/mL | < 1%  |
|  EMDP | Negative at 100,000 ng/mL | < 1%  |
|  Opiates
(Morphine, cutoff = 100 ng/mL) | Result
Positive at 100 ng/mL | % Cross-Reactivity
100%  |
| --- | --- | --- |
|  Apomorphine | Negative at 100,000 ng/mL | < 1%  |
|  Codeine | Positive at 300 ng/mL | 33%  |
|  Diacetylmorphine | Positive at 300 ng/mL | 33%  |
|  Dihydrocodeine | Positive at 100 ng/mL | 100%  |
|  Ethylmorphine | Positive at 50 ng/mL | 200%  |
|  Hydrocodone | Positive at 300 ng/mL | 33%  |
|  Hydromorphone | Positive at 100 ng/mL | 100%  |

{13}

|  Opiates (Morphine, cutoff = 100 ng/mL) | Result Positive at 100 ng/mL | % Cross-Reactivity 100%  |
| --- | --- | --- |
|  Levorphanol | Positive at 50,000 ng/mL | < 1%  |
|  Lidocaine | Negative at 100,000 ng/mL | < 1%  |
|  6-Monoacetylmorphine | Positive at 100,000 ng/mL | < 1%  |
|  Morphine 3-β-D-Glucuronide | Positive at 100,000 ng/mL | < 1%  |
|  Morphine 6-β-D-Glucuronide | Negative at 100,000 ng/mL | < 1%  |
|  Nalorphine | Positive 150 ng/mL | 67%  |
|  Naloxone | Positive at 25,000 ng/mL | < 1%  |
|  Naltrexone | Negative at 100,000 ng/mL | < 1%  |
|  Norcodeine | Negative at 100,000 ng/mL | < 1%  |
|  Oxycodone | Positive at 50,000 ng/mL | < 1%  |
|  Oxymorphone | Positive at 75,000 ng/mL | < 1%  |
|  Procaine | Negative at 100,000 ng/mL | < 1%  |
|  Thebaine | Positive at 1,000 ng/mL | 10%  |
|  Phencyclidine (Phencyclidine, cutoff = 25 ng/mL) | Result Positive at 25 ng/mL | % Cross-Reactivity 100%  |
| --- | --- | --- |
|  4-Hydroxy-Phencyclidine | Positive at 5,000 ng/mL | <1%  |
|  THC (Cannabinoids) (11-nor-9-carboxy-Δ⁹-THC, cutoff = 40 ng/mL) | Result Positive at 40 ng/mL | % Cross-Reactivity 100%  |
| --- | --- | --- |
|  Cannabidiol | Negative at 100,000 ng/mL | < 1%  |
|  Cannabinol | Negative at 100,000 ng/mL | < 1%  |
|  l-11-Hydroxy- Δ⁹-THC | Positive at 250 ng/mL | 16%  |
|  Δ⁹-Tetrahydrocannabinol | Positive at 10,000 ng/mL | < 1%  |
|  Δ⁸-Tetrahydrocannabinol (Δ⁶-Tetrahydrocannabinol) | Positive at 25,000 ng/mL | < 1%  |

# Non Cross-reactive Endogenous Compounds

Listed compounds were initially dissolved in appropriate solvents and then added to drug-free urine for evaluation with all eight Sure-Screen tests. Most of the compounds were evaluated for reactivity with the Sure-Screen tests at 100 µg/mL (albumin was evaluated at 20 mg/mL and bilirubin was evaluated at 200 µg/mL). Samples were evaluated in triplicate by in-house operators. The listed compounds gave negative results with all eight of the Sure-Screen tests.

{14}

15

Acetaldehyde
Creatinine
Hemoglobin, Human
Acetone
Epinephrine
Sodium Chloride
Albumin, Human
β-Estradiol
Tetrahydrocortisone
Bilirubin
Estriol
d,1-Thyroxine
Cholesterol
Glucose Std. Solution
Uric Acid

## Unrelated Compounds, Prescription and Over-the-Counter Medications

An extensive list of compounds were dissolved in solvents and added to drug-free urine for evaluation with all eight Sure-Screen tests. Most of the compounds were evaluated for reactivity at 100 µg/mL. Samples were evaluated in triplicate by in-house operators and the list of compounds evaluated appears in the package insert. Compounds that demonstrated reactivity are listed, below.

- Phenelzine-mAMP
- Pyrilamine-BZO
- Selegiline (Deprenyl)-mAMP
- Sildenafil (Viagra)-BZO

## Interference

pH and Specific Gravity:

All tests were assayed with six negative clinical samples with pH values of 4.0, 5.0, 6.0, 7.0, 8.0 and 9.0 ± 0.1. Each sample was assayed in triplicate. All results were negative. The affects of these conditions on samples containing drug is not known.

Similarly, all tests were assayed with drug-free urines with specific gravity values of 1.003, 1.005, 1.011, 1.016, 1.019, 1.025 and 1.033. Each sample was assayed in triplicate. All samples were negative. The affects of these conditions on samples containing drug is not known.

## Common Drugs:

Drug free urine samples were spiked with the Sure-Screen targeted drugs to the concentrations of 25% and 150% of the cutoff concentrations. 100 µg/mL of the common drugs listed below, were then added to the preparation and assayed. Evaluations were performed in triplicate by in-house operators. None of the common drugs listed in the following table affected the expected results.

COMMON DRUGS EVALUATED WITH ALL SURE-SCREEN TESTS

|  Acetylsalicylic Acid | Chlorpheniramine | Ibuprofen  |
| --- | --- | --- |
|  Acetaminophen | Cocaine-COC | Morphine-OPI  |
|  Brompheniramine maleate | Doxylamine | Phenobarbital  |
|  Caffeine | Dextromethorphan | d-Pseudoephedrine  |
|  Carbamazepine | Diphenylhydantoin | Salicylic Acid  |

There is the possibility that other substances and/or factors not listed above may interfere with the test and cause false results, e.g., technical or procedural errors.

{15}

f. Assay cut-off:

The PCP cutoff concentration is consistent with the cutoff currently recommended by SAMHSA. However, the cutoff concentrations for amphetamines, cocaine, methamphetamines, opiates, and THC are below those recommended by SAMHSA. There are currently no recommendations for the rest of the tests.

There has been no evaluation of false positive rates using these cutoff concentrations. The sponsor has, however, included the following information in their package insert:

A positive test result does not always mean a person took illegal drugs and a negative test result does not always mean a person did not take illegal drugs. There are a number of factors that influence the reliability of drug tests. Certain drug of abuse tests are more accurate than others.

For Preliminary Positive Tests: In general, the Substance Abuse and Mental Health Services Administration (SAMHSA) reports the accuracy of drug tests as:

|  60 out of 100 times a “preliminary positive” result from an opiate test is a “false preliminary positive” result. This means that the result of the first test was “preliminary positive” even though the person did not take an illegal drug.  |
| --- |
|  50 out of 100 times a “preliminary positive” test result from an amphetamine or methamphetamine test is a “false preliminary positive” result.  |
|  50 out of 100 times a “preliminary positive” result from a PCP (phencyclidine) test is a “false preliminary positive” result.  |
|  10 out of 100 times a “preliminary positive” result from a marijuana test is a “false preliminary positive” result.  |
|  2 out of 100 times a “preliminary positive” result from a cocaine test is a “false preliminary positive” result.  |

Data was generated from laboratory tests that have the following cutoff concentrations: Marijuana, 50 ng/mL; Cocaine, 300 ng/mL; Phencyclidine, 25 ng/mL; Opiates, 2000 ng/mL; Amphetamines, 1000 ng/mL. In general, the rates of false preliminary positive results will increase as the cutoff concentration of the test is lowered.

Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section (M,1, a), above.

2. Comparison studies:

a. Method comparison studies:

Performance was evaluated by assaying a panel of blind coded clinical urine samples containing varying concentrations of drugs with Sure-Screen. Results were then

{16}

compared to GC/MS or LC/MS/MS results. Samples were obtained from MEDTOX Laboratories. There were screened using a commercial immunoassay having traditional cutoff concentrations, i.e., significantly higher than Sure-Screen cutoff concentrations (except for PCP). Samples with negative results by both the commercial immunoassay system and Sure-Screen were not confirmed. Samples with positive results by either the commercial immunoassay system or Sure-Screen were confirmed by GC/MS or LC/MS/MS. Most samples were unaltered clinical samples, however, to include samples with concentrations close to the cutoff 6 BZO samples were diluted with negative urine. Testing was performed by MEDTOX personnel. Readings were taken at 5 minutes.

## Amphetamine

|  Confirmatory Result | Negative by immunoassay, or if positive, no drug present (above the limit of detection of the confirmatory method) | Concentration range of up to 50% below the cutoff (ng/mL) | Concentration range between the -50% of the cutoff and the cutoff (ng/mL) | Concentration range between the cutoff and 50% above the cutoff (ng/mL) | Concentration range of greater than 50% above the cutoff (ng/mL)  |
| --- | --- | --- | --- | --- | --- |
|  Range of sample concentrations |  |  | 180 – 255 | 334 – 402 | 474 – 11845  |
|  Positive | 0 | No samples analyzed in this range | 4 | 4 | 32  |
|  Negative | 55 | No samples analyzed in this range | 1 | 1 | 1  |

Samples are categorized according to d-amphetamine concentrations.

## Benzodiazepines

|  Confirmatory Results | Negative by immunoassay used to screen the samples, or if positive, no drug present (above the limit of detection of the confirmatory method) | Concentration range of up to 50% below the cutoff (ng/mL) | Concentration range between the -50% of the cutoff and the cutoff (ng/mL) | Concentration range between the cutoff and 50% above the cutoff (ng/mL) | Concentration range of greater than 50% above the cutoff (ng/mL)  |
| --- | --- | --- | --- | --- | --- |
|  Concentration Range |  |  | 113 - 151 | 220 – 281 | 428 - 12491  |

{17}

Nordiazepam, oxazepam, temazepam, alprazolam and α-hydroxy-alprazolam were added together to determine the total benzodiazepine concentration reported in the table. 6 samples were diluted with negative urine to obtain concentrations around the cutoff.

## Cocaine

|  Confirmatory Result | Negative by immunoassay, or, if positive, no drug present (above the limit of detection of the confirmatory method) | Concentration range of up to 50% below the cutoff (ng/mL) | Concentration range between the -50% of the cutoff and the cutoff (ng/mL) | Concentration range between the cutoff and 50% above the cutoff (ng/mL) | Concentration range of greater than 50% above the cutoff (ng/mL)  |
| --- | --- | --- | --- | --- | --- |
|  Concentration Range |  |  | 55 – 91 | 110 - 140 | 153 - 96924  |
|  Positive | 0 | No samples analyzed in this range | 6 | 5 | 36  |
|  Negative | 54 | No samples analyzed in this range | 0 | 0 | 0  |

Samples are categorized by benzoylecgonine concentrations (cocaine metabolite).

## Methamphetamine

|  Confirmatory Results | Negative by immunoassay used to screen the samples, or if positive, no drug present (above the limit of detection of the confirmatory method) | Concentration range of up to 50% below the cutoff (ng/mL) | Concentration range between the -50% of the cutoff and the cutoff (ng/mL) | Concentration range between the cutoff and 50% above the cutoff (ng/mL) | Concentration range of greater than 50% above the cutoff (ng/mL)  |
| --- | --- | --- | --- | --- | --- |
|  Concentration Range |  | 62 – 88 | 156 – 248 | 318 – 429 | 479 – 1499  |
|  Positive | 2 | 0 | 5 | 6 | 51  |
|  Negative | 98 | 2 | 0 | 0 | 0  |

Samples are categorized according to d-methamphetamine concentrations

{18}

19

Methadone

|  Confirmatory Results | Negative by immunoassay used to screen the samples, or if positive, no drug present (above the limit of detection of the confirmatory method | Concentration range of up to 50% below the cutoff (ng/mL) | Concentration range between the -50% of the cutoff and the cutoff (ng/mL) | Concentration range between the cutoff and 50% above the cutoff (ng/mL) | Concentration range of greater than 50% above the cutoff (ng/mL)  |
| --- | --- | --- | --- | --- | --- |
|  Concentration Range |  |  | 112 - 114 | 249 - 283 | 307 - 9411  |
|  Positive | 0 | No samples analyzed in this range | 2 | 6 | 44  |
|  Negative | 98 | No samples analyzed in this range | 2 | 1 | 0  |

Opiates

|  Confirmatory Results | Negative by immunoassay, or if positive, contains no drug (above the limit of detection of the confirmatory method | Concentration range of up to 50% below the cutoff (ng/mL) | Concentration range between the -50% of the cutoff and the cutoff (ng/mL) | Concentration range between the cutoff and 50% above the cutoff (ng/mL) | Concentration range of greater than 50% above the cutoff (ng/mL)  |
| --- | --- | --- | --- | --- | --- |
|  Concentration Range |  |  | 76 – 90 | 111 – 147 | 251 – 136360  |
|  Positive | 0 | No samples analyzed in this range | 4 | 4 | 36  |
|  Negative | 54 | No samples analyzed in this range | 0 | 0 | 0  |

Morphine, codeine, hydrocodone and hydromorphone were added together to determine the total opiate concentrations reported in this table.

{19}

20

Phencyclidine

|  Confirmatory Results | Negative by immunoassay used to screen the samples, or if positive, contained no drug (above the limit of detection of the confirmatory method | Concentration range of up to 50% below the cutoff (ng/mL) | Concentration range between the -50% of the cutoff and the cutoff (ng/mL) | Concentration range between the cutoff and 50% above the cutoff (ng/mL) | Concentration range of greater than 50% above the cutoff (ng/mL)  |
| --- | --- | --- | --- | --- | --- |
|  Concentration Range |  |  | 13 - 22 | 27 – 35 | 39 - 5439  |
|  Positive | 0 | No samples analyzed in this range | 2 | 5 | 33  |
|  Negative | 55 | No samples analyzed in this range | 3 | 0 | 0  |

Cannabinoid

|  Confirmatory Results | Negative by immunoassay used to screen the samples, or if positive, contained no drug (above the limit of detection of the confirmatory method | Concentration range of up to 50% below the cutoff (ng/mL) | Concentration range between the -50% of the cutoff and the cutoff (ng/mL) | Concentration range between the cutoff and 50% above the cutoff (ng/mL) | Concentration range of greater than 50% above the cutoff (ng/mL)  |
| --- | --- | --- | --- | --- | --- |
|  Concentration Range |  | 3 | 21 - 37 | 42 – 54 | 62 - 761  |
|  Positive | 0 | 0 | 5 | 8 | 34  |
|  Negative | 55 | 1 | 1 | 0 | 0  |

11-nor-9-carboxy- $\Delta^9$ -THC concentrations are reported in this table

## POC Studies

Performance was also evaluated by 13 POC staff at 44 POC locations. Operators ran 1000 blinded samples obtained from MEDTOX Laboratories. Sure-Screen test results were compared to GC/MS or LC/MS/MS results. Operators were provided with instructions from the package insert. Almost all operators had no formal laboratory training, but 88% of the operators had run point-of-care testing devices prior to this study. 26/44 operators had greater than a high school education.

Samples were selected similarly to how samples were selected for the in-house study, however this study included a high number of negative samples, and a much lower

{20}

percentage of positive samples, i.e., a total of 4 or 6 samples. Many studies included few, if any, samples that were challenging to the cutoff concentration of the assay. Samples with negative results by both the commercial immunoassay system and Sure-Screen were not confirmed. Samples with positive results by either the commercial immunoassay system or Sure-Screen were confirmed by GC/MS or LC/MS/MS.

The number of POC facilities and operators

|  Facility Type | Criminal Justice | Treatment Center | Clinic/Physician Office Laboratory | DAU Collection Site | Total  |
| --- | --- | --- | --- | --- | --- |
|  Sites | 2 | 2 | 7 | 2 | 13  |
|  Operators | 18 | 3 | 11 | 12 | 44  |
|  Samples | 375 | 75 | 250 | 300 | 1000  |

Sure-Screen results compared to confirmatory results are presented, below.

Amphetamine

|  Confirmatory Results | Negative by immunoassay used to screen the samples, or if positive, contained no drug (above the limit of detection of the confirmatory method | Concentration range of up to 50% below the cutoff (ng/mL) | Concentration range between the -50% of the cutoff and the cutoff (ng/mL) | Concentration range between the cutoff and 50% above the cutoff (ng/mL) | Concentration range of greater than 50% above the cutoff (ng/mL)  |
| --- | --- | --- | --- | --- | --- |
|  Concentration Range |  | 119 | 217-257 | 306 | 510-9489  |
|  Positive | 6 | 0 | 4 | 1 | 21  |
|  Negative | 967 | 1 | 0 | 0 | 0  |

Samples are categorized according to d-amphetamine concentrations.

Benzodiazepines

|  Confirmatory Results | Negative by immunoassay used to screen the samples, or if positive, contained no drug (above the limit of detection of the confirmatory method | Concentration range of up to 50% below the cutoff (ng/mL) | Concentration range between the -50% of the cutoff and the cutoff (ng/mL) | Concentration range between the cutoff and 50% above the cutoff (ng/mL) | Concentration range of greater than 50% above the cutoff (ng/mL)  |
| --- | --- | --- | --- | --- | --- |
|  Concentration Range |  | 34-38 | 113-174 | 245-268 | 315-32454  |
|  Positive | 0 | 1 | 5 | 2 | 17  |
|  Negative | 971 | 1 | 2 | 0 | 0  |

{21}

Nordiazepam, oxazepam, temazepam, alprazolam and α-hydroxy-alprazolam were added together in an unweighted fashion to determine the total benzodiazepine concentration reported in the table.

## Cocaine

|  Confirmatory Results | Negative by immunoassay used to screen the samples, or if positive, contained no drug (above the limit of detection of the confirmatory method | Concentration range of up to 50% below the cutoff (ng/mL) | Concentration range between the -50% of the cutoff and the cutoff (ng/mL) | Concentration range between the cutoff and 50% above the cutoff (ng/mL) | Concentration range of greater than 50% above the cutoff (ng/mL)  |
| --- | --- | --- | --- | --- | --- |
|  Concentration Range |  | 16-48 | 57-96 | 113-133 | 200-39644  |
|  Positive | 1 | 1 | 4 | 5 | 28  |
|  Negative | 959 | 2 | 0 | 0 | 0  |

Samples are categorized by benzoylecgonine concentrations (cocaine metabolite).

## Methamphetamine

|  Confirmatory Results | Negative by immunoassay used to screen the samples, or if positive, contained no drug (above the limit of detection of the confirmatory method | Concentration range of up to 50% below the cutoff (ng/mL) | Concentration range between the -50% of the cutoff and the cutoff (ng/mL) | Concentration range between the cutoff and 50% above the cutoff (ng/mL) | Concentration range of greater than 50% above the cutoff (ng/mL)  |
| --- | --- | --- | --- | --- | --- |
|  Concentration Range |  |  | 217 | 403 | 564-10585  |
|  Positive | 8 | No samples analyzed in this range | 1 | 1 | 14  |
|  Negative | 976 | No samples analyzed in this range | 0 | 0 | 0  |

{22}

Samples are categorized according to d-methamphetamine concentrations.

Methadone

|  Confirmatory Results | Negative by immunoassay used to screen the samples, or if positive, contained no drug (above the limit of detection of the confirmatory method | Concentration range of up to 50% below the cutoff (ng/mL) | Concentration range between the -50% of the cutoff and the cutoff (ng/mL) | Concentration range between the cutoff and 50% above the cutoff (ng/mL) | Concentration range of greater than 50% above the cutoff (ng/mL)  |
| --- | --- | --- | --- | --- | --- |
|  Concentration Range |  |  |  | 207 | 335-8377  |
|  Positive | 0 | No samples analyzed in this range | No samples analyzed in this range | 1 | 6  |
|  Negative | 993 | No samples analyzed in this range | No samples analyzed in this range | 0 | 0  |

Opiates

|  Confirmatory Results | Negative by immunoassay used to screen the samples, or if positive, contained no drug (above the limit of detection of the confirmatory method | Concentration range of up to 50% below the cutoff (ng/mL) | Concentration range between the -50% of the cutoff and the cutoff (ng/mL) | Concentration range between the cutoff and 50% above the cutoff (ng/mL) | Concentration range of greater than 50% above the cutoff (ng/mL)  |
| --- | --- | --- | --- | --- | --- |
|  Concentration Range |  | 28 | 60 | 124-143 | 241-11724  |
|  Positive | 8 | 1 | 1 | 2 | 25  |
|  Negative | 963 | 0 | 0 | 0 | 0  |

Morphine, codeine, hydrocodone and hydromorphone were added together in an unweighted fashion to determine the total opiate concentrations reported in this table.

{23}

PCP

|  Confirmatory Results | Negative by immunoassay used to screen the samples, or if positive, contained no drug (above the limit of detection of the confirmatory method | Concentration range of up to 50% below the cutoff (ng/mL) | Concentration range between the -50% of the cutoff and the cutoff (ng/mL) | Concentration range between the cutoff and 50% above the cutoff (ng/mL) | Concentration range of greater than 50% above the cutoff (ng/mL)  |
| --- | --- | --- | --- | --- | --- |
|  Concentration Range |  |  |  |  | 236-373  |
|  Positive | 0 | No samples analyzed in this range | No samples analyzed in this range | No samples analyzed in this range | 4  |
|  Negative | 996 | No samples analyzed in this range | No samples analyzed in this range | No samples analyzed in this range | 0  |

Cannabinoid

|  Confirmatory Results | Negative by immunoassay used to screen the samples, or if positive, contained no drug (above the limit of detection of the confirmatory method | Concentration range of up to 50% below the cutoff (ng/mL) | Concentration range between the -50% of the cutoff and the cutoff (ng/mL) | Concentration range between the cutoff and 50% above the cutoff (ng/mL) | Concentration range of greater than 50% above the cutoff (ng/mL)  |
| --- | --- | --- | --- | --- | --- |
|  Concentration Range |  | 5-17 | 23-26 | 47-59 | 60-481  |
|  Positive | 8 | 4 | 3 | 6 | 30  |
|  Negative | 946 | 3 | 0 | 0 | 0  |

11-nor-9-carboxy- $\Delta^9$ -THC concentrations are reported in this table.

.b. Matrix comparison:

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

3. Clinical studies:

a. Clinical Sensitivity:

{24}

Not applicable. Clinical studies are not typically submitted for this device type and matrix.

b. Clinical specificity:

Not applicable. Clinical studies are not typically submitted for this device type and matrix. The specificity is likely to be less than traditional assays, however, as the cutoff concentrations are significantly lower.

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

4. Clinical cut-off:

Validation of the clinical appropriateness of the cutoff is not typically submitted for this device type and matrix.

5. Expected values/Reference range:

No elicit drugs should be present in urine. Legitimate over-the-counter and prescription drugs may cause positive results.

N. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:

The device also includes tests for detected adulteration of the sample. Because these products are not medical devices, aspects related to this claim were not reviewed. References to the adulteration checks are therefore not included in the intended use statement, but appear in the package insert.

O. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

P. Conclusion:

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

25

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**Source:** [https://fda-staging.innolitics.com/device/K050394](https://fda-staging.innolitics.com/device/K050394)

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