Who is the manufacturer of ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card?

Advin Biotech, Inc. filed the 510(k) submission for ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card (K182123).

What is the FDA product code for ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card?

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

What is the regulatory pathway for ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card?

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

What are the predicate devices for ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card?

Advin Multi-Drug Screen Test Cup (k122809); Advin Multi-Drug Screen Test Dipcard (k122809).

Who can help prepare an FDA 510(k) submission like ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card?

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.

ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card

K182123 · Advin Biotech, Inc. · DJG · Mar 29, 2019 · Clinical Toxicology

Device Facts

Record ID	K182123
Device Name	ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
Applicant	Advin Biotech, Inc.
Product Code	DJG · Clinical Toxicology
Decision Date	Mar 29, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.3650
Device Class	Class 2

Intended Use

The ATTEST Drug Screen Cup and the ATTEST Drug Screen Dip Card are rapid lateral flow immunoassays for the qualitative detection of 6-Acetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, d/l-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: [Table of analytes/cutoffs]. The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 16 analytes, with and without on-board adulteration/specimen validity tests (SVT) in the dip card format or in the cup format. Only one cutoff concentration per analyte will be included per device. The drug screen tests are intended for prescription use only. The tests provide only a preliminary result. A more specific alternative chemical method should be used in order to obtain a confirmed presumptive result if the donor doesn't admit use or anytime required by testing procedures. Gas Chromatography / Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results. The tests are not intended to differentiate between illicit and prescription use of benzodiazepines, barbiturates, buprenorphine, oxycodone, propoxyphene and tricyclic antidepressants. There are no uniformly recognized cutoff levels for these drugs in urine.

Device Story

Rapid lateral flow immunoassay for qualitative detection of drugs of abuse in human urine; utilizes competitive binding principle. Device consists of test strips with drug-protein conjugates on nitrocellulose membrane and anti-drug antibody-colloidal gold conjugates on a pad. Urine sample rehydrates gold conjugate; if target drug is below cutoff, gold conjugate binds to immobilized drug-protein conjugate, forming visible line (negative). If drug exceeds cutoff, antibody sites are saturated, preventing line formation (preliminary positive). Used in professional clinical settings; operated by healthcare professionals. Provides preliminary results requiring confirmation via GC/MS or LC/MS. Benefits include rapid, point-of-care screening for multiple drug analytes (up to 16) and optional specimen validity testing (SVT) to detect tampering.

Clinical Evidence

Bench testing only. Precision/reproducibility evaluated at three sites using 180 replicates per format over 10 days. Analytical specificity and cross-reactivity tested against structurally similar compounds and endogenous substances. Method comparison performed against LC/MS quantitative methods using clinical urine specimens. No clinical studies performed.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding. Formats: Cup and Dip Card. Qualitative visual readout. Internal control line (C-line) for migration/volume verification. No external controls provided. Stable for 28 months. No electronic components or software algorithms.

Indications for Use

Indicated for qualitative detection of drugs of abuse and their metabolites in human urine for professional, prescription-only use. Target population includes individuals undergoing drug screening. Contraindications: Not for differentiating between illicit and prescription use of specific drugs (benzodiazepines, barbiturates, buprenorphine, oxycodone, propoxyphene, tricyclic antidepressants).

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

Advin Multi-Drug Screen Test Cup (k122809)
Advin Multi-Drug Screen Test Dipcard (k122809)

Related Devices

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Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue. March 29, 2019 Advin Biotech, Inc. Daniel Hsu Senior QA/RA Manager 10340 Camino Santa Fe, Suite G San Diego, CA 92121 Re: k182123 Trade/Device Name: ATTEST Drug Screen Cup ATTEST Drug Screen Dip Card Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG, DKZ, DIO, DJC Dated: February 7, 2019 Received: February 12, 2019 Dear Daniel Hsu: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Kellie B. Kelm -S Courtney H. Lias, Ph.D. for 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) k182123 #### Device Name ATTEST Drug Screen Cup ATTEST Drug Screen Dip Card #### Indications for Use (Describe) The ATTEST Drug Screen Cup and the ATTEST Drug Screen Dip Card are rapid lateral flow immunoassays for the qualitative detection of 6-Acetylmorphine, d-Ampletamine, Benzoylecgonine, EDDP, d/1-Methadone, d-Methamphetamine, d/Methylenedioxymethamphetamine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: | Analyte | Calibrator | Cutoff (ng/mL) | |---------------------------|----------------------------------------------------|----------------| | 6-Acetylmorphine | 6-monoacetylmorphine | 10 | | Amphetamine | d-Amphetamine | 500 | | Amphetamine | d-Amphetamine | 1,000 | | Barbiturates | Secobarbital/Pentobarbital | 300 | | Benzodiazepines | Oxazepam | 300 | | Buprenorphine | Buprenorphine | 10 | | EDDP | 2-ethylidene-1,5-dimethyl-3-3- diphenylpyrrolidine | 300 | | Cocaine | Benzoylecgonine | 150 | | Cocaine | Benzoylecgonine | 300 | | Ecstasy | d,l-Methylenedioxymethamphetamine | 500 | | Methamphetamine | d-Methamphetamine | 500 | | Methamphetamine | d-Methamphetamine | 1,000 | | Marijuana | 11-nor-Δ9-THC-9-COOH | 50 | | Methadone | d/l-Methadone | 300 | | Opiates | Morphine | 300 | | Opiates | Morphine | 2,000 | | Oxycodone | Oxycodone | 100 | | Phencyclidine | Phencyclidine | 25 | | Propoxyphene | Propoxyphene | 300 | | Tricyclic Antidepressants | Nortriptyline | 1,000 | The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 16 analytes, with and without on-board adulteration/specimen validity tests (SVT) in the cup format. The drug screen tests are intended for prescription use only. The tests provide only a preliminary result. A more specific alternative chemical method should be used in order to obtain a confirmed presumptive positive result if the donor doesn't admit use or anytime required by testing procedures. Gas Chromatography / Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results. 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}------------------------------------------------ ## 510(k) Summary | Date: | March 28, 2019 | |------------|--------------------------------------------------------------------------------------| | Submitter: | Advin Biotech, Inc. 10340 Camino Santa Fe, Suite G San Diego, California 92121 | | Contact: | Daniel Hsu Telephone: 858-866-8382, ext. 100 Email: daniel.hsu@advinbio.com | #### A. 510(k) Number: K182123 #### B. Purpose for Submission: - a. Addition of Amphetamine 1000, Cocaine 300, Methamphetamine 1000 and 6-Acetylmorphine 10 to a previously cleared device (k122809) - b. Update formulation of Opiate 300 assay from the same previously cleared device #### C. Measurand: d-Methamphetamine 6-Acetylmorphine, d-Amphetamine, Benzoylecqonine, and Morphine ## D. Type of Test: Qualitative lateral-flow immunoassay ### E. Applicant: Advin Biotech, Inc. ### F. Proprietary and Established Names: - a. ATTEST Drug Screen Cup - b. ATTEST Drug Screen Dip Card ### G. Regulatory Information: | Assay | PRODUCT CODE | CLASSIFICATION | REGULATION NUMBER/DESCRIPTION | PANEL | |-------|-----------------|----------------|--------------------------------------------------------------------|------------| | 6-AM | DJG | II | 862.3650/Enzyme Immunoassay, Opiates | Toxicology | | AMP | DKZ | II | 862.3100/ Enzyme Immunoassay, Amphetamine | Toxicology | | COC | DIO | II | 862.3250/Enzyme Immunoassay, Cocaine and cocaine metabolites | Toxicology | {5}------------------------------------------------ | MET | DJC | II | 862.3610/Methamphetamine Test System | Toxicology | |-----|-----|----|-----------------------------------------|------------| | OPI | DJG | II | 862.3650/Enzyme Immunoassay, Opiates | Toxicology | ### H. Intended Use The ATTEST Drug Screen Cup and the ATTEST Drug Screen Dip Card are rapid lateral flow immunoassays for the qualitative detection of 6-Acetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, dll-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: | Assay | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) | |-------------------------|--------------|-------------------------------------------------------|------------------------------------| | 6-Acetylmorphine | 6AM | 6-monoacetylmorphine | 10 | | Amphetamine 500 | AMP500 | d-Amphetamine | 500 | | Amphetamine 1000 | AMP1000 | d-Amphetamine | 1,000 | | Barbiturates | BAR | Secobarbital/Pentobarbital | 300 | | Benzodiazepines | BZO | Oxazepam | 300 | | Buprenorphine | BUP | Buprenorphine | 10 | | EDDP | EDDP | 2-ethylidene-1,5-dimethyl-3-3- diphenylpyrrolidine | 300 | | Cocaine 150 | COC150 | Benzoylecgonine | 150 | | Cocaine 300 | COC 300 | Benzoylecgonine | 300 | | Ecstasy | MDMA | d,l- Methylenedioxymethamphetamine | 500 | | Methamphetamine 500 | MET500 | d-Methamphetamine | 500 | | Methamphetamine 1000 | MET1000 | d-Methamphetamine | 1,000 | | Marijuana | THC | 11-nor-Δ⁹-THC-9-COOH | 50 | | Methadone | MTD | d/l-Methadone | 300 | | Opiates 300 | OPI300 | Morphine | 300 | | Opiates 2000 | OPI2000 | Morphine | 2,000 | | Oxycodone | OXY | Oxycodone | 100 | {6}------------------------------------------------ | Phencyclidine | PCP | Phencyclidine | 25 | |------------------------------|-----|---------------|-------| | Propoxyphene | PPX | Propoxyphene | 300 | | Tricyclic Antidepressants | TCA | Nortriptyline | 1,000 | The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 16 analytes, with and without on-board adulteration/specimen validity tests (SVT) in the dip card format or in the cup format. Only one cutoff concentration per analyte will be included per device. The drug screen tests are intended for prescription use only. The tests provide only a preliminary result. A more specific alternative chemical method should be used in order to obtain a confirmed presumptive result if the donor doesn't admit use or anytime required by testing procedures. Gas Chromatography / Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results. The tests are not intended to differentiate between illicit and prescription use of benzodiazepines, barbiturates, buprenorphine, oxycodone, propoxyphene and tricyclic antidepressants. There are no uniformly recognized cutoff levels for these drugs in urine. ### I. Device Descriptions: For professional use, the devices consist of: - a. 10 or 25 test cups or dip cards with or without adulteration/specimen validity tests - b. Package insert - c. Procedure Card ### J. Substantial Equivalence Information: - a. Predicate device names: - i. Advin Multi-Drug Screen Test Cup - ii. Advin Multi-Drug Screen Test Dipcard - b. Predicate 510(k) number(s): i. k122809 - - c. Comparisons with predicates: | Characteristic | Predicate (k122809) | Candidate Devices | |---------------------|---------------------------------------------------------------------------------------|-------------------| | Indications for use | Qualitative detection of drugs of abuse and/or their metabolites in human urine | Same | #### Predicate Similarities and Differences Table for All Assays {7}------------------------------------------------ | Methodology | Lateral flow immunochromatographic assay based on competitive binding | Same | | | |--------------------------------|-----------------------------------------------------------------------|----------------------------------------------------|--------------------|-------------------| | Specimen | Human urine | Same | | | | Analytes, calibrators, cutoffs | Assay | Calibrator | Cutoff (ng/mL) | | | | Amphetamine | d-amphetamine | 500 | | | | Barbiturates | Secobarbital | 300 | | | | Benzodiazepine | Oxazepam | 300 | | | | Buprenorphine | Buprenorphine | 10 | | | | Cocaine | Benzoylecgonine | 150 | | | | EDDP | 2-ethylidene-1,5-dimethyl-3-3-diphenyl-pyrrolidine | 300 | | | | Ecstasy | d/l-methylene-dioxy-meth-amphetamine | 500 | | | | Methamphetamine | d-meth-amphetamine | 500 | | | | Methadone | d/l-methadone | 300 | | | | Morphine | Morphine | 300 | | | | Opiates | Morphine | 2,000 | | | | Oxycodone | Oxycodone | 100 | | | | Phencyclidine | Phencyclidine | 25 | | | | Propoxyphene | d-propoxyphene | 300 | | | | Tricyclics | Nortriptyline | 1,000 | | | | Marijuana | THC-COOH | 50 | | | Same except the additions of: | | Assay | Calibrator | cutoff | | | | | 6-AM | 6-acetyl-morphine | | | | | Amphetamine | d-amphetamine | | | | Cocaine | Benzoylecgonine | 300 | | | | Meth-amphetamine | d-meth-amphetamine | 1,000 | | Test formats | Cup, Dip Card, Cassette | Cup and Dip Card only | | | ## K. Standard Referenced: Cutoffs shown in the table below are harmonized with DHHS/SAMHSA screening cutoffs for drugs of abuse in urine (Federal Register Notice, Volume 82. No.13, January 23, 2017): {8}------------------------------------------------ | Assay Name | Abbreviation | Calibrator Drug | Cutoff level (ng/mL) | |-----------------|--------------|---------------------------------------|----------------------------| | 6-AM | 6AM | 6-monoacetylmorphine | 10 | | Amphetamine | AMP | d-amphetamine | 500 | | Cocaine | COC | Benzoylecgonine | 150 | | Methamphetamine | MET | d-methamphetamine | 500 | | MDMA | MDMA | d/l- methylenedioxymethamphetamine | 500 | | Opiates 2000 | OPI | Morphine (free) | 2000 | | Oxycodone | OXY | Oxycodone | 100 | | PCP | PCP | Phencyclidine | 25 | | THC | THC | THC-COOH | 50 | ## L. Test Principle: The ATTEST Drug Screen Cup and the ATTEST Drug Screen Dip Card are rapid lateral flow immunoassays in which drug-protein conjuqates compete for limited antibody sites with drugs or drug metabolites that may be present in the urine. Each test strip consists of one or two drug-protein conjugates which are printed on nitrocellulose membrane in the test (T) regions. The anti-drug antibody-colloidal gold conjugates are dried onto a pad which is located beneath the nitrocellulose membrane bearing the test line(s). If target drugs are present in the urine specimen below the cut-off concentration of the assay, the solution of the colored antibodycolloidal qold conjuqate that has been rehydrated by the urine sample migrates by capillary action across the membrane to the immobilized drug-protein conjugate zone on the test (T) region. The colored antibody-gold conjugate then binds with the drug-protein conjugate to form visible lines in the test (T) regions. The formation of a visible line in the test (T) region on any strip indicates a negative result, regardless of the intensity of the visible line. If the tarqet druq level exceeds the cutoff concentration of the druq/metabolite antigen in the urine will bind to and saturate the limited antibody sites during the capillary migration up the strip. The saturated antibody sites will be unavailable to bind to the drugprotein conjugate on the membrane, so no visible lines will appear. Therefore, absence of a visible line in the test (T) region indicates a preliminary positive result. A separate antibodyantigen reaction forms control (C) lines which must appear on the strip to interpret the results. The lack of a visible control (C) line indicates an insufficient specimen volume or improper test technique and the test must be repeated. ## M. Performance Characteristics: - a. Analytical performance: - i. Precision/Reproducibility: The precision, reproducibility and sensitivity of the ATTEST Drug Screen Cup and the ATTEST Drug Screen Dip Card were evaluated at Advin Biotech and at three (3) external testing sites. Data obtained at all testing sites across the intended use populations indicate >99% correlation at +/-50% of each assay cutoff. {9}------------------------------------------------ - ii. Linearity/Assav Reportable Range: Not applicable. Devices intended for qualitative determinations only. - iii. Traceability, Stability, Expected Values (controls, calibrators, methods): - 1. Traceability: The assays shown in the table below are harmonized with the DHHS/SAMHSA screening cutoffs for drugs of abuse in urine (Federal Register Notice, Volume 82. No.13, January 23, 2017): | Assay Name | Abbreviation | Calibrator Drug | Cutoff level (ng/mL) | |-----------------|--------------|---------------------------------------|----------------------------| | 6-AM | 6AM | 6-monoacetylmorphine | 10 | | Amphetamine | AMP | d-amphetamine | 500 | | Cocaine | COC | Benzoylecgonine | 150 | | Methamphetamine | MET | d-methamphetamine | 500 | | MDMA | MDMA | d/l- methylenedioxymethamphetamine | 500 | | Opiates 2000 | OPI | Morphine (free) | 2000 | | Oxycodone | OXY | Oxycodone | 100 | | PCP | PCP | Phencyclidine | 25 | | THC | THC | THC-COOH | 50 | - 2. Stability: Device stability has been or will be determined using accelerated stress testing and real-time studies. All accelerated studies have been completed. Real-time stability testing in room temperature conditions have been completed for Amphetamine 1000, Cocaine 300 and Methamphetamine 1000 assays. In realtime, room temperature conditions, devices in both formats are stable for 28 months when stored at room temperature in sealed foil. Real-time stability studies for the 6-AM assay and the reformulated OPI 300 assay are ongoing. - 3. Controls: Devices have been evaluated with various 3rd party commercial controls. FDA-cleared controls manufactured by Biochemical Diagnostics, Inc. (a Kova International company) are recommended by Advin Biotech, Inc. for use in verifying the performance of the assays. - iv. Detection Limit/sensitivity: Assays contained within the devices bear the cutoff levels shown in the table in section H above. Field studies demonstrate the sensitivity of the assays in the hands of intended professional users and are summarized in section M.a.i. above. - v. Analytical Specificity: The specificity of each assay was determined through the testing of contrived solutions made by spiking certified standards of chemically-related or structurally-similar compounds into drug free urine. The relative cross {10}------------------------------------------------ reactivity (if any) represents the minimum concentration necessary to yield a result similar to the cutoff level of the respective assay. | Assay/Cutoff | Compound | Concentration (ng/mL) | Relative cross- reactivity (%) | |--------------|-------------------------------------------------------|--------------------------|-----------------------------------| | 6-AM 10 | 6-acetylmorphine | 10 | 100 | | | Diacetylmorphine (heroin) | 300 | 3.3 | | | Morphine | >100,000 | <0.1 | | | Codeine | >100,000 | <0.1 | | | Oxycodone | >100,000 | <0.1 | | | Oxymorphone | >100,000 | <0.1 | | AMP 500 | d-Amphetamine | 500 | 100 | | | I-Amphetamine | 50,000 | 1 | | | MDA | 8,000 | 6.5 | | | Phentermine | 45,000 | 1.1 | | AMP 1000 | d-Amphetamine | 1,000 | 100 | | | I-Amphetamine | 100,000 | 1 | | | MDA | 15,000 | 6.7 | | | Phentermine | 100,000 | 1.0 | | BAR 300 | Secobarbital | 300 | 100 | | | Amobarbital | 2,500 | 12 | | | Aprobarbital | 500 | 60 | | | Butabarbital | 100 | 300 | | | Butalbital | 300 | 100 | | | Cyclopentobarbital | 500 | 60 | | | Pentobarbital | 250 | 120 | | | Phenobarbital | 300 | 100 | | | Oxazepam | 300 | 100 | | | Alprazolam | 200 | 150 | | BZO 300 | α-Hydroxyalprazolam | 1,900 | 15.8 | | | Bromazepam | 1,000 | 30 | | | Clobazam | 200 | 150 | | | Clonazepam | 1,500 | 20 | | | 7-Aminoclonazepam | >100,000 | <0.3 | | | Clorazepate | 750 | 40 | | | Desalkylflurazepam | 1,200 | 25 | | | Diazepam | 1,000 | 30 | | | Flunitrazepam | 250 | 120 | | | Lorazepam | 3,900 | 7.7 | | | Lorazepam glucuronide | 5,000 | 6 | | | Nitrazepam | 250 | 120 | | | Norchlordiazepoxide | 500 | 60 | | | Nordiazepam | 390 | 76.9 | | | Temazepam | 150 | 200 | | | Triazolam | 2,500 | 12 | | BUP 40 | Buprenorphine | 10 | 100 | | | Buprenorphine-3-β-glucuronide | 3.5 | 286 | | | Norbuprenorphine | 7.5 | 133 | | | Norbuprenorphine glucuronide | 35 | 28 | | | Benzoylecgonine | 150 | 100 | | COC | Cocaethylene | 50,000 | 0.3 | | 150 | Cocaine | 5,000 | 3 | | | Ecgonine | 50,000 | 0.3 | | | Benzoylecgonine | 300 | 100 | | COC | Cocaethylene | 100,000 | 0.3 | | 300 | Cocaine | 10,000 | 3 | | | Ecgonine | 100,000 | 0.3 | | EDDP | 2-Ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine | 300 | 100 | | 300 | d/l-Methadone | >100,000 | <0.3 | | | d-Methamphetamine | 500 | 100 | | | I-Methamphetamine | 15,000 | 3.3 | | | d-Amphetamine | 50,000 | 1 | | MET | I-Amphetamine | 50,000 | 1 | | 500 | 1R, 2S(1)-Ephedrine | 100,000 | <0.5 | | | MDEA | 30,000 | 1.7 | | | MDMA | 3,500 | 14.3 | | | Mephentermine | 75,000 | 0.7 | | | d-Methamphetamine | 1,000 | 100 | | | I-Methamphetamine | 30,000 | 3.3 | | | d-Amphetamine | 100,000 | 1 | | MET | I-Amphetamine | 100,000 | 1 | | 1000 | 1R, 2S(1)-Ephedrine | >100,000 | <0.5 | | | MDEA | 60,000 | 1.7 | | | MDMA | 8,000 | 12.5 | | | Mephentermine | 100,000 | 1 | | | (+/-)- methylenedioxymethamphetamine (MDMA) | 500 | 100 | | MDMA | (+/-)-methylenedioxyamphetamine (MDA) | 3,900 | 12.8 | | 500 | (+/-)- methylenedioxyethylamphetamine (MDEA) | 500 | 100 | | MTD | d/l-Methadone | 300 | 100 | | 300 | EDDP | >100,000 | <0.3 | | | Morphine | 300 | 100 | | OPI | 6-Acetylmorphine (6-AM) | 400 | 75 | | | Codeine | 100 | 300 | | | Codeine-6-β-glucuronide | 150 | 200 | | 300 | Ethylmorphine | 150 | 200 | | | Diacetylmorphine (heroin) | 900 | 33.3 | | | Hydrocodone | 500 | 60 | | | Hydromorphone | 600 | 50 | | | Levorphanol | 10,000 | 3 | | | Morphine-3-glucuronide | 450 | 66.7 | | | | | | | | Norcodeine | 30,000 | 1 | | | Oxycodone | 70,000 | <0.5 | | | Thebaine | 20,000 | 1.5 | | | Morphine | 2,000 | 100 | | | 6-Acetylmorphine (6-AM) | 700 | 286 | | OPI 2000 | Codeine | 1,800 | 111 | | | Codeine-6-β-glucuronide | 1,250 | 160 | | | Ethylmorphine | 1,500 | 133 | | | Diacetylmorphine (heroin) | 11,000 | 18.2 | | | Hydrocodone | 5,000 | 40 | | | Hydromorphone | 5,000 | 40 | | | Levorphanol | >100,000 | <2 | | | Morphine-3-glucuronide | 2,600 | 77 | | | Norcodeine | >100,000 | <2 | | | Oxycodone | 70,000 | 3 | | | Thebaine | 95,000 | 2.1 | | | Oxycodone | 100 | 100 | | | Codeine | 50,000 | 0.2 | | OXY 100 | Ethylmorphine | 50,000 | 0.2 | | | Hydrocodone | 5,000 | 2 | | | Hydromorphone | 25,000 | 0.4 | | | Oxymorphone | 12,500 | 0.8 | | | | | | | PCP 25 | Phencyclidine | 25 | 100 | | | 4-OH-Phencyclidine | 1,500 | 1.7 | | PPX 300 | d-Propoxyphene | 300 | 100 | | | Norpropoxyphene | 300 | 100 | | | Nortriptyline | 1,000 | 100 | | | Amitriptyline | 4,000 | 25 | | | Clomipramine | 2,000 | 50 | | TCA 1000 | Desipramine | 500 | 200 | | | Doxepine | 1,000 | 100 | | | Imipramine | 1,000 | 100 | | | Promethazine | 1,000 | 100 | | | Trimipramine | 5,000 | 20 | | | 11-nor-Δ9-THC-COOH | 50 | 100 | | | (+/-)-11-Hydroxy-Δ9-THC | 5,000 | 1 | | THC 50 | Δ8-THC | 20,000 | 0.3 | | | Δ9-THC | 20,000 | 0.3 | | | Cannabinol | >100,000 | <0.1 | | | Cannabidiol (CBD) | >100,000 | <0.1 | | | | | | {11}------------------------------------------------ {12}------------------------------------------------ The potential interference (whether positive or negative) from compounds chemically dissimilar to target drugs, known endogenous agents, urine pH and specific gravity variances was also determined. Testing of compounds and endogenous agents was performed by spiking the substances into pooled urine containing target drugs at nearcutoff concentrations. Unless otherwise indicated, substances were tested for potential interference at concentrations of 100 µg/mL. {13}------------------------------------------------ The following substances demonstrated no positive or negative interference on the assays encompassed in this submission: | Acetaminophen | Acetone | Acetylsalicylic acid (aspirin) | |-------------------------|-------------------------|-----------------------------------| | Albumin | Ampicillin | Ascorbic acid | | Aspartame | Atropine | Benzocaine | | Bilirubin | Caffeine | Chloroquine | | Chlorpheniramine | Creatine | Dexbrompheniramine | | Dextromethorphan | Dimethylaminoantipyrine | Diphenhydramine | | Dimenhydrinate | Dopamine | Isoproterenol | | Ephedrine | Erythromycin | Ethanol | | Furosemide | Gabapentin | Glucose | | Guaiacol glyceryl ether | Hemoglobin | Ibuprofen | | Isoproterenol | Ketamine | Lidocaine | | Methylephedrine | Naproxen | Niacinamide | | Nicotine | Norephedrine | Oxalic acid | | Pantoprazole | Penicillin-G | Pheniramine | | Phenothiazine | I-Phenylephrine | B-Phenylethylamine | | Pregablin | Procaine | Quinidine | | Ranitidine | Riboflavin | Sertraline | | Sodium chloride | Sulindac | Theophylline | | Tyramine | | | In addition to the spiked testing described above, in light of industry-known interferences presumably arising from the metabolites of these drugs in human urine. Advin Biotech has evaluated its assays for potential false positive results using clinical urine specimens from donors taking self-reported prescription-level or OTC high-dose levels of each of the following drugs and found no false positive results: - a. Rantidine (Zantac®)-donors taking high-doses per OTC instructions for use - b. Sertraline (Zoloft®)-donor taking prescription dose (steady-state level) - c. Naproxen (Aleve®)-donor taking high-dose per OTC instructions for use - d. Pantoprazole (Protonix®)-donor taking high-dose per OTC instructions for use - e. Gabapentin (Neurontin®)-donor taking high prescription doses of 900mg/day - Pregabalin (Lyrica®)-donor taking prescription dose f. - g. Atomoxetine (Strattera®)-donor taking prescription dose To evaluate the potential effect of variances in urine pH on the assays, pooled urine specimens containing target drugs at near-cutoff concentrations were pH adjusted from 4.0 to 9.0 in increments of 1.0 and tested in duplicate. To evaluate the potential effect of variances of urine specific gravity on the assays, pooled urine specimens containing target drugs at near-cutoff concentrations were diluted using deionized water or concentrated using sodium chloride to achieve specific gravity results of 1.003, 1.010, 1.015, 1.020, 1.025 and 1.030. Each solution was tested in duplicate. The results demonstrated that pH levels of 4 to 9 and specific gravity levels of 1.003 to 1.030 do not affect the results of the assays. To mitigate the risk of specimen tampering, {14}------------------------------------------------ adulteration or substitution, the ATTEST Drug Screen Cup and the ATTEST Drug Screen Dip Card can be constructed with specimen validity tests (SVT). - b. Method Comparison/Accuracy Studies Advin Biotech performed a method comparison study of the ATTEST Drug Screen Cup and the ATTEST Drug Screen Dip Card using clinical urine specimens previously quantitated for the target drugs of abuse by gold-standard methods (GC/MS, LC/MS or equivalent). The results are shown in the table below. Data for previously-cleared assays (k122809) are taken from that submission and presented in combination with the new assays below: | Drug Test/Cutoff (ng/mL) | Result | Drug-free | -50% C/O to <-25% C/O | -25% C/O to C/O | C/O to +25% C/O | >+25% C/O to +50% C/O | >+50% C/O | Agreement | |--------------------------|--------|-----------|-----------------------|-----------------|-----------------|-----------------------|-----------|-----------| | 6-AM/10 | Neg | 40 | 4 | 1 | 0 | 0 | 0 | 100% | | 6-AM/10 | Pos | 0 | 0 | 0 | 1 | 4 | 35 | 100% | | AMP/500 | Neg | 40 | 3 | 0 | 0 | 0 | 0 | 97.7% | | AMP/500 | Pos | 0 | 0 | 1 | 2 | 2 | 45 | 100% | | AMP/1000 | Neg | 40 | 3 | 3 | 0 | 0 | 0 | 100% | | AMP/1000 | Pos | 0 | 0 | 0 | 3 | 3 | 40 | 100% | | BAR/300 | Neg | 40 | 1 | 1 | 0 | 0 | 0 | 95.2% | | BAR/300 | Pos | 0 | 0 | 2 | 5 | 2 | 36 | 100% | | BUP/10 | Neg | 40 | 1 | 1 | 0 | 0 | 0 | 95.5% | | BUP/10 | Pos | 0 | 0 | 2 | 8 | 0 | 32 | 100% | | BZO/300 | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 93.2% | | BZO/300 | Pos | 0 | 0 | 3 | 1 | 6 | 34 | 100% | | COC/150 | Neg | 40 | 0 | 3 | 0 | 0 | 0 | 97.70% | | COC/150 | Pos | 0 | 0 | 1 | 4 | 1 | 53 | 100% | | COC/300 | Neg | 40 | 3 | 2 | 0 | 0 | 0 | 100% | | COC/300 | Pos | 0 | 0 | 0 | 2 | 3 | 35 | 100% | | EDDP/300 | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 93.2% | | EDDP/300 | Pos | 0 | 0 | 3 | 5 | 2 | 33 | 100% | | MDMA/500 | Neg | 40 | 1 | 1 | 0 | 0 | 0 | 95.5% | | MDMA/500 | Pos | 0 | 0 | 2 | 5 | 1 | 34 | 100% | | MET/500 | Neg | 40 | 1 | 0 | 0 | 0 | 0 | 93.2% | | MET/500 | Pos | 0 | 0 | 3 | 1 | 3 | 51 | 100% | | MET/1000 | Neg | 40 | 3 | 3 | 0 | 0 | 0 | 100% | | MET/1000 | Pos | 0 | 0 | 0 | 2 | 3 | 40 | 100% | | MTD/300 | Neg | 40 | 0 | 2 | 0 | 0 | 0 | 95.5% | | MTD/300 | Pos | 0 | 0 | 2 | 4 | 0 | 37 | 100% | | OPI/300 | Neg | 40 | 2 | 1 | 0 | 0 | 0 | 97.72% | | OPI/300 | Pos | 0 | 0 | 1 | 3 | 1 | 46 | 100% | | OPI/2000 | Neg | 40 | 1 | 0 | 0 | 0 | 0 | 93.2% | | OPI/2000 | Pos | 0 | 0 | 2 | 4 | 3 | 40 | 100% | | OXY/100 | Neg | 40 | 1 | 0 | 0 | 0 | 0 | 93.2% | | OXY/100 | Pos | 0 | 0 | 3 | 7 | 1 | 33 | 100% | | PCP/25 | Neg | 40 | 0 | 3 | 0 | 0 | 0 | 97.7% | | PCP/25 | Pos | 0 | 0 | 1 | 3 | 8 | 33 | 100% | | PPX/300 | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 95.3% | | PPX/300 | Pos | 0 | 0 | 2 | 5 | 2 | 33 | 100% | | TCA/1000 | Neg | 40 | 0 | 2 | 0 | 0 | 0 | 95.5% | | TCA/1000 | Pos | 0 | 0 | 2 | 5 | 7 | 28 | 100% | | THC/50 | Neg | 40 | 1 | 2 | 0 | 0 | 0 | 97.7% | | THC/50 | Pos | 0 | 0 | 1 | 4 | 7 | 44 | 100% | ## The ATTEST Drug Screen Cup format {15}------------------------------------------------ | Drug Test/ Cutoff (ng/ml) | ATTEST Cup Result | Result w/ GC/MS or LC/MS | | |------------------------------|-------------------|----------------------------|----------------------| | | | Drug Concentration (ng/ml) | Analyte | | AMP/500 | Positive | 477 | Amphetamine | | BAR/300 | Positive | 265 | Barbital | | | Positive | 286 | Barbital | | BUP/10 | Positive | 8 | Buprenorphine | | | Positive | 9 | Buprenorphine | | BZO/300 | Positive | 244 | Oxazepam | | | Positive | 252 | Oxazepam | | | Positive | 295 | Oxazepam | | COC/150 | Positive | 146 | Benzoylecgonine | | EDDP/300 | Positive | 250 | EDDP | | | Positive | 263 | EDDP | | | Positive | 275 | EDDP | | MDMA/500 | Positive | 368 | MDMA | | | Positive | 381 | MDMA | | MET/500 | Positive | 394 | Methamphetamine | | | Positive | 461 | Methamphetamine | | | Positive | 478 | Methamphetamine | | OPI/300 | Positive | 289 | Morphine | | MTD/300 | Positive | 266 | Methadone | | | Positive | 273 | Methadone | | OPI/2000 | Positive | 1,898 | Morphine | | | Positive | 1,990 | Morphine | | OXY/100 | Positive | 88 | Oxycodone | | | Positive | 98 | Oxycodone | | | Positive | 99 | Oxycodone | | PCP/25 | Positive | 22.9 | Phencyclidine | | PPX/300 | Positive | 242 | Norpropoxyphene | | | Positive | 285 | Norpropoxyphene | | TCA/1000 | Positive | 786 | Nortriptyline | | | Positive | 859 | Nortriptyline | | THC/50 | Positive | 49 | 11-nor-Δ9-THC-9-COOH | # Summary of Discordant Results, ATTEST Cup format {16}------------------------------------------------ | Drug | | Drug- | Drug quantitation by gold-standard method relative to assay cutoff level | | | | | | |------------------------|--------|-------|--------------------------------------------------------------------------|-----------------|-----------------|-----------------------|-----------|-----------| | Test/Cutoff (ng/mL) | Result | free | -50% C/O to <-25% C/O | -25% C/O to C/O | C/O to +25% C/O | >+25% C/O to +50% C/O | >+50% C/O | Agreement | | 6-AM/10 | Neg | 40 | 4 | 1 | 0 | 0 | 0 | 100% | | | Pos | 0 | 0 | 0 | 1 | 4 | 35 | 100% | | AMP/500 | Neg | 40 | 3 | 0 | 0 | 0 | 0 | 97.7% | | | Pos | 0 | 0 | 1 | 2 | 2 | 45 | 100% | | AMP/1000 | Neg | 40 | 3 | 3 | 0 | 0 | 0 | 100% | | | Pos | 0 | 0 | 0 | 3 | 3 | 40 | 100% | | BAR/300 | Neg | 40 | 1 | 1 | 0 | 0 | 0 | 95.2% | | | Pos | 0 | 0 | 2 | 5 | 2 | 36 | 100% | | BUP/10 | Neg | 40 | 1 | 1 | 0 | 0 | 0 | 95.5% | | | Pos | 0 | 0 | 2 | 8 | 0 | 32 | 100% | | BZO/300 | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 93.2% | | | Pos | 0 | 0 | 3 | 1 | 6 | 34 | 100% | | COC/150 | Neg | 40 | 0 | 3 | 0 | 0 | 0 | 97.70% | | | Pos | 0 | 0 | 1 | 4 | 1 | 53 | 100% | | COC/300 | Neg | 40 | 3 | 2 | 0 | 0 | 0 | 100% | | | Pos | 0 | 0 | 0 | 2 | 3 | 35 | 100% | | EDDP/300 | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 93.2% | | | Pos | 0 | 0 | 3 | 5 | 2 | 33 | 100% | | MDMA/500 | Neg | 40 | 1 | 1 | 0 | 0 | 0 | 95.5% | | | Pos | 0 | 0 | 2 | 5 | 1 | 34 | 100% | | MET/500 | Neg | 40 | 1 | 0 | 0 | 0 | 0 | 93.2% | | | Pos | 0 | 0 | 3 | 1 | 3 | 51 | 100% | | MET/1000 | Neg | 40 | 3 | 3 | 0 | 0 | 0 | 100% | | | Pos | 0 | 0 | 0 | 2 | 3 | 40 | 100% | | MTD/300 | Neg | 40 | 0 | 2 | 0 | 0 | 0 | 95.5% | | | Pos | 0 | 0 | 2 | 4 | 0 | 37 | 100% | | OPI/300 | Neg | 40 | 2 | 1 | 0 | 0 | 0 | 97.72% | | | Pos | 0 | 0 | 1 | 3 | 1 | 46 | 100% | | OPI/2000 | Neg | 40 | 1 | 0 | 0 | 0 | 0 | 93.2% | | | Pos | 0 | 0 | 2 | 4 | 3 | 40 | 100% | | OXY/100 | Neg | 40 | 1 | 0 | 0 | 0 | 0 | 93.2% | | | Pos | 0 | 0 | 3 | 7 | 1 | 33 | 100% | | PCP/25 | Neg | 40 | 0 | 3 | 0 | 0 | 0 | 97.7% | | | Pos | 0 | 0 | 1 | 3 | 8 | 33 | 100% | | PPX/300 | Neg | 40 | 0 | 1 | 0 | 0 | 0 | 95.3% | | | Pos | 0 | 0 | 2 | 5 | 2 | 33 | 100% | | TCA/1000 | Neg | 40 | 0 | 2 | 0 | 0 | 0 | 95.5% | | | Pos | 0 | 0 | 2 | 5 | 7 | 28 | 100% | | THC/50 | Neg | 40 | 1 | 2 | 0 | 0 | 0 | 97.7% | | | Pos | 0 | 0 | 1 | 0 | 0 | 0 | 100% | # The ATTEST Drug Screen Dip Card format {17}------------------------------------------------ | Drug Test/ Cutoff (ng/ml) | ATTEST Dip Card Result | Drug Concentration (ng/ml) | Analyte | |------------------------------|------------------------|----------------------------|----------------------| | AMP/500 | Positive | 477 | Amphetamine | | BAR/300 | Positive | 265 | Barbital | | BAR/300 | Positive | 286 | Barbital | | BUP/10 | Positive | 8 | Buprenorphine | | BUP/10 | Positive | 9 | Buprenorphine | | BZO/300 | Positive | 244 | Oxazepam | | BZO/300 | Positive | 252 | Oxazepam | | BZO/300 | Positive | 295 | Oxazepam | | COC/150 | Positive | 146 | Benzoylecgonine | | EDDP/300 | Positive | 250 | EDDP | | EDDP/300 | Positive | 263 | EDDP | | EDDP/300 | Positive | 275 | EDDP | | MDMA/500 | Positive | 368 | MDMA | | MDMA/500 | Positive | 381 | MDMA | | MDMA/500 | Positive | 394 | Methamphetamine | | MET/500 | Positive | 461 | Methamphetamine | | MET/500 | Positive | 478 | Methamphetamine | | MTD/300 | Positive | 266 | Methadone | | MTD/300 | Positive | 273 | Methadone | | OPI/300 | Positive | 289 | Morphine | | OPI/2000 | Positive | 1,898 | Morphine | | OPI/2000 | Positive | 1,990 | Morphine | | OXY/100 | Positive | 88 | Oxycodone | | OXY/100 | Positive | 98 | Oxycodone | | OXY/100 | Positive | 99 | Oxycodone | | PCP/25 | Positive | 22.9 | Phencyclidine | | PPX/300 | Positive | 242 | Norpropoxyphene | | PPX/300 | Positive | 285 | Norpropoxyphene | | TCA/1000 | Positive | 786 | Nortriptyline | | TCA/1000 | Positive | 859 | Nortriptyline | | THC/50 | Positive | 49 | 11-nor-Δ9-THC-9-COOH | #### Summary of Discordant Results, ATTEST Dip Card format #### c. Clinical Studies - i. Clinical sensitivity: refer to accuracy table shown in section M.b. above - ii. Clinical specificity: refer to accuracy table show in section M.b. above - iii. Other clinical supportive data (when i and ii are not applicable): N/A ### d. Read Time To evaluate the reading time flexibility, the ATTEST Drug Screen Cup and the ATTEST Drug Screen Dip Card and were tested with drug standards at the concentration of 0, -50% and +50% cutoff level. The result was read and recorded at 4, 5, 10, 30, 60 and 75 minutes. Each solution was tested in duplicate. Data showed that the test results were stable for up to 75 minutes. {18}------------------------------------------------ ## N. Proposed Labeling The proposed labeling is deemed sufficient based on the outcomes of all intended user studies and meets the requirements of 21 CFR 809.10. ## O. Conclusions The data submitted in this premarket notification is complete and supports a substantial equivalence determination.