(373 days)
Not Found
No
The device description and performance studies focus on a standard enzyme immunoassay method and do not mention any AI or ML components.
No.
Explanation: This device is an in vitro diagnostic assay used for the qualitative and semi-quantitative determination of Cannabinoids in human oral fluid. It provides analytical results and is intended for diagnostic purposes, not for treating or preventing disease.
Yes
Explanation: The device is intended for the "qualitative and semi-quantitative determination of Cannabinoids in neat human oral fluid," which is a diagnostic purpose. It provides "preliminary analytical results" for clinical consideration, indicating its role in identifying specific substances in a biological sample.
No
The device is described as an enzyme immunoassay kit comprised of liquid reagents (R1 and R2), calibrators, and controls. It is intended for use with automated clinical chemistry analyzers, which are hardware devices. The description focuses on the chemical components and the enzymatic reaction, not on software functionality as the primary or sole component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "qualitative and semi-quantitative determination of Cannabinoids in neat human oral fluid". This involves testing a biological sample (oral fluid) in vitro (outside the body) to obtain diagnostic information (presence and concentration of cannabinoids).
- Device Description: The description details the components of the assay kit (reagents, calibrators, controls) which are used to perform the test in vitro.
- Performance Studies: The document describes performance studies conducted using human oral fluid samples, comparing the results of the immunoassay to a confirmatory method (GC/MS). This is typical for the validation of an IVD.
- Predicate Device: The mention of a predicate device with a K number (K110239) indicates that this device is being compared to a previously cleared IVD by a regulatory body like the FDA.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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 △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.
Product codes (comma separated list FDA assigned to the subject device)
LDJ, DLJ, LAS
Device Description
The LZI Oral Fluid Cannabinoids assay is a homogeneous enzyme immunoassay with ready-to-use 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 R1 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human oral fluid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescription use with a number of automated clinical chemistry analyzers.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Characteristics Summary:
Beckman AU400e Analyzer
Precision:
Semi-Quantitative Positive/Negative Results:
| Sample Concentration (ng/mL) | % of Cutoff | Number of Determination (Within Run Precision) | Immunoassay Result (Within Run Precision) | Number of Determination (Total Precision) | Immunoassay Result (Total Precision) |
|---|---|---|---|---|---|
| 0 | -100.0% | 20 | 20 Negative | 80 | 80 Negative |
| 1 | -75.0% | 20 | 20 Negative | 80 | 80 Negative |
| 2 | -50.0% | 20 | 20 Negative | 80 | 80 Negative |
| 3 | -25.0% | 20 | 20 Negative | 80 | 80 Negative |
| 4 | 0% | 20 | 17 Pos/3 Neg | 80 | 54 Positive/26 Negative |
| 5 | +25.0% | 20 | 20 Positive | 80 | 80 Positive |
| 6 | +50.0% | 20 | 20 Positive | 80 | 80 Positive |
| 7 | +75.0% | 20 | 20 Positive | 80 | 80 Positive |
| 8 | +100.0% | 20 | 20 Positive | 80 | 80 Positive |
Qualitative Positive/Negative Results:
| Sample Concentration (ng/mL) | % of Cutoff | Number of Determination (Within Run Precision) | Immunoassay Result (Within Run Precision) | Number of Determination (Total Precision) | Immunoassay Result (Total Precision) |
|---|---|---|---|---|---|
| 0 | -100.0% | 20 | 20 Negative | 80 | 80 Negative |
| 1 | -75.0% | 20 | 20 Negative | 80 | 80 Negative |
| 2 | -50.0% | 20 | 20 Negative | 80 | 80 Negative |
| 3 | -25.0% | 20 | 20 Negative | 80 | 80 Negative |
| 4 | 0% | 20 | 18 Pos/2 Neg | 80 | 59 Pos/21 Neg |
| 5 | +25.0% | 20 | 20 Positive | 80 | 80 Positive |
| 6 | +50.0% | 20 | 20 Positive | 80 | 80 Positive |
| 7 | +75.0% | 20 | 20 Positive | 80 | 80 Positive |
| 8 | +100.0% | 20 | 20 Positive | 80 | 80 Positive |
Method Comparison: Clinical Samples
42 positive and 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.
Qualitative Method Comparison Data (at 4 ng/mL cutoff compared to GC/MS analysis):
| GC/MS Concentration Range | Positive (EIA Result) | Negative (EIA Result) |
|---|---|---|
| Negative | 0 | 20 |
§ 862.3870 Cannabinoid test system.
(a)
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 includedelta -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.(b)
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).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three overlapping human profiles facing to the right, creating a sense of unity and collaboration. The overall design is simple, clean, and professional, reflecting the department's mission of promoting health and well-being.
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
1
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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: (408) 732-3856 (408) 732-3849 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, |
| LZI Oral Fluid Cannabinoids Calibrators | |
| LZI Oral Fluid Cannabinoids Controls |
4
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.
5
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.
6
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
| Characteristics | Subject Device (K141320) | Predicate Device (K110239) |
|---|---|---|
| LZI Oral Fluid Cannabinoids Enzyme | ||
| Immunoassay, Calibrators, and Controls | LZI Cannabinoid (cTHC) Enzyme | |
| Immunoassay, Calibrators and Controls | ||
| Intended Use | The LZI Oral Fluid Cannabinoids | |
| Enzyme Immunoassay is intended for the | ||
| qualitative and semi-quantitative | ||
| determination of Δ9-tetrahydrocannabinol | ||
| (THC) in neat human oral fluid, collected | ||
| into the LZI Oral Fluid THC Collector, | ||
| using the cutoff value 4 ng/mL with Δ9- | ||
| tetrahydrocannabinol (THC) as the | ||
| calibrator. The assay is designed for | ||
| prescription use with a number of | ||
| automated clinical chemistry analyzers. |
This assay provides a rapid screening procedure
for determining the presence of cannabinoids in
oral fluid. 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 Cannabinoids (cTHC) Enzyme
Immunoassay, when used in conjunction
with Hitachi 717 automated clinical
system analyzers, is intended for the
qualitative and semi-quantitative
determination of Cannabinoids in human
urine using 11-nor-Δ9-THC-9-COOH (the
major metabolite of THC referred to here
as cTHC) as calibrator at the cutoff values
of 25, 50, or 100 ng/mL. The assay is
designed for professional use with a
number of automated clinical chemistry
analyzers.
This assay provides a rapid screening procedure
for determining the presence of Cannabinoids
(cTHC) in urine. 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. |
| Analyte | Δ9-tetrahydrocannabinol (THC) | 11-nor-Δ9-THC-9-carboxylic acid
(cTHC) |
| Cutoff | 4 ng/mL | 25, 50, 100 ng/mL |
| Matrix | Oral fluid | Urine |
| Calibrator
Levels | 5 Levels
(0, 2, 4, 6, 12 ng/mL) | THC 25: 5 Levels
(0, 12.5, 25, 37.5, 50 ng/mL)
THC 50: 5 Levels
(0, 25, 50, 75, 100 ng/mL)
THC 100: 5 Levels
(0, 50, 100, 150, 200 ng/mL) |
| Control Levels | 2 Levels
(3 ng/mL, 5 ng/mL) | THC 25: 2 Levels,
(18.75 ng/mL, 31.25 ng/mL)
THC 50: 2 Levels,
(37.5 ng/mL, 62.5 ng/mL)
THC 100: 2 Levels,
(75 ng/mL, 125 ng/mL) |
| Storage | 2-8 °C until expiration date | 2-8 °C until expiration date |
7
Performance Characteristics Summary:
Beckman AU400e Analyzer
Precision:
Precision:
Semi-Quantitative Positive/Negative Results:
| 4 ng/mL Cutoff Result: | Within Run Precision | Total Precision | |||
|---|---|---|---|---|---|
| Sample | |||||
| Concentration | % of Cutoff | Number of | |||
| Determination | Immunoassay | ||||
| Result | Number of | ||||
| Determination | Immunoassay | ||||
| 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/ | ||
| 3 Neg | 80 | 54 Positive/ | |||
| 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/ | ||
| 2 Neg | 80 | 59 Pos/ | |||
| 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:
8
Qualitative Method Comparison Data:
| 4 ng/mL
Cutoff | Negative |