AssureTech Panel Dip Test, AssureTech Quick Cup Test

K170049 · Assure Tech. (Hangzhou) Co, Ltd. · NFT · May 2, 2017 · Clinical Toxicology

Device Facts

• Record ID: K170049
• Device Name: AssureTech Panel Dip Test, AssureTech Quick Cup Test
• Applicant: Assure Tech. (Hangzhou) Co, Ltd.
• Product Code: NFT · Clinical Toxicology
• Decision Date: May 2, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

AssureTech Panel Dip Tests and AssureTech Quick 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 and Methadone 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 or 2000 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 Configuration of the AssureTech Panel Dip Tests and the AssureTech Quick Cup Tests can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital 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. These tests are intended for over-the counter and for prescription use.

Device Story

Lateral flow immunochromatographic assays for qualitative detection of drugs of abuse in human urine; competitive binding principle. Device formats: dip card (with collection cup) or quick cup (integrated test). User collects urine; device detects target analytes via monoclonal antibody-coated particles. If drug concentration is below cutoff, antibody binding sites remain available to bind immobilized drug-conjugate, forming visible test line. If drug concentration exceeds cutoff, binding sites are saturated, preventing test line formation. Control line confirms proper test performance. Used in clinical or home settings; operated by healthcare professionals or lay users. Results are preliminary; positive results require confirmation via GC/MS or LC/MS. Assists in identifying potential drug use; clinical judgment required for interpretation.

Clinical Evidence

Bench testing only. Precision/reproducibility studies performed over 25 days using spiked urine samples confirmed by LC/MS. Analytical specificity and cross-reactivity evaluated for various metabolites. Lay-user study conducted with 280 participants per format (Panel Dip and Quick Cup) across diverse demographics; results showed high concordance with LC/MS across all drug analytes. No clinical studies required for this qualitative screening assay.

Technological Characteristics

Lateral flow immunochromatographic assay. Components: urine collection cup, dip card/quick cup plastic casing. Principle: competitive binding with monoclonal mouse antibodies on gold particles. Qualitative visual readout. No instrumentation required. Stable at 4-30°C for 24 months.

Indications for Use

Indicated for qualitative, simultaneous detection of drugs of abuse (Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, MDMA, Phencyclidine, Methadone) in human urine. Intended for OTC and prescription use. Not intended to distinguish between prescription use and abuse.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• The Chemtrue® Multi-Panel Drug Screen Dip Card Tests (K142396)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 2, 2017

ASSURE TECH (HANGZHOU) CO., LTD. C/O JOE SHIA LSI INTERNATIONAL. INC 504 E DIAMOND AVE. SUITE I GAITHERSBURG MD 20877

Re: k170049

Trade/Device Name: AssureTech Panel Dip Tests, AssureTech Quick Cup Test Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: II Product Code: NFT, NFW, NFY, NGG, NGL, NFV, PTH, NGM, PTG Dated: March 18, 2017 Received: March 24, 2017

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

Device Name AssureTech Panel Dip Tests AssureTech Quick Cup Tests

#### Indications for Use (Describe)

AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine. Phencyclidine and Methadone 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 |
| Cannabinoids | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Morphine | 300 ng/mL or 2000 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 |

Configuration of the AssureTech Panel Dip Tests and the AssureTech Quick Cup Tests can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam. Secobarbital and Oxyodone 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 is the preferred confirmatory method.

The tests are intended for over-the-counter and for prescription use.

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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### 510(k) SUMMARY

- April 21, 2017 1. Date: 2. Submitter: Assure Tech. Co., Ltd. Building 1, No.10, Xiyuansan Road, Westlake Economic Zone Hangzhou, China, 310030 3. Contact person: Eric Lin Assure Tech. Co., Ltd. Building 1, No.10, Xiyuansan Road, Westlake
- Economic Zone Hangzhou, China, 310030 Telephone: [phone] Email: [e-mail].
- 4. Device Name: AssureTech Panel Dip Tests AssureTech Quick Cup Tests

| Classification: | Class 2 | | |
|-------------------------------------------|----------------|----------------------------------------------------------------|--------------------|
| Product Code | Classification | Regulation Section | Panel |
| NFT<br>Amphetamine | II | 21 CFR § 862.3100, Amphetamine Test System | Toxicology<br>(91) |
| NFW<br>Cannabinoids | II | 21 CFR § 862.3870, Cannabinoids Test System | Toxicology<br>(91) |
| NFY<br>Cocaine | II | 21 CFR § 862.3250, Cocaine and Cocaine Metabolites Test System | Toxicology<br>(91) |
| NGG<br>Methamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology<br>(91) |
| NGL<br>Morphine | II | 21 CFR § 862.3650, Morphine Test System | Toxicology<br>(91) |
| NFV<br>Oxazepam | II | 21 CFR § 862.3170, Benzodiazepine Test System | Toxicology<br>(91) |
| NGL<br>Oxycodone | II | 21 CFR § 862.3650, Opiate Test System | Toxicology<br>(91) |
| PTH<br>Secobarbital | II | 21 CFR § 862.3150, Barbiturate Test System | Toxicology<br>(91) |
| NGL<br>Buprenorphine | II | 21 CFR § 862.3650, Opiate Test System | Toxicology<br>(91) |
| NGG<br>Methylenedioxy-<br>methamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology<br>(91) |
| NGM<br>Phencyclidine | unclassified | Enzyme Immunoassay<br>Phencyclidine | Toxicology<br>(91) |
| PTG<br>Methadone | II | 21 CFR § 862.3620, Methadone Test System | Toxicology<br>(91) |

- 5. Predicate Devices: K142396
The Chemtrue® Multi-Panel Drug Screen Dip Card Tests

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## 6. Intended Use

AssureTech Panel Dip Tests and AssureTech Quick 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 and Methadone 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 or 2000 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 |

Configuration of the AssureTech Panel Dip Tests and the AssureTech Quick Cup Tests can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital 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.

The tests are intended for over-the-counter and for prescription use.

### 7. Device Description

The AssureTech Panel Dip Tests and AssureTech Quick 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, Methylenedioxy-methamphetamine, Phencyclidine and Methadone (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

The AssureTech Panel Dip Tests comprise two items, a urine collection cup and the dip card with a plastic casing as the lateral flow device. The AssureTech Quick Cup Tests comprise a urine collection cup and a quick cup test with a lateral flow device that will start when the cap is screwed onto cup.

### 8. Substantial Equivalence Information

A summary comparison of features of the AssureTech Panel Dip Tests and AssureTech Quick Cup Tests and the predicate devices is provided in following tables.

### Table 1: Features Comparison of AssureTech Panel Dip Tests and the Predicate Devices

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| Item | Device | Predicate - K142396 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Indication(s)<br>for Use | For the qualitative determination of drugs of<br>abuse in human urine. | Same (but the number of<br>drugs detected is different) |
| Calibrator and<br>Cut-Off Values | Amphetamine (AMP): 1,000 ng/ml<br>Oxazepam (BZO):300 ng/ml<br>Cocaine(COC): 300 ng/ml<br>Marijuana (THC):50 ng/ml<br>Methamphetamine (MET): 1,000 ng/ml<br>Morphine (MOR): 300ng/mL or 2000 ng/ml<br>Oxycodone(OXY) : 100 ng/ml<br>Secobarbital (BAR): 300 ng/ml<br>Buprenorphine (BUP): 10 ng/ml<br>Methylenedioxy-methamphetamine(MDMA):<br>500 ng/ml<br>Phencyclidine (PCP): 25 ng/ml<br>Methadone (MTD): 300 ng/ml | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on the<br>principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Dip Card, Cup | Dip Card |

## Table 2: Features Comparison of AssureTech Quick Cup Tests and the Predicate Devices

| Item | Device | Predicate - K142396 |
|---------------|--------------------------------------|------------------------------|
| Indication(s) | For the qualitative determination of | Same (but the number of |
| for Use | drugs of abuse in human urine. | drugs detected is different) |

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| Calibrator and Cut-Off<br>Values | Amphetamine (AMP): 1,000 ng/ml<br>Oxazepam (BZO):300 ng/ml<br>Cocaine(COC): 300 ng/ml<br>Marijuana (THC):50 ng/ml<br>Methamphetamine (MET): 1,000 ng/ml<br>Morphine (MOR): 300ng/mL or 2000 ng/ml<br>Oxycodone(OXY) : 100 ng/ml<br>Secobarbital (BAR): 300 ng/ml<br>Buprenorphine (BUP): 10 ng/ml<br>Methylenedioxy-<br>methamphetamine(MDMA): 500 ng/ml<br>Phencyclidine (PCP): 25 ng/ml<br>Methadone (MTD): 300 ng/ml | Same |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on<br>the principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Intended Use | For over-the-counter and prescription | Same |
| Configurations | Dip Card, Cup | Dip Card |

### 9. Test Principle

The AssureTech Panel Dip Tests, and AssureTech Quick Cup Tests are rapid tests for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone 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 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

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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 for Oxazepam, Methylenedioxy-methamphetamine and Morphine. The rest data were reported in k153465, k151211, k152025 and k161044.

### Oxazepam

Panel Dip

| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off | Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|----------------|-----------------|-----------------|-----------------|------------------|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 8-/42+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Quick Cup

### Methylenedioxy-methamphetamine

Panel Dip

| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 13-/37+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Quick Cup

| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

### Morphine (300 ng/mL Cut-off)

Panel Dip

| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Quick Cup

| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 8-/42+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

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#### b. Linearity

Not applicable.

c. Stability

The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 45 °C and real time stability determination 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 (except for albumin at 100mg/dL) are summarized in the following tables. There were no differences observed for different devices.

| Acetominophen | Ecgonine methyl ester | D,L-Octopamine |
|----------------------|------------------------|--------------------------------|
| Acetophenetidin | EMDP | Oxalic acid |
| N-Acetylprocainamide | Erythromycin | Oxolinic acid |
| Acetylsalicylic acid | ẞ-Estradiol | Oxymetazoline |
| Albumin (100mg/dL) | Fenoprofen | Papaverine |
| Aminopyrine | Furosemide | Penicillin-G |
| Amoxicillin | Gentisic acid | Perphenazine |
| Ampicillin | Hemoglobin | Phenelzine |
| Apomorphine | Hydralazine | Prednisone |
| Ascorbic acid | Hydrochlorothiazide | DL-Propranolol |
| Aspartame | Hydrocortisone | D-Pseudoephedrine |
| Atropine | O-Hydroxyhippuric acid | Quinine |
| Benzilic acid | 3-Hydroxytyramine | Ranitidine |
| Benzoic acid | Ibuprofen | Salicylic acid |
| Bilirubin | D,L-Isoproterenol | Serotonin (5- Hydroxytyramine) |
| Chloralhydrate | Isoxsuprine | Sulfamethazine |
| Chloramphenicol | Ketamine | Sulindac |
| Chlorothiazide | Ketoprofen | Tetrahydrocortisone, 3-acetate |
| Chlorpromazine | Labetalol | Tetrahydrocortisone 3-(β- |
| | | Dglucuronide) |
| Cholesterol | Loperamide | Tetrahydrozoline |
| Clonidine | Maprotiline | Thiamine |
| Cortisone | Meperidine | Thioridazine |
| (-) Cotinine | Meprobamate | Triamterene |
| Creatinine | Methoxyphenamine | DL-Tyrosine |
| Deoxycorticosterone | Nalidixic acid | Trifluoperazine |
| Dextromethorphan | Naloxone | Trimethoprim |
| Diclofenac | Naltrexone | D L-Tryptophan |
| Diflunisal | Naproxen | Tyramine |
| Digoxin | Niacinamide | Uric acid |
| Diphenhydramine | Nifedipine | Verapamil |
| Disopyramide | Norethindrone | Zomepirac |
| EDDP | Noscapine | |

e. Specificity

To test specificity, drug metabolites and other components that are likely to interfere

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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 for Oxazepam, Methylenedioxy-methamphetamine and Morphine. The rest data were reported in k153465, k151211, k152025 and k161044. There were no differences observed for different devices.

| Oxazepam | Result | % Cross-Reactivity |
|-------------------------|---------------------|--------------------|
| (Cut-off=300 ng/mL) | Positive at (ng/mL) | |
| Oxazepam | 300 | 100% |
| Alprazolam | 150 | 200% |
| a-Hydroxyalprazolam | 1000 | 30% |
| Bromazepam | 1000 | 30% |
| Chiordiazepoxide | 63 | 476.2% |
| Clonazepam | 2500 | 12% |
| Clobazam | 75 | 400% |
| Clorazepate dipotassium | 100 | 300% |
| Desalkylflurazepam | 500 | 60% |
| Diazepam | 500 | 60% |
| Estazolam | 500 | 60% |
| Flunitrazepam | >50000 | <0.6% |
| D,L-Lorazepam | 10000 | 3% |
| Midazolam | 10000 | 3% |
| Nitrazepam | 75 | 400% |
| Norchiordiazepoxide | 62.5 | 480% |
| Nordiazepam | 125 | 240% |
| Temazepam | 75 | 400% |
| Trazolam | 1000 | 30% |

| Ecstasy | Result<br>Positive at(ng/ml) | % Cross-Reactivity |
|-------------------------------------------|------------------------------|--------------------|
| (Cut-off=500 ng/mL) | | |
| Methylenedioxymethamphetamine (MDMA) | 500 | 100% |
| 3,4-Methylenedioxyamphetamine (MDA) | 5,000 | 10% |
| 3,4-Methylenedioxyethylamphetamine (MDEA) | 300 | 166.7% |
| d-methamphetamine | >50000 | <1% |
| d-amphetamine | >50000 | <1% |
| l-amphetamine | >50000 | <1% |
| l-methamphetamine | >50000 | <1% |

| Morphine | Result | % Cross-Reactivity |
|------------------------------|--------------------|--------------------|
| (Cut-off=300 ng/mL) | Positive at(ng/ml) | |
| Morphine | 300 | 100% |
| Codeine | 300 | 100% |
| Ethylmorphine | 310 | 96.8% |
| Hydrocodone | 25000 | 1.2% |
| Hydromorphine | 10000 | 3% |
| Levorphanol | >100000 | <0.3% |
| 6-Acetylmorphine | 250 | 120% |
| Morphine 3- β -D-glucuronide | 10000 | 3% |
| Normorphine | 100000 | 0.3% |
| Oxycodone | >100000 | <0.3% |
| Oxymorphone | >100000 | <0.3% |
| Procaine | >100000 | <0.3% |
| Thebaine | >100000 | <0.3% |
| Heroine | 500 | 60% |

f. Effect of Urine Specific Gravity and Urine pH

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

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.

- 2. Comparison Studies
Method comparison studies for the AssureTech Panel Dip Tests and the AssureTech Quick Cup Tests were performed in-house 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 for Oxazepam, Methylenedioxy-methamphetamine and Morphine. The rest data were reported in k153465, k151211, k152025 and k161044.

### Oxazepam

| Panel<br>Dip | | Negative | Low Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|--------------|----------|----------|-------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |

Discordant Results

| Viewer | Sample Number | LC/MS Result | Dip Card<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer C | 41261 | 289.61 | Positive |
| Viewer A | 35578 | 310.69 | Negative |
| Viewer B | 35578 | 310.69 | Negative |

| Quick<br>Cup | | Negative | Low<br>Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|--------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 15 | 25 |

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

| C | Negative | 10 | 20 | 9 | 0 | 0 |
|--------------------|----------|----|----|---|---|---|
| Discordant Results | | | | | | |

| Viewer | Sample Number | LC/MS Result | Quick Cup Viewer Results |
|----------|---------------|--------------|--------------------------|
| Viewer C | 41261 | 289.6 | Positive |
| Viewer A | 73291 | 311.7 | Negative |
| Viewer B | 35578 | 310.6 | Negative |

# Methylenedioxy-methamphetamine

| Panel Dip | | 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 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |

## Discordant Results

| Viewer | Sample Number | LC/MS Result | Dip Card<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer A | 37623 | 491.17 | Positive |
| Viewer B | 37623 | 491.17 | Positive |
| Viewer C | 37623 | 491.17 | Positive |
| Viewer A | 61074 | 508.34 | Negative |
| Viewer B | 61074 | 508.34 | Negative |

| Quick<br>Cup | | Negative | Low Negative by<br>LC/MS<br>(less than -50%) | Near Cutoff Negative by<br>LC/MS<br>(Between -50% and<br>cutoff) | Near Cutoff Positive by<br>LC/MS<br>(Between the cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than +50%) |
|--------------|----------|----------|----------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |

## Discordant Results

| Viewer | Sample Number | LC/MS Result | Quick Cup<br>Viewer Results |
|--------|---------------|--------------|-----------------------------|
| | | | |

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

| Viewer A | 37623 | 491.17 | Positive |
|----------|-------|--------|----------|
| Viewer B | 37623 | 491.17 | Positive |
| Viewer C | 37623 | 491.17 | Positive |
| Viewer A | 61074 | 508.34 | Negative |
| Viewer C | 61074 | 508.34 | Negative |

# Morphine

| Panel Dip | | Negative | Low Negative by<br>LC/MS<br>(less than -50%) | Near Cutoff Negative by<br>LC/MS<br>(Between -50% and<br>cutoff) | Near Cutoff Positive by<br>LC/MS<br>(Between the<br>cutoff and +50%) | High Positive<br>by LC/MS<br>(greater than +50%) |
|-------------|----------|----------|----------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |

## Discordant Results

| Viewer | Sample Number | LC/MS Result | Dip Card<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer A | 90003 | 278.16 | Positive |
| Viewer B | 80161 | 280.75 | Positive |
| Viewer A | 59386 | 322.85 | Negative |
| Viewer B | 98199 | 306.08 | Negative |
| Viewer C | 98199 | 306.08 | Negative |

| Quick<br>Cup | | Negative | Low Negative by<br>LC/MS<br>(less than -50%) | Near Cutoff Negative by<br>LC/MS<br>(Between -50% and cutoff) | Near Cutoff Positive by<br>LC/MS<br>(Between the cutoff and +50%) | High Positive by LC/MS<br>(greater than +50%) |
|--------------|----------|----------|----------------------------------------------|---------------------------------------------------------------|-------------------------------------------------------------------|-----------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 14 | 25 |
| | Negative | 10 | 20 | 9 | 1 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 0 | 15 | 25 |
| | Negative | 10 | 20 | 10 | 0 | 0 |

## Discordant Results

| Viewer | Sample Number | LC/MS Result | Quick Cup Viewer Results |
|----------|---------------|--------------|--------------------------|
| Viewer A | 80161 | 280.75 | Positive |
| Viewer B | 80161 | 280.75 | Positive |

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

| Viewer B | 59386 | 322.85 | Negative |
|----------|-------|--------|----------|
|----------|-------|--------|----------|

### Lay-user study

A lay user study was performed at three intended user sites with 280 lay persons for each device format. 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 was tested. Typical results are shown below.

### The results summary for AMP:

| % of Cutoff | Number of<br>samples | Drug Concentration by<br>LC/MS (ng/mL) | Lay person Results | |
|--------------|----------------------|----------------------------------------|--------------------|-----------------|
| | | | No. of Positive | No. of Negative |
| -100% Cutoff | 20 | 0 | 0 | 20 |
| -75% Cutoff | 20 | 248 | 0 | 20 |
| -50% Cutoff | 140 | 508 | 0 | 140 |
| -25% Cutoff | 20 | 752 | 1 | 19 |
| +25% Cutoff | 20 | 1255 | 19 | 1 |
| +50% Cutoff | 40 | 1506 | 40 | 0 |
| +75% Cutoff | 20 | 1748 | 20 | 0 |

The results summary for BAR:

| % of Cutoff | Number of<br>samples | Drug Concentration by<br>LC/MS(ng/mL) | Lay person Results | |
|--------------|----------------------|---------------------------------------|--------------------|-----------------|
| | | | No. of Positive | No. of Negative |
| -100% Cutoff | 20 | 0 | 0 | 20 |
| -75% Cutoff | 20 | 73 | 0 | 20 |
| -50% Cutoff | 140 | 151 | 0 | 140 |
| -25% Cutoff | 20 | 223 | 1 | 19 |
| +25% Cutoff | 20 | 378 | 20 | 0 |
| +50% Cutoff | 40 | 456 | 40 | 0 |
| +75% Cutoff | 20 | 521 | 20 | 0 |

### The results summary for COC:

| % of Cutoff | Number of<br>samples | Drug Concentration by<br>LC/MS(ng/mL) | Lay person Results | |
|--------------|----------------------|---------------------------------------|--------------------|-----------------|
| | | | No. of Positive | No. of Negative |
| -100% Cutoff | 20 | 0 | 0 | 20 |
| -75% Cutoff | 20 | 76 | 0 | 20 |
| -50% Cutoff | 140 | 154 | 0 | 140 |
| -25% Cutoff | 20 | 222 | 1 | 19 |
| +25% Cutoff | 20 | 377 | 20 | 0 |
| +50% Cutoff | 40 | 452 | 40 | 0 |
| +75% Cutoff | 20 | 528 | 20 | 0 |

The results summary for BUP:

| % of Cutoff | Number of | Drug Concentration by | Lay person Results |
|-------------|-----------|-----------------------|--------------------|
|-------------|-----------|-----------------------|--------------------|

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

| | samples | LC/MS(ng/mL) | No. of Positive | No. of Negative |
|--------------|---------|--------------|-----------------|-----------------|
| -100% Cutoff | 20 | 0 | 0 | 20 |
| -75% Cutoff | 20 | 2.6 | 0 | 20 |
| -50% Cutoff | 140 | 4.8 | 0 | 140 |
| -25% Cutoff | 20 | 7.2 | 2 | 18 |
| +25% Cutoff | 20 | 12.6 | 20 | 0 |
| +50% Cutoff | 40 | 15.4 | 40 | 0 |
| +75% Cutoff | 20 | 17.3 | 20 | 0 |

### The results summary for MET:

| % of Cutoff | Number of<br>samples | Drug Concentration by<br>LC/MS(ng/mL) | Lay person Results | |
|--------------|----------------------|---------------------------------------|--------------------|-----------------|
| | | | No. of Positive | No. of Negative |
| -100% Cutoff | 20 | 0 | 0 | 20 |
| -75% Cutoff | 20 | 255 | 0 | 20 |
| -50% Cutoff | 140 | 496 | 0 | 140 |
| -25% Cutoff | 20 | 757 | 1 | 19 |
| +25% Cutoff | 20 | 1258 | 20 | 0 |
| +50% Cutoff | 40 | 1504 | 40 | 0 |
| +75% Cutoff | 20 | 1744 | 20 | 0 |

The results summary for MTD:

| % of Cutoff | Number of<br>samples | Drug Concentration by<br>LC/MS(ng/mL) | Lay person Results | |
|--------------|----------------------|---------------------------------------|--------------------|-----------------|
| | | | No. of Positive | No. of Negative |
| -100% Cutoff | 20 | 0 | 0 | 20 |
| -75% Cutoff | 20 | 73 | 0 | 20 |
| -50% Cutoff | 140 | 155 | 0 | 140 |
| -25% Cutoff | 20 | 228 | 0 | 20 |
| +25% Cutoff | 20 | 377 | 19 | 1 |
| +50% Cutoff | 40 | 454 | 40 | 0 |
| +75% Cutoff | 20 | 528 | 20 | 0 |

The results summary for MOR:

| % of Cutoff | Number of<br>samples | Drug Concentration by<br>LC/MS(ng/mL) | Lay person Results | |
|--------------|----------------------|---------------------------------------|--------------------|-----------------|
| | | | No. of Positive | No. of Negative |
| -100% Cutoff | 20 | 0 | 0 | 20 |
| -75% Cutoff | 20 | 77 | 0 | 20 |
| -50% Cutoff | 140 | 155 | 0 | 140 |
| -25% Cutoff | 20 | 227 | 1 | 19 |
| +25% Cutoff | 20 | 371 | 20 | 0 |
| +50% Cutoff | 40 | 447 | 40 | 0 |
| +75% Cutoff | 20 | 521 | 20 | 0 |

## The results summary for OXY:

| % of Cutoff | Number of<br>samples | Drug Concentration by<br>LC/MS(ng/mL) | Lay person Results | |
|--------------|----------------------|---------------------------------------|--------------------|-----------------|
| | | | No. of Positive | No. of Negative |
| -100% Cutoff | 20 | 0 | 20 | 0 |
| -75% Cutoff | 20 | 23 | 20 | 0 |

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

| -50% Cutoff | 140 | 53 | 0 | 140 |
|-------------|-----|-----|----|-----|
| -25% Cutoff | 20 | 72 | 1 | 19 |
| +25% Cutoff | 20 | 128 | 19 | 1 |
| +50% Cutoff | 40 | 154 | 40 | 0 |
| +75% Cutoff | 20 | 171 | 20 | 0 |

The results summary for PCP :

| % of Cutoff | Number of<br>samples | Drug Concentration by<br>LC/MS(ng/mL) | Lay person Results | |
|--------------|----------------------|---------------------------------------|--------------------|-----------------|
| | | | No. of Positive | No. of Negative |
| -100% Cutoff | 20 | 0 | 0 | 20 |
| -75% Cutoff | 20 | 7 | 0 | 20 |
| -50% Cutoff | 140 | 11 | 0 | 140 |
| -25% Cutoff | 20 | 18 | 2 | 18 |
| +25% Cutoff | 20 | 32 | 20 | 0 |
| +50% Cutoff | 40 | 39 | 40 | 0 |
| +75% Cutoff | 20 | 44 | 20 | 0 |

## The results summary for THC:

| % of Cutoff | Number of<br>samples | Drug Concentration by<br>LC/MS(ng/mL) | Lay person Results | |
|--------------|----------------------|---------------------------------------|--------------------|-----------------|
| | | | No. of Positive | No. of Negative |
| -100% Cutoff | 20 | 0 | 0 | 20 |
| -75% Cutoff | 20 | 13 | 0 | 20 |
| -50% Cutoff | 140 | 24 | 0 | 140 |
| -25% Cutoff | 20 | 38 | 1 | 19 |
| +25% Cutoff | 20 | 64 | 19 | 1 |
| +50% Cutoff | 40 | 77 | 40 | 0 |
| +75% Cutoff | 20 | 86 | 20 | 0 |

## The results summary for BZO:

| % of Cutoff | Number of<br>samples | Drug Concentration by<br>LC/MS(ng/mL) | Lay person Results | |
|--------------|----------------------|---------------------------------------|--------------------|-----------------|
| | | | No. of Positive | No. of Negative |
| -100% Cutoff | 20 | 0 | 0 | 20 |
| -75% Cutoff | 20 | 73 | 0 | 20 |
| -50% Cutoff | 140 | 146 | 0 | 140 |
| -25% Cutoff | 20 | 228 | 1 | 19 |
| +25% Cutoff | 20 | 377 | 20 | 0 |
| +50% Cutoff | 40 | 452 | 40 | 0 |
| +75% Cutoff | 20 | 519 | 20 | 0 |

## The results summary for MDMA:

| % of Cutoff | Number of<br>samples | Drug Concentration by<br>LC/MS(ng/mL) | Lay person Results | |
|--------------|----------------------|---------------------------------------|--------------------|-----------------|
| | | | No. of Positive | No. of Negative |
| -100% Cutoff | 20 | 0 | 0 | 20 |
| -75% Cutoff | 20 | 121 | 0 | 20 |
| -50% Cutoff | 140 | 253 | 0 | 140 |
| -25% Cutoff | 20 | 371 | 0 | 20 |
| +25% Cutoff | 20 | 628 | 19 | 1 |
| +50% Cutoff | 40 | 756 | 40 | 0 |

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

| +75% Cutoff | 20 | 879 | 20 | 0 |
|-------------|----|-----|----|---|
|-------------|----|-----|----|---|

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 devices, it's concluded that the AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are substantially equivalent to the predicate.