LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls

K141320 · Lin-Zhi International, Inc. · LDJ · May 28, 2015 · Clinical Toxicology

Device Facts

• Record ID: K141320
• Device Name: LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls
• Applicant: Lin-Zhi International, Inc.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: May 28, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

The LZI Oral Fluid Cannabinoids Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of cannabinoids in neat human oral fluid, collected into the LZI Oral Fluid THC Collector, at the cut-off value of 4 ng/mL with Δ⁹-tetrahydrocannabinol (THC) as calibrators. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS and LCMS or (2) permitting laboratories to establish quality control procedures. The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive. The LZI Oral Fluid Cannabinoids Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Oral Fluid Cannabinoids Enzyme Immunoassay at the cut-off value of 4 ng/mL. The LZI Oral Fluid Cannabinoids Controls are for use as assayed quality control materials to monitor the precision of the LZI Oral Fluid Cannabinoids Enzyme Immunoassay at the cut-off value of 4 ng/mL.

Device Story

LZI Oral Fluid Cannabinoids Enzyme Immunoassay is a homogeneous enzyme immunoassay kit; utilizes competitive binding between cannabinoids in oral fluid samples and enzyme-labeled cannabinoids for a fixed amount of antibody. Input: neat human oral fluid collected via LZI Oral Fluid THC Collector. Principle: enzyme activity (G6PDH) is inhibited when antibody binds to labeled drug; free drug in sample displaces labeled drug, increasing enzyme activity. Output: spectrophotometric absorbance change at 340 nm, proportional to drug concentration. Used in clinical laboratories; operated by trained laboratory personnel on automated clinical chemistry analyzers (e.g., Beckman AU400e). Provides preliminary screening results; requires confirmation by GC/MS or LC/MS. Assists clinicians in identifying potential cannabinoid presence to guide further diagnostic or confirmatory testing.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP05-A2 (N=80). Method comparison performed against GC/MS using 83 clinical oral fluid samples (42 positive, 41 negative). Linearity and recovery studies conducted across 0-12 ng/mL range. Interference testing performed for endogenous, exogenous, and structurally unrelated compounds. Stability studies confirmed performance for 22 days refrigerated and 2 months frozen.

Technological Characteristics

Homogeneous enzyme immunoassay. Reagents: mouse monoclonal anti-cannabinoids antibody, G6PDH-labeled cannabinoids, G6P, NAD, stabilizers, sodium azide preservative. Form factor: liquid reagents for automated clinical chemistry analyzers. Detection: spectrophotometric at 340 nm. Calibration/Controls: synthetic oral fluid matrix with Δ⁹-THC. Storage: 2-8°C.

Indications for Use

Indicated for qualitative and semi-quantitative determination of cannabinoids in neat human oral fluid for prescription use. Intended for use with automated clinical chemistry analyzers to provide preliminary analytical results for cannabinoids at a 4 ng/mL cut-off.

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

• Lin-Zhi International, Inc. Cannabinoid (cTHC) Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems (k110239)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 28, 2015

LIN-ZHI INTERNATIONAL, INC. BERNICE LIN VP OPERATIONS 670 ALMANOR AVE. SUNNYVALE CA 94085

Re: K141320

Trade/Device Name: LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators LZI Oral Fluid Cannabinoids Controls Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: II Product Code: LDJ, DLJ, LAS Dated: April 22, 2015 Received: April 23, 2015

Dear Bernice Lin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Katherine Serrano -S

For:

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) k141320

Device Name LZI Oral Fluid Cannabinoids Enzyme Immunoassay LZI Oral Fluid Cannabinoids Calibrators LZI Oral Fluid Cannabinoids Controls

Indications for Use (Describe)

The LZI Oral Fluid Cannabinoids Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of Cannabinoids in neat human oral fluid, collected into the LZI Oral Fluid THC Collector, at the cut-off value of 4 ng/mL with △9- tetrahydrocannabinol (THC) as calibrators. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.

The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS and LCMS or (2) permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical result. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

The LZI Oral Fluid Cannabinoids Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Oral Fluid Cannabinoids Enzyme Immunoassay at the cut-off value of 4 ng/mL.

The LZI Oral Fluid Cannabinoids Controls are for use as assayed quality control materials to monitor the precision of the LZI Oral Fluid Cannabinoids Enzyme Immunoassay at the cut-off value of 4 ng/mL.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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# 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

#### Preparation Date

May 22, 2015

#### Introduction

According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

#### Submitter name. Address, and Contact

Lin-Zhi International, Inc. 670 Almanor Avenue Sunnyvale, CA 94085 Phone: [phone] [phone] Fax: e-mail: bclin(@lin-zhi.com

Bernice Lin. Ph.D. Contact: VP Operations

#### Device Name and Classification

| Classification Name: | Enzyme Immunoassay, Oral Fluid Cannabinoids Class II, LAF (91 Toxicology), 21 CFR 862.3870 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------|
| | Drug Specific Calibrators, Class II, DLJ (91 Toxicology), 21 CFR 862.3200 |
| | Drug Specific Controls, Class I, LAS (91 Toxicology), 21 CFR 862.3280 |
| Common Name: | Homogeneous Oral Fluid Cannabinoids Enzyme Immunoassay |
| Proprietary Name: | LZI Oral Fluid Cannabinoids Enzyme Immunoassay,<br>LZI Oral Fluid Cannabinoids Calibrators<br>LZI Oral Fluid Cannabinoids Controls |

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# Legally Marketed Predicate Device(s)

The LZI Oral Fluid Cannabinoids Enzyme Immunoassay (k141320) is substantially equivalent to the Lin-Zhi International, Inc. Cannabinoid (cTHC) Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems (k110239) manufactured by Lin-Zhi International. Inc. The LZI Oral Fluid Cannabinoids Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance.

## Device Description

The LZI Oral Fluid Cannabinoids assay is a homogeneous enzyme immunoassay with ready-touse liquid reagent. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, cannabinoid derivative-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody would bind to free drug, the unbound cannabinoid derivative-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.

The LZI Oral Fluid Cannabinoids Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2 which are bottled separately but sold together within the kit.

The Ri solution contains mouse monoclonal anti-Cannabinoids antibody, glucose-6-phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09%) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with Cannabinoids, stabilizers, in buffer with sodium azide (0.09%) as preservative.

The LZI Oral Fluid Cannabinoids Enzyme Immunoassay calibrators and controls designated for use at the 4 ng/mL cutoffs contain 0, 2, 3, 4, 5, 6, and 12 ng/mL of Δ'-tetrahydrocannabinol (THC) in synthetic oral fluid with sodium azide (0.09%) as preservative. These five calibrators and two controls are sold as individual bottles.

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## Intended Use

The LZI Oral Fluid Cannabinoids Enzyme Immunoassay is intended for the qualitative and semiquantitative determination of cannabinoids in neat human oral fluid, collected into the LZI Oral Fluid THC Collector, at the cutoff value 4 ng/mL with A-tetrahydrocannabinol (THC) as calibrators. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.

The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC/MS or LC/MS or (2) permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

The LZI Oral Fluid Cannabinoids Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Oral Fluid Cannabinoids Enzyme Immunoassay at the cutoff value 4 ng/mL.

The LZI Oral Fluid Cannabinoids Controls are for use as assayed quality control materials to monitor the precision of the LZI Oral Fluid Cannabinoids Enzyme Immunoassay at the cutoff value of 4 ng/mL.

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# Comparison to Predicate Device

The LZI Oral Fluid Cannabinoids Enzyme Immunoassay (k141320) is substantially equivalent to the Lin-Zhi International, Inc. Cannabinoid (cTHC) Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems cleared by the FDA under the premarket notification k110239 for its stated intended use.

The following table compares LZI's Oral Fluid Cannabinoids Enzyme Immunoassay (k141320) with the predicate device.

| Device<br>Characteristics | Subject Device (k141320) | Predicate Device (k110239) |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | LZI Oral Fluid Cannabinoids Enzyme<br>Immunoassay, Calibrators, and Controls | LZI Cannabinoid (cTHC) Enzyme<br>Immunoassay, Calibrators and Controls |
| Intended Use | The LZI Oral Fluid Cannabinoids<br>Enzyme Immunoassay is intended for the<br>qualitative and semi-quantitative<br>determination of Δ9-tetrahydrocannabinol<br>(THC) in neat human oral fluid, collected<br>into the LZI Oral Fluid THC Collector,<br>using the cutoff value 4 ng/mL with Δ9-<br>tetrahydrocannabinol (THC) as the<br>calibrator. The assay is designed for<br>prescription use with a number of<br>automated clinical chemistry analyzers.<br><br>This assay provides a rapid screening procedure<br>for determining the presence of cannabinoids in<br>oral fluid. The assay provides only a preliminary<br>analytical result. A more specific alternative<br>chemical method must be used in order to obtain a<br>confirmed analytical result. Gas or Liquid<br>chromatography/ mass spectrometry (GC/MS or<br>LC/MS) is the preferred confirmatory method.<br>Clinical consideration and professional judgment<br>should be exercised with any drug of abuse test<br>result, particularly when the preliminary test result<br>is positive. | The LZI Cannabinoids (cTHC) Enzyme<br>Immunoassay, when used in conjunction<br>with Hitachi 717 automated clinical<br>system analyzers, is intended for the<br>qualitative and semi-quantitative<br>determination of Cannabinoids in human<br>urine using 11-nor-Δ9-THC-9-COOH (the<br>major metabolite of THC referred to here<br>as cTHC) as calibrator at the cutoff values<br>of 25, 50, or 100 ng/mL. The assay is<br>designed for professional use with a<br>number of automated clinical chemistry<br>analyzers.<br><br>This assay provides a rapid screening procedure<br>for determining the presence of Cannabinoids<br>(cTHC) in urine. The assay provides only a<br>preliminary analytical result. A more specific<br>alternative chemical method must be used in order<br>to obtain a confirmed analytical result. Gas or<br>liquid chromatography/mass spectrometry (GC/MS<br>or LC/MS) is the preferred confirmatory method.<br>Clinical consideration and professional judgment<br>should be exercised with any drug of abuse test<br>result, particularly when the preliminary test result<br>is positive. |
| Analyte | Δ9-tetrahydrocannabinol (THC) | 11-nor-Δ9-THC-9-carboxylic acid<br>(cTHC) |
| Cutoff | 4 ng/mL | 25, 50, 100 ng/mL |
| Matrix | Oral fluid | Urine |
| Calibrator<br>Levels | 5 Levels<br>(0, 2, 4, 6, 12 ng/mL) | THC 25: 5 Levels<br>(0, 12.5, 25, 37.5, 50 ng/mL)<br>THC 50: 5 Levels<br>(0, 25, 50, 75, 100 ng/mL)<br>THC 100: 5 Levels<br>(0, 50, 100, 150, 200 ng/mL) |
| Control Levels | 2 Levels<br>(3 ng/mL, 5 ng/mL) | THC 25: 2 Levels,<br>(18.75 ng/mL, 31.25 ng/mL)<br>THC 50: 2 Levels,<br>(37.5 ng/mL, 62.5 ng/mL)<br>THC 100: 2 Levels,<br>(75 ng/mL, 125 ng/mL) |
| Storage | 2-8 °C until expiration date | 2-8 °C until expiration date |

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# Performance Characteristics Summary:

Beckman AU400e Analyzer

#### Precision:

Precision:

#### Semi-Quantitative Positive/Negative Results:

| 4 ng/mL Cutoff Result: | | Within Run Precision | | Total Precision | |
|-------------------------|-------------|----------------------------|-----------------------|----------------------------|-----------------------------|
| Sample<br>Concentration | % of Cutoff | Number of<br>Determination | Immunoassay<br>Result | Number of<br>Determination | Immunoassay<br>Result |
| 0 ng/mL | -100.0% | 20 | 20 Negative | 80 | 80 Negative |
| 1 ng/mL | -75.0% | 20 | 20 Negative | 80 | 80 Negative |
| 2 ng/mL | -50.0% | 20 | 20 Negative | 80 | 80 Negative |
| 3 ng/mL | -25.0% | 20 | 20 Negative | 80 | 80 Negative |
| 4 ng/mL | 0% | 20 | 17 Pos/<br>3 Neg | 80 | 54 Positive/<br>26 Negative |
| 5 ng/mL | +25.0% | 20 | 20 Positive | 80 | 80 Positive |
| 6 ng/mL | +50.0% | 20 | 20 Positive | 80 | 80 Positive |
| 7 ng/mL | +75.0% | 20 | 20 Positive | 80 | 80 Positive |
| 8 ng/mL | +100.0% | 20 | 20 Positive | 80 | 80 Positive |

#### Qualitative Positive/Negative Results:

| 4 ng/mL Cutoff Result: | | Within Run Precision | | Total Precision | |
|------------------------|-------------|----------------------|------------------|-----------------|-------------------|
| Sample | | Number of | Immunoassay | Number of | Immunoassay |
| Concentration | % of Cutoff | Determination | Result | Determination | Result |
| 0 ng/mL | -100.0% | 20 | 20 Negative | 80 | 80 Negative |
| 1 ng/mL | -75.0% | 20 | 20 Negative | 80 | 80 Negative |
| 2 ng/mL | -50.0% | 20 | 20 Negative | 80 | 80 Negative |
| 3 ng/mL | -25.0% | 20 | 20 Negative | 80 | 80 Negative |
| 4 ng/mL | 0% | 20 | 18 Pos/<br>2 Neg | 80 | 59 Pos/<br>21 Neg |
| 5 ng/mL | +25.0% | 20 | 20 Positive | 80 | 80 Positive |
| 6 ng/mL | +50.0% | 20 | 20 Positive | 80 | 80 Positive |
| 7 ng/mL | +75.0% | 20 | 20 Positive | 80 | 80 Positive |
| 8 ng/mL | +100.0% | 20 | 20 Positive | 80 | 80 Positive |

## Method Comparison: Clinical Samples

Forty two (42) positive and forty one (41) negative unaltered oral fluid samples were evaluated by the LZI Oral Fluid Cannabinoid Enzyme Immunoassay using the Beckman AU400e clinical analyzer and compared to GC/MS. All samples were collected using the LZI Oral Fluid Collector and were processed following insert instructions. Results from the study are presented below:

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#### Qualitative Method Comparison Data:

| 4 ng/mL<br>Cutoff | Negative | < 50 % of the<br>cutoff<br>concentration<br>by GC/MS<br>analysis | Near Cutoff<br>Negative<br>(Between 50 %<br>below the<br>cutoff and the<br>cutoff<br>concentration) | Near Cutoff<br>Positive<br>(Between the<br>cutoff and 50<br>% above the<br>cutoff<br>concentration) | High Positive<br>(Greater than<br>50 % above the<br>cutoff<br>concentration) |
|-------------------|----------|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Positive | 0 | 0 | 2* | 5 | 35 |
| Negative | 20 | 13 | 6 | 2** | 0 |

| OF THC GC/MS concentration<br>(ng/mL) | Assay Cut-off | EIA Qualitative Result |
|---------------------------------------|---------------|------------------------|
| 3.6* | 4 ng/mL | + |
| 3.9* | | + |
| 4.1** | | - |
| 4.8** | | - |

Semi-Quantitative Method Comparison Data:

| 4 ng/mL<br>Cutoff | Negative | < 50 % of the<br>cutoff<br>concentration<br>by GC/MS<br>analysis | Near Cutoff<br>Negative<br>(Between 50 %<br>below the<br>cutoff and the<br>cutoff<br>concentration) | Near Cutoff<br>Positive<br>(Between the<br>cutoff and 50<br>% above the<br>cutoff<br>concentration) | High Positive<br>(Greater than<br>50 % above the<br>cutoff<br>Concentration) |
|-------------------|----------|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Positive | 0 | 0 | 1* | 6 | 35 |
| Negative | 20 | 13 | 7 | 1** | 0 |

| OF THC GC/MS<br>concentration<br>(ng/mL) | Assay Cut-off | EIA Semi-<br>Quantitative Result |
|------------------------------------------|---------------|----------------------------------|
| 2.8* | | + |
| 4.1** | 4 ng/mL | - |

#### Endogenous Compound Interference and Specificity - Cross-Reactivity:

No endogenous substance interference was observed when tested at physiologically relevant concentrations. Ascorbic Acid at concentrations above 2 mg/mL and pH levels 3, 4, and 5 can cause false-negative results. See product insert for list of compounds tested.

## Exogenous Compound Interference and Specificity - Cross-Reactivity:

Few exogenous substance interferences were observed. Ethyl Alcohol at concentrations above 3 %V/V and Reduced Fat Milk (2% milk fat) at concentrations above 1 %V/V can cause falsenegative results. See product insert for list of compounds tested.

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## Shipping/Recoverv Stabilitv Study:

No significant sample degradation occurred following real-time and accelerated stability studies up to 72 hours in amber glass vials. All sample shipments are shipped with gel-ice and are based on the assumption of a 24 hour priority overnight delivery.

#### Sample Storage Stability Study:

No significant sample degradation occurred following real-time stability studies on processed samples. Based on real-time studies, samples can be stored at 2-8 ℃ for up to 22 Days or at -20 °C for up to 29 Days in amber glass vials.

#### Open (and re-capped) vial Stability for Calibrator/Control:

Real time (2-8°C) and accelerated stability studies (at room temperature. ~25°C and 30°C) were carried out for 446 Davs (bevond 14 months) and results indicate that calibrators/controls are sensitive to temperature and must be stored at cold temperature (2-8℃). We claim an open (recapped)-vial stability up to 12 months when stored at cold temperature (2-8°C).

## Closed vial Stability for Calibrator/Control:

Real time (2-8°C) stability studies were carried out and are at 204 Days (beyond 6 Months) and results indicate that calibrators/controls are stable when stored at Cold (2-8°C), up to at least 6 months. Closed vial stability studies will remain on-going.

# Summary:

The information provided in this pre-market notification demonstrates that the LZI Oral Fluid Cannabinoid Enzyme Immunoassay (k141320) is substantially equivalent to the legally marketed predicate device for its general intended use. Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available predicate device as confirmed by gas chromatography/mass spectrometry (GC/MS), an independent analytical method. The information supplied in this pre-market notification provides reasonable assurance that the LZI Oral Fluid Cannabinoid Enzyme Immunoassay is safe and effective for its stated intended use.