What is the regulatory pathway for Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators?

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

What are the predicate devices for Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators?

DRI Phencyclidines Assay (K935320); LZI Multiple Analyte Drugs of Abuse Calibrators and Controls (K051088).

Who can help prepare an FDA 510(k) submission like Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators?

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.

Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

Q: Who is the manufacturer of Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators?

Immunalysis Corporation filed the 510(k) submission for Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (K152176).

Q: What is the FDA product code for Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators?

LCM. as a Class U device in the TX panel.

K152176 · Immunalysis Corporation · LCM · Sep 4, 2015 · TX

Device Facts

Record ID	K152176
Device Name	Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
Applicant	Immunalysis Corporation
Product Code	LCM · TX
Decision Date	Sep 4, 2015
Decision	SESE
Submission Type	Traditional
Device Class	Class U

Intended Use

The Immunalysis PCP Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 25ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of PCP in human urine with automated clinical chemistry analyzers. This assay is calibrated against PCP. 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 Gas Chromatography/ Mass Spectrometry (GC-MS) or permitting laboratories to establish quality control procedures. The Immunalysis PCP 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. 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 Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Morphine and PCP. The calibrators are designed for prescription use with immunoassays.

Device Story

Device is a homogeneous enzyme immunoassay for PCP detection in human urine. Input: human urine samples. Principle: competitive binding between drug in sample and enzyme-labeled drug conjugate for recombinant PCP antibodies; enzyme activity (G6PDH) measured via clinical chemistry analyzer. Output: qualitative (positive/negative at 25ng/mL cutoff) or semi-quantitative results. Used in clinical laboratories by technicians/scientists. Output used by clinicians to identify potential drug presence, requiring confirmation by GC-MS or LC/MS. Benefits: rapid preliminary screening for PCP abuse.

Clinical Evidence

Bench testing only. Precision study (N=80) at ±25%, ±50%, ±75%, ±100% of cutoff. Specificity/cross-reactivity tested against structurally similar and non-similar compounds. Interference tested for endogenous compounds, pH, specific gravity, and boric acid. Linearity/recovery verified. Method comparison against LC/MS (N=80) showed 100% agreement for both qualitative and semi-quantitative modes.

Technological Characteristics

Homogeneous enzyme immunoassay. Reagents: recombinant PCP antibodies, G6P, NAD, and PCP-derivative labeled with G6PDH in Tris buffer with sodium azide. Calibrators: liquid, ready-to-use synthetic urine matrix. Analyzers: automated clinical chemistry (e.g., Beckman Coulter AU 400e). Storage: 2-8°C.

Indications for Use

Indicated for qualitative and semi-quantitative analysis of PCP in human urine. Intended for laboratory use with automated clinical chemistry analyzers. Prescription use only.

Predicate Devices

DRI Phencyclidines Assay (K935320)
LZI Multiple Analyte Drugs of Abuse Calibrators and Controls (K051088)

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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" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked one behind the other, creating a sense of depth and unity. 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 II 829 TOWNE CENTER DRIVE POMONA CA 91767 September 4, 2015 Re: K152176 Trade/Device Name: Immunalysis PCP Urine Enzyme Immunoassay and Immunalysis Multi-Drug Calibrators Regulation Number: 21 CFR 862.3100 Regulatory Class: Unclassified Product Code: LCM. DKB Dated: August 3, 2015 Received: August 4, 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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, 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)K152176 #### Device Name Immunalysis PCP Urine Enzyme Immunoassay and Immunalysis Multi-Drug Calibrators Indications for Use (Describe) The Immunalysis PCP Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 25ng/mL. The assay is intended for use in laboratories for the qualitative analysis of PCP in human urine with automated clinical chemistry analyzers. This assay is callbrated against PCP. 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 Gas Chromatography/ Mass Spectrometry (GC-MS) or permitting laboratories to establish quality control procedures. The Immunalysis PCP 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. 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 Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Morphine and PCP. The calibrators are designed for prescription use with immunoassays. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters on a red background. The letters are bold and sans-serif. The background is a solid red color, and the word is centered on the background. ## 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: | September 3, 2015 | | B. Device Information | | | | 1. | Trade Name: | Immunalysis PCP Urine Enzyme Immunoassay Immunalysis Multi-Drug Calibrators | | 2. | Common Name: | Immunalysis PCP Urine Enzyme Immunoassay Immunalysis Multi-Drug Calibrators | | C. Regulatory Information | | | | 1. | 510(k) Number: | K152176 | | 2. | Device Classification: | Unclassified | | 3. | Regulation Section: | Enzyme Immunoassay, Phencyclidine CFR 862.3200 Clinical Toxicology Calibrator | | 4. | Panel: | Toxicology(91) | | 5. | Product Code: | LCM DKB | D. Legally Marketed Device to Which We are Claiming Equivalence (807.92(A)(3)) | 1. Predicate Device: | DRI Phencyclidines Assay LZI Multiple Analyte Drugs of Abuse Calibrators and Controls | |------------------------|---------------------------------------------------------------------------------------------| | 2. Predicate Company: | Diagnostic Reagents Inc. Lin-Zhi International, Inc. | | 3. Predicate K Number: | K935320 K051088 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters against a red background. The letters are bold and slightly blurred, giving them a soft, glowing effect. The red background is solid and uniform, providing a stark contrast to the white text. - E. Device Description - The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. 1. The antibody/ substrate reagent includes recombinant antibodies to Phencyclidine. glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes phencyclidine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. - 2. All of the Immunalysis Multi-Drug Calibrators 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 drug analyte into the negative calibrator matrix. These five calibrators (negative, Level 1, 2, 3 and 4) are sold as individual bottles. The concentration of drug analyte in the corresponding calibrators are summarized as follows: | Table 1 Immunalysis Multi-Drug Calibrators | | | | | |--------------------------------------------|------------------------|----------|----------|-----------| | Analyte | Multi-Drug Calibrators | | | | | | Level 1 | Level 2 | Level 3 | Level 4 | | Benzoylecgonine | 150ng/mL | 300ng/mL | 500ng/mL | 1000ng/mL | | Morphine | 100ng/mL | 300ng/mL | 500ng/mL | 1000ng/mL | | PCP | 12.5ng/mL | 25ng/mL | 50ng/mL | 100ng/mL | - F. Intended Use - 1. Immunalysis PCP Urine Enzyme Immunoassay The Immunalysis PCP Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 25ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of PCP in human urine with automated clinical chemistry analyzers. This assay is calibrated against PCP. 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 Gas Chromatography/ Mass Spectrometry (GC-MS) or permitting laboratories to establish quality control procedures. The Immunalysis PCP 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. 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. - 2. Immunalysis Multi-Drug Calibrators The Immunalysis Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Morphine and PCP. The calibrators are designed for prescription use with immunoassays. {5}------------------------------------------------ Image /page/5/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. - G. Comparison of the new device with the predicate device | Item | PCP Assay K935320 | Immunalysis PCP Urine EIA | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------| | Intended Use | For the qualitative and semi- quantitative determination of the presence of PCP in human urine at a cutoff of 25ng/mL | Same | | Type of Product | Analytical Reagents | Same | | Measured Analytes | PCP | Same | | Test Matrix | Urine | Same | | Cutoff Levels | 25ng/mL of PCP | Same | | Test System | Homogeneous Enzyme Immunoassay | Same | | Materials | Liquid Ready-to-Use Two Reagent Assay (R1 and R2) | Antibody/Substrate Reagents and Enzyme Labeled Conjugate | | Mass Spectroscopy Confirmation | Required for preliminary positive analytical results | Same | | Antibody | Monoclonal antibodies to PCP | Recombinant antibody to PCP | | Storage | 2 - 8°C until expiration date | Same | | Item | LZI Multiple Analyte K051088 | Immunalysis Multi-Drug Calibrators | |-------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | Analyte | benzoylecgonine, d- methamphetamine, methadone, morphine, oxazepam, secobarbital, phencyclidine, propoxyphene | benzoylecgonine, morphine, phencyclidine | | Matrix | Urine | Same | | Calibrator Levels | 5 Levels – See Table 2 Below | 4 Levels (Negative and Level 1, 2, 3 and 4) - See Device Description Table 1 | | Storage | 2 – 8°C until expiration date | Same | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a red rectangle with the word "IMMUNALYSIS" in white letters. The letters are bolded and slightly blurred. The red background is a solid color. - H. The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Phencyclidine Enzyme Immunoassay to the predicate - 1. Precision/Cutoff Characterization Study was performed for 20 days, 2 runs per day in duplicate (N=80) on concentration of ±25%, ±50%, ±75%, and ±100% of the cutoff. The study verified that the cutoff serves as a boundary between a negative and positive interpretation of a qualitative result. The instruments used for this was Beckman Coulter AU 400e. a. The following is a summary table of the Qualitative Analysis for the 25ng/mL cutoff test data results | Table 3 - Qualitative Analysis (for 25ng/mL cutoff) | | | | |-----------------------------------------------------|----------------|------------------------|-------------------------| | Concentration (ng/mL) | % of cutoff | # of determinations | Result | | 0 | -100% | 80 | 80 Negative | | 6.25 | -75% | 80 | 80 Negative | | 12.5 | -50% | 80 | 80 Negative | | 19 | -25% | 80 | 80 Negative | | 25 | Cutoff | 80 | 35 Negative/45 Positive | | 31 | +25% | 80 | 80 Positive | | 37.5 | +50% | 80 | 80 Positive | | 43.75 | +75% | 80 | 80 Positive | | 50 | +100% | 80 | 80 Positive | b. The following is a summary table of the Semi-Quantitative Analysis for the 25ng/mL cutoff test data results | Table 4 - Semi-Quantitative Analysis (for 25ng/mL cutoff) | | | | |-----------------------------------------------------------|-------------|------------------------|-------------------------| | Concentration (ng/mL) | % of cutoff | # of determinations | Result | | 0 | -100% | 80 | 80 Negative | | 6.25 | -75% | 80 | 80 Negative | | 12.5 | -50% | 80 | 80 Negative | | 19 | -25% | 80 | 80 Negative | | 25 | Cutoff | 80 | 30 Negative/50 Positive | | 31 | +25% | 80 | 80 Positive | | 37.5 | +50% | 80 | 80 Positive | | 43.75 | +75% | 80 | 80 Positive | | 50 | +100% | 80 | 80 Positive | {7}------------------------------------------------ ### IMMUNALYSIS - 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 cutoff. 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 25ng/mL cutoff is outlined | | | |----------------------------------------------------------------------------|--|--| | below: | | | | Table 5 - Structurally Related Compounds (for 25 ng/mL cutoff) - Qualitative | | | | |------------------------------------------------------------------------------|------------------------------|----------|----------------------| | Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) | | PCP | 25 | Positive | 100 | | Chlorpromazine | 140,000 | Positive | 0.01785 | | Clomipramine | 350,000 | Positive | 0.00714 | | Cyclobenzaprine | 25,000 | Positive | 0.10000 | | Dextromethorphan | 80,000 | Positive | 0.03125 | | Diphenhydramine | 220,000 | Positive | 0.01136 | | Doxepin | 90,000 | Positive | 0.02777 | | 4 – Hydroxyphencyclidine | 3,500 | Positive | 0.71429 | | Imipramine | 200,000 | Positive | 0.01250 | | Methoxetamine | 36,000 | Positive | 0.06944 | | Thioridazine | 140,000 | Positive | 0.01785 | | Venlafaxine | 1,000,000 | Positive | 0.00250 | b. The semi-quantitative result summary table for the 25ng/mL cutoff is outlined below: | Table 6 - Structurally Related Compounds (for 25ng/mL cutoff) – Semi-Quantitative | | | | |-----------------------------------------------------------------------------------|------------------------------|------------|----------------------| | Compound | Concentration Tested (ng/mL) | Mean Value | Cross-Reactivity (%) | | PCP | 25 | 26.7 | 100 | | Chlorpromazine | 140,000 | 25.9 | 0.01785 | | Clomipramine | 350,000 | 24.8 | 0.00714 | | Cyclobenzaprine | 25,000 | 24.9 | 0.10000 | | Dextromethorphan | 80,000 | 24.1 | 0.03125 | | Diphenhydramine | 220,000 | 26.6 | 0.01136 | | Doxepin | 90,000 | 27.1 | 0.02777 | | 4 – Hydroxyphencyclidine | 3,500 | 25.6 | 0.71429 | | Imipramine | 200,000 | 26.4 | 0.01250 | | Methoxetamine | 36,000 | 25.9 | 0.06944 | | Thioridazine | 140,000 | 25.4 | 0.01785 | | Venlafaxine | 1,000,000 | 23.9 | 0.00250 | - 3. Interference Structurally non-similar compounds, endogenous compounds, the effect of pH, the effect of specific gravity and boric acid 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. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters on a red background. The word is centered in the image and is written in all capital letters. The red background is in the shape of a horizontal arrow. | Table 7 - Structurally Non-Similar Compounds (for 25ng/mL cutoff) | | | | | | |-------------------------------------------------------------------|------------------------------------|---------------------------------|----------------------------------------|---------------------------------|----------------------------------------| | | Concentration | -25% Cutoff (19ng/mL) | | +25% Cutoff (31ng/mL) | | | Compound | Tested (ng/mL) | Result | Interference? | Result | Interference? | | Acetaminophen | 500000 | Negative | No | Positive | No | | 6-Acetylcodeine | 100000 | Negative | No | Positive | No | | 6-Acetylmorphine | 100000 | Negative | No | Positive | No | | Acetylsalicylic Acid | 500000 | Negative | No | Positive | No | | Alprazolam | 100000 | Negative | No | Positive | No | | 7-Aminoclonazepam | 100000 | Negative | No | Positive | No | | 7-Aminoflurnitrazepam | 100000 | Negative | No | Positive | No | | 7-Aminonitrazepam | 100000 | Negative | No | Positive | No | | Amitriptyline | 70000 | Negative | No | Positive | No | | Amobarbital | 100000 | Negative | No | Positive | No | | S-(+)-Amphetamine | 100000 | Negative | No | Positive | No | | Benzylpiperzine | 100000 | Negative | No | Positive | No | | Bromazepam | 100000 | Negative | No | Positive | No | | 4-bromo 2-5, dimethoxyphenethylamine | 100000 | Negative | No | Positive | No | | Buprenorphine | 100000 | Negative | No | Positive | No | | Bupropion | 100000 | Negative | No | Positive | No | | Butabarbital | 100000 | Negative | No | Positive | No | | Butalbital | 100000 | Negative | No | Positive | No | | Caffeine | 500000 | Negative | No | Positive | No | | Cannabidiol | 100000 | Negative | No | Positive | No | | Cannabinol | 100000 | Negative | No | Positive | No | | Carbamazepine | 100000 | Negative | No | Positive | No | | Carisoprodol | 100000 | Negative | No | Positive | No | | Chlordiazepoxide | 100000 | Negative | No | Positive | No | | cis-Tramadol | 100000 | Negative | No | Positive | No | | Clobazam | 100000 | Negative | No | Positive | No | | Clonazepam | 100000 | Negative | No | Positive | No | | Clozapine | 100000 | Negative | No | Positive | No | | Codeine | 100000 | Negative | No | Positive | No | | Cotinine | 100000 | Negative | No | Positive | No | | Demoxepam | 100000 | Negative | No | Positive | No | | Desalkyflurazepam | 100000 | Negative | No | Positive | No | | Desipramine | 100000 | Negative | No | Positive | No | | Diazepam | 100000 | Negative | No | Positive | No | | Digoxin | 100000 | Negative | No | Positive | No | | Dihydrocodeine | 100000 | Negative | No | Positive | No | | Dehydronorketamine | 100000 | Negative | No | Positive | No | | \$\\Delta^9\$THC | 100000 | Negative | No | Positive | No | | Table 7 - Structurally Non-Similar Compounds (for 25ng/mL cutoff) | | | | | | | Compound | Concentration Tested (ng/mL) | -25% Cutoff (19ng/mL) Result | -25% Cutoff (19ng/mL) Interference? | +25% Cutoff (31ng/mL) Result | +25% Cutoff (31ng/mL) Interference? | | EDDP | 100000 | Negative | No | Positive | No | | EDMP | 100000 | Negative | No | Positive | No | | 1R,2S Ephedrine | 100000 | Negative | No | Positive | No | | 1S,2R Ephedrine | 100000 | Negative | No | Positive | No | | Ethyl-ẞ-D-Glucuronide | 100000 | Negative | No | Positive | No | | Ethylmorphine | 100000 | Negative | No | Positive | No | | Fenfluramine | 100000 | Negative | No | Positive | No | | Fentanyl | 100000 | Negative | No | Positive | No | | Flunitrazepam | 100000 | Negative | No | Positive | No | | Fluoxetine | 100000 | Negative | No | Positive | No | | Flurazepam | 100000 | Negative | No | Positive | No | | Haloperidol | 100000 | Negative | No | Positive | No | | Heroin | 100000 | Negative | No | Positive | No | | Hexobarbital | 100000 | Negative | No | Positive | No | | Hydrocodone | 100000 | Negative | No | Positive | No | | Hydromorphone | 100000 | Negative | No | Positive | No | | 11-hydroxy-△' THC | 100000 | Negative | No | Positive | No | | Ibuprofen | 500000 | Negative | No | Positive | No | | Ketamine | 100000 | Negative | No | Positive | No | | Lamotrigine | 100000 | Negative | No | Positive | No | | Levorphanol Tartrate | 100000 | Negative | No | Positive | No | | Lidocaine | 100000 | Negative | No | Positive | No | | Lorazepam | 100000 | Negative | No | Positive | No | | Lorazepam Glucuronide | 50000 | Negative | No | Positive | No | | Lormetazepam | 100000 | Negative | No | Positive | No | | LSD | 100000 | Negative | No | Positive | No | | Maprotiline | 100000 | Negative | No | Positive | No | | MDA | 100000 | Negative | No | Positive | No | | MDEA | 100000 | Negative | No | Positive | No | | MDMA | 100000 | Negative | No | Positive | No | | Meperidine | 100000 | Negative | No | Positive | No | | Meprobamate | 100000 | Negative | No | Positive | No | | Methadone | 100000 | Negative | No | Positive | No | | Methylphenidate | 100000 | Negative | No | Positive | No | | R(-)-Methamphetamine | 100000 | Negative | No | Positive | No | | S(+)-Methamphetamine | 100000 | Negative | No | Positive | No | | Methaquolone | 100000 | Negative | No | Positive | No | | Methylone | 100000 | Negative | No | Positive | No | | Midazolam | 100000 | Negative | No | Positive | No | | Morphine | 100000 | Negative | No | Positive | No | | Morphine-3- ẞ-Glucuronide | 100000 | Negative | No | Positive | No | | Morphine-6ẞ-D-Glucuronide | 50000 | Negative | No | Positive | No | | Table 7 - Structurally Non-Similar Compounds (for 25ng/mL cutoff) | | | | | | | Compound | Concentration Tested (ng/mL) | -25% Cutoff (19ng/mL) Result | -25% Cutoff (19ng/mL) Interference? | +25% Cutoff (31ng/mL) Result | +25% Cutoff (31ng/mL) Interference? | | N-Desmethyltapentadol | 100000 | Negative | No | Positive | No | | Nalorphine | 100000 | Negative | No | Positive | No | | Naloxone | 100000 | Negative | No | Positive | No | | Naltrexone | 100000 | Negative | No | Positive | No | | Naproxen | 100000 | Negative | No | Positive | No | | Nitrazepam | 100000 | Negative | No | Positive | No | | 11-nor-9-carboxy-Δ9-THC | 100000 | Negative | No | Positive | No | | Norbuprenorphine | 50000 | Negative | No | Positive | No | | Norcodeine | 100000 | Negative | No | Positive | No | | Nordiazepam | 100000 | Negative | No | Positive | No | | Norketamine | 100000 | Negative | No | Positive | No | | Normorphine | 100000 | Negative | No | Positive | No | | Norproxyphene | 100000 | Negative | No | Positive | No | | Norpseudoephedrine | 100000 | Negative | No | Positive | No | | Nortriptyline | 100000 | Negative | No | Positive | No | | Olanzapine | 100000 | Negative | No | Positive | No | | Oxazepam | 100000 | Negative | No | Positive | No | | Oxycodone | 100000 | Negative | No | Positive | No | | Oxymorphone | 100000 | Negative | No | Positive | No | | Pentazocine | 100000 | Negative | No | Positive | No | | Pentobarbital | 100000 | Negative | No | Positive | No | | Phenobarbital | 100000 | Negative | No | Positive | No | | Phentermine | 100000 | Negative | No | Positive | No | | Phenylephrine | 100000 | Negative | No | Positive | No | | Phenylpropanolamine | 100000 | Negative | No | Positive | No | | Phenytoin | 100000 | Negative | No | Positive | No | | PMA | 100000 | Negative | No | Positive | No | | Prazepam | 100000 | Negative | No | Positive | No | | Propoxyphene | 100000 | Negative | No | Positive | No | | Propranolol | 100000 | Negative | No | Positive | No | | Protripyline | 100000 | Negative | No | Positive | No | | R,R Pseudoephedrine | 100000 | Negative | No | Positive | No | | S,S Pseudoephedrine | 100000 | Negative | No | Positive | No | | Ranitidine | 100000 | Negative | No | Positive | No | | Ritalinic Acid | 100000 | Negative | No | Positive | No | | Salicylic Acid | 100000 | Negative | No | Positive | No | | Secobarbital | 100000 | Negative | No | Positive | No | | Sertraline | 100000 | Negative | No | Positive | No | | Sufentanil Citrate | 50000 | Negative | No | Positive | No | | Tapentadol | 100000 | Negative | No | Positive | No | | Temazepam | 100000 | Negative | No | Positive | No | | Theophylline | 100000 | Negative | No | Positive | No | | Table 7 - Structurally Non-Similar Compounds (for 25ng/mL cutoff) | | | | | | | Compound | Concentration Tested (ng/mL) | -25% Cutoff (19ng/mL) Result | -25% Cutoff (19ng/mL) Interference? | +25% Cutoff (31ng/mL) Result | +25% Cutoff (31ng/mL) Interference? | | Triazolam | 100000 | Negative | No | Positive | No | | Trifluoromethylphenyl- piperazine | 100000 | Negative | No | Positive | No | | Trimipramine | 100000 | Negative | No | Positive | No | | Verapamil | 60000 | Negative | No | Positive | No | | Zolpidem Tartrate | 100000 | Negative | No | Positive | No | a. The following is a table of the structurally non-similar compounds for the 25ng/mL cutoff {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains 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 appears to be a rectangle with rounded corners. {10}------------------------------------------------ Image /page/10/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. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image contains the word "IMMUNALYSIS" in white letters against a red background. The word is written in all capital letters and appears to be bolded. The red background is a solid color, and the white letters stand out against it. b.The following is a table of the endogenous compounds results for the 25ng/mL cutoff | Table 8 - Endogenous Compounds (for 25ng/mL cutoff) | | | | | | |------------------------------------------------------------------------------|------------------------------|------------------------------|---------------|------------------------------|---------------| | Compound | Concentration Tested (ng/mL) | -25% Cutoff (19ng/mL) Result | Interference? | +25% Cutoff (31ng/mL) Result | Interference? | | Acetone | 1.0 g/dL | Negative | No | Positive | No | | Ascorbic Acid | 1.5 g/dL | Negative | No | Positive | No | | Bilirubin | 0.002 g/dL | Negative | No | Positive | No | | Creatinine | 0.5 g/dL | Negative | No | Positive | No | | Ethanol | 1.0 g/dL | Negative | No | Positive | No | | Galactose | 0.01 g/dL | Negative | No | Positive | No | | y-Globulin | 0.5 g/dL | Negative | No | Positive | No | | Glucose | 2.0 g/dL | Negative | No | Positive | No | | Hemoglobin | 0.115 g/dL | Negative | No | Positive | No | | Human Serum Albumin | 0.5 g/dL | Negative | No | Positive | No | | Oxalic Acid | 0.1 g/dL | Negative | No | Positive | No | | Riboflavin | 0.0075 g/dL | Negative | No | Positive | No | | Sodium Azide | 1% w/v | Negative | No | Positive | No | | Sodium Chloride | 6.0 g/dL | Negative | No | Positive | No | | Sodium Fluoride | 1% w/v | Negative | No | Positive | No | | Urea | 6.0 g/dL | Negative | No | Positive | No | | c. The following is a table of the boric acid for the 25ng/mL cutoff results | | | | | | | Table 9 - Boric Acid (for 25ng/mL cutoff) | | | | | | | Compound | Concentration Tested (ng/mL) | -25% Cutoff (19ng/mL) Result | Interference? | +25% Cutoff (31ng/mL) Result | Interference? | | Boric Acid | 1% w/v | NEG | No | NEG | Yes | | d.The following is a table of the boric acid for the 25ng/mL cutoff results | | | | | | | Table 10 - Boric Acid (for 25ng/mL cutoff) | | | | | | | Compound | Concentration Tested | -50% Cutoff (13ng/mL) Result | Interference? | +50% Cutoff (38ng/mL) Result | Interference? | (ng/mL) 1% w/v Yes NEG e. Boric Acid interferes with the assay and the limitations have been added to the labeling regarding this compound No NEG Boric Acid {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters on a red background. The background is in the shape of a horizontal hexagon. The text is bolded and centered within the shape. | Table 11 - Effect of pH (for 25ng/mL cutoff) | | | | | | |----------------------------------------------|-------|-----------------------|---------------|-----------------------|---------------| | Test Parameter | Value | -25% Cutoff (19ng/mL) | | +25% Cutoff (31ng/mL) | | | | | Result | Interference? | Result | Interference? | | pH | 3.0 | Negative | No | Positive | No | | pH | 4.0 | Negative | No | Positive | No | | pH | 5.0 | Negative | No | Positive | No | | pH | 6.0 | Negative | No | Positive | No | | pH | 7.0 | Negative | No | Positive | No | | pH | 8.0 | Negative | No | Positive | No | | pH | 9.0 | Negative | No | Positive | No | | pH | 10.0 | Negative | No | Positive | No | | pH | 11.0 | Negative | No | Positive | No | # f. The following is a table of the effect of pH results for the 25ng/mL cutoff g.The following is a summary table of the effect of specific gravity results for the 25ng/mL cutoff | Table 12 - Effect of Specific Gravity (for 25ng/mL cutoff) | | | | | | | |------------------------------------------------------------|-------|-----------------------|---------------|-----------------------|---------------|--| | Test Parameter | Value | -25% Cutoff (19ng/mL) | | +25% Cutoff (31ng/mL) | | | | | | Result | Interference? | Result | Interference? | | | Specific Gravity | 1.000 | Negative | No | Positive | No | | | Specific Gravity | 1.002 | Negative | No | Positive | No | | | Specific Gravity | 1.005 | Negative | No | Positive | No | | | Specific Gravity | 1.010 | Negative | No | Positive | No | | | Specific Gravity | 1.015 | Negative | No | Positive | No | | | Specific Gravity | 1.020 | Negative | No | Positive | No | | | Specific Gravity | 1.025 | Negative | No | Positive | No | | | Specific Gravity | 1.030 | Negative | No | Positive | No | | - 4. Linearity/ Recovery A drug free urine pool was spiked with high concentration of the target analyte as a high value specimen. Additional pools were made by serially diluting the high value specimen. The instrument used for this test was a Beckman Coulter AU 400e. a.The following is a summary table of the linearity/recovery: | Table 13 - Linearity/ Recovery | | | |--------------------------------|----------------------------|--------------| | Expected Concentration (ng/mL) | Mean Concentration (ng/mL) | Recovery (%) | | 10 | 9.5 | 94.7 | | 20 | 19.6 | 98.2 | | 25 | 27.0 | 108.1 | | 30 | 32.4 | 108.0 | | 40 | 42.2 | 105.6 | | 50 | 52.4 | 104.9 | | 60 | 64.6 | 107.6 | | 70 | 78.3 | 111.9 | | 80 | 85.4 | 106.8 | | 90 | 94.6 | 105.1 | {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters on a red background. The word is centered in the image and is written in all capital letters. The background is a solid red color, and the letters are a bright white color. The image is simple and easy to read. | Table 13 - Linearity/ Recovery | | | |--------------------------------|----------------------------|--------------| | Expected Concentration (ng/mL) | Mean Concentration (ng/mL) | Recovery (%) | | 100 | 100.8 | 100.8 | | 110 | 110.0 | 100.0 | - 5. Method Comparison Unaltered, anonymous and discarded clinical urine samples obtained from clinical testing laboratories were analyzed with the test device. The study verified that the product performance can be verified by Mass Spectrometry. The instrument used for this test was a Beckman Coulter AU 400e and an Agilent 6430 Liquid Chromatography Tandem Mass Spectrometry. - a. The following is a comparison table of qualitative assay performance for the 25ng/mL cutoff: - Table 14 Method Comparison for the 25ng/mL Qualitative | | LC/MS Confirmation | | | |----------------|--------------------|-----|----| | | (+) | (-) | | | Test Device | (+) | 40 | 0 | | | (-) | 0 | 40 | b. The following is a summary table of the qualitative assay performance for the 25ng/mL cutoff | Table 15 - Assay Performance verified by LC/MS – 25ng/mL Cutoff | | | | | | |-----------------------------------------------------------------|-------------------|-----------------|-----------------|---------------|-----| | Type | PCP Concentration | | | Agreement (%) | | | | < 12.5ng/mL | 12.5 ~ 24 ng/mL | 25 ~ 37.5 ng/mL | > 37.5 ng/mL | | | Qualitative/ Positive | 0 | 0 | 6 | 34 | 100 | | Qualitative/ Negative | 36 | 4 | 0 | 0 | 100 | c. The following is a comparison table of semi-quantitative assay performance for the 25ng/mL cutoff Table 16 - Method Comparison for the 25ng/mL - Semi-Quantitative | | | LC/MS Confirmation | | |--------|-----|--------------------|-----| | | | (+) | (-) | | Test | (+) | 40 | 0 | | Device | (-) | 0 | 40 | d.The following is a summary table of semi-quantitative assay per…