Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set

Q: Who is the manufacturer of Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set?

Immunalysis Corporation filed the 510(k) submission for Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set (K150925).

Q: What is the FDA product code for Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set?

DIO. It is classified under 21 CFR 862.3250 as a Class 2 device in the Clinical Toxicology panel.

Q: What is the regulatory pathway for Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set?

Randox Cocaine Metabolite Assay (K113751); Randox Multidrug Calibrator Set (K113751); Randox Multidrug Controls, Level 1 and 2 (K113751).

Q: Who can help prepare an FDA 510(k) submission like Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K150925 · Immunalysis Corporation · DIO · Jun 29, 2015 · Clinical Toxicology

Device Facts

Record ID	K150925
Device Name	Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set
Applicant	Immunalysis Corporation
Product Code	DIO · Clinical Toxicology
Decision Date	Jun 29, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.3250
Device Class	Class 2

Intended Use

Immunalysis Benzoylecgonine Urine Enzyme Immunoassay: The Immunalysis Benzoylecgonine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 150ng/mL and 300ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Benzoylecgonine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Benzoylecgonine. 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 Benzoylecgonine 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 Benzoylecgonine Urine Calibrators: The Immunalysis Benzoylecgonine Urine Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine. The calbrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. Immunalysis Benzoylecgonine Urine Control Set: The Immunalysis Benzoylecgonine Urine Control Set is intended for in vitro diagnostic use to monitor the performance of assays for the analyte currently listed in the package insert: Benzoylecgonine. The controls are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers

Device Story

Device is a homogeneous enzyme immunoassay for detecting Benzoylecgonine (cocaine metabolite) in human urine. Input: human urine samples. Principle: competitive binding between drug in sample and enzyme-labeled drug conjugate for polyclonal sheep antibody binding sites; G6PDH enzyme activity measured via NAD reduction. Output: qualitative (positive/negative) or semi-quantitative concentration result. Used in clinical laboratories by technicians on automated chemistry analyzers. Results provide preliminary screening; positive samples require confirmation via GC-MS or LC/MS. Clinical decision-making relies on these preliminary results combined with professional judgment. Benefits include rapid, high-throughput screening for drug abuse.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (N=80 per concentration), specificity/cross-reactivity testing against structurally related and non-related compounds, interference studies (endogenous, pH, specific gravity), and linearity/recovery. Method comparison performed against LC/MS on clinical urine samples showed high agreement (98-100% for qualitative and semi-quantitative modes).

Technological Characteristics

Homogeneous enzyme immunoassay. Reagents: polyclonal sheep anti-Benzoylecgonine, G6P, NAD, and Benzoylecgonine-G6PDH conjugate in HEPES buffer with sodium azide. Analyzed on automated clinical chemistry analyzers (e.g., Beckman Coulter AU 400e). Storage: 2-8°C. Calibrators/controls: liquid, ready-to-use, synthetic urine matrix.

Indications for Use

Indicated for qualitative and semi-quantitative analysis of Benzoylecgonine in human urine using automated clinical chemistry analyzers. Intended for prescription use in laboratory settings to provide preliminary analytical results for drug of abuse testing.

Regulatory Classification

Identification

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

Special Controls

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

Predicate Devices

Randox Cocaine Metabolite Assay (K113751)
Randox Multidrug Calibrator Set (K113751)
Randox Multidrug Controls, Level 1 and 2 (K113751)

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Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three lines that form the shape of a snake wrapped around a staff. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 29, 2015 IMMUNALYSIS CORPORATION JOSEPH GINETE REGULATORY AFFAIRS SPECIALIST II 829 TOWNE CENTER DRIVE POMONA CA 91767 Re: K150925 Trade/Device Name: Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: II Product Code: DIO, DLJ, LAS Dated: April 2, 2015 Received: April 6, 2015 Dear 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 {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) K150925 #### Device Name Immunalysis Benzoylecgonine Urine Enzyme Immunoassay Immunalysis Benzoylecgonine Urine Calibrators Immunalysis Benzoylecgonine Urine Control Set ### Indications for Use (Describe) Immunalysis Benzoylecgonine Urine Enzyme Immunoassay The Immunalysis Benzoylecgonine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 150ng/mL and 300ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Benzoylecgonine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Benzoylecgonine. 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 Benzoylecgonine 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 Benzoylecgonine Urine Calibrators The Immunalysis Benzoylecgonine Urine Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine. The calbrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. Immunalysis Benzoylecgonine Urine Control Set The Immunalysis Benzoylecgonine Urine Control Set is intended for in vitro diagnostic use to monitor the performance of assays for the analyte currently listed in the package insert: Benzoylecgonine. The controls are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | ü 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}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the word "IMMUNALYSIS" in white letters on a red background. The letters are bold and have a slight 3D effect. The background is a solid red color, and the word is centered in the image. ## 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 | 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 26, 2015 | - B. Device Information | 1. Trade Name: | Immunalysis Benzoylecgonine Urine Enzyme Immunoassay Immunalysis Benzoylecgonine Urine Calibrators Immunalysis Benzoylecgonine Urine Control Set | |--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2. Common Name: | Immunalysis Benzoylecgonine Urine Enzyme Immunoassay Immunalysis Benzoylecgonine Urine Calibrators Immunalysis Benzoylecgonine Urine Control Set | | C. Regulatory Information | | | 1. Device Classification: | II | | 2. Regulation Number: | 21 CFR862.3250 Cocaine and Cocaine Metabolite System 21 CFR 862.3200 Clinical Toxicology Calibrator 21 CFR 862.3280 Clinical Toxicology Control Material | | 3. Panel: | Toxicology(91) | | 4. Product Code: | DIO DLJ LAS | | D. Legally Marketed Device to Which We are Claiming Equivalence (807.92(A)(3)) | | | 1. Predicate Devices: | Randox Cocaine Metabolite Assay Randox Multidrug Calibrator Set Randox Multidrug Controls, Level 1 and 2 | |------------------------|----------------------------------------------------------------------------------------------------------------| | 2. Predicate Company: | Randox Laboratories, Ltd. | | 3. Predicate K Number: | K113751 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters with a drop shadow. The background is red. The text is centered in the image. - E. Device Descriptions - 1. The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes polyclonal sheep antibodies to Benzoylecgonine, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in HEPES buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes Benzoylecgonine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in HEPES buffer with Sodium Azide as a preservative. - 2. All of the Immunalysis Benzoylecgonine 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 1, HIGH Control 1, LOW Control 2 and HIGH Control 2 are prepared by spiking known concentrations of benzoylecgonine into the negative calibrator matrix. These five calibrators and four controls are sold as individual bottles. The concentration of benzoylecgonine in their corresponding calibrators and controls are summarized as follows: | Analyte | Benzoylecgonine Urine Calibrators | | | | | |-----------------|-----------------------------------|----------------|---------------|----------------|-----------| | | Negative | Level 1 | Level 2 | Level 3 | Level 4 | | | 0ng/mL | 150ng/mL | 300ng/mL | 500ng/mL | 1000ng/mL | | Benzoylecgonine | Benzoylecgonine Urine Control Set | | | | | | | LOW Control 1 | HIGH Control 1 | LOW Control 2 | HIGH Control 2 | | | | 112.5ng/mL | 187.5ng/mL | 225ng/mL | 375ng/mL | | ## F. Intended Use - 1. Immunalysis Benzoylecgonine Urine Enzyme Immunoassay: The Immunalysis Benzoylecgonine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 150ng/mL and 300ns/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Benzoylecgonine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Benzovlecgonine. 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 Benzoylecgonine 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 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the word "IMMUNALYSIS" in white letters on a red background. The letters are bold and slightly blurred, giving them a soft, glowing effect. The red background is solid and uniform, providing a stark contrast to the white text. consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. - 2. Immunalysis Benzoylecgonine Urine Calibrators: The Immunalysis Benzovlecgonine Urine Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. - 3. Immunalysis Benzoylecgonine Urine Control Set: The Immunalysis Benzoylecgonine Control Set is intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzoylecgonine. The controls are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers | Item | Cocaine Metabolite Assay K113751 | Immunalysis Benzoylecgonine Urine EIA | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | For the qualitative and semi- quantitative determination of the presence of benzoylecgonine in human urine at a cutoff of 300ng/mL | For the qualitative and semi- quantitative determination of the presence of benzoylecgonine in human urine at a cutoff of 150ng/mL and 300ng/mL | | Type of Product | Analytical Reagents | Same | | Test Matrix | Urine | Same | | Cutoff Levels | 300 ng/mL of Benzoylecgonine | 150 ng/mL and 300 ng/mL of Benzoylecgonine | | Test System | Homogeneous Enzyme Immunoassay | Same | | Materials | Liquid Ready-to-Use Two Reagent Assay | Antibody/Substrate Reagents and Enzyme | | Antibody | Mouse Monoclonal antibodies to Benzoylecgonine | Polyclonal Sheep antibody to Benzoylecgonine | | Storage | 2 - 8°C until expiration date | Same | | Calibrator and Control Matrix | Urine | Same | | Calibrator Levels | Five levels 0, 150, 300, 500, and 1000 ng/mL | Five levels 0, 150, 300, 500, and 1000 ng/mL | | Control Levels | Two levels 225 and 375 ng/mL | Four levels 112.5, 187.5, 225, and 375 ng/mL | | Calibrator and Control Storage | 2 – 8 °C until expiration date | Same | ### G. Comparison of the new device with the predicate device {6}------------------------------------------------ ## IMMUNALYSIS - H. The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Benzoylecgonine Urine Enzyme Immunoassay to the predicate - 1. Precision/ Cutoff Characterization/ Reproducibility 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. In addition, it also verified that product performance relative to the ability of the device to produce the same value during repeated measurements. The instruments used for this was Beckman Coulter AU 400e. | Concentration (ng/mL) | % of cutoff | # of determinations | Result | |-----------------------|-------------|---------------------|-----------------| | 0 | -100% | 80 | 80 Negative | | 37.5 | -75% | 80 | 80 Negative | | 75 | -50% | 80 | 80 Negative | | 112.5 | -25% | 80 | 80 Negative | | 150 | Cutoff | 80 | 36 Neg / 44 Pos | | 187.5 | +25% | 80 | 80 Positive | | 225 | +50% | 80 | 80 Positive | | 262.5 | +75% | 80 | 80 Positive | | 300 | +100% | 80 | 80 Positive | - a. The following is a summary table of the Qualitative Analysis for the 150ng/mI_cutoff test data - b. The following is a summary table of the Qualitative Analysis for the 300ng/mL cutoff test data results. | Table 3 - Qualitative Analysis (for 300 ng/mL cutoff) | | | | |-------------------------------------------------------|-------------|---------------------|-----------------| | Concentration (ng/mL) | % of cutoff | # of determinations | Result | | 0 | -100% | 80 | 80 Negative | | 75 | -75% | 80 | 80 Negative | | 150 | -50% | 80 | 80 Negative | | 225 | -25% | 80 | 80 Negative | | 300 | Cutoff | 80 | 37 Neg / 43 Pos | | 375 | +25% | 80 | 80 Positive | | 450 | +50% | 80 | 80 Positive | | 525 | +75% | 80 | 80 Positive | | 600 | +100% | 80 | 80 Positive | c. The following is a summary table of the Semi-Quantitative Analysis for the 150ng/mL cutoff test data results. | Table 4 - Semi-Quantitative Analysis (for 150ng/mL cutoff) | | | | |------------------------------------------------------------|-------------|---------------------|-------------| | Concentration (ng/mL) | % of cutoff | # of determinations | Result | | 0 | -100% | 80 | 80 Negative | | 37.5 | -75% | 80 | 80 Negative | | 75 | -50% | 80 | 80 Negative | | 112.5 | -25% | 80 | 80 Negative | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "IMMUNALYS" in white letters on a red background. The letters are bold and have a slight shadow effect, making them stand out from the background. The red background is a solid color and fills the entire frame. | Table 4 - Semi-Quantitative Analysis (for 150ng/mL cutoff) | | | | |------------------------------------------------------------|-------------|---------------------|-----------------| | Concentration (ng/mL) | % of cutoff | # of determinations | Result | | 150 | Cutoff | 80 | 25 Neg / 55 Pos | | 187.5 | +25% | 80 | 80 Positive | | 225 | +50% | 80 | 80 Positive | | 262.5 | +75% | 80 | 80 Positive | | 300 | +100% | 80 | 80 Positive | d. The following is a summary table of the Semi-Quantitative Analysis for the 300ng/mL cutoff test data results. | Table 5 - Semi-Quantitative Analysis (for 300ng/mL cutoff) | | | | |------------------------------------------------------------|-------------|---------------------|-----------------| | Concentration (ng/mL) | % of cutoff | # of determinations | Result | | 0 | -100% | 80 | 80 Negative | | 75 | -75% | 80 | 80 Negative | | 150 | -50% | 80 | 80 Negative | | 225 | -25% | 80 | 80 Negative | | 300 | Cutoff | 80 | 24 Neg / 56 Pos | | 375 | +25% | 80 | 80 Positive | | 450 | +50% | 80 | 80 Positive | | 525 | +75% | 80 | 80 Positive | | 600 | +100% | 80 | 80 Positive | 2. Specificity and Cross-Reactivity - Structurally similar compounds were spiked into drug free urine at levels that will yield 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. a. The qualitative result summary table for the 150ng/mL cutoff is outlined below: | Table 6 - Structurally Related Compounds (for 150 ng/mL cutoff) - Qualitative | | | | |-------------------------------------------------------------------------------|------------------------------|--------|----------------------| | Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) | | Benzoylecgonine | 150 | POS | 100.00 | | m-Hydroxybenzoylecgonine | 150 | POS | 100.00 | | Cocaine | 100,000 | POS | 0.15 | | Ecgonine | 59,000 | POS | 0.25 | | Ecgonine Methyl Ester | 100,000 | NEG | N.D. | | Cocaethylene | 100,000 | NEG | N.D. | | Norcocaine | 100,000 | NEG | N.D. | b. The qualitative result summary table for the 300ng/mL cutoff is outlined below: | Table 7 - Structurally Related Compounds (for 300 ng/mL cutoff) - Qualitative | | | | |-------------------------------------------------------------------------------|------------------------------|--------|----------------------| | Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) | | Benzoylecgonine | 300 | POS | 100.00 | | m-Hydroxybenzoylecgonine | 300 | POS | 100.00 | | Cocaine | 100,000 | NEG | N.D. | | Ecgonine | 100,000 | NEG | N.D. | | Ecgonine Methyl Ester | 100,000 | NEG | N.D. | | Cocaethylene | 100,000 | NEG | N.D. | {8}------------------------------------------------ IMMUNALY | Table 7 - Structurally Related Compounds (for 300 ng/mL cutoff) - Qualitative | | | | | |-------------------------------------------------------------------------------|------------------------------------------------------------|-----|------|--| | Compound | Concentration Tested (ng/mL) Result Cross-Reactivity (%) | | | | | Norcocaine | 100,000 | NEG | N.D. | | | c. The semi-quantitative result summary table for the 150ng/mL cutoff is | | | | | -Qualifi outlined below: | Table 8 - Structurally Related Compounds (for 150ng/mL cutoff) – Semi-Quantitative | | | | |------------------------------------------------------------------------------------|------------------------------|--------|----------------------| | Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) | | Benzoylecgonine | 150 | POS | 100.00 | | m-Hydroxybenzoylecgonine | 150 | POS | 100.00 | | Cocaine | 100,000 | POS | 0.15 | | Ecgonine | 59,000 | POS | 0.25 | | Ecgonine Methyl Ester | 100,000 | NEG | N.D. | | Cocaethylene | 100,000 | NEG | N.D. | | Norcocaine | 100,000 | NEG | N.D. | d. The semi-quantitative result summary table for the 300ng/mL cutoff is outlined below: | Table 9 - Structurally Related Compounds (for 300ng/mL cutoff) – Semi-Quantitative | | | | |------------------------------------------------------------------------------------|------------------------------|--------|----------------------| | Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) | | Benzoylecgonine | 300 | POS | 100.00 | | m-Hydroxybenzoylecgonine | 300 | POS | 100.00 | | Cocaine | 100,000 | NEG | N.D. | | Ecgonine | 100,000 | NEG | N.D. | | Ecgonine Methyl Ester | 100,000 | NEG | N.D. | | Cocaethylene | 100,000 | NEG | N.D. | | Norcocaine | 100,000 | NEG | N.D. | - 3. 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 table of the structurally non-similar compounds for the 150ng/mL cutoff: | Table 10 - Structurally Non-Similar Compounds (for 150ng/mL cutoff) | | | | | | |---------------------------------------------------------------------|------------------------------------|---------------------------------------|----------------------------------------------|---------------------------------------|----------------------------------------------| | Compound | Concentration Tested (ng/mL) | -25% Cutoff (112.5ng/mL) | | +25% Cutoff (187.5ng/mL) | | | | | Result | Interference? | Result | Interference? | | 4-Bromo- 2,5,Dimethoxyphenethylamine | 100,000 | Negative | No | Positive | No | | 6-Acetylcodeine | 100,000 | Negative | No | Positive | No | | 6-Acetylmorphine | 100,000 | Negative | No | Positive | No | | 7-Aminoclonazepam | 100,000 | Negative | No | Positive | No | | 7-Aminoflunitrazepam | 100,000 | Negative | No | Positive | No | | 7-Aminonitrazepam | 100,000 | Negative | No | Positive | No | | 11-hydroxy-delta-9-THC | 100,000 | Negative | No | Positive | No | | Table 10 - Structurally Non-Similar Compounds (for 150ng/mL cutoff) | | | | | | | | Concentration | | -25% Cutoff | +25% Cutoff | | | Compound | Tested | (112.5ng/mL) | | (187.5ng/mL) | | | | (ng/mL) | Result | Interference? | Result | Interference? | | 11-nor-9 carboxy-delta-THC | 100,000 | Negative | No | Positive | No | | Acetaminophen | 500,000 | Negative | No | Positive | No | | Acetylsalicylic Acid | 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 | | Benzylpiperazine | 100,000 | Negative | No | Positive | No | | 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 | | Butalbital | 100,000 | Negative | No | Positive | No | | Caffeine | 500,000 | Negative | No | Positive | No | | Cannabidiol | 100,000 | Negative | No | Positive | No | | Cannabinol | 100,000 | Negative | No | Positive | No | | Carbamazeprine | 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 | | cis-Tramadol | 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 | | Clozapine | 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 | | Dehydronorketamine | 100,000 | Negative | No | Positive | No | | Delta-9-THC | 100,000 | Negative | No | Positive | No | | Demoxepam | 100,000 | Negative | No | Positive | No | | Desakylflurazepam | 100,000 | Negative | No | Positive | No | | Desipramine | 100,000 | Negative | No | Positive | No | | Dextromethorphan | 100,000 | Negative | No | Positive | No | | Diazepam | 100,000 | Negative | No | Positive | No | | Digoxin | 100,000 | Negative | No | Positive | No | | Dihydrocodeine | 100,000 | Negative | No | Positive | No | | Diphenhydramine | 500,000 | Negative | No | Positive | No | | Doxepin | 100,000 | Negative | No | Positive | No | | 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 B D glucuronide | 100,000 | Negative | No | Positive | No | | Table 10 - Structurally Non-Similar Compounds (for 150ng/mL cutoff) | | | | | | | | Concentration | | -25% Cutoff | +25% Cutoff | | | Compound | Tested | (112.5ng/mL) | | (187.5ng/mL) | | | | (ng/mL) | Result | Interference? | Result | Interference? | | 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 | | Fluoxetine | 100,000 | Negative | No | Positive | No | | Flurazepam | 100,000 | Negative | No | Positive | No | | Haloperidol | 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 | 500,000 | Negative | No | Positive | No | | Imipramine | 100,000 | Negative | No | Positive | No | | Ketamine | 100,000 | Negative | No | Positive | No | | Lamotrignine | 100,000 | Negative | No | Positive | No | | Levorphanol Tartrate | 100,000 | Negative | No | Positive | No | | Lidocaine | 100,000 | Negative | No | Positive | No | | Lorazepam | 100,000 | Negative | No | Positive | No | | Lorazepam Glucuronide | 50,000 | Negative | No | Positive | No | | Lormetazepam | 100,000 | Negative | No | Positive | No | | LSD | 100,000 | Negative | No | Positive | No | | Maprotiline | 100,000 | Negative | No | Positive | No | | MDA | 100,000 | Negative | No | Positive | No | | MDEA | 100,000 | Negative | No | Positive | No | | MDMA | 100,000 | Negative | No | Positive | No | | Meperidine | 100,000 | Negative | No | Positive | No | | Meprobamate | 100,000 | Negative | No | Positive | No | | Methadone | 100,000 | Negative | No | Positive | No | | Methamphetamine | 100,000 | Negative | No | Positive | No | | Methaquolone | 100,000 | Negative | No | Positive | No | | Methoxetamine | 100,000 | Negative | No | Positive | No | | Methylone | 100,000 | Negative | No | Positive | No | | Methylphenidate | 100,000 | Negative | No | Positive | No | | Midazolam | 100,000 | Negative | No | Positive | No | | Morphine | 100,000 | Negative | No | Positive | No | | Morphine 3-D-glucuronide | 100,000 | Negative | No | Positive | No | | Morphine 6-D-glucuronide | 50,000 | 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 | | Naproxen | 100,000 | Negative | No | Positive | No | | N-desmethyltapentadol | 100,000 | Negative | No | Positive | No | | Nitrazepam | 100,000 | Negative | No | Positive | No | | Table 10 - Structurally Non-Similar Compounds (for 150ng/mL cutoff) | | | | | | | Compound | Concentration Tested (ng/mL) | -25% Cutoff (112.5ng/mL) | | +25% Cutoff (187.5ng/mL) | | | | | Result | Interference? | Result | Interference? | | Norbuprenorphine | 50,000 | Negative | No | Positive | No | | Norcodeine | 100,000 | Negative | No | Positive | No | | Nordiazepam | 100,000 | Negative | No | Positive | No | | Norketamine | 100,000 | Negative | No | Positive | No | | Normorphine | 100,000 | Negative | No | Positive | No | | Norproxyphene | 100,000 | Negative | No | Positive | No | | Norpseudoephedrine | 100,000 | Negative | No | Positive | No | | Nortriptyline | 100,000 | Negative | No | Positive | No | | Olanzapine | 100,000 | Negative | No | Positive | No | | Oxazepam | 100,000 | Negative | No | Positive | No | | Oxycodone | 100,000 | Negative | No | Positive | No | | Oxymorphone | 100,000 | Negative | No | Positive | No | | 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 | | Phenylephedrine | 100,000 | Negative | No | Positive | No | | Phenylpropanolamine | 100,000 | Negative | No | Positive | No | | Phenytoin | 100,000 | Negative | No | Positive | No | | PMA | 100,000 | Negative | No | Positive | No | | Prazepam | 100,000 | Negative | No | Positive | No | | Propoxyphene | 100,000 | Negative | No | Positive | No | | Propranolol | 100,000 | Negative | No | Positive | No | | Protriptyline | 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 | | Salicylic Acid | 100,000 | Negative | No | Positive | No | | Secobarbital | 100,000 | Negative | No | Positive | No | | Sertraline | 100,000 | Negative | No | Positive | No | | Sufentanil Citrate | 50,000 | Negative | No | Positive | No | | Tapentadol | 100,000 | Negative | No | Positive | No | | Temazepam | 100,000 | Negative | No | Positive | No | | Theophylline | 100,000 | Negative | No | Positive | No | | Thioridazine | 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 | | Table 10 - Structurally Non-Similar Compounds (for 150ng/mL cutoff) | | | | | | | Compound | Concentration Tested (ng/mL) | -25% Cutoff (112.5ng/mL) Result | -25% Cutoff (112.5ng/mL) Interference? | +25% Cutoff (187.5ng/mL) Result | +25% Cutoff (187.5ng/mL) Interference? | | Verapamil | 100,000 | Negative | No | Positive | No | | Zolpidem Tartrate | 100,000 | Negative…