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K Number
K230238
Device Name
BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx
Manufacturer
Shenzhen Bioeasy Biotechnology Co.,Ltd.
Date Cleared
2023-03-31

(60 days)

Product Code
DJGNFTNFVNFWNFYNGGNGLNGMPTGPTHQAWQBF
Regulation Number
862.3650
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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, 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.
More Information

K201630

K182530

No
The device description and performance studies indicate a standard immunochromatographic assay (lateral flow test) for qualitative detection. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI or ML. The results are interpreted visually or compared to LC/MS, not through an AI/ML model.

No.
The device is an in vitro diagnostic assay used to detect the presence of specific drugs or their metabolites in human urine, providing preliminary results for diagnostic purposes rather than therapy.

Yes

The device is explicitly stated to be "for in vitro diagnostic use only" and "single-use in vitro diagnostic devices" in the "Intended Use / Indications for Use" and "Device Description" sections, respectively. It detects specific substances (drugs and drug metabolites) in human urine, which is a diagnostic function.

No

The device description explicitly states it is an "immunochromatographic assay that use a lateral flow system" and a "single-use in vitro diagnostic device" that comes in a "Cup device" kit. This indicates a physical, hardware-based test, not a software-only device.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Explicit Statement: The "Intended Use / Indications for Use" section for both the OTC and Prescription versions clearly states: "It is for in vitro diagnostic use only."
  • Device Description: The "Device Description" section also explicitly states: "The products are single-use in vitro diagnostic devices."
  • Nature of the Test: The device performs a test on a biological sample (human urine) to detect the presence of specific substances (drugs and drug metabolites) for diagnostic purposes (identifying potential drug use). This aligns with the definition of an in vitro diagnostic device.

N/A

Intended Use / Indications for 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, 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:

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 yield 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:

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-Acetylmorphine10 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.

Product codes (comma separated list FDA assigned to the subject device)

DJG, NFT, NFW, NFY, NGG, NGL, NFV, PTG, PTH, NGM, QAW, QBF

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

OTC use / Prescription use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Analytical Performance

  • Precision: Studies 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. Samples prepared by spiking drug in negative urine samples. Each drug concentration confirmed by LC/MS. All sample aliquots blindly labeled. Tests performed two runs per day for 25 days per device in a randomized order for each concentration.
  • Stability and Traceability: Devices are stable at 4-30 ℃ for 24 months based on real time stability studies. All drug calibrators traceable to available commercial reference materials.
  • 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 were summarized.
  • Specificity: Drug metabolites and other structurally related compounds likely to cross-react in urine samples were spiked into negative urine and tested using three lots of each device. The lowest concentration that caused a positive result for each compound was listed.
  • 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.

Comparison Studies

  • Method comparison studies: Performed in-house with three laboratory assistants. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. Samples were blind labeled and compared to LC/MS results.

Lay-user study

  • Study type: Lay user study.
  • Sample size: 140 lay persons.
  • Data source: Three intended user sites.
  • Annotation protocol: Urine samples prepared at concentrations of negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. Concentrations confirmed by LC/MS. Each sample aliquoted into individual containers and blind-labeled. Each participant provided with package insert, 1 blind labeled sample and a device. Each device was tested.
  • Key results: All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis showed a reading Grade Level of 7.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Precision Study Results for AMP500, COC150, MET500, EDDP, 6-AM:
For each drug and lot, at -100%, -75%, -50% cut-off concentrations, all 50 tests showed negative results.
At +25%, +50%, +75%, +100% cut-off concentrations, all 50 tests showed positive results for all drugs and lots.
At the cut-off concentration, the results at the cut-off were approximately 50-/50+ (e.g., for AMP500 Lot 1, 22-/28+; Lot 2, 26-/24+; Lot 3, 26-/24+).

Lay-user study: Percentage of correct results

  • AMP: 100% agreement for -100%, -75%, -50%, -25% cut-off (20 Negative results). 95% agreement for +25% cut-off (19 Positive, 1 Negative). 100% agreement for +50%, +75% cut-off (20 Positive results).
  • BAR: 100% agreement for -100%, -75%, -50%, -25% cut-off (20 Negative results). 95% agreement for +25% cut-off (19 Positive, 1 Negative). 100% agreement for +50%, +75% cut-off (20 Positive results).
  • COC: 100% agreement for -100%, -75%, -50% cut-off (20 Negative results). 95% agreement for -25% cut-off (1 Positive, 19 Negative). 95% agreement for +25% cut-off (19 Positive, 1 Negative). 100% agreement for +50%, +75% cut-off (20 Positive results).
  • BZO: 100% agreement for -100%, -75%, -50% cut-off (20 Negative results). 95% agreement for -25% cut-off (1 Positive, 19 Negative). 95% agreement for +25% cut-off (19 Positive, 1 Negative). 100% agreement for +50%, +75% cut-off (20 Positive results).
  • MET: 100% agreement for -100%, -75%, -50%, -25% cut-off (20 Negative results). 95% agreement for +25% cut-off (19 Positive, 1 Negative). 100% agreement for +50%, +75% cut-off (20 Positive results).
  • MTD: 100% agreement for -100%, -75%, -50%, -25% cut-off (20 Negative results). 95% agreement for +25% cut-off (19 Positive, 1 Negative). 100% agreement for +50%, +75% cut-off (20 Positive results).
  • MOP: 100% agreement for -100%, -75%, -50% cut-off (20 Negative results). 95% agreement for -25% cut-off (1 Positive, 19 Negative). 95% agreement for +25% cut-off (19 Positive, 1 Negative). 100% agreement for +50%, +75% cut-off (20 Positive results).
  • OXY: 100% agreement for -100%, -75%, -50%, -25% cut-off (20 Negative results). 95% agreement for +25% cut-off (19 Positive, 1 Negative). 100% agreement for +50%, +75% cut-off (20 Positive results).
  • THC: 100% agreement for -100%, -75%, -50% cut-off (20 Negative results). 95% agreement for -25% cut-off (1 Positive, 19 Negative). 95% agreement for +25% cut-off (19 Positive, 1 Negative). 100% agreement for +50%, +75% cut-off (20 Positive results).
  • TCA: 100% agreement for -100%, -75%, -50%, -25% cut-off (20 Negative results). 95% agreement for +25% cut-off (19 Positive, 1 Negative). 100% agreement for +50%, +75% cut-off (20 Positive results).
  • BUP: 100% agreement for -100%, -75%, -50% cut-off (20 Negative results). 95% agreement for -25% cut-off (1 Positive, 19 Negative). 95% agreement for +25% cut-off (19 Positive, 1 Negative). 100% agreement for +50%, +75% cut-off (20 Positive results).
  • PCP: 100% agreement for -100%, -75%, -50% cut-off (20 Negative results). 95% agreement for -25% cut-off (1 Positive, 19 Negative). 95% agreement for +25% cut-off (19 Positive, 1 Negative). 100% agreement for +50%, +75% cut-off (20 Positive results).
  • MDMA: 100% agreement for -100%, -75%, -50%, -25% cut-off (20 Negative results). 95% agreement for +25% cut-off (19 Positive, 1 Negative). 100% agreement for +50%, +75% cut-off (20 Positive results).
  • EDDP: 100% agreement for -100%, -75%, -50% cut-off (20 Negative results). 95% agreement for -25% cut-off (1 Positive, 19 Negative). 100% agreement for +25% cut-off (20 Positive results). 100% agreement for +50%, +75% cut-off (20 Positive results).
  • PPX: 100% agreement for -100%, -75%, -50% cut-off (20 Negative results). 95% agreement for -25% cut-off (1 Positive, 19 Negative). 100% agreement for +25% cut-off (20 Positive results). 100% agreement for +50%, +75% cut-off (20 Positive results).

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K201630

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K182530

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

0

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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

1

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

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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

2

Indications for Use

510(k) Number (if known)

K230238

Device Name

BIOEASYTM U-Catch MAX Multi-Drug Test Cup

Indications for Use (Describe)

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:

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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4

Indications for Use

510(k) Number (if known)

K230238

Device Name

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

Indications for Use (Describe)

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:

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-Acetylmorphine10 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.

5

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6

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 CodeClassificationRegulation SectionPanel
DJG
MonoacetylmorphineII21 CFR § 862.3650, Morphine Test SystemToxicology (91)
DKZ
AmphetamineII21 CFR § 862.3100, Amphetamine Test SystemToxicology (91)
LDJ
CannabinoidsII21 CFR § 862.3870, Cannabinoids Test SystemToxicology (91)
DIO
CocaineII21 CFR § 862.3250, Cocaine and Cocaine Metabolites Test SystemToxicology (91)
LAF
MethamphetamineII21 CFR § 862.3610, Methamphetamine Test SystemToxicology (91)
DJG
MorphineII21 CFR § 862.3650, Morphine Test SystemToxicology (91)
JXM
OxazepamII21 CFR § 862.3170, Benzodiazepine Test SystemToxicology (91)
DJG
OxycodoneII21 CFR § 862.3650, Opiate Test SystemToxicology (91)
DIS
SecobarbitalII21 CFR § 862.3150, Barbiturate Test SystemToxicology (91)
DJG
BuprenorphineII21 CFR § 862.3650, Opiate Test SystemToxicology (91)

7

| LAF
Methylenedioxy-

methamphetamineII21 CFR § 862.3610, Methamphetamine Test SystemToxicology (91)
LCM
PhencyclidineunclassifiedEnzyme Immunoassay
PhencyclidineToxicology (91)
DJR
MethadoneII21 CFR § 862.3620, Methadone
Test SystemToxicology (91)
DJR
2-ethylidene-1, 5-
dimethyl-3, 3-
diphenylpyrrolidine
(EDDP)II21 CFR § 862.3620, Methadone
Test SystemToxicology (91)
LFG
NortriptylineII21 CFR, 862.3910 Tricyclic
Antidepressant Drugs Test SystemToxicology (91)
JXN
PropoxypheneII21 CFR, 862.3700 Propoxyphene
Test SystemToxicology (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

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, 2- ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline Cannabinoids and 6-Acetylmorphine in human urine at the cutoff concentrations of:

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-Acetylmorphine10 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

ItemDevicePredicate - K201630
Indication(s)For the qualitative determination of drugs ofSame (but the number of

9

for Useabuse in human urine.drugs detected is different)
Calibrator and
Cut-Off ValuesAmphetamine (AMP): 500 ng/ml
Oxazepam (BZO):300 ng/ml
Cocaine (COC): 150 ng/ml
11-Nor-△9-Tetrahydrocannabinol-9-COOH
(THC):50 ng/ml
Methamphetamine (MET): 500 ng/ml
Morphine (MOR): 300 ng/mL
Oxycodone(OXY) : 100 ng/ml
Secobarbital (BAR): 300 ng/ml
Methadone (MTD): 300 ng/ml
Buprenorphine (BUP): 10 ng/ml
D,L-Methylenedioxymethamphetamine
(MDMA): 500 ng/ml
Phencyclidine (PCP): 25 ng/ml
Nortriptyline (TCA): 1000 ng/ml
2-ethylidene-1,5-dimethyl-3,3-
diphenylpyrrolidine (EDDP): 300 ng/ml
d-Propoxyphene (PPX): 300 ng/mlSame except
THC at 20 ng/mL
MethodologyCompetitive binding, lateral flow
immunochromatographic assays based on the
principle of antigen antibody
immunochemistry.Same
Type of TestQualitativeSame
Specimen TypeHuman UrineSame
Intended UseFor over-the-counterFor prescription use
ConfigurationsCupSame

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

ItemDevicePredicate – K201630
Indication(s)
for UseFor the qualitative determination of
drugs of abuse in human urine.Same
Calibrator and Cut-Off
ValuesAmphetamine (AMP): 500 ng/mlSame except
Oxazepam (BZO):300 ng/mlTHC 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/ml
Methadone (MTD): 300 ng/ml

10

| | Buprenorphine (BUP): 10 ng/ml
D,L-Methylenedioxymethamphetamine
(MDMA): 500 ng/ml
Phencyclidine (PCP): 25 ng/ml
Nortriptyline (TCA): 1000 ng/ml
2-ethylidene-1,5-dimethyl-3,3-
diphenylpyrrolidine (EDDP): 300 ng/ml
d-Propoxyphene (PPX): 300 ng/ml
6-Acetylmorphine (6-AM): 10 ng/mL | |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Methodology | Competitive binding, lateral flow
immunochromatographic assays based on
the principle of antigen antibody
immunochemistry. | 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 by
LC/MS (ng/mL)-100%
Cut-off-75%
Cut-off-50%
Cut-off-25%
Cut-offCut-offCut-off
+25%Cut-off
+50%Cut-off
+75%Cut-off
+100%
Lot
Number0127250374480590695825915
Lot 150-/0+50-/0+50-/0+50-/0+22-/28+50+/0-50+/0-50+/0-50+/0-
Lot 250-/0+50-/0+50-/0+50-/0+26-/24+50+/0-50+/0-50+/0-50+/0-
Lot 350-/0+50-/0+50-/0+50-/0+26-/24+50+/0-50+/0-50+/0-50+/0-
COC150
Concentration by
LC/ MS (ng/mL)-100%
Cut-off-75%
Cut-off-50%
Cut-off-25%
Cut-offCut-offCut-off
+25%Cut-off
+50%Cut-off
+75%Cut-off
+100%
Lot
Number038.277.8113154191230262302
Lot 150-/0+50-/0+50-/0+50-/0+28-/22+50+/0-50+/0-50+/0-50+/0-
Lot 250-/0+50-/0+50-/0+50-/0+29-/21+50+/0-50+/0-50+/0-50+/0-
Lot 350-/0+50-/0+50-/0+50-/0+22-/28+50+/0-50+/0-50+/0-50+/0-
MET500
Concentration by
LC/MS (ng/mL)-100%
Cut-off-75%
Cut-off-50%
Cut-off-25%
Cut-offCut-off+25%
Cut-off+50%
Cut-off+75%
Cut-off+100%
Cut-off
Lot
Number01292403684766057058601010
Lot 150-/0+50-/0+50-/0+50-/0+27-/23+50+/0-50+/0-50+/0-50+/0-
Lot 250-/0+50-/0+50-/0+50-/0+23-/27+50+/0-50+/0-50+/0-50+/0-
Lot 350-/0+50-/0+50-/0+50-/0+25-/25+50+/0-50+/0-50+/0-50+/0-
EDDP
Concentration by
LC/MS (ng/mL)
Lot-100%
Cut-off-75%
Cut-off-50%
Cut-off-25%
Cut-offCut-off+25%
Cut-off+50%
Cut-off+75%
Cut-off+100%
Cut-off
Number072.0146216293360426507582
50-/0+50-/0+50-/0+50-/0+24-/26+50+/0-50+/0-50+/0-50+/0-
Lot 150-/0+50-/0+50-/0+50-/0+24-/26+50+/0-50+/0-50+/0-50+/0-
Lot 250-/0+50-/0+50-/0+50-/0+26-/24+50+/0-50+/0-50+/0-50+/0-
Lot 350-/0+50-/0+50-/0+50-/0+25-/25+50+/0-50+/0-50+/0-50+/0-
6-AM
Concentration by
LC/MS (ng/mL)-100%
Cut-off-75%
Cut-off-50%
Cut-off-25%
Cut-offCut-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 |
|---------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot
Number | 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

AcetaminophenCreatinineKetaminePrednisone
AcetophenetidinDeoxycorticosteroneKetoprofen(±)-Propranolol
N-AcetylprocainamideDextromethorphanLabetalolPseudoephedrine
Acetylsalicylic acidDiclofenacLoperamideQuinine
Albumin (100mg/dL)DiflunisalMeperidineRanitidine
AminopyrineDigoxinMeprobamateSalicylic acid
AmoxicillinDiphenhydramineMethoxyphenamineSerotonin (5- Hydroxytyramine)
Ampicillin1% EthanolNalidixic acidSulfamethazine
ApomorphineEcgonine methyl esterNaloxoneSulindac
Ascorbic acidß-EstradiolNaltrexoneTetrahydrocortisone 3-(ß-
Dglucuronide)
AspartameErythromycinNaproxenTetrahydrocortisone 3-acetate
AtropineFenoprofenNiacinamideTetrahydrozoline
Benzilic acidFurosemideNifedipineThiamine
Benzoic acidGentisic acidNorethindroneThioridazine
BilirubinHemoglobinNoscapineTriamterene
Chloral hydrateHydralazine(±)-OctopamineTrifluoperazine
ChloramphenicolHydrochlorothiazideOxalic acidTrimethoprim
ChlorothiazideHydrocortisoneOxolinic acidDL-Tryptophan
ChlorpromazineO-Hydroxyhippuric acidOxymetazolineTyramine
Cholesterol3-HydroxytyraminePapaverineDL-Tyrosine
ClonidineIbuprofenPenicillin GUric acid
CortisoneIsoproterenolPerphenazineVerapamil
(-)-CotinineIsoxsuprinePhenelzineZomepirac

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.

AMP500Result%Cross-Reactivity
(Cut-off=500 ng/mL)Positive at (ng/ml)
D - Amphetamine500100%
L - Amphetamine100005%
DL - Amphetamine150033%
Phentermine150003.3%
Hydroxyamphetamine400012.5%
Methylenedioxyamphetamine (MDA)100005%
d-Methamphetamine> 100000100000
Drugs% of Cut-offNumber of samplesConcentration by LC/MS (ng/mL)Lay person resultsThe percentage of correct results (%)
AMP-100% Cut-off200No. of Positive 0No. of Negative 20100
-75% Cut-off20130No. of Positive 0No. of Negative 20100
-50% Cut-off20251020100
-25% Cut-off20383020100
+25% Cut-off2063519195
+50% Cut-off20755200100
+75% Cut-off20885200100
BAR-100% Cut-off200020100
-75% Cut-off2075.9020100
-50% Cut-off20150020100
-25% Cut-off20220020100
+25% Cut-off2036019195
+50% Cut-off20429200100
+75% Cut-off20501200100
COC-100% Cut-off200020100
-75% Cut-off2037.6020100
-50% Cut-off2074.8020100
-25% Cut-off2011011995
+25% Cut-off2018319195
+50% Cut-off20224200100
+75% Cut-off20248200100
BZO-100% Cut-off200020100
-75% Cut-off2070.8020100
-50% Cut-off20148020100
-25% Cut-off2022411995
+25% Cut-off2039019195
+50% Cut-off20452200100
+75% Cut-off20504200100
MET-100% Cut-off200020100
-75% Cut-off20124020100
-50% Cut-off20242020100
-25% Cut-off20367020100
+25% Cut-off2061019195
+50% Cut-off20705200100
+75% Cut-off20825200100
MTD-100% Cut-off200020100
-75% Cut-off2076.8020100
-50% Cut-off20147020100
-25% Cut-off20226020100
+25% Cut-off2037519195
+50% Cut-off20441200100
+75% Cut-off20504200100
MOP-100% Cut-off200020100
-75% Cut-off2079020100
-50% Cut-off20158020100
-25% Cut-off2024611995
+25% Cut-off2038919195
+50% Cut-off20469200100
+75% Cut-off20530200100
OXY-100% Cut-off200020100
-75% Cut off2024.5020100
-50% Cut-off2049.3020100
-25% Cut-off2071.1020100
+25% Cut-off2011819195
+50% Cut-off20147200100
+75% Cut-off20169200100
-100% Cut-off200020100
-75% Cut-off2013020100
THC-50% Cut-off2025.3020100
-25% Cut-off204111995
+25% Cut-off206519195
+50% Cut-off2079200100
+75% Cut-off2093200100
-100% Cut-off200020100
-75% Cut-off20273020100
TCA-50% Cut-off20509020100
-25% Cut-off20809020100
+25% Cut-off20119019195
+50% Cut-off201510200100
+75% Cut-off201680200100
-100% Cut-off200020100
-75% Cut-off20273020100
BUP-50% Cut-off205.14020100
-25% Cut-off206.7611995
+25% Cut-off2012.819195
+50% Cut-off2015.1200100
+75% Cut-off2017.2200100
-100% Cut-off200020100
-75% Cut-off202.57020100
PCP-50% Cut-off2012.5020100
-25% Cut-off2017.911995
+25% Cut-off2030.819195
+50% Cut-off2036.4200100
+75% Cut-off2042.8200100
-100% Cut-off200020100
-75% Cut-off206.27020100
MDMA-50% Cut-off20250020100
-25% Cut-off20351020100
+25% Cut-off2060019195
+50% Cut-off20745200100
+75% Cut-off20925200100
-100% Cut-off200020100
-75% Cut-off20137020100
EDDP-50% Cut-off20141020100
-25% Cut-off2022411995
+25% Cut-off20375200100
+50% Cut-off20447200100
+75% Cut-off20554200100
-100% Cut-off200020100
-75% Cut-off2076.2020100
+75% Cut-off20522200100
PPX-100% Cut-off200020100
-75% Cut-off2077.4020100
-50% Cut-off20150020100
-25% Cut-off2022711995
+25% Cut-off20351200100
+50% Cut-off20420200100
+75% Cut-off20492200100

19

20

21

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.

  1. 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.