ORATECT ORAL FLUID DRUG SCREEN DEVICES

K103227 · Branan Medical Corporation · DIO · Apr 11, 2012 · Clinical Toxicology

Device Facts

• Record ID: K103227
• Device Name: ORATECT ORAL FLUID DRUG SCREEN DEVICES
• Applicant: Branan Medical Corporation
• Product Code: DIO · Clinical Toxicology
• Decision Date: Apr 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Indications for Use

The Oratect Oral fluid Drug Screen Device is a one-step lateral flow immunoassay device for the qualitative detection of d-Methamphetamine (ME). Delta-9-Tetrahydrocannabinol (TH), Cocaine (CO), d-Amphetamine (AM), morphine (OP) and Phencyclidine (PC) in human oral fluid. The Oratect tests detect these drugs at the cutoff concentration listed below. These products are for in vitro diagnostic use and intended for prescription point of care use. The Oratect® Oral Fluid Drug Screen Device provides only preliminary drug test results. A more specific alternative method must be used in order to obtain a confirmed analytical result. Liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS) is the preferred confirmatory method. Samples for confirmatory testing should be collected with the Oratect Oral Fluid Collection Tube (50 mL polypropylene tube) provided. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels. OratectCheck™ Oral Fluid Controls (Negative and Positive controls of the analytes) are available but not supplied with the Oratect® Oral Fluid Drug Screen Devices. The OratectCheck™ Oral Fluid Controls are used as quality control materials with Oratect® Oral Fluid Drug Screen Devices.

Device Story

Oratect is a lateral flow immunoassay for qualitative detection of drugs of abuse in human oral fluid. Device uses competitive immunoassay principle; presence of analyte produces negative signal. Used at point-of-care by healthcare professionals; provides results in under 15 minutes. Input is oral fluid sample; output is visual interpretation of test lines. Preliminary positive results require confirmation via LC/MS/MS. OratectCheck controls are available for quality monitoring. Device aids clinical decision-making by providing rapid preliminary screening for specific drug analytes.

Clinical Evidence

Bench testing only. Precision/reproducibility evaluated at three point-of-care sites by four operators using spiked oral fluid samples across concentrations (negative, cutoff, +/- 25-100%). Method comparison performed against GC/MS/LC-MS/MS reference methods. Results demonstrated high agreement with reference methods. Interference studies confirmed no significant impact from endogenous compounds, pH, or common dietary/hygiene substances.

Technological Characteristics

Lateral flow immunochromatographic assay. Uses specific antibodies for d-Amphetamine, Cocaine, d-Methamphetamine, Cannabinoids, Opiates, and PCP. Point-of-care form factor; visual interpretation. No electronic components or software. Cut-off values: Amphetamine/Methamphetamine 50 ng/mL, THC 40 ng/mL, Cocaine 20 ng/mL, Morphine 40 ng/mL, PCP 10 ng/mL.

Indications for Use

Indicated for qualitative detection of d-Methamphetamine, Delta-9-Tetrahydrocannabinol, Cocaine, d-Amphetamine, morphine, and Phencyclidine in human oral fluid for prescription point-of-care use. Not for monitoring drug levels.

Regulatory Classification

Identification

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

Special Controls

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

Predicate Devices

• STC Amphetamine-Specific Intercept Micro-plate EIA and controls (k992918)
• STC Cocaine Metabolite Intercept Micro-plate EIA and controls (k001197)
• STC Methamphetamine Intercept Micro-plate EIA and controls (k993208)
• STC Cannabinoids Intercept Micro-plate EIA and controls (k002375)
• STC Opiates Intercept Micro-plate EIA and controls (k981341)
• STC PCP Intercept Micro-plate EIA and controls (k000399)

Submission Summary (Full Text)

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

A. 510(k) Number:
k103227

B. Purpose for Submission:
New device

C. Measurand:
Amphetamine, Methamphetamine, Cocaine, Opiates, PCP and THC

D. Type of Test:
Qualitative, immunochromatographic

E. Applicant:
Branan Medical Corporation

F. Proprietary and Established Names:
Oratect® Oral Fluid Drug Screen Device
OratectCheck Saliva/Oral Fluid Controls (Positive and Negative)

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DKZ | II | 862.3100 – Amphetamine test system | 91-Toxicology |
| DJC | II | 862.3610 – Methamphetamine test system | 91-Toxicology |
| DIO | II | 862.3250-Cocaine and cocaine metabolite test system | 91-Toxicology |
| DJG | II | 862.3650-Opiate test system | 91-Toxicology |
| LCM | Unclassified | Enzyme immunoassay Phencyclidine | 91-Toxicology |
| LDJ | II | 862.3870-Cannabinoid test system | 91-Toxicology |
| DIF | Class I, Reserved | 862.3280 – clinical toxicology control material | 91-Toxicology |

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H. Intended Use:

1. Intended use(s):

See indications for use below

2. Indication(s) for use:

The Oratect Oral fluid Drug Screen Device is a one-step lateral flow immunoassay device for the qualitative detection of d-Methamphetamine (ME). Delta-9-Tetrahydrocannabinol (TH), Cocaine (CO), d-Amphetamine (AM), morphine (OP) and Phencyclidine (PC) in human oral fluid. The Oratect tests detect these drugs at the cutoff concentration listed below.

| Test | cutoff |
| --- | --- |
| Oratect Oral Fluid Drug Screen Device d-Amphetamine | 50 ng/mL |
| Oratect Oral Fluid Drug Screen Device d-Methamphetamine | 50 ng/mL |
| Oratect Oral Fluid Drug Screen Device Delta-9-Tetrahydrocannabinol | 40 ng/mL |
| Oratect Oral Fluid Drug Screen Device Cocaine | 20 ng/mL |
| Oratect Oral Fluid Drug Screen Device Morphine | 40 ng/mL |
| Oratect Oral Fluid Drug Screen Device Phencyclidine | 10 ng/mL |

These products are for in vitro diagnostic use and intended for prescription point of care use.

The Oratect® Oral Fluid Drug Screen Device provides only preliminary drug test results. A more specific alternative method must be used in order to obtain a confirmed analytical result. Liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS) is the preferred confirmatory method. Samples for confirmatory testing should be collected with the Oratect Oral Fluid Collection Tube (50 mL polypropylene tube) provided. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.

OratectCheck™ Oral Fluid Controls (Negative and Positive controls of the analytes) are available but not supplied with the Oratect® Oral Fluid Drug Screen Devices. The OratectCheck™ Oral Fluid Controls are used as quality control materials with Oratect® Oral Fluid Drug Screen Devices.

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Special conditions for use statement(s):

The Oratect Oral Fluid Drug Screen Device provides only preliminary drug test results. For a quantitative result or for a confirmation of a presumptive positive result obtained by the Oratect Oral Fluid Drug Screen Device, a more specific alternative method must be used. GC/MS or LC/MS is the preferred confirmatory method.

These products are for in vitro diagnostic use and intended for prescription point of care use.

4. Special instrument requirements:

Not applicable, as the device is a visually-read single-use device

I. Device Description:

The Oratect® Oral Fluid Drug Screen Device contains one or two membrane strips and a collection pad. Each strip consists of a membrane, a colloidal gold conjugate pad, a sample pad and an absorbent pad.

Membrane:

ME/TH/CO test strip: Methamphetamine, THC and Cocaine-protein conjugates are coated onto specific region on the membrane known as the "Test Region".

AM/OP/PC test strip: Amphetamine, Morphine, Phencyclidine protein conjugates are coated onto the test region of the membrane.

Colloidal Gold Conjugate Pad: The colloidal gold conjugate pad for the ME/TH/CO test strip contains mouse monoclonal anti-methamphetamine, anti-THC and anti-cocaine antibody colloidal gold conjugates coated onto a fibrous pad. The colloidal gold conjugate pad for the AM/OP/PC test strip contains mouse monoclonal anti-amphetamine, anti-morphine, anti-phencyclidine antibody colloidal gold conjugates.

Collection Pad: The collection pad consists of an absorbent material.

Oratect Oral Fluid Collection Tube (50 mL polypropylene tube) for confirmation shipping

J. Substantial Equivalence Information:

1. Predicate device name(s):

STC Amphetamine-Specific Intercept Micro-plate EIA and controls, Orasure Technologies Inc

STC Cocaine Metabolite Intercept Micro-plate EIA and controls, Orasure Technologies Inc

STC Methamphetamine Intercept Micro-plate EIA and controls, Orasure Technologies Inc

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STC Cannabinoids Intercept Micro-plate EIA and controls, Orasure Technologies Inc
STC Opiates Intercept Micro-plate EIA and controls, Orasure Technologies Inc
STC PCP Intercept Micro-plate EIA and controls, Orasure Technologies Inc

2. Predicate K number(s):

k992918, k001197, k993208, k002375, k981341 and k000399, respectively

3. Comparison with predicate:

| Similarities/Differences | | |
| --- | --- | --- |
| Item | Device | Predicates |
| Intended use | Preliminary Drug screening test for the qualitative detection of drug analytes in oral fluid (human saliva)
For InVitro Diagnostic Use | Same |
| Test Principle | Specific non-radioimmunoassay. The assay of small drugs of abuse molecules are based on competitive immunoassay methodology, the presence of analyte will produce a negative signal.
Competitive lateral flow immunochromatographic assay | Specific non-radioimmunoassay. The assay of small drugs of abuse molecules are based on competitive immunoassay methodology, the presence of analyte will produce a negative signal.
Competitive enzyme-labeled immunoassay |
| Specimen | Oral fluid | Same |
| Drug analytes | d-amphetamine, cocaine. d-methamphetamine, cannabinoids, Opiates and PCP | Same |
| Test result interpretation | Visual reading | Instrument reading |
| Control matrix | Synthetic oral fluid | Oral fluid diluent |
| Testing site | Point-of-care | Laboratory |

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

None were referenced

L. Test Principle:

The Oratect Oral Fluid Drug Screen Device is based on a competitive immunoassay procedure in which drug derivatives immobilized on the membrane compete with the drug(s) which may be present in oral fluid for limited antibody binding sites on the colored colloidal gold antibody conjugate.

When no drug is present in the sample, the colored colloidal gold antibody conjugate will bind to the drug derivatives on the membrane to form visible bands at specific

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test regions, a negative result. When a sufficient amount of drug is present in the sample, the drug will saturate the antibodies, and the colored colloidal gold conjugate cannot bind to the drug derivatives on the membrane giving a positive result.

The device has an internal process control which indicates that sufficient volume of test sample was applied to the device. Also, the flow of the blue lines indicates that a sufficient amount of oral fluid has been collected.

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

# 1. Analytical performance:

# a. Precision/Reproducibility:

Precision studies were performed at three point-of-care sites using drug-free oral fluid spiked to the following concentrations: negative (zero), cutoff, $+/-25\%$ , $+/-50\%$ , $+/-75\%$ and $100\%$ of the cutoff. The samples were aliquoted, randomized and blinded, then given to each site. A minimum of 45 determinations were made at each concentration. Testing was performed once a day over 10 days by 4 intended use operators (2 at site 1 [technician training certificate], and 1 each at sites 2 [medical technologist] and 3 [vocational nurse]). The intended users performed the testing by following the instructions for use. Sample concentrations were confirmed by LC/MS/MS or GC/MS.

Methamphetamine

| Conc. | Site 1 | | Site 2 | | Site 3 | | Combined | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Operator 1 | | | | | | | |
| | Neg | Pos | Neg | Pos | Neg | Pos | Neg | Pos |
| Negative | 180 | 0 | 180 | 0 | 120 | 0 | 480 | 0 |
| -75% | 15 | 0 | 15 | 0 | 15 | 0 | 45 | 0 |
| -50% | 30 | 0 | 30 | 0 | 15 | 0 | 75 | 0 |
| -25% | 29 | 1 | 28 | 2 | 15 | 0 | 72 | 3 |
| Cutoff | 10 | 5 | 8 | 7 | 8 | 7 | 26 | 19 |
| 125% | 2 | 28 | 2 | 28 | 2 | 13 | 6 | 69 |
| 150% | 0 | 32 | 1 | 29 | 0 | 15 | 1 | 76 |
| 175% | 0 | 11 | 0 | 15 | 0 | 15 | 0 | 45 |
| 100% | 0 | 15 | 0 | 15 | 0 | 15 | 0 | 45 |

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THC

| Conc. | Site 1 | | Site 2 | | Site 3 | | Combined | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Operator 1 | | | | | | | |
| | Neg | Pos | Neg | Pos | Neg | Pos | Neg | Pos |
| Negative | 195 | 0 | 195 | 0 | 120 | 0 | 510 | 0 |
| -75% | 15 | 0 | 15 | 0 | 15 | 0 | 45 | 0 |
| -50% | 30 | 0 | 30 | 0 | 15 | 0 | 75 | 0 |
| -25% | 30 | 1 | 28 | 2 | 15 | 0 | 72 | 3 |
| Cutoff | 9 | 6 | 8 | 7 | 8 | 7 | 25 | 20 |
| 125% | 4 | 26 | 1 | 29 | 2 | 13 | 6 | 68 |
| 150% | 1 | 29 | 1 | 29 | 0 | 15 | 2 | 73 |
| 175% | 0 | 15 | 0 | 15 | 0 | 15 | 0 | 45 |
| 100% | 0 | 15 | 0 | 15 | 0 | 15 | 0 | 45 |

Cocaine

| Conc. | Site 1 | | Site 2 | | Site 3 | | Combined | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Operator 1 | | | | | | | |
| | Neg | Pos | Neg | Pos | Neg | Pos | Neg | Pos |
| Negative | 180 | 0 | 180 | 0 | 120 | 0 | 480 | 0 |
| -75% | 15 | 0 | 15 | 0 | 15 | 0 | 45 | 0 |
| -50% | 30 | 0 | 30 | 0 | 15 | 0 | 75 | 0 |
| -25% | 29 | 1 | 29 | 1 | 15 | 0 | 73 | 2 |
| Cutoff | 10 | 5 | 8 | 7 | 9 | 6 | 27 | 18 |
| 125% | 3 | 27 | 3 | 27 | 1 | 14 | 7 | 68 |
| 150% | 2 | 28 | 3 | 27 | 0 | 15 | 5 | 70 |
| 175% | 0 | 15 | 0 | 15 | 0 | 15 | 0 | 45 |
| 100% | 0 | 15 | 0 | 15 | 0 | 15 | 0 | 45 |

Amphetamine

| Conc. | Site 1 | | Site 2 | | Site 3 | | Combined | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Operator 1 | | | | | | | |
| | Neg | Pos | Neg | Pos | Neg | Pos | Neg | Pos |
| Negative | 180 | 0 | 180 | 0 | 120 | 0 | 480 | 0 |
| -75% | 15 | 0 | 15 | 0 | 15 | 0 | 45 | 0 |
| -50% | 30 | 0 | 30 | 0 | 15 | 0 | 75 | 0 |
| -25% | 29 | 1 | 27 | 3 | 12 | 3 | 68 | 7 |
| Cutoff | 8 | 7 | 7 | 8 | 7 | 8 | 22 | 23 |
| 125% | 3 | 27 | 1 | 29 | 0 | 15 | 4 | 71 |
| 150% | 1 | 29 | 1 | 29 | 0 | 15 | 2 | 73 |
| 175% | 0 | 15 | 0 | 15 | 0 | 15 | 0 | 45 |
| 100% | 0 | 15 | 0 | 15 | 0 | 15 | 0 | 45 |

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Opiates

| Conc. | Site 1 | | Site 2 | | Site 3 | | Combined | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Operator 1 | | | | | | | |
| | Neg | Pos | Neg | Pos | Neg | Pos | Neg | Pos |
| Negative | 121 | 0 | 180 | 0 | 120 | 0 | 480 | 0 |
| -75% | 15 | 0 | 15 | 0 | 15 | 0 | 45 | 0 |
| -50% | 30 | 0 | 30 | 0 | 15 | 0 | 75 | 0 |
| -25% | 28 | 2 | 28 | 2 | 15 | 0 | 71 | 4 |
| Cutoff | 9 | 6 | 8 | 7 | 6 | 9 | 23 | 22 |
| 125% | 3 | 27 | 2 | 28 | 0 | 15 | 5 | 70 |
| 150% | 1 | 29 | 0 | 30 | 0 | 15 | 1 | 74 |
| 175% | 0 | 15 | 0 | 15 | 0 | 15 | 0 | 45 |
| 100% | 0 | 15 | 0 | 15 | 0 | 15 | 0 | 45 |

PCP

| Conc. | Site 1 | | Site 2 | | Site 3 | | Combined | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Operator 1 | | | | | | | |
| | Neg | Pos | Neg | Pos | Neg | Pos | Neg | Pos |
| Negative | 195 | 0 | 195 | 0 | 120 | 0 | 510 | 0 |
| -75% | 15 | 0 | 15 | 0 | 15 | 0 | 45 | 0 |
| -50% | 28 | 2 | 29 | 1 | 14 | 1 | 71 | 4 |
| -25% | 27 | 3 | 26 | 4 | 14 | 1 | 67 | 8 |
| Cutoff | 10 | 5 | 8 | 7 | 7 | 8 | 25 | 20 |
| 125% | 1 | 29 | 1 | 29 | 0 | 15 | 2 | 73 |
| 150% | 1 | 29 | 1 | 29 | 0 | 15 | 2 | 73 |
| 175% | 0 | 15 | 0 | 15 | 0 | 15 | 0 | 45 |
| 100% | 0 | 15 | 0 | 15 | 0 | 15 | 0 | 45 |

b. Linearity/assay reportable range:

Not applicable, the device is intended for qualitative use.

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

There is a blue line located in each test window. The purpose of the blue line is to indicate that a sufficient amount of saliva sample has been collected.

A colored line appearing in the control zone is considered as an internal procedural control. Users are informed not to interpret the test if no red line appears in the control zone.

Positive controls are prepared by spiking synthetic oral fluid matrix with known concentration of drug standards which are traceable to NIST standards. The positive control concentrations are confirmed by LC/MS/MS.

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Negative control is a synthetic oral fluid containing no drug.

Control standards are not supplied with this device but can be purchased separately from Branan Medical Corporation. Users are advised to follow federal, state and local guidelines for QC testing requirements.

## Stability:

Accelerated studies have been conducted for the control material. Protocols and acceptance criteria were described and found to be acceptable. The manufacturer claims that when stored un-opened at -15 °C, the product is stable until expiration date which is 24 months. Open vial stability is 7 days when stored at 4 °C. Real time studies have been conducted and are on-going.

## Shipping/recovery study:

A shipping study was performed to demonstrate the recovery of drug from oral fluid when collected in the Oratect polypropylene collection tube (provided for confirmation testing) by testing the full range of expected transport conditions (maximum time and temperature) for confirmation testing. Conditions simulating transport to 3 different destination sites with varied weather conditions (2-8°C, room temperature and 40°C) were performed. Negative oral fluid samples in glass bottles were spiked with a single analyte/bottle to concentrations of -50% and +50% of the cutoff. The samples were tested on the Oratect Oral Fluid Drug Screen device and the results were recorded. One (1) ml of each sample was transferred/pippetted into an amber glass vial for testing on the reference method (LC/MS/MS).

Results of the shipping study are shown in the table below:

| | Temperatures | Cutoffs | AMP | COC | MET | OPI | PCP | THC |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Oratect Oral Fluid Drug Screen results (POS/NEG) | | -50% | Neg | Neg | Neg | Neg | Neg | Neg |
| | | +50% | Pos | Pos | Pos | Pos | Pos | Pos |
| LC/MS/MS results before application to device (ng/mL) | | -50% | 28 | 12 | 26 | 22 | 5.2 | 19.7 |
| | | +50% | 83 | 35 | 80 | 57 | 15 | 68 |
| LC/MS/MS result after shipping in the Oratect polypropylene tube (ng/mL) | 2-8°C | -50% | 28 | 13 | 24 | 20 | 5.2 | 19 |
| | | +50% | 75 | 34 | 84 | 59 | 14.1 | 62.6 |
| | 20-25°C | -50% | 29 | 12 | 26 | 22 | 5.3 | 18.7 |
| | | +50% | 73 | 39 | 91 | 57 | 13.2 | 60.1 |
| | 40°C | -50% | 28 | 12 | 25 | 19 | 4.4 | 17.4 |
| | | +50% | 78 | 37 | 81 | 57 | 13.4 | 62.3 |

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LC/MS/MS recovery results for the confirmation collection device are shown in the table below:

| Drug Analyte | Cut-off level | Target Concentration (ng/mL) | Concentration original glass container (LC/MS/MS) | % Recovery |
| --- | --- | --- | --- | --- |
| AMP | -50 | 25 | 23 | 96 |
| | +50 | 75 | 71 | 100 |
| COC | -50 | 10 | 11 | 100 |
| | +50 | 30 | 34 | 103 |
| MET | -50 | 25 | 27 | 111 |
| | +50 | 75 | 84 | 95 |
| OPI | -50 | 20 | 20 | 90 |
| | +50 | 60 | 57 | 96 |
| PCP | -50 | 5 | 5 | 100 |
| | +50 | 15 | 17 | 94 |
| THC | -50 | 20 | 21 | 95 |
| | +50 | 60 | 65 | 105 |

Sample Storage and Stability:

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

Samples may be stored in the 50 mL polypropylene tube for up to two weeks when stored at 2-8°C or up to 24 months when stored below -15°C.

d. Detection limit:

Not applicable, this is a qualitative assay.

e. Analytical specificity:

Cross-reactivity was evaluated by spiking similarly structured drug compounds to a concentration of 10,000 ng/mL into drug free oral fluid. These samples were serially diluted to determine the lowest concentration that produced a positive result. The table below summarizes the results:

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| Drug | Compound | Concentration ng/mL producing a positive response | % Cross-reactivity |
| --- | --- | --- | --- |
| AMP | l-Amphetamine | 2000 | 2.5% |
| | D,l-p-Chloramphetamine | 400 | 12.5% |
| | MDA | 400 | 12.5% |
| | Phentermine | 100 | 50% |
| | B-Phenylethylamine | 10,000 | 0.5% |
| | Tyramine | 10,000 | 0.5% |
| | l-Methamphetamine | >10,000 | 0% |
| COC | Benzoylecgonine | 600 | 3.3% |
| MET | d,l-Ephedrine | 10,000 | 0.5% |
| | 1R, 2S, l-Ephedrine | 6000 | 0.83% |
| | p-Hydroxymethamphetamine | 1500 | 3.3% |
| | MDEA | 1500 | 3.3% |
| | MDMA | 150 | 33.3% |
| | d,l-Methamphetamine | 60 | 83.3% |
| | l-Methamphetamine | 3000 | 1.7% |
| | Methoxyphenamine | 10,000 | 0.5% |
| | l-Amphetamine | >10,000 | 0% |
| OPI | 6-Acetylcodeine | 40 | 100% |
| | 6-Acetylmorphine | 50 | 80% |
| | Codeine | 40 | 100% |
| | Dihydrocodeine | 200 | 20% |
| | Ethyl morphine | 75 | 53.3% |
| | Herion | 40 | 100% |
| | Hydrocodone | 200 | 20% |
| | Hydromorphone | 300 | 13.3% |
| | Nalorphine | 1000 | 4% |
| THC | Cannabinol | 100 | 40% |
| | Δ-8-Tetrahydrocannabinol | 100 | 40% |
| | 11-nor- Δ8-THC-COOH | 20 | 200% |
| | 11-nor- Δ9-THC-COOH | 10 | 400% |
| | 11-Hydroxy- Δ9-THC | 400 | 10% |

Potential interference from structurally unrelated and endogenous compounds were tested by spiking the potentially interfering compound into human oral fluid drug controls having drug concentration at +/-25 % of the cutoff. All were tested at a concentration of 10,000 ng/mL. If a false result was observed the testing was repeated at the +/-50% of the cutoff for drug. No negative or positive interference was seen in this study.

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| Compound | Compound | Compound |
| --- | --- | --- |
| Acetaminophen | 1R, 2R-(-) Ephedrine | Perphenazine |
| Acetylsalicylic acid | 1S, 2R(+) Ephedrine | Pheniramine |
| l-Ascorbic Acid | (-) Ephineohrine | (+/-) Phenylpropanolamine |
| Aspartame | Erythromycin | Procaine |
| Benzilic Acid | Ethanol | Promazine |
| Benzocaine | Glutethimide | Promethazine |
| Benzoic Acid | Hemoglobin | Ranitidine |
| Bilirubin | Ibuprofen | Ribofavin |
| Betethal | Lidocaine | Salicylic acid |
| Caffeine | Meperidine | Serotonin |
| (+) Chorpheniramine | Naloxone | Tetracycline |
| Cholesterol | Nalltrexone | Thiamine |
| Dextromrthorphan | (+) Naproxen | Tryptamine |
| Diphenhydramine | Papaverine | d,l-Tryptophan |
| Doxylamine | Pentazocine | |

Potential interference from pH was tested by using human oral fluid controls at drug concentrations of $+ / 25$ and $+ / - 50\%$ of the cutoff. The pH of the samples was adjusted to various pH levels ranging from 4.5-8.5 in 1 pH unit increments. No negative or positive interference from pH was observed.

The following potential interferents were evaluated by spiking into human oral fluid controls having drug concentrations at $+/-25\%$ and $+ - 50\%$ of the cutoff: Alcohol, Mouthwash, MSG, Baking soda, Cough Syrup, Cranberry juice, Salt, Sugar, Toothpaste, Gum, Orange juice, food coloring (red, blue and green), Tea and cola. None of these substances caused positive or negative interference. Prior to the test being administered the donor was instructed not to eat, drink, smoke or chew tobacco. Potential interference from cigarette smoking, was evaluated by asking a participant to smoke a cigarette, after 15 minutes an oral fluid sample was collected and spiked with each drug at concentrations of cutoff $+/-25\%$ and $+/-50\%$ . None of these substances caused positive or negative interference.

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.

# f. Assay cut-off:

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

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2. Comparison studies:

a. Method comparison with predicate device:

Performance for the Oratect Oral Fluid Drug Screen Device was evaluated at typical point-of-care sites with a total of 3 operators who are typical operators at these sites. Operators collected samples from volunteer donors by swabbing the mouth and testing on the proposed device. Immediately after collecting the sample the volunteer was asked to spit into the confirmation collection tube for testing and comparison to the GC/MS. The operators were only provided the labeling to perform the testing. The results are presented in the table below:

| MET50 | | Negative | Negative (<50% cutoff concentration by GC/MS) | Near cutoff negative (-50% to the cutoff concentration) | Near cutoff positive (cutoff to 50%) | High Positive (>50% cutoff) | % Agreement |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | Positive | 0 | 0 | 5 | 3 | 58 | 97.5% |
| | Negative | 180 | 9 | 9 | 1 | 0 | 98.4% |
| THC40 | | Negative | Negative (<50% cutoff concentration by GC/MS) | Near cutoff negative (-50% to the cutoff concentration) | Near cutoff positive (cutoff to 50%) | High Positive (>50% cutoff) | % Agreement |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | Positive | 0 | 0 | 10 | 7 | 36 | 100% |
| | Negative | 185 | 20 | 7 | 0 | 0 | 95.5% |
| COC20 | | Negative | Negative (<50% cutoff concentration by GC/MS) | Near cutoff negative (-50% to the cutoff concentration) | Near cutoff positive (cutoff to 50%) | High Positive (>50% cutoff) | % Agreement |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | Positive | 0 | 0 | 3 | 5 | 38 | 100% |
| | Negative | 210 | 6 | 3 | 0 | 0 | 98.6% |

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The summary of discordant results is listed in the table below:

| Assay | Cutoff Value (ng/mL) | Device Pos/Neg | Major metabolite present by GC/MS or LC/MS/MS value (ng/mL) |
| --- | --- | --- | --- |
| Met50 | 50 | Positive | 25.4 Methamphetamine |
| | | Positive | 35 Methamphetamine |
| | | Positive | 38.5 Methamphetamine |
| | | Positive | 42.1 Methamphetamine |
| THC | 40 | Negative | 20.4 Delta-9-Tetrahydrocannabinol |
| | | Positive | 24.3 Delta-9-Tetrahydrocannabinol |

{13}

| Assay | Cutoff Value (ng/mL) | Device Pos/Neg | Major metabolite present by GC/MS or LC/MS/MS value (ng/mL) |
| --- | --- | --- | --- |
| COC20 | 20 | Positive | 15.7 Cocaine/Benzoyl Ecgonine |
| | | Positive | 15.9 Cocaine/Benzoyl Ecgonine |
| | | Positive | 17.4 Cocaine/Benzoyl Ecgonine |
| AMP50 | 50 | Positive | 26.1 Amphetamine |
| | | Positive | 28.3 Amphetamine |
| | | Positive | 32.5 Amphetamine |
| | | Positive | 34.8 Amphetamine |
| | | Positive | 38.3 Amphetamine |
| | | Positive | 40.9 Amphetamine |
| | | Positive | 49.2 Amphetamine |
| OPI40 | 40 | Positive | 27.5 Morphine/Codeine/6-Acetyl morphine |
| | | Positive | 32.7 Morphine/Codeine/6-Acetyl morphine |
| | | Positive | 38.7 Morphine/Codeine/6-Acetyl morphine |
| | | Negative | 40.2 Morphine/Codeine/6-Acetyl morphine |
| | | Negative | 43.9 Morphine/Codeine/6-Acetyl morphine |
| | | Positive | 39 Morphine/Codeine |
| PCP10 | 10 | Positive | 7.4 PCP |
| | | Negative | 10.8 PCP |
| | | Negative | 15.0 PCP |

b. Matrix comparison:

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

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable.

b. Clinical specificity:

Not applicable.

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

Not applicable.

4. Clinical cut-off:

Not applicable.

{14}

5. Expected values/Reference range:

Not applicable.

N. Proposed Labeling:

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

O. Conclusion:

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

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