The Immunalysis Cannabinoids Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 50ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Cannabinoids in human urine with automated clinical chemistry analyzers. This assay is calibrated against 11-nor-9-carboxy-A9-THC (cTHC). This in-vitro device is for prescription use only.

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

The Immunalysis Cannabinoids Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Immunalysis cTHC Urine Control Set: The Immunalysis cTHC Urine Control Set is used as control materials in the Immunalysis Cannabinoids Urine Enzyme Immunoassay.

Immunalysis cTHC Urine Calibrators: The Immunalysis cTHC Urine Calibrators are used as calibrators in the Immunalysis Cannabinoids Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of Cannabinoids in urine on automated clinical chemistry analyzers.

Device Description

The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes monoclonal and polyclonal antibodies to Cannabinoids, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes Cannabinoids derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. Calibrators and controls are sold separately. Reagents are liquid, ready to use.

All of the Immunalysis cTHC Urine Calibrators and Controls are liquid and ready to use. Each contains a known concentration of a specific drug analyte as a mixture.

The negative calibrator is a processed, drug-free synthetic urine matrix with sodium azide as a preservative. The Level 1, 2, 3 and 4 calibrators, as well as the LOW Control and HIGH Control are prepared by spiking known concentrations of 11-nor-9-carboxy-Δ'-THC (cTHC) into the negative calibrator matrix. The negative calibrator, Level 1 calibrator, Level 2 calibrator, Level 3 calibrator, Level 4 calibrator and two controls are sold as individual bottles.

AI/ML Overview

The document describes the Immunalysis Cannabinoids Urine Enzyme Immunoassay, its calibrators, and control set, which are intended for qualitative and semi-quantitative analysis of Cannabinoids in human urine with a cutoff of 50ng/mL. The study evaluates the performance of the device against this cutoff.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the document for each test. However, the studies demonstrate the device's performance relative to its intended use and consistency around the 50 ng/mL cutoff. The implicit acceptance criteria appear to be:

Qualitative Analysis: Accurate classification of samples as negative below the -25% cutoff and positive above the +25% cutoff, with consistent results at the cutoff.
Semi-Qualitative Analysis: Similar to qualitative, with consistent results around the cutoff.
Specificity and Cross-Reactivity: Structurally similar compounds should show expected cross-reactivity, and structurally dissimilar compounds should not interfere.
Interference: Various endogenous compounds, pH levels, and specific gravity should not cause interference.
Recovery: Expected concentrations should be recovered within an acceptable range.
Method Comparison: High agreement with LC/MS confirmation for both qualitative and semi-quantitative modes.
Calibration and Control Performance: Traceability and stability of calibrators and controls within specifications.

Test Category	Acceptance Criteria (Implicit from study design)	Reported Device Performance
Qualitative Analysis (50ng/mL cutoff)	Samples at -100%, -75%, -50%, -25% of cutoff should be Negative. Samples at +25%, +50%, +75%, +100% of cutoff should be Positive. At cutoff (50ng/mL), mixed results are expected.	Table 2: - Samples at 0, 12.5, 25, 37.5 ng/ml (cutoffs -100% to -25%) showed 80 Negative results (100% agreement).- Samples at 50 ng/ml (cutoff) showed 40 Negative/40 Positive results.- Samples at 62.5, 75, 87.5, 100 ng/ml (cutoffs +25% to +100%) showed 80 Positive results (100% agreement).
Semi-Quantitative Analysis (50ng/mL cutoff)	Similar to qualitative analysis.	Table 3: - Samples at 0, 12.5, 25, 37.5 ng/ml showed 80 Negative results (100% agreement).- Samples at 50 ng/ml (cutoff) showed 38 Negative/42 Positive results.- Samples at 62.5, 75, 87.5, 100 ng/ml showed 80 Positive results (100% agreement).
Specificity & Cross-Reactivity (Structurally Related Compounds - Qualitative)	Expected varying cross-reactivity for structurally similar compounds at specific concentrations.	Table 4: - 11-nor-9-carboxy-Δ9-THC (50ng/mL): 100% Cross-Reactivity (Positive)- (±) 11-Hydroxy-Δ9-THC (100ng/mL): 50.0% Cross-Reactivity (Positive)- 11-nor-Δ8-carboxy-THC (40ng/mL): 125.0% Cross-Reactivity (Positive)- Cannabinol (75ng/mL): 66.7% Cross-Reactivity (Positive)- Cannabidiol (1,000,000ng/mL): <0.005% Cross-Reactivity (Negative)- Δ9-THC (50ng/mL): 100.0% Cross-Reactivity (Positive)
Specificity & Cross-Reactivity (Structurally Related Compounds - Semi-Quantitative)	Expected varying cross-reactivity for structurally similar compounds at specific concentrations.	Table 5: (Same as Table 4, showing consistent results for semi-quantitative mode.)
Interference (Structurally Non-Similar Compounds)	No interference (Negative results at -25% cutoff, Positive at +25% cutoff for target analyte).	Table 6: All listed compounds (e.g., Acetaminophen, Alprazolam, Caffeine, Cocaine, Codeine) tested at high concentrations (100,000 - 500,000 ng/mL) showed "No Interference?" at -25% and +25% of cutoff for Cannabinoids. Results were Negative at 37.5 ng/mL and Positive at 62.5 ng/mL of Cannabinoids, indicating no effect on Cannabinoids detection.
Interference (Endogenous Compounds)	No interference.	Table 7: All listed compounds (e.g., Acetone, Ascorbic Acid, Bilirubin, Creatinine, Ethanol, Glucose, Hemoglobin) at specified concentrations showed "No Interference?" at -25% and +25% of cutoff for Cannabinoids. Results were Negative at 37.5 ng/mL and Positive at 62.5 ng/mL of Cannabinoids.
Interference (Boric Acid)	No interference.	Table 8: Boric Acid (1% w/v) showed "No Interference?" at -25% and +25% of cutoff for Cannabinoids. Results were Negative at 37.5 ng/mL and Positive at 62.5 ng/mL of Cannabinoids.
Interference (Effect of pH)	No interference across physiological pH range (pH 3.0 - 11.0).	Table 9: pH values from 3.0 to 11.0 showed "No Interference?" at -25% and +25% of cutoff for Cannabinoids. Results were Negative at 37.5 ng/mL and Positive at 62.5 ng/mL of Cannabinoids.
Interference (Specific Gravity)	No interference across a range of specific gravity (1.000 - 1.030).	Table 10: Specific Gravity values from 1.000 to 1.030 showed "No Interference?" at -25% and +25% of cutoff for Cannabinoids. Results were Negative at 37.5 ng/mL and Positive at 62.5 ng/mL of Cannabinoids.
Recovery (Linearity)	Recovery between 90-110% of expected concentration (typical for linearity studies).	Table 11: Recoveries ranged from 96.2% to 109.7% for expected concentrations from 20 ng/mL to 220 ng/mL.
Method Comparison (Qualitative Assay Performance)	High agreement with LC/MS confirmation.	Table 12: 40 positive and 40 negative samples by Test Device perfectly matched LC/MS Confirmation, yielding 100% agreement. Table 13: Qualitative/Positive (100% agreement) and Qualitative/Negative (100% agreement) verified by LC/MS.
Method Comparison (Semi-Quantitative Assay Performance)	High agreement with LC/MS confirmation.	Table 14: 40 positive and 40 negative samples by Test Device perfectly matched LC/MS Confirmation, yielding 100% agreement. Table 15: Semi-Quantitative/Positive (100% agreement) and Semi-Quantitative/Negative (100% agreement) verified by LC/MS.
Calibrator/Control Traceability	Traceable to commercially available standards.	All components traced to a commercially available standard solution.
Calibrator/Control Stability (Closed Vial)	12 months.	Supported an initial expiration date of 12 months (accelerated study at 25°C for 40 days, within specifications). Real-time studies ongoing.
Calibrator/Control Stability (Open Vial)	60 days.	Supported an initial open vial expiration date of 60 days (at 5°C, within specifications for 60 days).
Calibrator/Control Value Assignment	Values assigned once mass spectrometry results are within acceptable ranges.	Calibrators and controls tested by mass spectrometry, adjusted, and re-tested until within acceptable ranges.

2. Sample Size Used for the Test Set and the Data Provenance

Precision/Cutoff Characterization Study:
- Sample Size: 80 determinations for each concentration level (0 ng/mL, 12.5 ng/mL, 25 ng/mL, 37.5 ng/mL, 50 ng/mL, 62.5 ng/mL, 75 ng/mL, 87.5 ng/mL, 100 ng/mL). This totals 720 determinations for the qualitative and semi-quantitative analysis sections combined (80 x 9 concentrations). The document states "20 days, 2 runs per day in duplicate (N=80)" for each concentration, which implies the N=80 refers to the total number of measurements for that specific concentration over the study period.
- Data Provenance: Not explicitly stated (e.g., country of origin). The samples for this specific study were likely artificially prepared (spiked) to control concentrations precisely. This would be a prospective study using controlled samples.
Specificity and Cross-Reactivity Study:
- Sample Size: Not explicitly stated per compound, but each compound was "spiked into drug free urine at levels that will yield a result that is equivalent to the cutoffs."
- Data Provenance: Artificially prepared samples (spiked into drug-free urine). This is a prospective study using controlled samples.
Interference Study:
- Sample Size: Not explicitly stated per compound. Each potential interferent was "spiked into drug free urine containing the target analyte at ±25% of the cutoff."
- Data Provenance: Artificially prepared samples (spiked into drug-free urine). This is a prospective study using controlled samples.
Recovery Study:
- Sample Size: Not explicitly stated for each dilution, but a drug-free urine pool was spiked and serially diluted.
- Data Provenance: Artificially prepared samples (spiked into drug-free urine). This is a prospective study using controlled samples.
Method Comparison Study:
- Sample Size: 80 clinical urine samples (40 positive, 40 negative) for both qualitative and semi-quantitative evaluations.
- Data Provenance: "Unaltered, anonymous and discarded clinical urine samples obtained from clinical testing laboratories." This indicates retrospective clinical samples, but the country of origin is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

For Precision/Cutoff, Specificity, Interference, Recovery: The ground truth was established by known concentrations of analytes (spiked samples) and the inherent characteristics of the chemicals themselves. No human expert consensus was required for these controlled laboratory studies
For Method Comparison Study: The ground truth was established by Liquid Chromatography/Mass Spectrometry (LC/MS) or Gas Chromatography/Mass Spectrometry (GC-MS). The document explicitly states: "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/Mass Spectrometry (LC/MS) is the preferred confirmatory method." While it doesn't specify the number or qualifications of experts operating the LC/MS, these are highly trained laboratory professionals.

4. Adjudication Method for the Test Set

Given that the primary ground truth relies on LC/MS (a highly accurate quantitative method) for clinical samples and known concentrations for spiked samples, no human adjudication method (like 2+1 or 3+1 consensus) was necessary or mentioned. The LC/MS results serve as the definitive reference.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay for chemical analysis in urine, not an imaging or AI-assisted diagnostic tool that would involve human "readers" interpreting results improved by AI. The document describes traditional laboratory performance studies for a chemical immunoassay.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, this entire study represents a standalone performance evaluation of the Immunalysis Cannabinoids Urine Enzyme Immunoassay. The device itself (the immunoassay kit run on automated clinical chemistry analyzers) operates without direct human-in-the-loop decision-making during the assay process, beyond sample loading and results interpretation which is standard for IVD. The data tables show "Result" obtained from the device.

7. The Type of Ground Truth Used

For controlled studies (Precision/Cutoff, Specificity, Interference, Recovery): Known concentrations of analytes (spiked samples) serve as the ground truth.
For clinical sample comparison (Method Comparison): Liquid Chromatography/Mass Spectrometry (LC/MS) or Gas Chromatography/Mass Spectrometry (GC-MS) was used as the confirmatory ground truth.

8. The Sample Size for the Training Set

This document describes studies for regulatory submission (510(k)), which focus on verification and validation of a developed product.
No information is provided about a "training set" because this is an in vitro diagnostic assay, not typically an AI/machine learning algorithm that requires a separate, explicitly defined "training set" in the context of the performance studies presented. The immunoassay functions based on chemical reactions, not on learning from data similar to an AI model.

9. How the Ground Truth for the Training Set Was Established

As a training set is not explicitly mentioned or relevant for this type of immunoassay, this question is not applicable to the provided document. The "ground truth" concept applies to the test sets for performance evaluation (as described in point 7), not to an algorithm's training process for this device.

Summary

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

June 5, 2015

IMMUNALYSIS CORPORATION MR JOSEPH GINETE REGULATORY AFFAIRS SPECIALIST II 829 TOWNE CENTER DR POMONA CA 91767

Re: K151203

Trade/Device Name: Immunalysis Cannabinoids Urine Enzyme Immunoassay. Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: II Product Code: LDJ, DLJ, LAS Dated: May 4, 2015 Received: May 5, 2015

Dear Mr. Joseph Ginete:

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 (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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,

Courtney H. Lias -S

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)

K151203

Device Name

Immunalysis Cannabinoids Urine Enzyme Immunoassay Immunalvsis cTHC Urine Control Set Immunalysis cTHC Urine Calibrators

Indications for Use (Describe)

Immunalysis cTHC Urine Control Set: The Immunalysis cTHC Urine Control Set is used as control materials in the Immunalysis Cannabinoids Urine Enzyme Immunoassay.

Type of Use (Select one or both, as applicable)

For Transportation (49 CFR 390 Subpart B)	For-Hire Operation (49 CFR 390 Subpart C)
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Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

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

A. Contact Information

A. Contact Information
	1. Manufacturer:	Immunalysis Corporation
	2. Contact Name:	Joseph Ginete
	3. Contact Title:	Regulatory Affairs Specialist II
	4. Address:	829 Towne Center Drive Pomona, CA 91767
	5. Phone:	(909) 482-0840
	6. Fax:	(909) 482-0850
	7. Email:	jginete@immunalysis.com
	8. Summary prepared on:	June 03, 2015
B. Device Information
	1. Trade Name:	Immunalysis Cannabinoids Urine Enzyme ImmunoassayImmunalysis cTHC Urine Control SetImmunalysis cTHC Urine Calibrators
	2. Common Name:	Immunalysis Cannabinoids Urine Enzyme ImmunoassayImmunalysis cTHC Urine Control SetImmunalysis cTHC Urine Calibrators
	3. Device Classification:	II
	4. Regulation Number:	CFR 862.3870 Enzyme Immunoassay, CannabinoidsCFR 862.3200 Calibrator, Drug SpecificCFR 862.3280 Clinical Toxicology Control Materials
	5. Panel:	Toxicology(91)
	6. Product Code:	LDJDLJLAS

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IMMUNALYSIS

C. Legally Marketed Device to Which We are Claiming Equivalence (807.92(A)(3))

1. Predicate Device:	LZI Cannabinoids (cTHC) Enzyme Immunoassay
	LZI Cannabinoids (cTHC) Drugs of Abuse (DAU)
	Calibrators
	LZI Cannabinoids (cTHC) Drugs of Abuse (DAU)
	Controls
2. Predicate Company:	Lin-Zhi Internationals, Inc.
3. Predicate K Number:	K110239

D. Device Description

1. The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes monoclonal and polyclonal antibodies to Cannabinoids, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes Cannabinoids derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. Calibrators and controls are sold separately. Reagents are liquid, ready to use
1. All of the Immunalysis cTHC Urine Calibrators and Controls are liquid and ready to use. Each contains a known concentration of a specific drug analyte as a mixture.

Table 1 Immunalysis cTHC Urine Calibrators and Controls
Analyte	cTHC Calibrators				cTHC Controls
	Level 1	Level 2	Level 3	Level 4	LOW Control 1	HIGH Control 1
cTHC	20ng/mL	50ng/mL	100ng/mL	2000ng/mL	37.5ng/mL	62.5ng/mL

E. Intended Use

1. The Immunalysis Cannabinoids Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 50ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Cannabinoids in human urine with automated clinical chemistry analyzers. This assay is calibrated against cTHC. This in-vitro device is for prescription use only.

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IMMUNALYSIS

The Immunalysis Cannabinoids Urine Enzyme Immunoassay Kit 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/Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

1. Immunalysis cTHC Urine Control: The Immunalysis cTHC Urine Controls are used as control materials in Immunalysis Cannabinoids Urine Enzyme Immunoassay.
1. Immunalysis cTHC Urine Calibrators: The Immunalysis cTHC Urine Calibrators are used as calibrators in the Immunalysis Cannabinoids Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of Cannabinoids in urine on automated clinical chemistry analyzers.

Item	Cannabinoids Assay K110239	Immunalysis Cannabinoids Urine EIA
Intended Use	For the qualitative and semi-quantitative determination of thepresence of Cannabinoids in humanurine at a cutoff of 25ng/mL,50ng/mL and 100ng/mL	For the qualitative and semi-quantitativedetermination of the presence ofCannabinoids in human urine at a cutoff of50ng/mL
Type of Product	Analytical Reagents	Analytical Reagents
Measured Analytes	Cannabinoids	Cannabinoids
Test Matrix	Urine	Urine
Cutoff Levels	25ng/mL, 50ng/mL and 100ng/mL ofCannabinoids	50ng/mL of Cannabinoids
Test System	Homogeneous Enzyme Immunoassay	Homogenous Enzyme Immunoassay
Materials	Liquid Ready-to-Use Two ReagentAssay (R1 and R2)	Antibody/Substrate Reagents and EnzymeLabeled Conjugate
Mass SpectroscopyConfirmation	Required for preliminary positiveanalytical results	Required for preliminary positiveanalytical results
Antibody	Mouse Monoclonal antibodies toCannabinoids	Monoclonal and polyclonal antibodies toCannabinoids
Storage	2 – 8°C until expiration date	2 – 8°C until expiration date
Calibrator Form	Liquid	Liquid
Calibrator Levels	Three sets of Five (5) Levels	Five (5) Levels (including negative)
Control Levels	Three sets of Two (2) Levels	Two (2) Levels

F. Comparison of the new device with the predicate device

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G. The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Cannabinoids Urine Enzyme Immunoassay to the predicate
- 1. Precision/Cutoff Characterization Study was performed for 20 days, 2 runs per day in duplicate (N=80) on concentration of ±25%, ±50%, ±75%, and ±100% of the cutoff. The study verified that the cutoff serves as a boundary between a negative and positive interpretation of a qualitative result. The instruments used for this was Beckman Coulter AU 400e.

50ng/mL cutoff test data results.
Table 2 - Qualitative Analysis (for 50ng/mL cutoff)
Concentration (ng/mL)	% of cutoff	# of determinations	Result
0	-100%	80	80 Negative
12.5	-75%	80	80 Negative
25	-50%	80	80 Negative
37.5	-25%	80	80 Negative
50	Cutoff	80	40 Negative/40 Positive
62.5	+25%	80	80 Positive
75	+50%	80	80 Positive
87.5	+75%	80	80 Positive
100	+100%	80	80 Positive

a. The following is a summary table of the Qualitative Analysis for the
b. The following is a summary table of the Semi-Quantitative Analysis for the 50ng/mL cutoff test data results.

Table 3 - Semi-Quantitative Analysis (for 50ng/mL cutoff)
Concentration (ng/mL)	% of cutoff	# of determinations	Result
0	-100%	80	80 Negative
12.5	-75%	80	80 Negative
25	-50%	80	80 Negative
37.5	-25%	80	80 Negative
50	Cutoff	80	38 Negative/42 Positive
62.5	+25%	80	80 Positive
75	+50%	80	80 Positive
87.5	+75%	80	80 Positive
100	+100%	80	80 Positive

1. Specificity and Cross-Reactivity - Structurally similar compounds were spiked into drug free urine at levels that will vield a result that is equivalent to the cutoffs. The study verified assay performance relative to the ability of the device to exclusively determine certain drugs. The instrument used for this test was a Beckman Coulter AU 400e.

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below:
Table 4 - Structurally Related Compounds (for 50 ng/mL cutoff) - Qualitative
Compound	Concentration Tested (ng/mL)	Result	Cross-Reactivity (%)
11-nor-9-carboxy- Δ9-THC	50	Positive	100.0
(±) 11-Hydroxy- Δ9-THC	100	Positive	50.0
11-nor- Δ8-carboxy-THC	40	Positive	125.0
Cannabinol	75	Positive	66.7
Cannabidiol	1,000,000	Negative	<0.005
Δ9-THC	50	Positive	100.0

a. The qualitative result summary table for the 50ng/mL cutoff is outlined
b. The semi-quantitative result summary table for the 50ng/mL cutoff is outlined below:

Table 5 - Structurally Related Compounds (for 50ng/mL cutoff) – Semi-Quantitative
Compound	Concentration Tested (ng/mL)	Cross-Reactivity (%)
11-nor-9-carboxy- Δ9-THC	50	100.0
(±) 11-Hydroxy- Δ9-THC	100	50.0
11-nor- Δ8-carboxy-THC	40	125.0
Cannabinol	75	66.7
Cannabidiol	1,000,000	<0.005
Δ9-THC	50	100.0

1. Interference Structurally non-similar compounds, endogenous compounds, the effect of pH and the effect of specific gravity was evaluated by spiking the potential interferent into drug free urine containing the target analyte at ±25% of the cutoff. All potential interferents analyzed verified that assay performance is unaffected by externally ingested compounds or an internally existing physiological condition. The instrument used for this test was a Beckman Coulter AU 400e.
- a. The following is a summary table of the structurally non-similar compounds for the 50ng/mL cutoff :

Table 6 - Structurally Non-Similar Compounds (for 50ng/mL cutoff)
Compound	ConcentrationTested (ng/mL)	-25% Cutoff (37.5ng/mL)		+25% Cutoff (62.5ng/mL)
6-Acetylmorphine	100,000	Negative	No	Positive	No
7-Aminoclonazepam	100,000	Negative	No	Positive	No
Acetaminophen	500,000	Negative	No	Positive	No
Alprazolam	100,000	Negative	No	Positive	No
Amitriptyline	100,000	Negative	No	Positive	No
Amobarbital	100,000	Negative	No	Positive	No
S-(+)-Amphetamine	100,000	Negative	No	Positive	No
Benzoylecgonine	500,000	Negative	No	Positive	No
Benzylpiperazine	100,000	Negative	No	Positive	No
4-Bromo-2,5,Dimethoxyphenethylamine	100,000	Negative	No	Positive	No
Table 6 - Structurally Non-Similar Compounds (for 50ng/mL cutoff)
	Concentration	-25% Cutoff (37.5ng/mL)		+25% Cutoff (62.5ng/mL)
Compound	Tested (ng/mL)	Result	Interference?	Result	Interference?
Bromazepam	100,000	Negative	No	Positive	No
Buprenorphine	100,000	Negative	No	Positive	No
Bupropion	100,000	Negative	No	Positive	No
Butabarbital	100,000	Negative	No	Positive	No
Caffeine	500,000	Negative	No	Positive	No
Carbamazepine	100,000	Negative	No	Positive	No
Carisoprodol	100,000	Negative	No	Positive	No
Chlordiazepoxide	100,000	Negative	No	Positive	No
Chlorpromazine	100,000	Negative	No	Positive	No
Clobazam	100,000	Negative	No	Positive	No
Clomipramine	100,000	Negative	No	Positive	No
Clonazepam	100,000	Negative	No	Positive	No
Cocaine	100,000	Negative	No	Positive	No
Codeine	100,000	Negative	No	Positive	No
Cotinine	100,000	Negative	No	Positive	No
Cyclobenzaprine	100,000	Negative	No	Positive	No
N-Desmethyltapentadol	100,000	Negative	No	Positive	No
Despiramine	100,000	Negative	No	Positive	No
Dextromethorphan	100,000	Negative	No	Positive	No
Diazepam	100,000	Negative	No	Positive	No
Dihydrocodeine	100,000	Negative	No	Positive	No
Diphenhydramine (DPH)	500,000	Negative	No	Positive	No
Doxepin	100,000	Negative	No	Positive	No
Ecgonine	100,000	Negative	No	Positive	No
Ecgonine methyl ester	100,000	Negative	No	Positive	No
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine(EDDP)	100,000	Negative	No	Positive	No
1R,2S(-)-Ephedrine	100,000	Negative	No	Positive	No
1S,2R(+)-Ephedrine	100,000	Negative	No	Positive	No
Ethyl ẞ-D-glucuronide	100,000	Negative	No	Positive	No
Ethylmorphine	100,000	Negative	No	Positive	No
Fenfluramine	100,000	Negative	No	Positive	No
Fentanyl	100,000	Negative	No	Positive	No
Flunitrazepam	100,000	Negative	No	Positive	No
Flurazepam	100,000	Negative	No	Positive	No
Heroin	100,000	Negative	No	Positive	No
Hexobarbital	100,000	Negative	No	Positive	No
Hydrocodone	100,000	Negative	No	Positive	No
Hydromorphone	100,000	Negative	No	Positive	No
Ibuprofen	100,000	Negative	No	Positive	No
Imipramine	100,000	Negative	No	Positive	No
Ketamine	100,000	Negative	No	Positive	No
Lamotrigine	100,000	Negative	No	Positive	No
Table 6 - Structurally Non-Similar Compounds (for 50ng/mL cutoff)
Compound	ConcentrationTested (ng/mL)	-25% Cutoff (37.5ng/mL)		+25% Cutoff (62.5ng/mL)
		Result	Interference?	Result	Interference?
Levorphanol Tartrate	100,000	Negative	No	Positive	No
Lidocaine	100,000	Negative	No	Positive	No
Lorazepam	100,000	Negative	No	Positive	No
Lysergic acid diethylamide(LSD)	100,000	Negative	No	Positive	No
Maprotiline	100,000	Negative	No	Positive	No
(+)-3,4-Methylenedioxyamphetamine (MDA)	100,000	Negative	No	Positive	No
3,4-methylenedioxy-N-ethyl-amphetamine (MDEA)	100,000	Negative	No	Positive	No
3,4-methylenedioxy-methamphetamine (MDMA)	100,000	Negative	No	Positive	No
Meperidine	100,000	Negative	No	Positive	No
Meprobamate	100,000	Negative	No	Positive	No
Methadone	500,000	Negative	No	Positive	No
S(+)-Methamphetamine	100,000	Negative	No	Positive	No
Methaquolone	100,000	Negative	No	Positive	No
Methylphenidate	100,000	Negative	No	Positive	No
Morphine	100,000	Negative	No	Positive	No
Morphine-3β-D-glucuronide	100,000	Negative	No	Positive	No
Morphine-6ß-D-glucuronide	100,000	Negative	No	Positive	No
Nalorphine	100,000	Negative	No	Positive	No
Naloxone	100,000	Negative	No	Positive	No
Naltrexone	100,000	Negative	No	Positive	No
Nitrazepam	100,000	Negative	No	Positive	No
Norbuprenorphine	100,000	Negative	No	Positive	No
Norcodeine	100,000	Negative	No	Positive	No
Nordiazepam	100,000	Negative	No	Positive	No
Normorphine	100,000	Negative	No	Positive	No
Norpropoxyphene	100,000	Negative	No	Positive	No
Nortriptyline	100,000	Negative	No	Positive	No
Oxezepam	100,000	Negative	No	Positive	No
Oxycodone	100,000	Negative	No	Positive	No
Oxymorphone	100,000	Negative	No	Positive	No
Phencyclidine (PCP)	100,000	Negative	No	Positive	No
Pentazocine	100,000	Negative	No	Positive	No
Pentobarbital	100,000	Negative	No	Positive	No
Phenobarbital	100,000	Negative	No	Positive	No
Phentermine	100,000	Negative	No	Positive	No
Phenylepherine	100,000	Negative	No	Positive	No
Phenylpropanolamine	100,000	Negative	No	Positive	No
Phenytoin	100,000	Negative	No	Positive	No
para-Methoxyamphetamine	100,000	Negative	No	Positive	No
Table 6 - Structurally Non-Similar Compounds (for 50ng/mL cutoff)
Compound	ConcentrationTested (ng/mL)	-25% Cutoff (37.5ng/mL)		+25% Cutoff (62.5ng/mL)
		Result	Interference?	Result	Interference?
(PMA)
Prazepam	100,000	Negative	No	Positive	No
Propoxyphene	100,000	Negative	No	Positive	No
Propranolol	100,000	Negative	No	Positive	No
Protripyline	100,000	Negative	No	Positive	No
R,R(-)-Pseudoephedrine	100,000	Negative	No	Positive	No
S,S(+)-Pseudoephedrine	100,000	Negative	No	Positive	No
Ranitidine	100,000	Negative	No	Positive	No
Ritalinic Acid	100,000	Negative	No	Positive	No
Salicyclic Acid	100,000	Negative	No	Positive	No
Secobarbial	100,000	Negative	No	Positive	No
Sertraline	100,000	Negative	No	Positive	No
Sufentanil Citrate	100,000	Negative	No	Positive	No
Temazepam	100,000	Negative	No	Positive	No
Theophylline	100,000	Negative	No	Positive	No
Thiordazine	100,000	Negative	No	Positive	No
cis-Tramadol	100,000	Negative	No	Positive	No
Trazodone	100,000	Negative	No	Positive	No
Triazolam	100,000	Negative	No	Positive	No
Trifluoromethylphenyl-piperazine	100,000	Negative	No	Positive	No
Trimipramine	100,000	Negative	No	Positive	No
Venlafaxine	100,000	Negative	No	Positive	No
Zolpidem	100,000	Negative	No	Positive	No

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b. The following is a summary table of the endogenous compounds results for the 50ng/mL cutoff:

Table 7 - Endogenous Compounds (for 50ng/mL cutoff)
	ConcentrationTested (ng/mL)	-25% Cutoff (37.5ng/mL)		+25% Cutoff (62.5ng/mL)
Compound		Result	Interference?	Result	Interference?
Acetone	1.0 g/dL	Negative	No	Positive	No
Ascorbic Acid	1.5 g/dL	Negative	No	Positive	No
Bilirubin	0.002 g/dL	Negative	No	Positive	No
Creatinine	0.5 g/dL	Negative	No	Positive	No
Ethanol	1.0 g/dL	Negative	No	Positive	No
Galactose	0.01 g/dL	Negative	No	Positive	No
γ-Globulin	0.5 g/dL	Negative	No	Positive	No
Glucose	2.0 g/dL	Negative	No	Positive	No
Hemoglobin	300 mg/dL	Negative	No	Positive	No
Human Serum Albumin	0.5 g/dL	Negative	No	Positive	No
Oxalic Acid	0.1 g/dL	Negative	No	Positive	No
Riboflavin	0.0075 g/dL	Negative	No	Positive	No
Sodium Azide	1% w/v	Negative	No	Positive	No
Sodium Chloride	6.0 g/dL	Negative	No	Positive	No

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Table 7 - Endogenous Compounds (for 50ng/mL cutoff)
Compound	Concentration Tested (ng/mL)	-25% Cutoff (37.5ng/mL)	+25% Cutoff (62.5ng/mL)
		Result Interference?	Result Interference?
Sodium Fluoride	1% w/v	Negative No	Positive No
Urea	6.0 g/dL	Negative No	Positive No

c. The following is a summary table of Boric Acid for the 50ng/mL cutoff results:

Table 8 - Boric Acid (for 50ng/mL cutoff)
Compound	Concentration Tested (ng/mL)	-25% Cutoff (37.5ng/mL)		+25% Cutoff (62.5ng/mL)
		Result	Interference?	Result	Interference?
Boric Acid	1% w/v	Negative	No	Positive	No

d. The following is a summary table of the effect of pH results for the 50ng/mL cutoff:

Table 9 - Effect of pH (for 50ng/mL cutoff)
Test Parameter	Value	-25% Cutoff (37.5ng/mL)		+25% Cutoff (62.5ng/mL)
		Result	Interference?	Result	Interference?
pH	3.0	Negative	No	Positive	No
pH	4.0	Negative	No	Positive	No
pH	5.0	Negative	No	Positive	No
pH	6.0	Negative	No	Positive	No
pH	7.0	Negative	No	Positive	No
pH	8.0	Negative	No	Positive	No
pH	9.0	Negative	No	Positive	No
pH	10.0	Negative	No	Positive	No
pH	11.0	Negative	No	Positive	No

e. The following is a summary table of the effect of specific gravity results for 50ng/mL cutoff:

Table 10 - Effect of Specific Gravity (for 50ng/mL cutoff)
		-25% Cutoff (37.5ng/mL)		+25% Cutoff (62.5ng/mL)
Test Parameter	Value	Result	Interference?	Result	Interference?
Specific Gravity	1.000	Negative	No	Positive	No
Specific Gravity	1.002	Negative	No	Positive	No
Specific Gravity	1.005	Negative	No	Positive	No
Specific Gravity	1.010	Negative	No	Positive	No
Specific Gravity	1.015	Negative	No	Positive	No
Specific Gravity	1.020	Negative	No	Positive	No
Specific Gravity	1.025	Negative	No	Positive	No
Specific Gravity	1.030	Negative	No	Positive	No

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1. Recovery A drug free urine pool was spiked with high concentration of the target analyte as a high value specimen. Additional pools were made by serially diluting the high value specimen. The instrument used for this test was a Beckman Coulter AU 400e.

Table 11 - Linearity/ Recovery
Expected Concentration (ng/mL)	Mean Concentration (ng/mL)	Recovery (%)
20	19.3	96.3
40	40.4	101.0
50	52.1	104.3
60	64.4	107.4
80	77.8	97.3
100	101.2	101.2
120	128.4	107.0
140	144.5	103.2
160	156.1	97.5
180	173.1	96.2
200	219.4	109.7
220	223.7	101.7

a. The following is a summary table of the linearity/recovery:

1. Method Comparison Unaltered, anonymous and discarded clinical urine samples obtained from clinical testing laboratories were analyzed with the test device. The study verified that the product performance can be verified by Mass Spectrometry. The instrument used for this test was a Beckman Coulter AU 400e and an Agilent 6430 Liquid Chromatography Tandem Mass Spectrometry.
- a. The following is a comparison table of qualitative assay performance for the 50ng/mL cutoff:

Table 12 - Method Comparison (for 50ng/mL cutoff) - Qualitative

	LC/MS Confirmation
	(+)	(-)
TestDevice	(+)	40	0
	(-)	0	40

b. The following is a summary table of qualitative assay performance for the 50ng/mL cutoff:

Table 13 - Assay Performance verified by LC/MS – 50ng/mL Cutoff
Type	Cannabinoids Concentration			Agreement(%)
	<25ng/mL	25~49 ng/mL	50~75 ng/mL	> 75 ng/mL
Qualitative/ Positive	0	0	10	30	100
Qualitative/ Negative	36	4	0	0	100

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c. The following is a comparison table of semi-quantitative assay performance for the 50ng/mL cutoff:
Table 14 - Method Comparison (for 50ng/mL cutoff) - Semi-Quantitative

	LC/MS Confirmation
	(+)	(-)
TestDevice	40	0
(+)	0	40

d. The following is a summary table of semi-quantitative assay performance for the 50ng/mL cutoff:

Table 15 - Assay Performance verified by LC/MS – 50ng/mL Cutoff
Type	Cannabinoids Concentration				Agreement (%)
	< 25ng/mL	25 ~ 49 ng/mL	50 ~ 75 ng/mL	> 75 ng/mL
Semi-Quantitative/ Positive	0	0	10	30	100
Semi-Quantitative / Negative	36	4	0	0	100

1. Calibrator and Control Analytical Performance Immunalysis cTHC Urine Calibrators and Controls
- a. cTHC Calibrator and Control Traceability all components of the calibrator and controls have been traced to a commercially available standard solution
- b.cTHC Calibrators and Controls Stability A closed vial stability study was performed at 25°C to establish the initial vial expiration dating. The stability study supported an initial expiration date of 12 months. The instrument used for this test was an Agilent 1200 Series Liquid Chromatograph coupled to Agilent 6410 Tandem Mass Spectrometer. All calibrator levels (1, 2, 3, and 4) and all control levels (Low Control and High Control) for cTHC were within specifications for Day 0, 8, 16, 24, 32, and 40. This accelerated stability study was performed to establish initial expiration dating. Real time stability studies are ongoing.
- c.cTHC Calibrators and Controls Stability An open vial stability study was performed at 5℃ to establish the initial open vial expiration dating. The stability study supported an initial open vial expiration date of 60 days. The instrument used for this test was an Agilent 1200 Series Liquid Chromatograph coupled to Agilent 6410 Tandem Mass Spectrometer. All calibrator levels (1, 2, 3, and 4) and all control levels (Low Control and High Control) for cTHC were within specifications for Day 0, 7, 14, 21, 30, 45 and 60. This stability study was performed to establish initial expiration dating.
- d.cTHC Calibrator and Control Value Assignment Calibrators and controls are manufactured and are tested by mass spectrometry. If any of the analytes are not of the acceptable range, then the calibrator and controls is adjusted and re-tested. Values are assigned to the calibrators and controls once the mass spectrometry results are within the acceptable ranges.

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H. Conclusion

The information provided in this pre-market notification demonstrates that the Immunalysis Cannabinoids Urine Enzyme Immunoassay is substantially equivalent to the legally marketed predicate device for its general intended use.

Regulation Number and Section

§ 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).