Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets

Q: Who is the manufacturer of Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets?

Immunalysis Corporation filed the 510(k) submission for Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets (K151395).

Q: What is the FDA product code for Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets?

DJR. It is classified under 21 CFR 862.3620 as a Class 2 device in the Clinical Toxicology panel.

Q: What is the regulatory pathway for Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets?

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

Q: What are the predicate devices for Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets?

DRI® Methadone Metabolite Enzyme Immunoassay (K023617).

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

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.

K151395 · Immunalysis Corporation · DJR · Jul 24, 2015 · Clinical Toxicology

Device Facts

Record ID	K151395
Device Name	Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets
Applicant	Immunalysis Corporation
Product Code	DJR · Clinical Toxicology
Decision Date	Jul 24, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.3620
Device Class	Class 2

Intended Use

The Immunalysis EDDP Specific Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with cutoffs of 100 ng/mL, 300n g/mL and 1000 ng/mL. The assay is intended for use in laboratories for the qualitative and semiquantitative analysis of EDDP in human urine with automated clinical chemistry analyzers. This assay is calibrated against EDDP. 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 EDDP Specific 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/Tandem Mass Spectrometry (LC-MS/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.

Device Story

Device is a homogeneous enzyme immunoassay for detecting EDDP in human urine; utilizes recombinant fab antibodies to EDDP, glucose-6-phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in antibody/substrate reagent; enzyme conjugate reagent contains EDDP derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH). Used in clinical laboratories on automated chemistry analyzers; operators are laboratory technicians. Input is human urine sample; output is qualitative or semi-quantitative EDDP concentration. Results are preliminary; require confirmation by GC-MS or LC-MS/MS. Healthcare providers use results to guide clinical decisions regarding drug abuse testing; benefits include rapid preliminary screening to determine if further confirmatory testing is necessary.

Clinical Evidence

Bench testing only. Performance evaluated via precision/reproducibility studies (N=80 per concentration), specificity/cross-reactivity testing against structurally related and non-related compounds, interference studies (endogenous compounds, pH, specific gravity), and method comparison against LC-MS/MS. Method comparison showed high agreement (98-100%) with LC-MS/MS across 100, 300, and 1000 ng/mL cutoffs.

Technological Characteristics

Homogeneous enzyme immunoassay. Reagents: recombinant fab antibodies to EDDP, G6P, NAD, and EDDP-G6PDH conjugate in Tris buffer with sodium azide. Form factor: liquid, ready-to-use reagents, calibrators, and controls. Connectivity: compatible with 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 EDDP in human urine using automated clinical chemistry analyzers. Intended for laboratory use by prescription only. Provides preliminary analytical results requiring confirmation by GC-MS or LC-MS/MS.

Regulatory Classification

Identification

A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.

Special Controls

*Classification.* Class II (special controls). A methadone 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® Methadone Metabolite Enzyme Immunoassay (K023617)

Related Devices

K092258 — RANDOX METABOLITE (EDDP) ASSAY · Randox Laboratories, Ltd. · Nov 9, 2010
K152176 — Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators · Immunalysis Corporation · Sep 4, 2015
K150925 — Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set · Immunalysis Corporation · Jun 29, 2015
K170416 — LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators · Lin-Zhi International, Inc. · Jun 26, 2017
K980746 — CEDIA DAU EDDP ASSAY · Boehringer Mannheim Corp. · May 26, 1998

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 features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 24, 2015 IMMUNALYSIS CORPORATION JOSEPH GINETE REGULATORY AFFAIRS SPECIALIST II 829 TOWNE CENTER DRIVE POMONA CA 91767 Re: K151395 Trade/Device Name: Immunalysis EDDP Specific Urine Enzyme Immunoassay. Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: II Product Code: DJR, DLJ, LAS Dated: May 22, 2015 Received: May 26, 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Courtney H. Lias -S Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) k151395 #### Device Name Immunalysis EDDP Specific Urine Enzyme Immunoassay Immunalysis EDDP Urine Calibrators Immunalysis EDDP Urine Control Sets #### Indications for Use (Describe) Immunalysis EDDP Specific Urine Enzyme Immunoassay The Immunalysis EDDP Specific Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with cutoffs of 100 ng/mL, 300n g/mL and 1000 ng/mL. The assay is intended for use in laboratories for the qualitative and semiquantitative analysis of EDDP in human urine with automated clinical chemistry analyzers. This assay is calibrated against EDDP. 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 EDDP Specific 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/Tandem Mass Spectrometry (LC-MS/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 EDDP Urine Calibrators The Immunalysis EDDP Urine Calibrators are used as calibrators in the Immunalysis EDDP Specific Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of EDDP in urine on automated clinical chemistry analyzers. ### Immunalysis EDDP Urine Control Sets The Immunalysis EDDP Urine Control Sets are used as control materials in Immunalysis EDDP Specific Urine Enzyme Immunoassay. 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. 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 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. # 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: | July 8, 2015 | | | B. Device Information | | | | 1. Trade Name: | Immunalysis EDDP Specific Urine Enzyme Immunoassay Immunalysis EDDP Calibrators and Control Sets | | 2. | Common Name: | Immunalysis EDDP Specific Urine Enzyme Immunoassay Immunalysis EDDP Calibrators and Control Sets | | | C. Regulatory Information | | | | 1. Device Classification: | II I, reserved | | | 2. Regulation Number: | 21 CFR862.3250 Enzyme Immunoassay, Methadone 21 CFR 862.3200 Calibrator, Drug Specific 21 CFR 862.3280 Drug Specific Control Materials | | | 3. Panel: | Toxicology(91) | | 4. | Product Code: | DJR DLJ LAS | - D. Legally Marketed Device to Which We are Claiming Equivalence (807.92(A)(3)) - 1. Predicate Device: DRI® Methadone Metabolite Enzyme Immunoassay - 2. Predicate Company: Microgenics - 3. Predicate K Number: K023617 {4}------------------------------------------------ Image /page/4/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 or details in the image. The font is sans-serif and the letters are bold. - E. Device Description - The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. 1. The antibody/ substrate reagent includes recombinant fab antibodies to EDDP. glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes EDDP derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. - 2. All of the Immunalysis EDDP Calibrators and Controls are liquid and ready to use. These calibrators and controls do not have any especially unique technical characteristics. 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, and LOW Control 3 and HIGH Control 3 are prepared by spiking known concentrations of EDDP into the negative calibrator matrix. These five calibrators and six controls are sold as individual bottles. The concentration of EDDP in their corresponding calibrators and controls are summarized as follows: | Analyte | EDDP Calibrators | | | | EDDP Controls | | EDDP Controls | | EDDP Controls | | |--------------|------------------|---------|---------|---------|---------------|----------------|---------------|----------------|---------------|----------------| | | Level 1 | Level 2 | Level 3 | Level 4 | LOW Control 1 | HIGH Control 1 | LOW Control 2 | HIGH Control 2 | LOW Control 3 | HIGH Control 3 | | EDDP (ng/mL) | 100 | 300 | 500 | 1000 | 75 | 125 | 225 | 375 | 750 | 1250 | esponding Calibrators and Controls are Summarized as follows: Table 1: Immunoassay EDDP Urine Calibrators and Controls ### F. Intended Use - The Immunalysis EDDP Specific Urine Enzyme Immunoassay is a homogeneous 1. enzyme immunoassay with cutoffs of 100ng/mL, 300ng/mL and 1000ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of EDDP in human urine with automated clinical chemistry analyzers. The 100ng/mL and 300ng/mL cutoff is for qualitative and semi-quantitative analysis. The 1000ng/mL cutoff is for qualitative analysis only. This assay is calibrated against EDDP. 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 EDDP Specific 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 {5}------------------------------------------------ Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/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. - 2. Immunalysis EDDP Urine Controls The Immunalysis EDDP Urine Controls are used as control materials in Immunalysis EDDP Specific Urine Enzyme Immunoassay. - 3. Immunalysis EDDP Urine Calibrators The Immunalysis EDDP Urine Calibrators are used as calibrators in the Immunalysis EDDP Specific Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of EDDP in urine on automated clinical chemistry analyzers. | Item | EDDP Assay K023617 | Immunalysis EDDP Specific Urine EIA | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | For the qualitative and semi- quantitative determination of the presence of EDDP in human urine at a cutoff of 300ng/mL and 1000ng/mL | For the qualitative and semi-quantitative determination of the presence of EDDP in human urine at a cutoff of 100ng/mL, 300ng/mL and 1000ng/mL | | Type of Product | Analytical Reagents | Analytical Reagents | | Measured Analytes | EDDP | EDDP | | Test Matrix | Urine | Urine | | Cutoff Levels | 300ng/mL and 1000ng/mL of EDDP | 100ng/mL, 300ng/mL and 1000ng/mL of EDDP | | Test System | Homogeneous Enzyme Immunoassay | Homogenous Enzyme Immunoassay | | 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 | | Antibodv | Mouse Monoclonal antibodies to EDDP | Recombinant antibody to EDDP | | Storage | 2 - 8°C until expiration date | 2 – 8°C until expiration date | | Calibrator Form | Liquid | Liquid | | Calibrator Levels | Four (4) Levels | Four (4) Levels | | Control Levels | Four (4) Levels | Six (6) Levels | G. Comparison of the new device with the predicate device - H. The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis EDDP Specific Urine Enzyme Immunoassay to the predicate {6}------------------------------------------------ ## IMMUNALYSIS - 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. | a. The following is a summary table of the Qualitative Analysis for the | |-------------------------------------------------------------------------| | 100ng/mL cutoff test data results. | | Table 2 - Qualitative Analysis (for 100ng/mL cutoff) | | | | |------------------------------------------------------|-------------|---------------------|-------------------------| | Concentration (ng/mL) | % of cutoff | # of determinations | Result | | 0 | -100% | 80 | 80 Negative | | 25 | -75% | 80 | 80 Negative | | 50 | -50% | 80 | 80 Negative | | 75 | -25% | 80 | 80 Negative | | 100 | Cutoff | 80 | 43 Negative/37 Positive | | 125 | +25% | 80 | 80 Positive | | 150 | +50% | 80 | 80 Positive | | 175 | +75% | 80 | 80 Positive | | 200 | +100% | 80 | 80 Positive | 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 | 40 Negative / 40 Positive | | 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 1000ng/mL cutoff test data results. | Table 4 - Qualitative Analysis (for 1000 ng/mL cutoff) | | | | |--------------------------------------------------------|-------------|---------------------|---------------------------| | Concentration (ng/mL) | % of cutoff | # of determinations | Result | | 0 | -100% | 80 | 80 Negative | | 250 | -75% | 80 | 80 Negative | | 500 | -50% | 80 | 80 Negative | | 750 | -25% | 80 | 80 Negative | | 1000 | Cutoff | 80 | 46 Negative / 34 Positive | | 1250 | +25% | 80 | 80 Positive | | 1500 | +50% | 80 | 80 Positive | | 1750 | +75% | 80 | 80 Positive | | 2000 | +100% | 80 | 80 Positive | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "IMMUNALYSIS" 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 the overall image has a simple and clean design. The word is centered in the image. | Table 5 - Semi-Quantitative Analysis (for 100ng/mL cutoff) | | | | |------------------------------------------------------------|-------------|---------------------|---------------------------| | Concentration (ng/mL) | % of cutoff | # of determinations | Result | | 0 | -100% | 80 | 80 Negative | | 25 | -75% | 80 | 80 Negative | | 50 | -50% | 80 | 80 Negative | | 75 | -25% | 80 | 80 Negative | | 100 | Cutoff | 80 | 10 Negative / 70 Positive | | 125 | +25% | 80 | 80 Positive | | 150 | +50% | 80 | 80 Positive | | 175 | +75% | 80 | 80 Positive | | 200 | +100% | 80 | 80 Positive | d. The following is a summary table of the Semi-Quantitative Analysis for the 100ng/mL cutoff test data results. e. The following is a summary table of the Semi-Quantitative Analysis for the 300ng/mL cutoff test data results. | Table 6 - 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 | 13 Negative / 67 Positive | | 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 100ng/mL cutoff is outlined below: | Table 7 - Structurally Related Compounds (for 100 ng/mL cutoff) - Qualitative | | | | |-------------------------------------------------------------------------------|------------------------------|----------|----------------------| | Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) | | EDDP | 100 | Positive | 100 | | Methadone | 700,000 | Positive | 0.01 | | EMDP | 1,000,000 | Negative | <0.01 | | Chlorpromazine | 90,000 | Positive | 0.11 | | Diphenhydramine | 1,000,000 | Positive | 0.01 | | Methylphenidate | 100,000 | Positive | 0.10 | | Doxylamine | 1,000,000 | Negative | <0.01 | | LAAM | 1,000,000 | Negative | <0.01 | | (±)-alpha methadol | 1,000,000 | Positive | 0.01 | {8}------------------------------------------------ Image /page/8/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. | Table 7 - Structurally Related Compounds (for 100 ng/mL cutoff) - Qualitative | | | | |-------------------------------------------------------------------------------|------------------------------|----------|----------------------| | Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) | | (-)-iso-methadone | 100,000 | Negative | <0.1 | b. The qualitative result summary table for the 300ng/mL cutoff is outlined below: | Table 8 - Structurally Related Compounds (for 300 ng/mL cutoff) - Qualitative | | | | |-------------------------------------------------------------------------------|------------------------------|----------|----------------------| | Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) | | EDDP | 300 | Positive | 100 | | Methadone | 1,000,000 | Negative | <0.03 | | EMDP | 1,000,000 | Negative | <0.03 | | Chlorpromazine | 300,000 | Positive | 0.1 | | Diphenhydramine | 1,000,000 | Negative | <0.03 | | Methylphenidate | 360,000 | Positive | 0.08 | | Doxylamine | 1,000,000 | Negative | <0.03 | | LAAM | 1,000,000 | Negative | <0.03 | | (±)-alpha methadol | 1,000,000 | Negative | <0.03 | | (-)-iso-methadone | 100,000 | Negative | <0.3 | - c. The semi-quantitative result summary table for the 1000ng/mL cutoff is outlined below: | Table 9 - Structurally Related Compounds (for 1000 ng/mL cutoff) - Qualitative | | | | |--------------------------------------------------------------------------------|------------------------------|----------|----------------------| | Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) | | EDDP | 1,000 | Positive | 100 | | Methadone | 1,000,000 | Negative | <0.1 | | EMDP | 1,000,000 | Negative | <0.1 | | Chlorpromazine | 1,000,000 | Negative | <0.1 | | Diphenhydramine | 1,000,000 | Negative | <0.1 | | Methylphenidate | 1,000,000 | Negative | <0.1 | | Doxylamine | 1,000,000 | Negative | <0.1 | | LAAM | 1,000,000 | Negative | <0.1 | | (±)-alpha methadol | 1,000,000 | Negative | <0.1 | | (-)-iso-methadone | 100,000 | Negative | <1.0 | - d. The semi-quantitative result summary table for the 100ng/mL cutoff is outlined below: | Table 10 - Structurally Related Compounds (for 100ng/mL cutoff) - Semi- | | | | | |-------------------------------------------------------------------------|------------------------------|----------|----------------------|--| | Quantitative | | | | | | Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) | | | EDDP | 100 | Positive | 100 | | | Methadone | 700.000 | Positive | 0.01 | | | EMDP | 1,000,000 | Negative | <0.01 | | | Chlorpromazine | 90,000 | Positive | 0.11 | | | Diphenhydramine | 1,000,000 | Positive | 0.01 | | | Methylphenidate | 100,000 | Positive | 0.10 | | | Doxylamine | 1,000,000 | Negative | <0.01 | | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains 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 background is a solid red color, and the letters are a bright white color. The image is simple and easy to read. | Table 10 - Structurally Related Compounds (for 100ng/mL cutoff) – Semi- | | | | |-------------------------------------------------------------------------|------------------------------|----------|----------------------| | Quantitative | | | | | Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) | | LAAM | 1,000,000 | Negative | <0.01 | | (±)-alpha methadol | 1,000,000 | Positive | 0.0001 | | (-)-iso-methadone | 100,000 | Negative | <0.1 | - e. The semi-quantitative result summary table for the 300ng/mL cutoff is outlined below: | Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) | |--------------------|------------------------------|----------|----------------------| | EDDP | 300 | Positive | 100 | | Methadone | 1,000,000 | Negative | <0.03 | | EMDP | 1,000,000 | Negative | <0.03 | | Chlorpromazine | 300,000 | Positive | 0.1 | | Diphenhydramine | 1,000,000 | Negative | <0.03 | | Methylphenidate | 360,000 | Positive | 0.08 | | Doxylamine | 1,000,000 | Negative | <0.03 | | LAAM | 1,000,000 | Negative | <0.03 | | (±)-alpha methadol | 1,000,000 | Negative | <0.03 | | (-)-iso-methadone | 100,000 | Negative | <0.3 | - 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 100ng/mL cutoff: | Table 12 - Structurally Non-Similar Compounds (for 100ng/mL cutoff) | | | | | | |---------------------------------------------------------------------|------------------------------------|------------------------------------|-------------------------------------------|-------------------------------------|--------------------------------------------| | | Concentration | -25% Cutoff | | +25% Cutoff | | | Compound | Tested | (75ng/mL) | | (125ng/mL) | | | | (ng/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 | | 6-Acetylcodeine | 100,000 | Negative | No | Positive | No | | 6-Acetylmorphine | 100,000 | Negative | No | Positive | No | | Alprazolam | 100,000 | Negative | No | Positive | No | | 7-Aminoclonazepam | 100,000 | Negative | No | Positive | No | | 7-Aminoflurnitrazepam | 100,000 | Negative | No | Positive | No | | 7-Aminonitrazepam | 100,000 | Negative | No | Positive | No | | Amitriptyline | 100,000 | Negative | No | Positive | No | | Table 12 - Structurally Non-Similar Compounds (for 100ng/mL cutoff) | | | | | | | | Concentration | -25% Cutoff | | +25% Cutoff | | | Compound | Tested | (75ng/mL) | | (125ng/mL) | | | | (ng/mL) | Result | Interference? | Result | Interference? | | 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 | 75,000 | Negative | No | Positive | No | | Carbamazepine | 100,000 | Negative | No | Positive | No | | Carisoprodol | 100,000 | Negative | No | Positive | No | | Chlordiazepoxide | 100,000 | Negative | No | Positive | No | | cis-Tramadol | 100,000 | Negative | No | Positive | No | | Clobazam | 100,000 | Negative | No | Positive | No | | Clomipramine | 50,000 | 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 | | Demoxepam | 100,000 | Negative | No | Positive | No | | Desipramine | 30,000 | Negative | No | Positive | No | | Desalkylflurazepam | 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 | | v, THC | 100,000 | Negative | No | Positive | No | | Doxepin | 100,000 | Negative | No | Positive | No | | 1R,2S (-) Ephedrine | 100,000 | Negative | No | Positive | No | | 1S,2R (+) Ephedrine | 100,000 | Negative | No | Positive | No | | Ethyl-ß-D-Glucuronide | 100,000 | Negative | No | Positive | No | | Ethylmorphine | 100,000 | Negative | No | Positive | No | | Fenfluramine | 100,000 | Negative | No | Positive | No | | Fentanyl | 100,000 | Negative | No | Positive | No | | Flunitrazepam | 100,000 | Negative | No | Positive | No | | 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 | | Table 12 - Structurally Non-Similar Compounds (for 100ng/mL cutoff) | | | | | | | Compound | Concentration Tested (ng/mL) | -25% Cutoff (75ng/mL) Result | -25% Cutoff (75ng/mL) Interference? | +25% Cutoff (125ng/mL) Result | +25% Cutoff (125ng/mL) Interference? | | Hexobarbital | 100,000 | Negative | No | Positive | No | | Hydrocodone | 100,000 | Negative | No | Positive | No | | Hydromorphone | 100,000 | Negative | No | Positive | No | | 11-hydroxy- Δ9 THC | 100,000 | Negative | No | Positive | No | | Ibuprofen | 500,000 | Negative | No | Positive | No | | Imipramine | 50,000 | Negative | No | Positive | No | | Ketamine | 100,000 | Negative | No | Positive | No | | Lamotrigine | 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 | | Lormetrazepam | 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 | 50,000 | Negative | No | Positive | No | | Meprobamate | 100,000 | Negative | No | Positive | No | | S(+)-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 | | Midazolam | 100,000 | Negative | No | Positive | No | | Morphine | 100,000 | Negative | No | Positive | No | | Morphine-3β-D-Glucuronide | 100,000 | Negative | No | Positive | No | | Morphine-6β-D-Glucuronide | 50,000 | Negative | No | Positive | No | | N-Desmethyltapentadol | 100,000 | Negative | No | Positive | No | | Nalorphine | 100,000 | Negative | No | Positive | No | | Naloxone | 100,000 | Negative | No | Positive | No | | Naltrexone | 100,000 | Negative | No | Positive | No | | Naproxen | 100,000 | Negative | No | Positive | No | | Nitrazepam | 100,000 | Negative | No | Positive | No | | 11-nor-9-carboxy -Δ9-THC | 100,000 | Negative | No | Positive | No | | 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 | | Table 12 - Structurally Non-Similar Compounds (for 100ng/mL cutoff) | | | | | | | Compound | Concentration Tested (ng/mL) | -25% Cutoff (75ng/mL) Result | -25% Cutoff (75ng/mL) Interference? | +25% Cutoff (125ng/mL) Result | +25% Cutoff (125ng/mL) Interference? | | 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 | 50,000 | 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 | 30,000 | Negative | No | Positive | No | | Trazodone | 100,000 | Negative | No | Positive | No | | Triazolam | 100,000 | Negative | No | Positive…