BIOEASY™ U-Catch MAX Multi-Drug Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1.5-dimethyl-3.3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
Amphetamine (AMP): 500 ng/mL
Buprenorphine (BUP): 10 ng/mL
Secobarbital (BAR): 300 ng/mL
Oxazepam (BZO): 300 ng/mL
Cocaine (COC): 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP): 300 ng/mL
Methamphetamine (MET): 500 ng/mL
Methylenedioxymethamphetamine (MDMA): 500 ng/mL
Morphine (MOP 300): 300 ng/mL
Methadone (MTD): 300 ng/mL
Oxycodone (OXY): 100 ng/mL
Phencyclidine (PCP): 25 ng/mL
d-Propoxyphene (PPX): 300 ng/mL
Nortriptyline (TCA): 1000 ng/mL
Marijuana (THC): 50 ng/mL
BIOEASY™ U-Catch MAX Multi-Drug Test Cup offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.
The tests may vield positive results for the prescription drugs Burenorphine. Oxazenam, Secobarbital, d-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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline Cannabinoids and 6-Acetylmorphine in human urine at the cutoff concentrations of:
Amphetamine (AMP): 500 ng/mL
Buprenorphine (BUP): 10 ng/mL
Secobarbital (BAR): 300 ng/mL
Oxazepam (BZO): 300 ng/mL
Cocaine (COC): 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP): 300 ng/mL
Methamphetamine (MET): 500 ng/mL
Methylenedioxymethamphetamine (MDMA): 500 ng/mL
Morphine (MOP 300): 300 ng/mL
Methadone (MTD): 300 ng/mL
Oxycodone (OXY): 100 ng/mL
Phencyclidine (PCP): 25 ng/mL
d-Propoxyphene (PPX): 300 ng/mL
Nortriptyline (TCA): 1000 ng/mL
Cannabinoids (THC): 50 ng/mL
6-Acetylmorphine: 10 ng/mL
BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use.
The tests may yield positive results for the prescription drugs Buprenorphine. Nortriptyline, Oxazepam, Secobarbital, d-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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

Device Description

The BIOEASY™ U-Catch MAX Multi-Drug Test Cup and BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx are immunochromatographic assays that use a lateral flow system for the qualitative detection of target drug or drug metabolites in human urine. The products are single-use in vitro diagnostic devices. The BIOEASY™ U-Catch MAX Multi-Drug Test Cup kit contains a Cup 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 a detailed breakdown of the acceptance criteria and study information for the BIOEASY™ U-Catch MAX Multi-Drug Test Cup, organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

For the purpose of this analysis, the "acceptance criteria" are not explicitly defined as pass/fail thresholds in the provided document, but rather implied by the successful demonstration of performance metrics. The "reported device performance" refers to the results obtained from the various analytical and lay-user studies.

Performance Metric Category	Specific Test/Analyte	Implied Acceptance Criteria (Demonstrated Performance)	Reported Device Performance and Remarks
Analytical Performance	Precision (All Analytes: AMP, COC, MET, EDDP, 6-AM)	At concentrations -100%, -75%, -50%, -25% Cut-off: All results should be negative. At concentrations +25%, +50%, +75%, +100% Cut-off: All results should be positive. At Cut-off concentration: Results should show an approximate 50% positive and 50% negative rate, indicating accurate detection around the cutoff. (This is a standard expectation for qualitative tests at the cutoff).	For each of the five new analytes (AMP500, COC150, MET500, EDDP, 6-AM): - -100% to -25% Cut-off concentrations: 100% negative results (50-/0+ for each Lot). - +25% to +100% Cut-off concentrations: 100% positive results (50+/0- for each Lot). - Cut-off concentration: - AMP500: Lot 1 (22-/28+), Lot 2 (26-/24+), Lot 3 (26-/24+) - COC150: Lot 1 (28-/22+), Lot 2 (29-/21+), Lot 3 (22-/28+) - MET500: Lot 1 (27-/23+), Lot 2 (23-/27+), Lot 3 (25-/25+) - EDDP: Lot 1 (24-/26+), Lot 2 (24-/26+), Lot 3 (26-/24+) - 6-AM: Lot 1 (26-/24+), Lot 2 (24-/26+), Lot 3 (23-/27+) These results consistently demonstrate accurate qualitative detection across the tested range and appropriate performance at the cutoff for all three lots.
	Linearity	Not applicable (qualitative test).	Not applicable.
	Stability and Traceability	Devices should be stable for a reasonable duration at specified conditions. Calibrators should be traceable to commercial reference materials.	Stable at 4-30 ℃ for 24 months based on real-time studies. All drug calibrators traceable to available commercial reference materials.
	Interference	No interference from common physiological/pathological substances or specified compounds at given concentrations. At 25% below cut-off, all results negative. At 25% above cut-off, all results positive.	All tested compounds showed no interference at a concentration of 100 µg/mL. Urine samples spiked with target drugs at 25% below Cut-Off were all negative, and those at 25% above Cut-Off were all positive.
	Specificity	Cross-reactivity with structurally related compounds should be understood and documented, with threshold concentrations causing positive results identified.	Detailed cross-reactivity data provided for each analyte (AMP500, COC150, MET500, EDDP, 6-AM), showing concentrations at which related compounds cause a positive result and their corresponding % cross-reactivity. This demonstrates that the device's specificity profile is characterized and understood.
	Effect of Urine Specific Gravity and pH	Performance should remain consistent across specified ranges of urine specific gravity (1.000 to 1.035) and pH (4 to 9). At 25% below cut-off, all results negative. At 25% above cut-off, all results positive.	Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off for all tested urine specific gravity and pH ranges. Indicates robust performance across these physiological variations.
Comparison Studies	Method Comparison (All Analytes: AMP, COC, MET, EDDP, 6-AM)	High agreement between device results and LC/MS (Liquid Chromatography/Mass Spectrometry) results for clinical samples, especially for samples significantly above and below the cutoff. Limited discordant results near the cutoff are expected for qualitative tests.	For each of the five new analytes, 80 unaltered clinical samples (40 negative, 40 positive based on LC/MS) were tested by 3 laboratory assistants. The tables show very high agreement with LC/MS results outside the near-cutoff range. For instance, for AMP500: 0 positives in "low negative" samples, 0 negatives in "high positive" samples. Discordant results primarily occurred in the "near cutoff" range, which is expected for qualitative tests (e.g., for AMP500, LC/MS results of 473-494 ng/mL (below cutoff) were sometimes positive by the device, and LC/MS results of 520-570 ng/mL (above cutoff) were sometimes negative by the device). These discordant results, being close to the cutoff, are acceptable for a qualitative assay.
Lay-User Study	Ease of Use/Correctness of Results by Lay Users (All 15 Analytes)	High percentage of correct results by lay users demonstrating the device is suitable for OTC use. Instructions should be easily understood. Typically, >90% or >95% accuracy for samples significantly off the cutoff.	140 lay persons participated. - Samples significantly below cutoff (-100%, -75%, -50%): 100% correct negative results for all analytes. - Samples significantly above cutoff (+50%, +75%): 100% correct positive results for all analytes. - Samples near cutoff (-25%, +25%): Generally 95% correct results across all analytes, with some showing 100%. All lay users indicated that the device instructions were easily followed. Flesch-Kincaid analysis showed a reading Grade Level of 7 for the package insert. The high percentage of correct results by lay users demonstrates the device's suitability for OTC use.

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

Test Set Sample Size:
- Precision Studies: For each of the 5 new analytes (AMP, COC, MET, EDDP, 6-AM), 9 concentrations were tested across 3 lots. Each concentration was tested two runs per day for 25 days. Total samples for precision: 5 analytes * 9 concentrations * 3 lots * 25 days * 2 runs/day = 6,750 individual tests.
- Method Comparison Studies: For each of the 5 new analytes, 80 unaltered clinical samples (40 negative and 40 positive) were tested. Total samples for method comparison: 5 analytes * 80 samples = 400 clinical samples.
- Lay-User Study: 140 lay persons. Each participant (lay person) received one blind-labeled sample and a device. For each of the 15 analytes, there were 7 concentration levels tested, with 20 samples per level. Total unique tests performed by lay users: 15 analytes * 7 concentration levels * 20 samples/level * 1 device/sample = 2,100 tests.
Data Provenance:
- Precision Studies: Samples were prepared by spiking drug in negative urine samples. "Each drug concentration was confirmed by LC/MS." This suggests prepared samples, not necessarily clinical samples.
- Method Comparison Studies: Unaltered clinical samples. The country of origin is not specified but is likely from the United States given the FDA submission context. The study is retrospective as these were "unaltered clinical samples" which typically implies pre-collected samples.
- Lay-User Study: Urine samples were prepared at various concentrations by spiking drugs into drug-free pooled urine specimens. The concentrations were confirmed by LC/MS. This indicates a controlled, prospective study design using artificially prepared (but LC/MS confirmed) samples. Country of origin not explicitly stated, but performed at "three intended user sites" which likely corresponds to a US setting for OTC validation.

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

Precision Studies: Ground truth (drug concentration) was established by LC/MS. The document states that "Each drug concentration was confirmed by LC/MS," indicating a highly accurate analytical method. This method does not typically involve human experts for interpretation in the same way clinical imaging or pathology might.
Method Comparison Studies: Ground truth was established by LC/MS results. The study directly compared the device results to LC/MS results. Again, this is an analytical method, not requiring expert human interpretation from a medical perspective (like radiologists).
Lay-User Study: Ground truth (drug concentration) was established by LC/MS. "The concentrations of the samples were confirmed by LC/MS." No medical experts were involved in establishing the ground truth for these samples. The "experts" in this context were the personnel operating the LC/MS equipment, who would be trained lab technicians or chemists.

4. Adjudication Method for the Test Set

Precision Studies: No explicit adjudication method described. The results are quantitative (expressed as number of positive/negative readings) and directly compared to the known LC/MS concentration of the spiked samples.
Method Comparison Studies: No explicit adjudication method described beyond direct comparison to LC/MS results. Discordant results are individually listed but not subject to a separate adjudication process beyond the LC/MS reference.
Lay-User Study: No explicit adjudication method described. Lay person results were directly compared to the known (LC/MS confirmed) concentration of the samples. The primary focus for the lay-user study appears to be the percentage of correct results at various concentrations, not reconciliation of disagreements between readers or methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done in the conventional sense of human readers interpreting medical images or data with and without AI assistance.
The "Method Comparison Studies" involved three laboratory assistants as "viewers" interpreting the test cups. This could be considered a multi-reader study, but it was comparing the device's performance to LC/MS as a reference, not comparing human readers' performance with and without AI.
The "Lay-user study" involved 140 lay persons interpreting the device. This is a multi-reader study for ease of use and interpretation, but not focused on clinical comparative effectiveness against experts or AI assistance.
Therefore, no effect size for human readers improving with AI vs without AI assistance can be reported from this document as the device is a drug test cup, not an AI diagnostic tool and the studies were not designed for this type of comparison.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device described is a "competitive binding, lateral flow immunochromatographic assay" in the form of a "Multi-Drug Test Cup." This is a physical or chemical diagnostic test, not a software algorithm or AI.
Therefore, the concept of a "standalone algorithm" does not apply here. The device itself is the standalone test that produces a visual result (a line or absence of a line). Its performance is its standalone performance. The "human-in-the-loop" here refers to the human interpreting the visual result, which is evaluated in the lay-user study.

7. The Type of Ground Truth Used

The primary ground truth used across all analytical performance studies (Precision, Interference, Specificity, Effect of Urine Specific Gravity and pH) and the Method Comparison Studies was LC/MS (Liquid Chromatography/Mass Spectrometry).
For the Lay-User Study, the ground truth for spiked samples was also established by LC/MS.

8. The Sample Size for the Training Set

No explicit training set is mentioned in the context of this device. This is because the BIOEASY™ U-Catch MAX Multi-Drug Test Cup is a lateral flow immunoassay, which is a chemical/biological test, not a machine learning or AI model that requires a "training set" in the computational sense. The device is developed and validated through laboratory experimentation and calibration rather than a data-driven training process.

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

As there is no "training set" in the context of a machine learning or AI model, this question is not applicable. The performance characteristics were established through standard laboratory testing procedures using known concentrations of analytes, confirmed by LC/MS.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a solid blue square and the full name written in a smaller font next to it.

March 31, 2023

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

Re: K230238

Trade/Device Name: BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG, NFT, NFW, NFY, NGG, NGL, NFV, PTG, PTH, NGM, QAW, QBF Dated: January 27, 2023 Received: January 30, 2023

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

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eral agencies. You must comply with all the Act's
ration and listing (21 CFR Part 807): labeling (21 CFR Part

Page 2

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Paula V. Paula V. Caposino -S Caposino -S Date: 2023.03.31
Caposino -S 20:52:54 -04'00'

Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K230238

Device Name

BIOEASYTM U-Catch MAX Multi-Drug Test Cup

Indications for Use (Describe)

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300)	300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
d-Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL

BIOEASY™ U-Catch MAX Multi-Drug Test Cup offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may vield positive results for the prescription drugs Burenorphine. Oxazenam, Secobarbital, d-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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

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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The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Indications for Use

510(k) Number (if known)

K230238

Device Name

BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx

Indications for Use (Describe)

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300)	300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
d-Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Cannabinoids (THC)	50 ng/mL
6-Acetylmorphine	10 ng/mL

BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use.

The tests may yield positive results for the prescription drugs Buprenorphine. Nortriptyline, Oxazepam, Secobarbital, d-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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

Type of Use (Select one or both, as applicable)
✘ Prescription Use (Part 21 CFR 801 Subpart D)	▢ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) SUMMARY

K230238

The purpose of this submission is to add analytes Amphetamine 500, Cocaine 150, Methamphetamine 500, 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP), and 6-acetylmorphine (6-AM) to previously cleared devices (K182530). These five new analytes were evaluated in this submission. For other analytes, please refer to K182530 for Buprenorphine, Secobarbital, Oxazepam, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline and Cannabinoids. In this submission the performance results are presented for the five new analytes, but the lay user study was conducted using the entire panel except of 6-AM.

March 31, 2023 1. Date: Shenzhen Bioeasy Biotechnology Co., Ltd. 2. Submitter: No.2-1 Liuxian 1st Road, Xin'an Sub-District Shenzhen 518101, China 3. Contact person: Joe Shia LSI International Inc 504E Diamond Ave., Suite I
Email: shiajl@yahoo.com. 4. Device Name: BIOEASYTM U-Catch MAX Multi-Drug Test Cup BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx

Gaithersburg, MD 20877 Telephone: 240-505-7880

Classification:	Class 2
Product Code	Classification	Regulation Section	Panel
DJGMonoacetylmorphine	II	21 CFR § 862.3650, Morphine Test System	Toxicology (91)
DKZAmphetamine	II	21 CFR § 862.3100, Amphetamine Test System	Toxicology (91)
LDJCannabinoids	II	21 CFR § 862.3870, Cannabinoids Test System	Toxicology (91)
DIOCocaine	II	21 CFR § 862.3250, Cocaine and Cocaine Metabolites Test System	Toxicology (91)
LAFMethamphetamine	II	21 CFR § 862.3610, Methamphetamine Test System	Toxicology (91)
DJGMorphine	II	21 CFR § 862.3650, Morphine Test System	Toxicology (91)
JXMOxazepam	II	21 CFR § 862.3170, Benzodiazepine Test System	Toxicology (91)
DJGOxycodone	II	21 CFR § 862.3650, Opiate Test System	Toxicology (91)
DISSecobarbital	II	21 CFR § 862.3150, Barbiturate Test System	Toxicology (91)
DJGBuprenorphine	II	21 CFR § 862.3650, Opiate Test System	Toxicology (91)

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LAFMethylenedioxy-methamphetamine	II	21 CFR § 862.3610, Methamphetamine Test System	Toxicology (91)
LCMPhencyclidine	unclassified	Enzyme ImmunoassayPhencyclidine	Toxicology (91)
DJRMethadone	II	21 CFR § 862.3620, MethadoneTest System	Toxicology (91)
DJR2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine(EDDP)	II	21 CFR § 862.3620, MethadoneTest System	Toxicology (91)
LFGNortriptyline	II	21 CFR, 862.3910 TricyclicAntidepressant Drugs Test System	Toxicology (91)
JXNPropoxyphene	II	21 CFR, 862.3700 PropoxypheneTest System	Toxicology (91)

5. Predicate Devices: K201630

The Assure Tech Panel Dip Tests/AssureTech Quick Cup Tests

1. Intended Use
  BIOEASY™ U-Catch MAX Multi-Drug Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2- ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off leve
Amphetamine (AMP)	500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300)	300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
d-Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Marijuana (THC)	50 ng/mL

BIOEASY™ U-Catch MAX Multi-Drug Test Cup offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, d-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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

{8}------------------------------------------------

Drug (Identifier)	Cut-off level
Amphetamine (AMP)	500 ng/mL
Buprenorphine (BUP)	10 ng/mL
Secobarbital (BAR)	300 ng/mL
Oxazepam (BZO)	300 ng/mL
Cocaine (COC)	150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)	300 ng/mL
Methamphetamine (MET)	500 ng/mL
Methylenedioxymethamphetamine (MDMA)	500 ng/mL
Morphine (MOP 300)	300 ng/mL
Methadone (MTD)	300 ng/mL
Oxycodone (OXY)	100 ng/mL
Phencyclidine (PCP)	25 ng/mL
d-Propoxyphene (PPX)	300 ng/mL
Nortriptyline (TCA)	1000 ng/mL
Cannabinoids (THC)	50 ng/mL
6-Acetylmorphine	10 ng/mL

BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use.

The tests may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, d-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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

1. Device Description
  The BIOEASY™ U-Catch MAX Multi-Drug Test Cup and BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx are immunochromatographic assays that use a lateral flow system for the qualitative detection of target drug or drug metabolites in human urine. The products are single-use in vitro diagnostic devices. The BIOEASY™ U-Catch MAX Multi-Drug Test Cup kit contains a Cup device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.
1. Substantial Equivalence Information
  A summary comparison of features of the BIOEASY™ U-Catch MAX Multi-Drug Test Cup and the predicate devices is provided in following tables.

Table 1: Features Comparison of BIOEASY™ U-Catch MAX Multi-Drug Test Cup and the Predicate Devices

Item	Device	Predicate - K201630
Indication(s)	For the qualitative determination of drugs of	Same (but the number of

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

for Use	abuse in human urine.	drugs detected is different)
Calibrator andCut-Off Values	Amphetamine (AMP): 500 ng/mlOxazepam (BZO):300 ng/mlCocaine (COC): 150 ng/ml11-Nor-△9-Tetrahydrocannabinol-9-COOH(THC):50 ng/mlMethamphetamine (MET): 500 ng/mlMorphine (MOR): 300 ng/mLOxycodone(OXY) : 100 ng/mlSecobarbital (BAR): 300 ng/mlMethadone (MTD): 300 ng/mlBuprenorphine (BUP): 10 ng/mlD,L-Methylenedioxymethamphetamine(MDMA): 500 ng/mlPhencyclidine (PCP): 25 ng/mlNortriptyline (TCA): 1000 ng/ml2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP): 300 ng/mld-Propoxyphene (PPX): 300 ng/ml	Same exceptTHC at 20 ng/mL
Methodology	Competitive binding, lateral flowimmunochromatographic assays based on theprinciple of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Intended Use	For over-the-counter	For prescription use
Configurations	Cup	Same

Table 2: Features Comparison of BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx and the Predicate Devices

Item	Device	Predicate – K201630
Indication(s)for Use	For the qualitative determination ofdrugs of abuse in human urine.	Same
Calibrator and Cut-OffValues	Amphetamine (AMP): 500 ng/ml	Same except
	Oxazepam (BZO):300 ng/ml	THC at 20 ng/mL
	Cocaine(COC): 150 ng/ml
	11-Nor-Δ9-Tetrahydrocannabinol-9-COOH(THC):50 ng/ml
	Methamphetamine (MET): 500 ng/ml
	Morphine (MOR): 300ng/mL
	Oxycodone(OXY) : 100 ng/ml
	Secobarbital (BAR): 300 ng/mlMethadone (MTD): 300 ng/ml

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

	Buprenorphine (BUP): 10 ng/mlD,L-Methylenedioxymethamphetamine(MDMA): 500 ng/mlPhencyclidine (PCP): 25 ng/mlNortriptyline (TCA): 1000 ng/ml2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP): 300 ng/mld-Propoxyphene (PPX): 300 ng/ml6-Acetylmorphine (6-AM): 10 ng/mL
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 prescription use	Same
Configurations	Cup	Cup

9. Test Principle

The BIOEASY™ U-Catch MAX Multi-Drug Test Cup tests are rapid tests for the qualitative detection of target drug or drug metabolites 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 antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The 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, cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative urine 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 Amphetamine 500, Cocaine 150, Methamphetamine 500, 2ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP), and 6-acetylmorphine (6-AM). The data for Buprenorphine, Methylenedioxymethamphetamine, Secobarbital, Oxazepam, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene,

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

AMP500
Concentration byLC/MS (ng/mL)	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	Cut-off+25%	Cut-off+50%	Cut-off+75%	Cut-off+100%
LotNumber	0	127	250	374	480	590	695	825	915
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	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+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-
COC150
Concentration byLC/ MS (ng/mL)	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	Cut-off+25%	Cut-off+50%	Cut-off+75%	Cut-off+100%
LotNumber	0	38.2	77.8	113	154	191	230	262	302
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+	29-/21+	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-
MET500
Concentration byLC/MS (ng/mL)	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
LotNumber	0	129	240	368	476	605	705	860	1010
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+	25-/25+	50+/0-	50+/0-	50+/0-	50+/0-
EDDP
Concentration byLC/MS (ng/mL)Lot	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
Number	0	72.0	146	216	293	360	426	507	582
	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	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+	25-/25+	50+/0-	50+/0-	50+/0-	50+/0-
6-AMConcentration byLC/MS (ng/mL)	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off

LC/MS (ng/mL)	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
LotNumber	0	2.46	4.88	7.42	9.98	12.3	14.6	16.8	20.1
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+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	23-/27+	50+/0-	50+/0-	50+/0-	50+/0-

The following cut-off values are verified

A BAY AVAAV AAR VAA VATERIA PAY TAAAAA VI
Vrug (Identifier)	Cut-off level

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

Amphetamine (AMP)	500 ng/mL
Cocaine (COC)	150 ng/mL
Methamphetamine (MET)	500 ng/mL
2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP)	300 ng/mL
6-acetylmorphine (6-AM)	10 ng/mL

b. Linearity

Not applicable.

c. Stability and Traceability

The devices are stable at 4-30 ℃ for 24 months based on real time stability studies. All drug calibrators of the device are traceable to available commercial reference materials.

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 lots of each device. Compounds that showed no interference at a concentration of 100ug/mL are summarized in the following tables

Acetaminophen	Creatinine	Ketamine	Prednisone
Acetophenetidin	Deoxycorticosterone	Ketoprofen	(±)-Propranolol
N-Acetylprocainamide	Dextromethorphan	Labetalol	Pseudoephedrine
Acetylsalicylic acid	Diclofenac	Loperamide	Quinine
Albumin (100mg/dL)	Diflunisal	Meperidine	Ranitidine
Aminopyrine	Digoxin	Meprobamate	Salicylic acid
Amoxicillin	Diphenhydramine	Methoxyphenamine	Serotonin (5- Hydroxytyramine)
Ampicillin	1% Ethanol	Nalidixic acid	Sulfamethazine
Apomorphine	Ecgonine methyl ester	Naloxone	Sulindac
Ascorbic acid	ß-Estradiol	Naltrexone	Tetrahydrocortisone 3-(ß-Dglucuronide)
Aspartame	Erythromycin	Naproxen	Tetrahydrocortisone 3-acetate
Atropine	Fenoprofen	Niacinamide	Tetrahydrozoline
Benzilic acid	Furosemide	Nifedipine	Thiamine
Benzoic acid	Gentisic acid	Norethindrone	Thioridazine
Bilirubin	Hemoglobin	Noscapine	Triamterene
Chloral hydrate	Hydralazine	(±)-Octopamine	Trifluoperazine
Chloramphenicol	Hydrochlorothiazide	Oxalic acid	Trimethoprim
Chlorothiazide	Hydrocortisone	Oxolinic acid	DL-Tryptophan
Chlorpromazine	O-Hydroxyhippuric acid	Oxymetazoline	Tyramine
Cholesterol	3-Hydroxytyramine	Papaverine	DL-Tyrosine
Clonidine	Ibuprofen	Penicillin G	Uric acid
Cortisone	Isoproterenol	Perphenazine	Verapamil
(-)-Cotinine	Isoxsuprine	Phenelzine	Zomepirac

e. Specificity

To test specificity, drug metabolites and other structurally related compounds that are likely to cross-react in urine samples were spiked into negative urine and were tested using three lots of each device. The lowest concentration that caused a positive result for each compound are listed below for Amphetamine 500, Cocaine 150,

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

Methamphetamine 500, 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP), and 6-acetylmorphine (6-AM). The data for Buprenorphine,

Methylenedioxymethamphetamine, Secobarbital, Oxazepam, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline and Cannabinoids were reported in K182530.

AMP500	Result	%Cross-Reactivity
(Cut-off=500 ng/mL)	Positive at (ng/ml)
D - Amphetamine	500	100%
L - Amphetamine	10000	5%
DL - Amphetamine	1500	33%
Phentermine	15000	3.3%
Hydroxyamphetamine	4000	12.5%
Methylenedioxyamphetamine (MDA)	10000	5%
d-Methamphetamine	> 100000	<0.5%
1-Methamphetamine	> 100000	<0.5%
Ephedrine	> 100000	<0.5%
Methylenedioxyethylamphetamine(MDE)	> 100000	<0.5%
3,4-methylenedioxy-methamphetamine(MDMA)	> 100000	<0.5%

COC150(Cut-off=150 ng/mL)	ResultPositive at (ng/ml)	%Cross-Reactivity
Benzoylecgonine	150	100%
Cocaine HCl	375	40%
Cocaethylene	6250	2.4%
Ecgonine	16000	0.9%
Norcocaine	50000	0.3%

MET500	Result	%Cross-Reactivity
(Cut-off=500 ng/mL)	Positive at (ng/ml)
D(+)-Methamphetamine	500	100%
(+/-)3,4-Methylenedioxy-n-ethylamphetamine(MDEA)	5000	10%
D/L-Methamphetamine	500	100%
p-Hydroxymethamphetamine	5000	10%
D-Amphetamine	> 100000	<0.5%
L-Amphetamine	>100000	<0.5%
Chloroquine	25000	2%
(+/-)-Ephedrine	2000	25%
L-Methamphetamine	5000	10%
(+/-)3,4-Methylenedioxyamphetamine (MDA)	> 100000	<0.5%
β-Phenylethylamine	3750	13.3%
Trimethobenzamide	10000	5%
(+/-)3,4-methylenedioxymethamphetamine(MDMA)	5000	10%

EDDP(Cut-off=300 ng/mL)	ResultPositive at (ng/ml)	% Cross-Reactivity
-----------------------------	-------------------------------	--------------------

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

EDDP	300	100%
Methadone	300000	0.1%
Doxylamine	>100000	<0.3%
LAAM HCl	>100000	<0.3%
Alpha Methadol	>100000	<0.3%
EMDP	>100000	<0.3%
Disopyramide	>100000	<0.3%

6-AM(Cut-off=10 ng/mL)	ResultPositive at (ng/ml)	% Cross-Reactivity
6-acetylmorphine	10	100%
Acetylcodeine	>10000	<0.1%
Buprenorphine	>10000	<0.1%
Codeine	>10000	<0.1%
Diacetylmorphine	1000	0.01%
Dihydrocodeine	>10000	<0.1%
Ethylmorphine	>10000	<0.1%
Hydrocodone	>10000	<0.1%
Hydromorphone	5000	0.002%
Morphine	10000	0.001%
Morphine-3-glucuronide	>10000	<0.1%
Nalorphine	5000	0.002%
Thebaine	>20000	<0.05%
Dextromethorphan	>100,000	<0.01%
Heroin	100000	0.0001%
Imipramine	>100,000	<0.01%
LAAM (Levacetylmethadol)	>100,000	<0.01%
Levorphanol	>100,000	<0.01%
Meperidine	>100,000	<0.01%
Methadone	>100,000	<0.01%
Mitragynine (kratom)	>20,000	<0.05%
Morphine 6-D-glucuronide	>100,000	<0.01%
Naloxone	>100,000	<0.01%
Naltrexone	>100,000	<0.01%
Naproxen	>100,000	<0.01%
Norbuprenorphine	>10,000	<0.1%
Norbuprenorphine glucuronide	>100,000	<0.01%
Norcodeine	>100,000	<0.01%
Norhydrocodone	>100,000	<0.01%
Normorphine	>100,000	<0.01%
Noroxycodone	>100,000	<0.01%
Noroxymorphone	>100,000	<0.01%
Norpropoxyphene	>100,000	<0.01%
Oxycodone	>100,000	<0.01%
Oxymorphone	>100,000	<0.01%
Oxymorphone-3β-D-glucuronide	>100,000	<0.01%
Tapentadol HCl	>100,000	<0.01%

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

Tramadol	>100,000	<0.01%
----------	----------	--------

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.

1. Comparison Studies
  Method comparison studies for the BIOEASY™ U-Catch MAX Multi-Drug Test Cup were performed in-house with three laboratory assistants. 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 Amphetamine 500, Cocaine 150, Methamphetamine 500, 2-ethylidene-1, 5-dimethyl-3, 3diphenylpyrrolidine (EDDP), and 6-acetylmorphine (6-AM). The data for Buprenorphine, Methylenedioxymethamphetamine, Secobarbital, Oxazepam, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline and Cannabinoids were reported in K182530.

AMP500 U-Catch Low Near Cutoff Near Cutoff MAX Multi-Negative by Positive by Negative Negative by High Positive Drug Test TC/MS LC/MS LC/MS by LC/MS Cup (less than (Between (Between the (greater than -50%) -50% and cutoff and +50%) cutoff) +50%) 0 0 3 17 20 Viewer Positive A Negative 7 16 14 3 0 Positive 0 0 2 18 20 Viewer 7 2 B Negative । ୧ ા ર 0 0 3 18 20 Viewer Positive 0 C Negative 7 16 14 2 0

Discordant Results

Viewer	Sample Number	LC/MS Result	Dip CardViewer Results
Viewer A	AMPLC063	473	Positive
Viewer C	AMPLC063	473	Positive
Viewer B	AMPLC040	477	Positive
Viewer A	AMPLC039	490	Positive
Viewer B	AMPLC039	490	Positive
Viewer C	AMPLC039	490	Positive
Viewer A	AMPLC004	494	Positive
Viewer C	AMPLC004	494	Positive
Viewer A	AMPLC018	520	Negative
Viewer B	AMPLC018	520	Negative
Viewer A	AMPLC064	525	Negative
Viewer B	AMPLC064	525	Negative
Viewer C	AMPLC064	525	Negative

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

Viewer A	AMPLC009	540	Negative
Viewer C	AMPLC014	570	Negative

COC150
U-CatchMAX Multi-Drug TestCup		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%)
ViewerA	Positive	0	0	2	19	19
	Negative	7	16	15	2	0
ViewerB	Positive	0	0	2	18	19
	Negative	7	16	15	3	0
ViewerC	Positive	0	0	2	19	19
	Negative	7	16	15	2	0

Discordant Results

Discordant Results
Viewer	Sample Number	LC/MS Result	Easy Cup Viewer Results
Viewer B	COCLC046	139	Positive
Viewer A	COCLC019	142	Positive
Viewer C	COCLC019	142	Positive
Viewer B	COCLC026	142	Positive
Viewer A	COCLC060	145	Positive
Viewer C	COCLC060	145	Positive
Viewer A	COCLC049	154	Negative
Viewer B	COCLC049	154	Negative
Viewer C	COCLC049	154	Negative
Viewer A	COCLC024	157	Negative
Viewer B	COCLC062	157	Negative
Viewer C	COCLC062	157	Negative
Viewer B	COCLC029	159	Negative

MET500

U-CatchMAX Multi-Drug TestCup		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%)
ViewerA	Positive	0	0	2	17	20
	Negative	7	16	15	3	0
ViewerB	Positive	0	0	3	18	20
	Negative	7	16	14	2	0
ViewerC	Positive	0	0	2	17	20
	Negative	7	16	15	3	0

Discordant Results

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

Viewer	Sample Number	LC/MS Result	Dip Card Viewer Results
Viewer B	METL055	427	Positive
Viewer B	METL005	447	Positive
Viewer C	METL005	447	Positive
Viewer A	METL020	465	Positive
Viewer B	METL020	465	Positive
Viewer A	METL063	486	Positive
Viewer C	METL063	486	Positive
Viewer B	METL053	525	Negative
Viewer C	METL053	525	Negative
Viewer A	METL060	530	Negative
Viewer C	METL060	530	Negative
Viewer A	METL036	540	Negative
Viewer B	METL036	540	Negative
Viewer A	METL059	555	Negative
Viewer C	METL059	555	Negative

EDDP

U-CatchMAX Multi-Drug TestCup		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%)
ViewerA	Positive	0	0	2	18	20
	Negative	6	18	14	2	0
ViewerB	Positive	0	0	2	18	20
	Negative	6	18	14	2	0
ViewerC	Positive	0	0	3	18	20
	Negative	6	18	13	2	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Easy Cup Viewer Results
Viewer A	EDDPLC042	244	Positive
Viewer C	EDDPLC042	244	Positive
Viewer B	EDDPLC004	291	Positive
Viewer C	EDDPLC004	291	Positive
Viewer A	EDDPLC051	294	Positive
Viewer B	EDDPLC051	294	Positive
Viewer C	EDDPLC051	294	Positive
Viewer A	EDDPLC074	303	Negative
Viewer B	EDDPLC074	303	Negative
Viewer C	EDDPLC074	303	Negative
Viewer B	EDDPLC052	327	Negative
Viewer A	EDDPLC018	330	Negative

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

Viewer C	EDDPLC018	330	Negative
----------	-----------	-----	----------

6-AM
U-CatchMAX Multi-Drug TestCup		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%)
ViewerA	Positive	0	0	2	16	22
	Negative	6	17	15	2	0
ViewerB	Positive	0	0	2	16	22
	Negative	6	17	15	2	0
ViewerC	Positive	0	0	2	15	22
	Negative	6	17	15	3	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Dip Card Viewer Results
Viewer B	6-AMLC016	9.23	Positive
Viewer A	6-AMLC074	9.68	Positive
Viewer C	6-AMLC074	9.68	Positive
Viewer B	6-AMLC026	9.93	Positive
Viewer A	6-AMLC037	9.95	Positive
Viewer C	6-AMLC037	9.95	Positive
Viewer A	6-AMLC009	10.3	Negative
Viewer C	6-AMLC009	10.3	Negative
Viewer B	6-AMLC027	11.1	Negative
Viewer C	6-AMLC027	11.1	Negative
Viewer A	6-AMLC038	11.4	Negative
Viewer B	6-AMLC038	11.4	Negative
Viewer C	6-AMLC035	11.8	Negative

Lay-user study

A lay user study was performed at three intended user sites with 140 lay persons. The lay users had diverse educational and professional backgrounds and ranged in age from 20 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. Results are shown below.

Drugs	% of Cut-off	Number of samples	Concentration by LC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
AMP	-100% Cut-off	20	0	No. of Positive 0	No. of Negative 20	100
	-75% Cut-off	20	130	No. of Positive 0	No. of Negative 20	100
	-50% Cut-off	20	251	0	20	100
	-25% Cut-off	20	383	0	20	100
	+25% Cut-off	20	635	19	1	95
	+50% Cut-off	20	755	20	0	100
	+75% Cut-off	20	885	20	0	100
BAR	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	75.9	0	20	100
	-50% Cut-off	20	150	0	20	100
	-25% Cut-off	20	220	0	20	100
	+25% Cut-off	20	360	19	1	95
	+50% Cut-off	20	429	20	0	100
	+75% Cut-off	20	501	20	0	100
COC	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	37.6	0	20	100
	-50% Cut-off	20	74.8	0	20	100
	-25% Cut-off	20	110	1	19	95
	+25% Cut-off	20	183	19	1	95
	+50% Cut-off	20	224	20	0	100
	+75% Cut-off	20	248	20	0	100
BZO	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	70.8	0	20	100
	-50% Cut-off	20	148	0	20	100
	-25% Cut-off	20	224	1	19	95
	+25% Cut-off	20	390	19	1	95
	+50% Cut-off	20	452	20	0	100
	+75% Cut-off	20	504	20	0	100
MET	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	124	0	20	100
	-50% Cut-off	20	242	0	20	100
	-25% Cut-off	20	367	0	20	100
	+25% Cut-off	20	610	19	1	95
	+50% Cut-off	20	705	20	0	100
	+75% Cut-off	20	825	20	0	100
MTD	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	76.8	0	20	100
	-50% Cut-off	20	147	0	20	100
	-25% Cut-off	20	226	0	20	100
	+25% Cut-off	20	375	19	1	95
	+50% Cut-off	20	441	20	0	100
	+75% Cut-off	20	504	20	0	100
MOP	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	79	0	20	100
	-50% Cut-off	20	158	0	20	100
	-25% Cut-off	20	246	1	19	95
	+25% Cut-off	20	389	19	1	95
	+50% Cut-off	20	469	20	0	100
	+75% Cut-off	20	530	20	0	100
OXY	-100% Cut-off	20	0	0	20	100
	-75% Cut off	20	24.5	0	20	100
	-50% Cut-off	20	49.3	0	20	100
	-25% Cut-off	20	71.1	0	20	100
	+25% Cut-off	20	118	19	1	95
	+50% Cut-off	20	147	20	0	100
	+75% Cut-off	20	169	20	0	100
	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	13	0	20	100
THC	-50% Cut-off	20	25.3	0	20	100
	-25% Cut-off	20	41	1	19	95
	+25% Cut-off	20	65	19	1	95
	+50% Cut-off	20	79	20	0	100
	+75% Cut-off	20	93	20	0	100
	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	273	0	20	100
TCA	-50% Cut-off	20	509	0	20	100
	-25% Cut-off	20	809	0	20	100
	+25% Cut-off	20	1190	19	1	95
	+50% Cut-off	20	1510	20	0	100
	+75% Cut-off	20	1680	20	0	100
	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	273	0	20	100
BUP	-50% Cut-off	20	5.14	0	20	100
	-25% Cut-off	20	6.76	1	19	95
	+25% Cut-off	20	12.8	19	1	95
	+50% Cut-off	20	15.1	20	0	100
	+75% Cut-off	20	17.2	20	0	100
	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	2.57	0	20	100
PCP	-50% Cut-off	20	12.5	0	20	100
	-25% Cut-off	20	17.9	1	19	95
	+25% Cut-off	20	30.8	19	1	95
	+50% Cut-off	20	36.4	20	0	100
	+75% Cut-off	20	42.8	20	0	100
	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	6.27	0	20	100
MDMA	-50% Cut-off	20	250	0	20	100
	-25% Cut-off	20	351	0	20	100
	+25% Cut-off	20	600	19	1	95
	+50% Cut-off	20	745	20	0	100
	+75% Cut-off	20	925	20	0	100
	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	137	0	20	100
EDDP	-50% Cut-off	20	141	0	20	100
	-25% Cut-off	20	224	1	19	95
	+25% Cut-off	20	375	20	0	100
	+50% Cut-off	20	447	20	0	100
	+75% Cut-off	20	554	20	0	100
	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	76.2	0	20	100
	+75% Cut-off	20	522	20	0	100
PPX	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	77.4	0	20	100
	-50% Cut-off	20	150	0	20	100
	-25% Cut-off	20	227	1	19	95
	+25% Cut-off	20	351	20	0	100
	+50% Cut-off	20	420	20	0	100
	+75% Cut-off	20	492	20	0	100

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

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

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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.

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 U-Catch MAX Multi-Drug Test Cup is substantially equivalent to the predicate.

Regulation Number and Section

§ 862.3650 Opiate test system.

(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).