BIOEASY Multi-Drug Test Cup

• K Number: K182530
• Device Name: BIOEASY Multi-Drug Test Cup
• Manufacturer: Shenzhen Bioeasy Biotechnology Co.,Ltd.
• Date Cleared: 2018-11-09 ( 56 days)
• Product Code: NFT , NFV , NFW , NFY , NGG , NGI , NGL , NGM , PTG , PTH , QAW , QBF
• Regulation Number: 862.3100
• Type: Traditional
• Panel: Toxicology
• Reference & Predicate Devices: K153050
• Predicate For: K192301 , K192515 , K193480

Intended Use

BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:

Drug(Identifier)	Cut-off level
Amphetamine	1000 ng/mL
Oxazepam	300 ng/mL
Cocaine	300 ng/mL
Marijuana	50 ng/mL
Methamphetamine	1000 ng/mL
Morphine	300 ng/mL
Oxycodone	100 ng/mL
Secobarbital	300 ng/mL
Buprenorphine	10 ng/mL
Methylenedioxy-methamphetamine	500 ng/mL
Phencyclidine	25 ng/mL
Methadone	300 ng/mL
Nortriptyline	1000 ng/mL
d-Propoxyphene	300 ng/mL

Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

Device Description

The BIOEASY Multi-Drug Test Cup tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the successful outcomes of the various performance studies. The reported device performance is excellent, demonstrating near-perfect agreement with the LC/MS ground truth for samples outside the +/-25% cutoff range, and reasonable agreement within the +/-25% cutoff range, which is expected for qualitative tests around the cutoff.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred)	Reported Device Performance Summary
Precision	Consistent and accurate results across different lots and concentrations.	For -100% to -25% of cutoff: 100% negative results. For +25% to +100% of cutoff: 100% positive results. At cutoff: varying split between positive/negative (e.g., Amphetamine Lot 1: 23-/27+), which is expected for qualitative assays at the decision point.
Stability	Device remains effective for its stated shelf life.	Stable at 4-30 °C for 24 months (accelerated stability). Real-time studies ongoing.
Interference	No significant interference from common physiological/pathological substances.	No interference observed for a wide range of common substances at specified concentrations (summarized in tables on page 9-10).
Specificity (Cross-reactivity)	Correct identification of target drugs/metabolites, with acceptable cross-reactivity to similar compounds.	Detailed cross-reactivity tables provided for each drug, showing specificity to the target analyte and acceptable cross-reactivity percentages for related compounds (pages 10-13).
Effect of Urine Specific Gravity & pH	Performance unaffected by variations in urine specific gravity and pH.	No differences observed for samples at +/-25% cut-off levels with specific gravity from 1.000 to 1.035 and pH 4-9.
Method Comparison (Professional User)	High agreement with LC/MS reference method.	For each drug, out of 80 samples (40 negative, 40 positive), most samples outside the near cut-off range were correctly identified. Discordant results primarily occurred in the near cut-off positive/negative ranges, where the device correctly identified values slightly above the cutoff as positive and slightly below as negative in many cases, even when LC/MS showed a value across the cutoff. Overall strong agreement.
Lay-user Study	High percentage of correct results by untrained users, and ease of understanding instructions.	For -100% to -50% of cutoff: 100% correct negative results. For +50% to +100% of cutoff: 100% correct positive results. At -25% and +25% of cutoff: 95% correct results for most drugs, with Nortriptyline at +25% having 90%. All lay users found instructions easy to follow, and Flesch-Kincaid score indicated Grade Level 7 reading.

2. Sample Size Used for the Test Set and Data Provenance

• Precision Studies:

  • For each of the 14 analytes, 8 concentrations were tested (ranging from -100% cut off to +100% cut off).
  • For each concentration, tests were performed two runs per day for 25 days, using 3 different lots of the device.
  • Total samples per lot per concentration: 50 (2 runs/day * 25 days).
  • Total samples per drug per concentration for 3 lots: 150 (50 * 3 lots).
  • Total samples per drug: 1,200 (150 * 8 concentrations).
  • Total samples for all 14 drugs in precision study: 16,800.
  • Data Provenance: The text does not explicitly state the country of origin but implies it was performed "in-house" by the manufacturer (Shenzhen Bioeasy Biotechnology Co., Ltd. in China). These samples were prepared by spiking drug in negative samples. The study appears to be prospective in nature for the purpose of device validation.

• Interference & Specificity Studies:

  • "Three batches of each device" were used.
  • The number of individual samples tested for each interfering substance or cross-reactant is not explicitly stated, but it involved "drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels."

• Effect of Urine Specific Gravity and pH:

  • "Three lots of each device" were used.
  • "Urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels." The exact number of samples at each specific gravity/pH level is not detailed.

• Method Comparison (Professional User) Studies:

  • For each of the 14 analytes: 80 unaltered clinical samples (40 negative and 40 positive).
  • Total samples for 14 drugs: 1120 samples.
  • Data Provenance: "clinical samples" are mentioned, but their country of origin is not specified. The study is retrospective, as these are "unaltered clinical samples" compared to LC/MS results.

• Lay-user Study:

  • 300 lay persons were involved.
  • The text describes sample numbers for various concentrations. For each drug, a total of 300 samples were prepared the following way: 20 at -100% Cutoff, 20 at -75%, 160 at -50%, 20 at -25%, 20 at +25%, 40 at +50%, 20 at +75%.
  • Total samples per drug: 300.
  • Total samples for all 14 drugs in lay-user study: 4,200.
  • Data Provenance: The text does not explicitly state the country of origin for the urine samples, but the study was conducted at "three intended user sites." These samples were prepared by spiking drugs into drug-free pooled urine specimens. The study itself is prospective in terms of collecting performance data from lay users.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Method Comparison Studies: The ground truth was established by LC/MS (Liquid Chromatography-Mass Spectrometry). This is a highly accurate analytical method, considered the gold standard for drug confirmation in urine. No human experts are explicitly mentioned for establishing the ground truth in these studies, as the LC/MS directly provides it. The "three laboratory assistants" who ran the devices are operators, not ground truth experts.

• Precision, Interference, Specificity, Effect of Urine Specific Gravity and pH, Lay-user Studies: The ground truth for these studies was established by LC/MS to confirm the drug concentrations in the spiked urine samples.

4. Adjudication Method for the Test Set

• Precision Studies: Not explicitly stated, however, the results were quantified as positive/negative based on the criteria for each concentration and then tabulated. No formal adjudication process among multiple readers is described for the precision data, as the device's output (presence/absence of line) is objectively recorded.

• Method Comparison Studies: Three "laboratory assistants" viewed the device results, and their readings were compared against the LC/MS ground truth. There is no mention of an adjudication process (e.g., 2+1, 3+1) among these three assistants. Each viewer's discordant results were individually reported.

• Lay-user Study: The results from each lay person were recorded (positive/negative) and then compared to the known LC/MS-confirmed concentration of the sample. No adjudication among lay users is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This device is a rapid, qualitative drug test cup, which provides a direct visual result (lines appearing/not appearing). It does not involve AI assistance, nor does it involve human readers interpreting complex images or data that AI would augment. Therefore, there's no discussion of human readers improving with AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes, in the context of the device's output. The "Precision" studies and the "Interference," "Specificity," and "Effect of Urine Specific Gravity and pH" studies represent the standalone performance of the device itself to detect the analytes, as the results are based on the chemical reactions within the cup. The "Method Comparison" study also evaluates the standalone performance of the device's reading mechanism when interpreted by professional users, directly comparing it to the LC/MS reference.

7. The Type of Ground Truth Used

• The primary ground truth used across all analytical and clinical (in-house) studies was LC/MS (Liquid Chromatography-Mass Spectrometry). For the precision, interference, specificity, and pH/SG studies, the samples were spiked with known concentrations confirmed by LC/MS. For the method comparison study, unaltered clinical samples were directly compared against LC/MS results.

8. The Sample Size for the Training Set

• This device is a lateral flow immunochromatographic assay, not an AI/machine learning model. Therefore, there is no concept of a "training set" in the traditional sense for an algorithm. The development and optimization of the test's chemical components and cutoff concentrations implicitly involve internal R&D and calibration, but this is distinct from training an AI model on a dataset.

9. How the Ground Truth for the Training Set was Established

• As stated above, this is not applicable as it's not an AI/machine learning device requiring a training set. The "ground truth" for establishing the device's analytical performance (e.g., cutoff levels, cross-reactivity) would have been determined through empirical testing and comparison against established analytical methods like LC/MS during the device's development and validation.

Summary

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November 9, 2018

Shenzhen Bioeasy Biotechnology Co., Ltd. % Joe Shia, Director LSI International 504E Diamond Ave., Suite I Gaithersburg, MD 20877

Re: K182530

Trade/Device Name: BIOEASY Multi-Drug Test Cup Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT, NFW, NFY, NGG, NGI, NFV, NGL, PTH, NGM, PTG, QAW, QBF Dated: September 9, 2018 Received: September 14, 2018

Dear Joe Shia:

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.

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

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requirements, including, but not limited to: registration and listing (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 (OS) 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 (Sections 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Kellie B. Kelm -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

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Indications for Use

510(k) Number (if known) K182530

Device Name BIOEASY Multi-Drug Test Cup

Indications for Use (Describe)

BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:

Drug(Identifier)	Cut-off level
Amphetamine	1000 ng/mL
Oxazepam	300 ng/mL
Cocaine	300 ng/mL
Marijuana	50 ng/mL
Methamphetamine	1000 ng/mL
Morphine	300 ng/mL
Oxycodone	100 ng/mL
Secobarbital	300 ng/mL
Buprenorphine	10 ng/mL
Methylenedioxy-methamphetamine	500 ng/mL
Phencyclidine	25 ng/mL
Methadone	300 ng/mL
Nortriptyline	1000 ng/mL
d-Propoxyphene	300 ng/mL

Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K182530 510(k) SUMMARY

• November 9, 2018 1. Date:
• Shenzhen Bioeasy Biotechnology Co., Ltd. 2. Submitter: No.2-1, Liuxian 1st Road Baoan District Shenzhen, China 518101
• Joe Shia 3. Contact person: LSI International Inc. 504 East Diamond Ave. Gaithersburg, MD 20877 Telephone: [phone] Email: [e-mail]
• 4. Device Name: BIOEASY Multi-Drug Test Cup

Classification:	Class 2
Product Code	Classification	Regulation Section	Panel
NFTAmphetamine	II	21 CFR § 862.3100, AmphetamineTest System	Toxicology (91)
NFWCannabinoids	II	21 CFR § 862.3870, CannabinoidsTest System	Toxicology (91)
NFYCocaine	II	21 CFR § 862.3250, Cocaine andCocaine Metabolites Test System	Toxicology (91)
NGGMethamphetamine	II	21 CFR § 862.3610,Methamphetamine Test System	Toxicology (91)
NGIMorphine	II	21 CFR § 862.3640, MorphineTest System	Toxicology (91)
NFVOxazepam	II	21 CFR § 862.3170,Benzodiazepine Test System	Toxicology (91)
NGLOxycodone	II	21 CFR § 862.3650, Opiate TestSystem	Toxicology (91)
PTHSecobarbital	II	21 CFR § 862.3150, BarbiturateTest System	Toxicology (91)
NGLBuprenorphine	II	21 CFR § 862.3650,Opiate Test System	Toxicology (91)
NGGMethylenedioxy-methamphetamine	II	21 CFR § 862.3610,Methamphetamine Test System	Toxicology (91)
NGMPhencyclidine	unclassified	Enzyme ImmunoassayPhencyclidine	Toxicology (91)
PTGMethadone	II	21 CFR § 862.3620, MethadoneTest System	Toxicology (91)
QAWNortriptyline	II	21 CFR, 862.3910 TricyclicAntidepressant Drugs Test System	Toxicology (91)
QBFPropoxyphene	II	21 CFR, 862.3700 PropoxypheneTest System	Toxicology (91)

5. Predicate Devices: K153050

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The CO-INNOVATION BIOTECH Rapid Multi-Drug Test Dip Card and Rapid Multi-Drug Test Cup

• 6. Indications for Use
     BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine	1000 ng/mL
Oxazepam	300 ng/mL
Cocaine	300 ng/mL
Marijuana	50 ng/mL
Methamphetamine	1000 ng/mL
Morphine	300 ng/mL
Oxycodone	100 ng/mL
Secobarbital	300 ng/mL
Buprenorphine	10 ng/mL
Methylenedioxy-methamphetamine	500 ng/mL
Phencyclidine	25 ng/mL
Methadone	300 ng/mL
Nortriptyline	1000 ng/mL
d-Propoxyphene	300 ng/mL

Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

• 7. Device Description
     The BIOEASY Multi-Drug Test Cup tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch
• 8. Substantial Equivalence Information
     A summary comparison of features of the BIOEASY Multi-Drug Test Cup tests and the predicate devices is provided in following table.

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Item	Device	Predicate - K153050
Indication(s)for Use	For the qualitative determination ofdrugs of abuse in human urine.	Same (but the number ofdrugs detected is different)
Calibrator and Cut-OffValues	Amphetamine (AMP): 1,000 ng/mlOxazepam (BZO):300 ng/mlCocaine(COC): 300 ng/mlMarijuana (THC):50 ng/mlMethamphetamine (MET): 1,000 ng/mlMorphine (MOR): 300ng/mlOxycodone(OXY) : 100 ng/mlSecobarbital (BAR): 300 ng/mlBuprenorphine (BUP): 10 ng/mlMethylenedioxy-methamphetamine(MDMA): 500 ng/mlPhencyclidine (PCP): 25 ng/mlMethadone (MTD): 300 ng/mlNortriptyline (TCA): 1000 ng/mlPropoxyphene (PPX): 300 ng/ml	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Intended Use	For over-the-counter	Same
Configurations	Cup	Same

Table 1: Features Comparison of BIOEASY Multi-Drug Test Cup tests and the Predicate Devired

9. Test Principle

The BIOEASY Multi-Drug Test Cup tests are rapid tests for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and Propox yphene in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibodycoated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices

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regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.

10. Performance Characteristics

• 1. Analytical Performance

a. Precision

Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following tables.

Amphetamine

Lot Number	-100% cut off	-75% cut off	-50% cut off	-25% cutoff	cut off	+25% cut off	+50% cut off	+75% cut off	+100% cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	23-/27+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	28-/22+	50+/0-	50+/0-	50+/0-	50+/0-

Secobarbital

LotNumber	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	27-/23+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	28-/22+	50+/0-	50+/0-	50+/0-	50+/0-

Buprenorphine

LotNumber	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	27-/23+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	25-/25+	50+/0-	50+/0-	50+/0-	50+/0-

Oxazepam

LotNumber	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	25-/25+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	27-/23+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	28-/22+	50+/0-	50+/0-	50+/0-	50+/0-

Cocaine

LotNumber	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	28-/22+	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	28-/22+	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-

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Methylenedioxy-methamphetamine

LotNumber	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	26-/24+	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	25-/24+	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	26-/24+	50+/0-	50+/0-	50+/0-

Methamphetamine

LotNumber	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	27-/23+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	23-/27+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	29-/21+	50+/0-	50+/0-	50+/0-	50+/0-

Morphine

LotNumber	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	28-/22+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	27-/23+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-

Methadone

LotNumber	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	27-/23+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	25-/25+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	29-/21+	50+/0-	50+/0-	50+/0-	50+/0-

Oxycodone

LotNumber	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	23-/27+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	28-/22+	50+/0-	50+/0-	50+/0-	50+/0-

Phencyclidine

LotNumber	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	28-/22+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	23-/27+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	28-/22+	50+/0-	50+/0-	50+/0-	50+/0-

Propoxyphene

LotNumber	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	25-/25+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	28-/22+	50+/0-	50+/0-	50+/0-	50+/0-

Nortriptyline

{9}------------------------------------------------

LotNumber	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	21-/29+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-

Marijuana

LotNumber	-100%cut off	-75%cut off	-50%cut off	-25%cutoff	cut off	+25%cut off	+50%cut off	+75%cut off	+100%cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	28-/22+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-

c. Stability

The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 45 °C. Real time stability determinations are ongoing at both 4 °C and 30 °C.

d. Interference

Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three batches of each device. Compounds that showed no interference at a concentration of 100µg/mL (albumin was tested at 100 mg/dL) are summarized in the following tables.

Acetaminophen	β-Estradiol	Oxalic acid
Acetophenetidin	Erythromycin	Oxolinic acid
N-Acetylprocainamide	Ethanol	Oxymetazoline
Acetylsalicylic acid	Fenoprofen	Papaverine
Albumin (100 mg/dL)	Furosemide	Penicillin G
Aminopyrine	Gentisic acid	Perphenazine
Amoxicillin	Hemoglobin	Phenelzine
Ampicillin	Hydralazine	Prednisone
Apomorphine	Hydrochlorothiazide	(±)-Propranolol
Ascorbic acid	Hydrocortisone	Pseudoephedrine
Aspartame	O-Hydroxyhippuric acid	Quinine
Atropine	3-Hydroxytyramine	Ranitidine
Benzilic acid	Ibuprofen	Salicylic acid
Benzoic acid	Isoproterenol	Serotonin (5- Hydroxytyramine)
Bilirubin	Isoxsuprine	Sulfamethazine
Chloral hydrate	Ketamine	Sulindac
Chloramphenicol	Ketoprofen	Tetrahydrocortisone 3-(β-
		Dglucuronide)
Chlorothiazide	Labetalol	Tetrahydrocortisone 3-acetate
Chlorpromazine	Loperamide	Tetrahydrozoline
Cholesterol	Meperidine	Thiamine
Clonidine	Meprobamate	Thioridazine
Cortisone	Methoxyphenamine	Triamterene
(-)-Cotinine	Nalidixic acid	Trifluoperazine
Creatinine	Naloxone	Trimethoprim
Deoxycorticosterone	Naltrexone	DL-Tryptophan
Dextromethorphan	Naproxen	Tyramine
Diclofenac	Niacinamide	DL-Tyrosine

{10}------------------------------------------------

Diflunisal	Nifedipine	Uric acid
Digoxin	Norethindrone	Verapamil
Diphenhydramine	Noscapine	Zomepirac
Ecgonine methyl ester	(±)-Octopamine

e. Specificity

To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device. The lowest concentration that caused a positive result for each compound are listed below.

AMP(Amphetamine)(D - Amphetamine, Cut-off=1000 ng/mL)	Result	%Cross-Reactivity
D - Amphetamine	Positive at 1000 ng/mL	100%
L - Amphetamine	Positive at 20000 ng/mL	5%
DL - Amphetamine	Positive at 3000 ng/mL	33%
Phentermine	Positive at 30000 ng/mL	3.3%
Hydroxyamphetamine	Positive at 8000 ng/mL	12.5%
Methylenedioxyamphetamine (MDA)	Positive at 20000 ng/mL	5%
d-Methamphetamine	Positive> 100000 ng/mL	<1%
1-Methamphetamine	Positive> 100000 ng/mL	<1%
Ephedrine	Positive> 100000 ng/mL	<1%
Methylenedioxyethylamphetamine (MDE)	Positive> 100000 ng/mL	<1%
3,4-methylenedioxy-methamphetamine(MDMA)	Positive> 100000 ng/mL	<1%

BAR(Barbital)(Secobarbital, Cut-off=300 ng/mL)	Result	%Cross-Reactivity
Secobarbital	Positive at 300 ng/mL	100%
Amobarbital	Positive at 1000 ng/mL	30%
Alphenal	Positive at 62.5 ng/mL	480%
Aprobarbital	Positive at 250 ng/mL	120%
Butabarbital	Positive at 100 ng/mL	300%
Butethal	Positive at 500 ng/mL	60%
Butalbital	Positive at 5000 ng/mL	6%
Cyclopentobarbital	Positive at 500 ng/mL	60%
Pentobarbital	Positive at 200 ng/mL	150%
Phenobarbital	Positive at 300 ng/mL	100%

BUP(Buprenorphine)(Buprenorphine, Cut-off=10 ng/mL)	Result	%Cross-Reactivity
Buprenorphine	Positive at 10 ng/mL	100%
Buprenorphine -3-D-Glucuronide	Positive at 10 ng/mL	100%
Norbuprenorphine	Positive at 50 ng/mL	20%
Norbuprenorphine-3-D-Glucuronide	Positive at 10 ng/mL	10%
Morphine	Positive> 100000 ng/mL	<0.01%
Oxymorphone	Positive> 100000 ng/mL	<0.01%
Hydromorphone	Positive> 100000 ng/mL	<0.01%

BZO(Benzodiazepines)	Result	%Cross-Reactivity
----------------------	--------	-------------------

{11}------------------------------------------------

(Oxazepam, Cut-off=300 ng/mL)
Oxazepam	Positive at_300_ng/mL	100%
Alprazolam	Positive at_150_ng/mL	200%
a-Hydroxyalprazolam	Positive at_1000_ng/mL	30%
Bromazepam	Positive at_1000_ng/mL	30%
Chlordiazepoxide	Positive at_63_ng/mL	476.2%
Clonazepam	Positive at_2500_ng/mL	12%
Clobazam	Positive at_75_ng/mL	400%
Clorazepate dipotassium	Positive at_100_ng/mL	300%
Desalkylflurazepam	Positive at_500_ng/mL	60%
Diazepam	Positive at_500_ng/mL	60%
Estazolam	Positive at_500_ng/mL	60%
Flunitrazepam	Positive > 50000 ng/mL	<0.6%
D,L-Lorazepam	Positive at_10000_ng/mL	3%
Midazolam	Positive at_10000_ng/mL	3%
Nitrazepam	Positive at_75_ng/mL	400%
Norchlordiazepoxide	Positive at_62.5_ng/mL	480%
Nordiazepam	Positive at_125_ng/mL	240%
Temazepam	Positive at_75_ng/mL	400%
Triazolam	Positive at_1000_ng/mL	33%

COC(Cocaine)(Benzoylecgonine, Cut-off=300 ng/mL)	Result	%Cross-Reactivity
Benzoylecgonine	Positive at 300 ng/mL	100%
Cocaine HCl	Positive at 750 ng/mL	40%
Cocaethylene	Positive at 12500 ng/mL	2.4%
Ecgonine	Positive at 32000 ng/mL	0.9%
Norcocaine	Positive at 100000 ng/mL	0.3%

MDMA(Methylenedioxymethamphetamine)(Methylenedioxymethamphetamine,Cut-off=500 ng/mL)	Result	%Cross-Reactivity
Methylenedioxymethamphetamine (MDMA)	Positive at 500 ng/mL	100%
3,4-Methylenedioxyamphetamine (MDA)	Positive at 5000 ng/mL	10%
3,4-Methylenedioxyethylamphetamine (MDEA)	Positive at 300 ng/mL	166.7%
d-methamphetamine	Positive > 50000 ng/mL	<1%
d-amphetamine	Positive > 50000 ng/mL	<1%
l-amphetamine	Positive > 50000 ng/mL	<1%
l-methamphetamine	Positive > 50000 ng/mL	<1%

MET(Methamphetamine)(D(+)-Methamphetamine, Cut-off=1000 ng/mL)	Result	%Cross-Reactivity
D(+)-Methamphetamine	Positive at 1000 ng/mL	100%
(+/-)3,4-Methylenedioxy-n-ethylamphetamine(MDEA)	Positive at 10000 ng/mL	10%
D/L-Methamphetamine	Positive at 1000 ng/mL	100%
p-Hydroxymethamphetamine	Positive at 10000 ng/mL	10%

{12}------------------------------------------------

D-Amphetamine	Positive > 100000 ng/mL	<1%
L-Amphetamine	Positive >100000 ng/mL	<1%
Chloroquine	Positive at 50000 ng/mL	2%
(+/-)-Ephedrine	Positive at 4000 ng/mL	25%
L-Methamphetamine	Positive at 10000 ng/mL	10%
(+/-)3,4-Methylenedioxyamphetamine (MDA)	Positive >100000 ng/mL	<1%
β-Phenylethylamine	Positive at 7500 ng/mL	13.3%
Trimethobenzamide	Positive at 20000 ng/mL	5%
(+/-)3,4-methylenedioxymethamphetamine(MDMA)	Positive at 10000 ng/mL	10%

MOP(Morphine)(Morphine, Cut-off=300 ng/mL)	Result	%Cross-Reactivity
Morphine	Positive at_300 ng/mL	100%
Codeine	Positive at 300 ng/mL	100%
Ethylmorphine	Positive at_310 ng/mL	96.8%
Hydrocodone	Positive at_25000 ng/mL	1.2%
Hydromorphone	Positive 10000 ng/mL	3%
Levorphanol	Positive > 100000 ng/mL	<0.3%
6-Acetylmorphine	Positive at_250 ng/mL	120%
Morphine-3- β -D-glucuronide	Positive at 10000 ng/mL	3%
Normorphine	Positive at 100000 ng/mL	0.3%
Oxycodone	Positive > 10000 ng/mL	<3%
Oxymorphone	Positive > 10000 ng/mL	<3%
Procaine	Positive > 10000 ng/mL	3%
Thebaine	Positive > 10000 ng/mL	<3%
Heroin	Positive at 500 ng/mL	60%

MTD(Methadone)(Methadone, Cut-off=300 ng/mL)	Result	%Cross-Reactivity
Methadone	Positive at 300ng/mL	100%
Doxylamine	Positive at 5000ng/mL	6%
LAAM	Positive at 10000ng/mL	3%
Alpha Methadol	Positive at 2000ng/mL	15%
EDDP	Positive > 100000ng/mL	<0.3%
EMDP	Positive > 100000ng/mL	<0.3%

OXY(Oxycodone)(Oxycodone, Cut-off=300 ng/mL)	Result	%Cross-Reactivity
Oxycodone	Positive at 100 ng/mL	100%
Dihydrocodeine	Positive >100000ng/mL	<0.1%
Codeine	Positive >100000ng/mL	<0.1%
Hydromorphone	Positive >100000ng/mL	<0.1%
Morphine	Positive >100000ng/mL	<0.1%
Buprenorphine	Positive >100000ng/mL	<0.1%
Ethylmorphine	Positive >100000ng/mL	<0.1%
Oxymorphone	Positive at 250 ng/mL	40%

{13}------------------------------------------------

r y y are a	1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -	0 00/
Hydrocodone	Positive at 3125 ng/mL	J. L. / V

PCP(Phencyclidine)(Phencyclidine, Cut-off=25 ng/mL)	Result	%Cross-Reactivity
Phencyclidine	Positive at 25 ng/mL	100%
4-Hydroxyphencyclidine	Positive at 75 ng/mL	33.3%

PPX(Propoxyphene)(d-Propoxyphene, Cut-off=300ng/mL)	Result	%Cross-Reactivity
d-Propoxyphene	Positive at 300 ng/mL	100%
D-Norpropoxyphene	Positive at 333 ng/mL	90.1%

TCA(Nortriptyline)(Nortriptyline, Cut-off=1000 ng/mL)	Result	%Cross-Reactivity
Nortriptyline	Positive at 1000 ng/mL	100%
Amitriptyline	Positive at 750 ng/mL	133.3%
Clomipramine	Positive at 10000 ng/mL	10%
Desipramine	Positive at 200 ng/mL	500%
Doxepin	Positive at 1250ng/mL	80%
Imipramine	Positive at 625 ng/mL	160%
Maprotiline	Positive at 2000 ng/mL	50%
Nordoxepin	Positive at 1000 ng/mL	100%
Promazine	Positive at 1500 ng/mL	66.7%
Promethazine	Positive at 25000 ng/mL	4%
Trimipramine	Positive at 3000 ng/mL	33.3%
Cyclobenzaprine	Positive at 5000 ng/mL	20%
Norclomipramine	Positive at 3000 ng/mL	33.3%

THC(Cannabinoids)(11-nor-△9-THC-9-COOH, Cut-off = 50 ng/mL)	Result	% Cross-Reactivity
11-nor-△9-THC-9-COOH	Positive at 50 ng/mL	100%
11-Hydroxy-△9-Tetrahydrocannabinol	Positive at 50 ng/mL	100%
11-Nor-△8-Tetrahydrocannabinol-9-COOH	Positive at 50 ng/mL	100%
Cannabinol	Positive at 20000 ng/mL	0.25%
△8-Tetrahydrocannabinol	Positive at 15000 ng/mL	0.33%
△9-Tetrahydrocannabinol	Positive at 15000 ng/mL	0.33%
Cannabidiol	Positive> 100000 ng/mL	<0.05%
11-Nor-△9-THC-carboxy glucuronide	Positive at 75 ng/mL	66.7%
(-)-11-nor-9-carboxy-△ 9-THC	Positive at 50 ng/mL	100%

f. Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels. These samples were tested using three lots of each device. Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off. There were no differences observed for different devices.

{14}------------------------------------------------

2. Comparison Studies

Method comparison studies for the BIOEASY Multi-Drug Test Cup tests were performed inhouse with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to LC/MS results. The results are presented in the tables below.

Amphetamine

	Negative	Low Negative by LC/MS (less than -50%)	Near Cutoff Negative by LC/MS (Between -50% and cutoff)	Near Cutoff Positive by LC/MS (Between the cutoff and +50%)	High Positive by LC/MS (greater than +50%)
Viewer A Positive	0	0	2	19	19
Viewer A Negative	5	16	17	2	0
Viewer B Positive	0	0	4	20	19
Viewer B Negative	5	16	15	1	0
Viewer C Positive	0	0	3	19	19
Viewer C Negative	5	16	16	2	0

	Discordant Results
Viewer	Sample Number	LC/MS Result	BIOEASY CupViewer Results
Viewer A	AMPC439	981	Positive
Viewer A	AMPC449	768	Positive
Viewer B	AMPC439	981	Positive
Viewer B	AMPC449	768	Positive
Viewer B	AMPC412	976	Positive
Viewer B	AMPC387	981	Positive
Viewer C	AMPC412	976	Positive
Viewer C	AMPC493	961	Positive
Viewer C	AMPC387	981	Positive
Viewer A	AMPC341	1010	Negative
Viewer A	AMPC482	1010	Negative
Viewer B	AMPC482	1010	Negative
Viewer C	AMPC341	1010	Negative
Viewer C	AMPC352	1120	Negative

Secobarbital

		Negative	LowNegative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
Viewer	Positive	0	0	2	17	22
A	Negative	6	15	17	1	0
Viewer	Positive	0	0	2	16	22
B	Negative	6	15	17	2	0
Viewer	Positive	0	0	1	17	22

{15}------------------------------------------------

C	Negative	6	15	18	1	0
Discordant Results
Viewer	Sample Number	LC/MS Result	BIOEASY Cup Viewer Results
Viewer A	BARC477	291	Positive
Viewer A	BARC375	265	Positive
Viewer B	BARC477	291	Positive
Viewer B	BARC375	265	Positive
Viewer C	BARC364	269	Positive
Viewer A	BARC384	312	Negative
Viewer B	BARC384	312	Negative
Viewer B	BARC414	315	Negative
Viewer C	BARC414	315	Negative

Buprenorphine

		Negative	LowNegative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
Viewer	Positive	0	0	1	20	18
A	Negative	5	18	16	2	0
Viewer	Positive	0	0	0	20	18
B	Negative	5	18	17	2	0
Viewer	Positive	0	0	2	21	18
C	Negative	5	18	15	1	0

Discordant Results

Viewer	Sample Number	LC/MS Result	BIOEASY CupViewer Results
Viewer A	BUPC379	9.67	Positive
Viewer C	BUPC359	8.94	Positive
Viewer C	BUPC379	9.67	Positive
Viewer A	BUPC322	10.1	Negative
Viewer A	BUPC429	11.2	Negative
Viewer B	BUPC322	10.1	Negative
Viewer B	BUPC348	10.2	Negative
Viewer C	BUPC348	10.2	Negative

Oxazepam

		Low	Near Cutoff	Near Cutoff
	Negative	Negative by	Negative by	Positive by	High Positive
		LC/MS	LC/MS	LC/MS	by LC/MS
		(less than	(Between	(Between the	(greater than
		-50%)	-50% and	cutoff and	+50%)
			cutoff)	+50%)

{16}------------------------------------------------

Viewer		0	0	2	20	18
A	Positive	0	0	2	20	18
	Negative	5	15	18	2	0
Viewer		0	0	1	21	18
B	Positive	0	0	1	21	18
	Negative	5	15	19	1	0
Viewer		0	0	2	21	18
C	Positive	0	0	2	21	18
	Negative	5	15	18	1	0

Discordant Results

Viewer	Sample Number	LC/MS Result	BIOEASY Cup Viewer Results
Viewer A	BZOC343	298	Positive
Viewer A	BZOC322	296	Positive
Viewer B	BZOC322	296	Positive
Viewer C	BZOC343	298	Positive
Viewer C	BZOC435	292	Positive
Viewer A	BZOC301	314	Negative
Viewer A	BZOC348	312	Negative
Viewer B	BZOC348	312	Negative
Viewer C	BZOC301	314	Negative

Cocaine

		Negative	Low Negative by LC/MS(less than -50%)	Near Cutoff Negative by LC/MS(Between -50% and cutoff)	Near Cutoff Positive by LC/MS(Between the cutoff and +50%)	High Positive by LC/MS(greater than +50%)
Viewer	Positive	0	0	2	21	19
A	Negative	6	17	15	0	0
Viewer	Positive	0	0	2	20	19
B	Negative	6	17	15	1	0
Viewer	Positive	0	0	1	20	19
C	Negative	6	17	14	1	0
Discordant Results

Discordant Results

Viewer	Sample Number	LC/MS Result	BIOEASY Cup Viewer Results
Viewer A	COCC368	298	Positive
Viewer A	COCC340	294	Positive
Viewer B	COCC368	298	Positive
Viewer B	COCC315	282	Positive
Viewer C	COCC340	294	Positive
Viewer B	COCC317	301	Negative
Viewer C	COCC317	301	Negative

Methylenedioxymethamphetamine

{17}------------------------------------------------

		Negative	LowNegative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
Viewer	Positive	0	0	1	19	20
A	Negative	5	16	18	1	0
Viewer	Positive	0	0	2	19	20
B	Negative	5	16	17	1	0
Viewer	Positive	0	0	2	19	20
C	Negative	5	16	17	1	0

Discordant Results

Viewer	Sample Number	LC/MS Result	BIOEASY CupViewer Results
Viewer A	MDMAC310	490	Positive
Viewer B	MDMAC306	497.5	Positive
Viewer B	MDMAC365	484.5	Positive
Viewer C	MDMAC310	490	Positive
Viewer C	MDMAC306	497.5	Positive
Viewer A	MDMAC316	505	Negative
Viewer B	MDMAC316	505	Negative
Viewer C	MDMAC484	565	Negative

Methamphetamine

		Negative	LowNegative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
Viewer	Positive	0	0	2	20	18
A	Negative	5	16	17	2	0
Viewer	Positive	0	0	1	21	18
B	Negative	5	16	18	1	0
Viewer	Positive	0	0	1	21	18
C	Negative	5	16	18	1	0

Discordant Results

Viewer	Sample Number	LC/MS Result	BIOEASY CupViewer Results
Viewer A	METC498	921	Positive
Viewer A	METC479	984	Positive
Viewer B	METC467	973	Positive
Viewer C	METC479	984	Positive
Viewer A	METC343	1020	Negative
Viewer A	METC473	1110	Negative
Viewer B	METC473	1110	Negative

{18}------------------------------------------------

Viewer C	METC343	1020	Negative
----------	---------	------	----------

Morphine

		Negative	Low Negative by LC/MS (less than -50%)	Near Cutoff Negative by LC/MS (Between -50% and cutoff)	Near Cutoff Positive by LC/MS (Between the cutoff and +50%)	High Positive by LC/MS (greater than +50%)
Viewer	Positive	0	0	2	18	21
A	Negative	5	16	17	1	0
Viewer	Positive	0	0	2	18	21
B	Negative	5	16	17	1	0
Viewer	Positive	0	0	2	17	21
C	Negative	5	16	17	2	0

Discordant Results

Viewer	Sample Number	LC/MS Result	BIOEASY CupViewer Results
Viewer A	MOPC355	287	Positive
Viewer A	MOPC429	298	Positive
Viewer B	MOPC408	286	Positive
Viewer B	MOPC429	298	Positive
Viewer C	MOPC408	286	Positive
Viewer C	MOPC433	276	Positive
Viewer A	MOPC393	301	Negative
Viewer B	MOPC416	339	Negative
Viewer C	MOPC416	339	Negative
Viewer C	MOPC393	301	Negative

Methadone

		Negative	Low Negative by LC/MS (less than -50%)	Near Cutoff Negative by LC/MS (Between -50% and cutoff)	Near Cutoff Positive by LC/MS (Between the cutoff and +50%)	High Positive by LC/MS (greater than +50%)
Viewer A	Positive	0	0	2	21	18
Viewer A	Negative	5	15	18	1	0
Viewer B	Positive	0	0	2	20	18
Viewer B	Negative	5	15	18	2	0
Viewer C	Positive	0	0	3	22	18
Viewer C	Negative	5	15	17	0	0

Discordant Results

Viewer	Sample Number	LC/MS Result	BIOEASY Cup Viewer Results
Viewer A	MTDC314	289	Positive
Viewer A	MTDC389	299	Positive

{19}------------------------------------------------

Viewer B	MTDC314	289	Positive
Viewer B	MTDC408	290	Positive
Viewer C	MTDC389	299	Positive
Viewer C	MTDC373	279	Positive
Viewer C	MTDC408	290	Positive
Viewer A	MTDC447	309	Negative
Viewer B	MTDC447	309	Negative
Viewer B	MTDC427	336	Negative

Oxycodone

			LowNegative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
Viewer	A	Positive	0	4	18	22
		Negative	6	15	0	0
Viewer	B	Positive	0	3	18	22
		Negative	6	15	0	0
Viewer	C	Positive	0	3	18	22
		Negative	6	16	0	0

Discordant Results

Viewer	Sample Number	LC/MS Result	BIOEASY CupViewer Results
Viewer A	OXYC467	97.5	Positive
Viewer A	OXYC369	94.6	Positive
Viewer A	OXYC334	98.4	Positive
Viewer A	OXYC470	95.1	Positive
Viewer B	OXYC467	97.5	Positive
Viewer B	OXYC310	96.1	Positive
Viewer B	OXYC470	95.1	Positive
Viewer C	OXYC310	96.1	Positive
Viewer C	OXYC369	94.6	Positive
Viewer C	OXYC334	98.4	Positive

Phencyclidine

		Negative	Low Negative by LC/MS(less than -50%)	Near Cutoff Negative by LC/MS(Between -50% and cutoff)	Near Cutoff Positive by LC/MS(Between the cutoff and +50%)	High Positive by LC/MS(greater than +50%)
Viewer A	Positive	0	0	1	18	20
	Negative	3	18	18	2	0
Viewer B	Positive	0	0	2	20	20
	Negative	3	18	17	0	0

{20}------------------------------------------------

Viewer		0	0	2	19	20
C	Positive	0	0	2	19	20
C	Negative	3	18	17	1	0

Discordant Results

Viewer	Sample Number	LC/MS Result	BIOEASY CupViewer Results
Viewer A	PCPC441	24.8	Positive
Viewer B	PCPC411	24.7	Positive
Viewer B	PCPC441	24.8	Positive
Viewer C	PCPC462	24.7	Positive
Viewer C	PCPC411	24.7	Positive
Viewer A	PCPC477	25.3	Negative
Viewer A	PCPC368	27.8	Negative
Viewer C	PCPC477	25.3	Negative

Propoxyphene

		Negative	LowNegative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
Viewer	Positive	0	0	1	18	20
A	Negative	5	15	19	2	0
Viewer	Positive	0	0	2	19	20
B	Negative	5	15	18	1	0
Viewer	Positive	0	0	1	19	20
C	Negative	5	15	19	1	0

Discordant Results

Viewer	Sample Number	LC/MS Result	BIOEASY Cup Viewer Results
Viewer A	PPXC472	286	Positive
Viewer B	PPXC472	286	Positive
Viewer B	PPXC320	278	Positive
Viewer C	PPXC320	278	Positive
Viewer A	PPXC493	318	Negative
Viewer A	PPXC382	306	Negative
Viewer B	PPXC382	306	Negative
Viewer C	PPXC493	318	Negative

Nortriptyline

		Negative	LowNegative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
Viewer	Positive	0	0	2	20	19

{21}------------------------------------------------

A	Negative	5	15	18	1	0
Viewer	Positive	0	0	2	18	19
B	Negative	5	15	18	3	0
Viewer	Positive	0	0	2	19	19
C	Negative	5	15	18	2	0

Discordant Results

Viewer	Sample Number	LC/MS Result	BIOEASY CupViewer Results
Viewer A	TCAC319	979	Positive
Viewer A	TCAC470	944	Positive
Viewer B	TCAC319	979	Positive
Viewer B	TCAC346	958	Positive
Viewer C	TCAC346	958	Positive
Viewer C	TCAC470	944	Positive
Viewer A	TCAC479	1190	Negative
Viewer B	TCAC398	1050	Negative
Viewer B	TCAC331	1180	Negative
Viewer B	TCAC479	1190	Negative
Viewer C	TCAC398	1050	Negative
Viewer C	TCAC331	1180	Negative

Marijuana

		Negative	LowNegative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
Viewer	Positive	0	0	2	19	18
A	Negative	6	14	18	3	0
Viewer	Positive	0	0	2	20	18
B	Negative	6	14	18	2	0
Viewer	Positive	0	0	2	19	18
C	Negative	6	14	18	3	0

Discordant Results

Viewer	Sample Number	LC/MS Result	BIOEASY CupViewer Results
Viewer A	THCC402	46	Positive
Viewer A	THCC368	48.8	Positive
Viewer B	THCC363	46.95	Positive
Viewer B	THCC402	46	Positive
Viewer C	THCC363	46.95	Positive
Viewer C	THCC368	48.8	Positive
Viewer A	THCC478	55.5	Negative
Viewer A	THCC493	50.5	Negative
Viewer A	THCC496	57.5	Negative
Viewer B	THCC478	55.5	Negative

{22}------------------------------------------------

Viewer B	THCC318	56	Negative
Viewer C	THCC493	50.5	Negative
Viewer C	THCC318	56	Negative
Viewer C	THCC496	57.5	Negative

Lay-user study

A lay user study was performed at three intended user sites with 300 lay persons for the device. The lay users had diverse educational and professional backgrounds and ranged in age from 18 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. Each device was tested. Summary results are shown below.

The results summary for AMP:

% of Cutoff	Number ofsamples	Drug Concentrationby LC/MS/MS(ng/mL)	Lay person ResultsNo. of Positive	Lay person ResultsNo. of Negative	The percentage ofcorrect results (%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	261	0	20	100
-50% Cutoff	160	507	0	160	100
-25% Cutoff	20	771	1	19	95
+25% Cutoff	20	1290	19	1	95
+50% Cutoff	40	1560	40	0	100
+75% Cutoff	20	1870	20	0	100

The results summary for BAR:

% of Cutoff	Number of samples	Drug Concentration by LC/MS/MS(ng/mL)	Lay person Results		The percentage of correct results (%)
			No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	75.9	0	20	100
-50% Cutoff	160	150	0	160	100
-25% Cutoff	20	220	1	19	95
+25% Cutoff	20	360	19	1	95
+50% Cutoff	40	429	40	0	100
+75% Cutoff	20	501	20	0	100

The results summary for COC:

% of Cutoff	Number ofsamples	Drug ConcentrationbyLC/MS/MS(ng/mL)	Lay person Results		The percentage ofcorrect results(%)
	No. ofPositive		No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	81.5	0	20	100
-50% Cutoff	160	151	0	160	100
-25% Cutoff	20	225	1	19	95
+25% Cutoff	20	395	19	1	95
+50% Cutoff	40	455	40	0	100

{23}------------------------------------------------

00. 7-0/.	EACV International Comments of the Comments of Children of the Children Comments of the Children Children of the Children Children of the Children Children of the Children Child		An1 V V

The results summary for BUP:

% of Cutoff	Number ofsamples	Drug ConcentrationbyLC/MS/MS(ng/mL)	Lay person Results		The percentage ofcorrect results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	2.57	0	20	100
-50% Cutoff	160	5.14	0	160	100
-25% Cutoff	20	6.76	1	19	95
+25% Cutoff	20	12.8	19	1	95
+50% Cutoff	40	15.1	40	0	100
+75% Cutoff	20	17.2	20	0	100

The results summary for MET:

% of Cutoff	Number of samples	Drug Concentration by LC/MS/MS(ng/mL)	Lay person Results		The percentage of correct results (%)
			No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	268	0	20	100
-50% Cutoff	160	526	0	160	100
-25% Cutoff	20	769	1	19	95
+25% Cutoff	20	1270	19	1	95
+50% Cutoff	40	1560	40	0	100
+75% Cutoff	20	1780	20	0	100

The results summary for MTD:

% of Cutoff	Number of samples	Drug Concentration by LC/MS/MS(ng/mL)	Lay person Results		The percentage of correct results (%)
			No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	76.8	0	20	100
-50% Cutoff	160	147	0	160	100
-25% Cutoff	20	226	1	19	95
+25% Cutoff	20	375	19	1	95
+50% Cutoff	40	441	40	0	100
+75% Cutoff	20	504	20	0	100

The results summary for MOP:

% of Cutoff	Number ofsamples	Drug ConcentrationbyLC/MS/MS(ng/mL)	Lay person Results		The percentage of
			No. ofPositive	No. ofNegative	correct results(%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	79	0	20	100
-50% Cutoff	160	158	0	160	100
-25% Cutoff	20	246	1	19	95
+25% Cutoff	20	389	20	0	100
+50% Cutoff	40	469	40	0	100

{24}------------------------------------------------

+75% Cutoff	20	530	20	0	100
The results summary for OYY.

The results summary for OXY:

% of Cutoff	Number ofsamples	Drug ConcentrationbyLC/MS/MS(ng/mL)	Lay person Results		The percentage ofcorrect results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	24.5	0	20	100
-50% Cutoff	160	49.3	0	160	100
-25% Cutoff	20	71.1	1	19	95
+25% Cutoff	20	118	19	1	95
+50% Cutoff	40	147	40	0	100
+75% Cutoff	20	169	20	0	100

The results summary for PCP:

% of Cutoff	Number ofsamples	Drug ConcentrationbyLC/MS/MS(ng/mL)	Lay person Results		The percentage ofcorrect results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	6.27	0	20	100
-50% Cutoff	160	12.5	0	160	100
-25% Cutoff	20	17.9	1	19	95
+25% Cutoff	20	30.8	19	1	95
+50% Cutoff	40	36.4	40	0	100
+75% Cutoff	20	42.8	20	0	100

The results summary for THC:

% of Cutoff	Number of samples	Drug Concentration by LC/MS/MS(ng/mL)	Lay person Results		The percentage of correct results (%)
			No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	13	0	20	100
-50% Cutoff	160	25.3	0	160	100
-25% Cutoff	20	41	1	19	95
+25% Cutoff	20	65	19	1	95
+50% Cutoff	40	79	40	0	100
+75% Cutoff	20	93	20	0	100

The results summary for BZO:

% of Cutoff	Number ofsamples	DrugConcentration byLC/MS/MS(ng/mL)	Lay person Results		The percentage ofcorrect results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	70.8	0	20	100
-50% Cutoff	160	148	0	160	100
-25% Cutoff	20	224	1	19	95
+25% Cutoff	20	390	19	1	95
+50% Cutoff	40	452	40	0	100
+75% Cutoff	20	504	20	0	100

{25}------------------------------------------------

The results summary for MDMA:

% of Cutoff	Number ofsamples	Drug ConcentrationbyLC/MS/MS(ng/mL)	Lay person Results		The percentage ofcorrect results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	137	0	20	100
-50% Cutoff	160	250	0	160	100
-25% Cutoff	20	351	1	19	95
+25% Cutoff	20	600	19	1	95
+50% Cutoff	40	745	40	0	100
+75% Cutoff	20	925	20	0	100

The results summary for TCA:

% of Cutoff	Number ofsamples	Drug ConcentrationbyLC/MS/MS(ng/mL)	Lay person Results		The percentage ofcorrect results(%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	273	0	20	100
-50% Cutoff	160	509	0	160	100
-25% Cutoff	20	809	1	19	95
+25% Cutoff	20	1190	18	2	90
+50% Cutoff	40	1510	40	0	100
+75% Cutoff	20	1680	20	0	100

The results summary for PPX:

% of Cutoff	Number ofsamples	Drug ConcentrationbyLC/MS/MS(ng/mL)	Lay person Results		The percentage ofcorrect results(%)
			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	77.4	0	20	100
-50% Cutoff	160	150	0	160	100
-25% Cutoff	20	227	1	19	95
+25% Cutoff	20	351	19	1	95
+50% Cutoff	40	420	40	0	100
+75% Cutoff	20	492	20	0	100

Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

• 3. Clinical Studies
     Not applicable.

11. Conclusion

Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, method comparison, and lay-user studies of the device, it's concluded that the BIOEASY Multi-Drug Test Cup tests are substantially equivalent to the predicate.

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).