Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls

Q: Who is the manufacturer of Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls?

Immunalysis Corporation filed the 510(k) submission for Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls (K143502).

Q: What is the FDA product code for Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls?

DJG. It is classified under 21 CFR 862.3650 as a Class 2 device in the Clinical Toxicology panel.

Q: What is the regulatory pathway for Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls?

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

Q: What are the predicate devices for Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls?

DRI® DAU Opiate Assay (K011150); LZI Multiple Analyte Urine Drugs of Abuse Calibrators and Controls (K051088).

Q: Who can help prepare an FDA 510(k) submission like Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls?

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.

K143502 · Immunalysis Corporation · DJG · May 20, 2015 · Clinical Toxicology

Device Facts

Record ID	K143502
Device Name	Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls
Applicant	Immunalysis Corporation
Product Code	DJG · Clinical Toxicology
Decision Date	May 20, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.3650
Device Class	Class 2

Intended Use

The Immunalysis Opiates Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 300ng/mL and 2000ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of opiates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Morphine. This in-vitro diagnostic 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 Opiates 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. The Immunalysis Opiates Urine Calibrators 300 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 300 consists of 4 levels, with Level 1 containing 100ng/mL, Level 2 containing 300ng/mL, Level 3 containing 500ng/mL and Level 4 containing 1000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. The Immunalysis Multi-Drug Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methadone, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam for Immunalysis Multi-Drug Controls 1 and Benzoylecgonine, Methamphetamine and Morphine for Immunalysis Multi-Drug Controls 2. The controls are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. The Immunalysis Opiates Urine Calibrators 2000 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 2000 consists of 4 levels, with Level 1 containing 1000ng/mL, Level 2 containing 2000ng/mL, Level 3 containing 4000ng/mL and Level 4 containing 6000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers.

Device Story

The Immunalysis Opiates Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay used in clinical laboratories to detect opiates in human urine. The device utilizes monoclonal antibodies to morphine, glucose-6-phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in a Tris buffer, along with an enzyme conjugate (morphine derivative labeled with G6PDH). When used on automated clinical chemistry analyzers, the assay provides qualitative or semi-quantitative results. The output is a preliminary analytical result; positive results require confirmation via GC-MS or LC/MS. The device includes specific calibrators (300 ng/mL and 2000 ng/mL levels) and multi-drug controls to monitor assay performance. Healthcare providers use these results to guide clinical decision-making, such as determining the need for confirmatory testing or assessing patient drug use, ultimately aiding in clinical toxicology and drug abuse monitoring.

Clinical Evidence

Bench testing only. Precision/reproducibility evaluated over 20 days (N=80) at ±0%, ±25%, ±50%, ±75%, and ±100% of cutoffs. Linearity/recovery confirmed via serial dilutions. Analytical specificity tested against structurally related and non-related compounds; interference noted for Boric Acid and Riboflavin. Method comparison study (N=80) against LC/MS showed high agreement (98-100% for positives, 100% for negatives) across both qualitative and semi-quantitative modes.

Technological Characteristics

Homogeneous enzyme immunoassay (EIA). Reagents: monoclonal antibodies to morphine, G6P, NAD, and morphine-labeled G6PDH enzyme conjugate in Tris buffer with sodium azide preservative. Form factor: liquid, ready-to-use reagents, calibrators, and controls. Connectivity: designed for use on automated clinical chemistry analyzers (e.g., Beckman Coulter AU 400e). Storage: 2–8°C.

Indications for Use

Indicated for the qualitative and semi-quantitative analysis of opiates in human urine for prescription use in laboratory settings using automated clinical chemistry analyzers. Provides preliminary analytical results requiring confirmation by GC-MS or LC/MS.

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate 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

DRI® DAU Opiate Assay (K011150)
LZI Multiple Analyte Urine Drugs of Abuse Calibrators and Controls (K051088)

Related Devices

K962323 — IMMULITE OPIATES SCREEN/CONTROL MODULE · Diagnostic Products Corp. · Mar 10, 1997
K020368 — OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); CATALOG # 0021 (5000 TESTS KIT) · Lin-Zhi International, Inc. · Jun 4, 2002

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, formed by three overlapping profiles of human faces. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 IMMUNALYSIS CORPORATION JOSEPH GINETE REGULATORY AFFAIRS SPECIALIST 829 TOWNE CENTER DR POMONA CA 91767 May 20, 2015 Re: K143502 Trade/Device Name: Immunalysis Opiates Urine Enzyme Immunoassay Immunalysis Opiates Urine Calibrators 300 Immunalysis Multi-Drug Controls Immunalysis Opiates Urine Calibrators 2000 Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG, DLJ, DIF Dated: March 26, 2015 Received: March 27, 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 {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) K143502 #### Device Name Immunalysis Opiates Urine Enzyme Immunalysis Opiates Urine Calibrators 300, Immunalysis Multi-Drug Controls, and Immunalysis Opiates Urine Calibrators 2000 #### Indications for Use (Describe) Immunalysis Opiates Urine Enzyme Immunoassay The Immunalysis Opiates Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 300 ng/mL and 2000 ng/mL. The assay is intended for use in laboratories for the qualitative andlysis of opiates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Morphine. This in-vitro diagnostic 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 Opiates 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 Opiates Urine Calibrators 300 The Immunalysis Opiates Urine Calibrators 300 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 300 consists of 4 levels, with Level 1 containing 100ng/mL, Level 2 containing 300ng/mL, Level 3 containing 500ng/mL and Level 4 containing 1000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. #### Immunalysis Multi-Drug Controls The Immunalysis Multi-Drug Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam for Immunalysis Multi-Drug Controls 1 and Benzoylecgonine, Methamphetamine and Morphine for Immunalysis Multi-Drug Controls 2. The controls are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. #### Immunalysis Opiates Urine Calibrators 2000 The Immunalysis Opiates Urine Calibrators 2000 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package inset: Morphine. The Immunalysis Opiates Urine Calibrators 2000 consists of 4 levels, with Level 1 containing 1000ng/mL, Level 2 containing 2000ng/mL, Level 3 containing 4000ng/mL and Level 4 containing 6000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters against a red background. The word is written in all capital letters and is centered in the image. The red background is a solid color, and the white letters are easy to read. The image is simple and straightforward, with a clear focus on the word "IMMUNALYSIS". B. C. # 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: | May 18, 2015 | | | Device Information | | | 1. | Trade Name: | Immunalysis Opiates Urine Enzyme Immunoassay | | | | Immunalysis Opiates Urine Calibrators 300 | | | | Immunalysis Multi-Drug Controls | | | | Immunalysis Opiates Urine Calibrators 2000 | | 2. | Common Name: | Immunalysis Opiates Urine Enzyme Immunoassay | | | | Immunalysis Opiates Urine Calibrators 300 | | | | Immunalysis Multi-Drug Controls | | | | Immunalysis Opiates Urine Calibrators 2000 | | | Regulatory Information | | | 1. | Device Classification: | II | | 2. | Regulation Number: | CFR 862.3650 Opiate Test System | | | | CFR 862.3200 Clinical Toxicology Calibrator | | | | CFR 862.3280 Clinical Toxicology Control Materials | | 3. | Panel: | Toxicology(91) | | 4. | Product Code: | DJG | | | | DLJ | | | | DJE | {5}------------------------------------------------ # IMMUNALYSIS - D. Legally Marketed Device to Which We are Claiming Equivalence (807.92(A)(3)) | 1. Predicate Device: | DRI® DAU Opiate Assay | |------------------------|-------------------------------------------| | | LZI Multiple Analyte Urine Drugs of Abuse | | | Calibrators and Controls | | 2. Predicate Company: | Microgenics | | | Lin-Zhi International, Inc. | | 3. Predicate K Number: | K011150 | | | K051088 | ### E. Device Description - 1. The assay consists of antibody/substrate reagent and enzyme conjugate reagent. The antibody/substrate reagent includes monoclonal antibodies to morphine, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes morphine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. - 2. All of the Immunalysis Opiates Urine Calibrators 300 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 are prepared by spiking known concentrations of morphine into the negative calibrator matrix. These five calibrators are sold as individual bottles. The concentration of morphine in their corresponding calibrators are summarized as follows: | Table 1 Immunalysis Opiates Urine Calibrators 300 | | | | | |---------------------------------------------------|---------------------|----------|----------|-----------| | Analyte | Opiates Calibrators | | | | | | Level 1 | Level 2 | Level 3 | Level 4 | | Morphine | 100ng/mL | 300ng/mL | 500ng/mL | 1000ng/mL | - 3. All of the Immunalysis Multi-Drug 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 LOW Control 1, HIGH Control 1, LOW Control 2 and HIGH Control 2 are prepared by spiking known concentrations of drug analyte into the negative calibrator matrix. These four controls are sold as control sets. The concentration of drug analyte in their corresponding controls are summarized as follows: {6}------------------------------------------------ | Table 2 Immunalysis Multi-Drug Controls 1 | | | |-------------------------------------------|---------------------|----------------| | Analyte | Multi-Drug Controls | | | | LOW Control 1 | HIGH Control 1 | | Benzoylecgonine | 112.5ng/mL | 187.5ng/mL | | Methadone | 225ng/mL | 375ng/mL | | Methamphetamine | 375ng/mL | 625ng/mL | | Morphine | 225ng/mL | 375ng/mL | | PCP | 19ng/mL | 31ng/mL | | Secobarbital | 150ng/mL | 250ng/mL | | Oxazepam | 150ng/mL | 250ng/mL | | Table 3 Immunalysis Multi-Drug Controls 2 | | | |-------------------------------------------|---------------------|----------------| | | Multi-Drug Controls | | | Analyte | LOW Control 2 | HIGH Control 2 | | Benzoylecgonine | 225ng/mL | 375ng/mL | | Methamphetamine | 750ng/mL | 1250ng/mL | | Morphine | 1500ng/mL | 2500ng/mL | - 4. All of the Immunalysis Opiates Urine Calibrators 2000 are liquid and ready to use. Each contains a known concentration of a specific drug analyte. 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 are prepared by spiking known concentrations of morphine into the negative calibrator matrix. These five calibrators are sold as individual bottles. The concentration of morphine in the corresponding calibrators are summarized as follows: | Table 4 Immunalysis Opiates Urine Calibrators 2000 | | | | | |----------------------------------------------------|---------------------|-----------|-----------|-----------| | | Opiates Calibrators | | | | | Analyte | Level 1 | Level 2 | Level 3 | Level 4 | | Morphine | 1000ng/mL | 2000ng/mL | 4000ng/mL | 6000ng/mL | - F. Intended Use - The Immunalysis Opiates Urine Enzyme Immunoassay is a homogeneous enzyme 1. immunoassay with a dual cutoff of 300ng/mL and 2000ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of opiates in human urine with automated clinical chemistry analyzers. This assay is calibrated against Morphine. This in-vitro diagnostic 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 Opiates 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. {7}------------------------------------------------ ### IMMUNALYSIS - 2. The Immunalysis Opiates Urine Calibrators 300 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 300 consists of 4 levels, with Level 1 containing 100ng/mL, Level 2 containing 300ng/mL, Level 3 containing 500ng/mL and Level 4 containing 1000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. The Immunalysis Multi-Drug Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methadone, Methamphetamine, Morphine, PCP, Secobarbital and Oxazepam for Immunalysis Multi-Drug Controls 1 and Benzoylecgonine, Methamphetamine and Morphine for Immunalysis Multi-Drug Controls 2. The controls are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. The Immunalysis Opiates Urine Calibrators 2000 are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Morphine. The Immunalysis Opiates Urine Calibrators 2000 consists of 4 levels, with Level 1 containing 1000ng/mL, Level 2 containing 2000ng/mL, Level 3 containing 4000ng/mL and Level 4 containing 6000ng/mL of morphine. The calibrators are designed for prescription use with homogenous enzyme immunoassays on automated clinical chemistry analyzers. | Item | Opiates Assay K011150 | Immunalysis Opiates Urine EIA | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | For the qualitative and semi-quantitative determination of the presence of opiates in human urine at a cutoff of 300ng/mL and 2000ng/mL | For the qualitative and semi-quantitative determination of the presence of opiates in human urine at a cutoff of 300ng/mL and 2000ng/mL | | Type of Product | Analytical Reagents | Analytical Reagents | | Measured Analytes | Opiates | Opiates | | Test Matrix | Urine | Urine | | Cutoff Levels | 300ng/mL and 2000ng/mL of Morphine | 300ng/mL and 2000ng/mL of Morphine | | Test System | Homogeneous Enzyme Immunoassay | Homogeneous Enzyme Immunoassay (EIA) | | Materials | Antibody/Substrate Reagents and Enzyme Labeled Conjugate | Antibody/Substrate Reagents and Enzyme Labeled Conjugate | | Mass Spectroscopy Confirmation | Required for preliminary positive analytical results | Required for preliminary positive analytical results | | Antibody | Monoclonal antibody to Opiates | Monoclonal antibody to Opiates | | Storage | 2 – 8°C until expiration date | 2 – 8°C until expiration date | - G. Comparison of the new device with the predicate device {8}------------------------------------------------ # IMMUNALYSIS | Item | LZI Multiple Analyte K051088 | Immunalysis Opiates Urine Calibrators 300 | |-------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | Analyte | benzoylecgonine, d- methamphetamine, methadone, morphine, oxazepam, secobarbital, phencyclidine, propoxyphene | Morphine | | Matrix | Urine | Same | | Calibrator Levels | 5 Levels – See Table 5 Below | 5 Levels (Negative and Level 1, 2, 3 and 4) - See Device Description Table 1 | | Storage | 2 – 8°C until expiration date | Same | | Item | LZI Multiple Analyte K051088 | Immunalysis Multi-Drug Controls | |----------------|------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------| | Analyte | benzoylecgonine, d- methamphetamine, methadone, morphine, oxazepam, secobarbital, phencyclidine, propoxyphene | benzoylecgonine, methadome, methamphetamine, morphine, PCP, secobarbital, oxazepam | | Matrix | Urine | Urine | | Control Levels | 2 Levels – See Table 5 Below | 4 Levels (LOW Control 1, HIGH Control 1, LOW Control 2 and HIGH Control 2) – See Device Description Table 2 and Table 3 | | Storage | 2 – 8°C until expiration date | 2 – 8°C until expiration date | | Item | LZI Multiple Analyte K051088 | Immunalysis Opiates Urine Calibrators 2000 | |-------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | Analyte | benzoylecgonine, d- methamphetamine, methadone, morphine, oxazepam, secobarbital, phencyclidine, propoxyphene | Morphine | | Matrix | Urine | Same | | Calibrator Levels | 5 Levels – See Table 5 Below | 5 Levels (Negative and Level 1, 2, 3 and 4) - See Device Description Table 4 | | Storage | 2 - 8°C until expiration date | Same | | Table 5 LZI Multiple Analyte Urine Drugs of Abuse Calibrators and Controls | | | | | | | |----------------------------------------------------------------------------|------------------------------|-----------|--------------|-----------|---------------------------|-----------| | Analyte | Multiple Analyte Calibrators | | | | Multiple Analyte Controls | | | | Low | Cutoff | Intermediate | High | Level 1 | Level 2 | | d-Methamphetamine | 250ng/mL | 500ng/mL | 750ng/mL | 1000ng/mL | 375ng/mL | 625ng/mL | | Morphine | 1000ng/mL | 2000ng/mL | 4000ng/mL | 6000ng/mL | 1500ng/mL | 2500ng/mL | | Phencyclidine | 12.5ng/mL | 25ng/mL | 50ng/mL | 100ng/mL | 18ng/mL | 35ng/mL | | Benzoylecgonine | 75ng/mL | 150ng/mL | 300ng/mL | 1000ng/mL | 110ng/mL | 190ng/mL | | Oxazepam | 100ng/mL | 200ng/mL | 500ng/mL | 1000ng/mL | 100ng/mL | 300ng/mL | | Secobarbital | 100ng/mL | 200ng/mL | 500ng/mL | 1000ng/mL | 100ng/mL | 300ng/mL | | Propoxyphene | 150ng/mL | 300ng/mL | 600ng/mL | 1000ng/mL | 225ng/mL | 375ng/mL | | Methadone | 150ng/mL | 300ng/mL | 600ng/mL | 1000ng/mL | 225ng/mL | 375ng/mL | {9}------------------------------------------------ - H. The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Opiates 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. In addition, it also verified the product performance relative to the ability of the device to produce the same value during repeated measurements. The instruments used for this was a Beckman Coulter AU 400e. | a. The following is a summary table of the Qualitative Analysis for the | | |-------------------------------------------------------------------------|--| | 300ng/mL cutoff test data results. | | | 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 Negative/43 Positive | | 375 | +25% | 80 | 80 Positive | | 450 | +50% | 80 | 80 Positive | | 525 | +75% | 80 | 80 Positive | | 600 | +100% | 80 | 80 Positive | b. The following is a summary table of the Qualitative Analysis for the 2000ng/mL cutoff test data results. | Table 7 - Qualitative Analysis (for 2000ng/mL cutoff) | | | | |-------------------------------------------------------|-------------|---------------------|-------------------------| | Concentration (ng/mL) | % of cutoff | # of determinations | Result | | 0 | -100% | 80 | 80 Negative | | 500 | -75% | 80 | 80 Negative | | 1000 | -50% | 80 | 80 Negative | | 1500 | -25% | 80 | 80 Negative | | 2000 | Cutoff | 80 | 42 Negative/38 Positive | | 2500 | +25% | 80 | 80 Positive | | 3000 | +50% | 80 | 80 Positive | | 3500 | +75% | 80 | 80 Positive | | 4000 | +100% | 80 | 80 Positive | c. The following is a summary table of the Semi-Quantitative Analysis for the 300ng/mL cutoff test data results. | Table 8 - 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 | 20 Negative/60 Positive | | 375 | +25% | 80 | 80 Positive | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the word "IMMUNALYS" in white letters on a red background. The letters are bold and slightly blurred, giving the impression of a title or heading. The red background is solid and provides a strong contrast to the white text. | Table 8 - Semi-Quantitative Analysis (for 300ng/mL cutoff) | | | | |------------------------------------------------------------|-------------|---------------------|-------------| | Concentration (ng/mL) | % of cutoff | # of determinations | Result | | 450 | +50% | 80 | 80 Positive | | 525 | +75% | 80 | 80 Positive | | 600 | +100% | 80 | 80 Positive | d. The following is a summary table of the Semi-Quantitative Analysis for the 2000ng/mL cutoff test data results. | Table 9 - Semi-Quantitative Analysis (for 2000ng/mL cutoff) | | | | | |-------------------------------------------------------------|-------------|---------------------|-------------------------|--| | Concentration (ng/mL) | % of cutoff | # of determinations | Result | | | 0 | -100% | 80 | 80 Negative | | | 500 | -75% | 80 | 80 Negative | | | 1000 | -50% | 80 | 80 Negative | | | 1 200 | -25% | 80 | 80 Negative | | | 2000 | Cutoff | 80 | 41 Negative/39 Positive | | | 2500 | +25% | 80 | 80 Positive | | | 3000 | +50% | 80 | 80 Positive | | | 3500 | +75% | 80 | 80 Positive | | | 4000 | +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 300ng/mL cutoffs is outlined below: | Table 10 - Structurally Related Compounds (for 300ng/mL cutoff) - Qualitative | | | | |-------------------------------------------------------------------------------|------------------------------|--------|----------------------| | Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) | | 6-Acetylmorphine | 150 | POS | 200.0 | | Codeine | 200 | POS | 150.0 | | Dihydrocodeine | 150 | POS | 200.0 | | Ethylmorphine | 300 | POS | 100.0 | | Heroin | 300 | POS | 100.0 | | Hydrocodone | 400 | POS | 75.0 | | Levorphanol | 8,000 | POS | 3.8 | | Morphine-3-Glucuronide | 200 | POS | 150.0 | | Morphine-6-Glucuronide | 100 | POS | 300.0 | | Hydromorphone | 700 | POS | 42.9 | | Nalorphine | 2,000 | POS | 15.0 | | Naloxone | 60,000 | POS | 0.5 | | Norcodeine | 25,000 | POS | 1.2 | | Normorphine | 25,000 | POS | 1.2 | | Oxycodone | 10,000 | POS | 3.0 | | Oxymorphone | 20,000 | POS | 1.5 | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters on a red background. The word is written in all capital letters and is centered in the image. The red background is a solid color and there are no other objects in the image. b. The qualitative result summary table for the 2000ng/mL cutoff is outlined below: | Table 11 - Structurally Related Compounds (for 2000ng/mL cutoff) - Qualitative | | | | |--------------------------------------------------------------------------------|------------------------------|--------|----------------------| | Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) | | 6-Acetylmorphine | 2,000 | POS | 100.0 | | Codeine | 2,000 | POS | 100.0 | | Dihydrocodeine | 600 | POS | 333.3 | | Ethylmorphine | 2,000 | POS | 100.0 | | Heroin | 4,000 | POS | 50.0 | | Hydrocodone | 4,000 | POS | 50.0 | | Levorphanol | 100,000 | POS | 2.0 | | Morphine-3-Glucuronide | 2,000 | POS | 100.0 | | Morphine-6-Glucuronide | 600 | POS | 333.3 | | Hydromorphone | 8,000 | POS | 25.0 | | Nalorphine | 28,000 | POS | 7.1 | | Naloxone | 500,000 | POS | 0.4 | | Norcodeine | 300,000 | POS | 0.7 | | Normorphine | 300,000 | POS | 0.7 | | Oxycodone | 100,000 | POS | 2.0 | | Oxymorphone | 200,000 | NEG | 1.0 | c. The semi-quantitative result summary table for the 300ng/mL cutoff is outlined below: | Table 12 - Structurally Related Compounds (for 300ng/mL cutoff) – Semi-Quantitative | | | | |-------------------------------------------------------------------------------------|------------------------------|--------|----------------------| | Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) | | 6-Acetylmorphine | 150 | POS | 200.0 | | Codeine | 200 | NEG | 150.0 | | Dihydrocodeine | 150 | POS | 200.0 | | Ethylmorphine | 300 | POS | 100.0 | | Heroin | 300 | POS | 100.0 | | Hydrocodone | 400 | POS | 75.0 | | Levorphanol | 8,000 | POS | 3.8 | | Morphine-3-Glucuronide | 200 | POS | 150.0 | | Morphine-6-Glucuronide | 100 | POS | 300.0 | | Hydromorphone | 700 | POS | 42.9 | | Nalorphine | 2,000 | POS | 15.0 | | Naloxone | 60,000 | POS | 0.5 | | Norcodeine | 25,000 | POS | 1.2 | | Normorphone | 25,000 | POS | 1.2 | | Oxycodone | 10,000 | POS | 3.0 | | Oxymorphone | 20,000 | POS | 1.5 | {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters on a red background. The word is written in all capital letters and is centered in the image. The font is bold and sans-serif. The red background is a solid color. | Table 13 - Structurally Related Compounds (for 2000ng/mL cutoff) – Semi-Quantitative | | | | |--------------------------------------------------------------------------------------|------------------------------|--------|----------------------| | Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) | | 6-Acetylmorphine | 2,000 | POS | 100.0 | | Codeine | 2,000 | POS | 100.0 | | Dihydrocodeine | 600 | POS | 333.3 | | Ethylmorphine | 2,000 | POS | 100.0 | | Heroin | 4,000 | POS | 50.0 | | Hydrocodone | 4,000 | POS | 50.0 | | Levorphanol | 100,000 | POS | 2.0 | | Morphine-3-Glucuronide | 2,000 | POS | 100.0 | | Morphine-6-Glucuronide | 600 | POS | 333.3 | | Hydromorphone | 8,000 | POS | 25.0 | | Nalorphine | 28,000 | POS | 7.1 | | Naloxone | 500,000 | POS | 0.4 | | Norcodeine | 300,000 | POS | 0.7 | | Normorphine | 300,000 | POS | 0.7 | | Oxycodone | 100,000 | POS | 2.0 | | Oxymorphone | 200,000 | NEG | 1.0 | - d. The semi-quantitative result summary table for the 2000ng/mL cutoff is outlined below: - 3. Interference Structurally non-similar compounds, endogenous compounds, the effect of pH and the effect of specific gravity was evaluated by spiking the potential interferents into drug free urine containing morphine at ±25% of the cutoffs. Boric Acid and Riboflavin caused a false negative response at the concentrations tested. All other 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 300ng/mL cutoff: | Table 14 - Structurally Non-Similar Compounds (for 300ng/mL cutoff) | | | | | | | |---------------------------------------------------------------------|------------------------------------|---------------------------|---------------|---------------------------|---------------|--| | Compound | Concentration Tested (ng/mL) | -25% Cutoff (225ng/mL) | | +25% Cutoff (375ng/mL) | | | | | | Result | Interference? | Result | Interference? | | | 4-Bromo- 2,5,Dimethoxyphenethylamine | 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 | | | Amphetamine | 500,000 | Negative | No | Positive | No | | | Amitriptyline | 100,000 | Negative | No | Positive | No | | | Amobarbital | 100,000 | Negative | No | Positive | No | | | Benzoylecgonine | 500,000 | 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 | | | Table 14 - Structurally Non-Similar Compounds (for 300ng/mL cutoff) | | | | | | | | | Concentration | -25% Cutoff | | +25% Cutoff | | | | Compound | Tested | (225ng/mL) | | (375ng/mL) | | | | | (ng/mL) | Result | Interference? | Result | Interference? | | | Buprion | 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 | | | Cocaine | 100,000 | Negative | No | Positive | No | | | Clomipramine | 100,000 | Negative | No | Positive | No | | | Clonazepam | 100,000 | Negative | No | Positive | No | | | Chloropromazine | 100,000 | Negative | No | Positive | No | | | Cyclobenzaprine | 100,000 | Negative | No | Positive | No | | | N-Desmethyltapentadol | 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 | | | Diphenhydramine | 500,000 | Negative | No | Positive | No | | | Doxepin | 100,000 | Negative | No | Positive | No | | | Ephedrine | 100,000 | Negative | No | Positive | No | | | EDDP | 100,000 | Negative | No | Positive | No | | | Ethyl-glucuronide | 100,000 | Negative | No | Positive | No | | | Fenfluramine | 100,000 | Negative | No | Positive | No | | | Fluoxetine | 100,000 | Negative | No | Positive | No | | | Flurazepam | 100,000 | Negative | No | Positive | No | | | Hexobarbital | 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 | | | Lidocaine | 100,000 | Negative | No | Positive | No | | | LSD | 100,000 | Negative | No | Positive | No | | | Lorazepam | 100,000 | Negative | No | Positive | No | | | Maprotiline | 100,000 | Negative | No | Positive | No | | | MDEA | 100,000 | Negative | No | Positive | No | | | MDA | 100,000 | Negative | No | Positive | No | | | MDMA | 100,000 | Negative | No | Positive | No | | | Meperidine | 50.000 | Negative | No | Positive | No | | | Methadone | 500,000 | Negative | No | Positive | No | | | Methaqualone | 100,000 | Negative | No | Positive | No | | | Methamphetamine | 500,000 | Negative | No | Positive | No | | | Meprobamate | 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 | | | Nordiazepam | 100,000 | Negative | No | Positive | No | | | Nortryptyline | 100,000 | Negative | No | Positive | No | | | Norpropoxyphene | 100,000 | Negative | No | Positive | No | | | Table 14 - Structurally Non-Similar Compounds (for 300ng/mL cutoff) | | | | | | | | | Concentration | -25% Cutoff | | +25% Cutoff | | | | Compound | Tested | (225ng/mL) | | (375ng/mL) | | | | | (ng/mL) | Result | Interference? | Result | Interference? | | | Oxazepam | 100,000 | Negative | No | Positive | No | | | Pentobarbital | 100,000 | Negative | No | Positive | No | | | Phenobarbital | 100,000 | Negative | No | Positive | No | | | Pentazocine | 100,000 | Negative | No | Positive | No | | | Phencyclidine | 100,000 | Negative | No | Positive | No | | | Phentermine | 100,000 | Negative | No | Positive | No | | | Phenylpropanolamine | 500,000 | Negative | No | Positive | No | | | PMA | 100,000 | Negative | No | Positive | No | | | (-)Pseudoephedrine | 100,000 | Negative | No | Positive | No | | | (+)Pseudoephedrine | 100,000 | Negative | No | Positive | No | | | Phenytoin | 100,000 | Negative | No | Positive | No | | | Protryptyline | 100,000 | Negative | No | Positive | No | | | Ranitidine | 100,000 | Negative | No | Positive | No | | | Ritalinic Acid | 100,000 | Negative | No | Positive | No | | | Secobarbital | 100,000 | Negative | No | Positive | No | | | Sufentanil | 100,000 | Negative | No | Positive | No | | | Temazepam | 100,000 | Negative | No | Positive | No | | | 11-nor-9 carboxy THC | 100,000 | Negative | No | Positive | No | | | Tramadol | 100,000 | Negative | No | Positive | No | | | Trimipramine | 100,000 | Negative | No | Positive | No | | | Venlafaxine | 100,000 | Negative | No | Positive | No | | {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters on a red background. The letters are bold and slightly blurred, giving them a three-dimensional appearance. The red background is a solid color, and the overall image has a simple and clean design. {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows 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 provides a strong contrast to the white text, making it easily readable. b. The following is a summary table of the structurally non-similar compounds for the 2000ng/mL cutoff: | Table 15 - Structurally Non-Similar Compounds (for 2000ng/mL cutoff) | | | | | | | |----------------------------------------------------------------------|------------------------------------|----------------------------|---------------|----------------------------|---------------|--| | Compound | Concentration Tested (ng/mL) | -25% Cutoff (1500ng/mL) | | +25% Cutoff (2500ng/mL) | | | | | | Result | Interference? | Result | Interference? | | | 4-Bromo- 2,5,Dimethoxyphenethylamine | 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 | | | Amphetamine | 500,000 | Negative | No | Positive | No | | | Amitriptyline | 100,000 | Negative | No | Positive | No | | | Amobarbital | 100,000 | Negative | No | Positive | No | | | Benzoylecgonine | 500,000 | 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 | | | Buprion | 100,000 | Negative | No | Positive | No | | | Butabarbital | 100,000 | Negative | No | Positive | No | | | Caffeine | 500,000 | Negative | No | Positive | No | | | Table 15 - Structurally Non-Similar Compounds (for 2000ng/mL cutoff) | | | | | | | | | Concentration | | -25% Cutoff | +25% Cutoff | | | | Compound | Tested | (1500ng/mL) | | (2500ng/mL) | | | | | (ng/mL) | Result | Interference? | Result | Interference? | | | Carbamazepine | 100,000 | Negative | No | Positive | No | | | Cocaine | 100,000 | Negative | No | Positive | No | | | Clomipramine | 100,000 | Negative | No | Positive | No | | | Clonazepam | 100,000 | Negative | No | Positive | No | | | Chloropromazine | 100,000 | Negative | No | Positive | No | | | Cyclobenzaprine | 100,000 | Negative | No | Positive | No | | | N-Desmethyltapentadol | 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 | | | Diphenhydramine | 500,000 | Negative | No | Positive | No | | | Doxepin | 100,000 | Negative | No | Positive | No | | | Ephedrine | 100,000 | Negative | No | Positive | No | | | EDDP | 100,000 | Negative | No | Positive | No | | | Ethyl-glucuronide | 100,000 | Negative | No | Positive | No | | | Fenfluramine | 100,000 | Negative | No | Positive | No | | | Fluoxetine | 100,000 | Negative | No | Positive | No | | | Flurazepam | 100,000 | Negative | No | Positive | No | | | Hexobarbital | 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 | | | Lidocaine | 100,000 | Negative | No | Positive | No | | | LSD | 100,000 | Negative | No | Positive | No | | | Lorazepam | 100,000 | Negative | No | Positive | No | | | Maprotiline | 100,000 | Negative | No | Positive | No | | | MDEA | 100,000 | Negative | No | Positive | No | | | MDA | 100,000 | Negative | No | Positive | No | | | MDMA | 100,000 | Negative | No | Positive | No | | | Meperidine…