SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx

K252550 · Guangzhou Wondfo Biotech Co., Ltd. · NFT · Nov 18, 2025 · Clinical Toxicology

Device Facts

• Record ID: K252550
• Device Name: SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx
• Applicant: Guangzhou Wondfo Biotech Co., Ltd.
• Product Code: NFT · Clinical Toxicology
• Decision Date: Nov 18, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

SAFElife™ T-Cup Multi-Drug Urine Test Cup: SAFElife™ T-Cup Multi-Drug Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Fentanyl, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Opiates, Methadone, Norfentanyl, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids and Tramadol in human urine at the cutoff concentrations of: [Table of cutoffs]. SAFElife™ T-Cup Multi-Drug Urine Test Cup offers any combinations from 1 to 19 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use. The tests may yield positive results for the prescription drugs Buprenorphine, Fentanyl, Nortriptyline, Oxazepam, Secobarbital, Oxycodone and Tramadol 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. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the recommended confirmatory method. SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx: SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Fentanyl, Methylenedioxymethamphetamine, Methamphetamine, Morphine, Opiates, Methadone, Norfentanyl, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids and Tramadol in human urine with below cutoff concentrations and approximate detection time: [Table of cutoffs]. SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx offers any combinations from 1 to 19 drugs of abuse tests with or without on-board adulteration/specimen validity test (SVT) but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use. The tests may yield positive results for the prescription drugs Buprenorphine, Fentanyl, Nortriptyline, Oxazepam, Secobarbital, Oxycodone and Tramadol 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. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the recommended confirmatory method.

Device Story

Lateral flow immunochromatographic assay; detects drugs of abuse in human urine via competitive binding antigen-antibody reaction. Input: urine sample added to test cup; migrates via capillary action. Principle: target drug in sample competes with immobilized drug-conjugate for limited antibody-coated particle binding sites. Output: visual colored band formation on test line (negative result) or absence of band (positive result); control line confirms proper flow. Used in home (OTC) or clinical settings; operated by patients or professionals. Provides preliminary results; requires professional judgment and confirmatory testing (GC/MS or LC/MS) for clinical decisions. Benefits: rapid, simultaneous screening for multiple substances.

Clinical Evidence

No clinical diagnostic data. Bench testing included precision/reproducibility studies across 25 days and analytical specificity/interference testing. Method comparison study performed with 80 unaltered urine samples compared to LC/MS or GC/MS. Lay user study (n=140) assessed usability and comprehension; participants successfully performed testing and interpreted results with acceptable agreement across cutoff concentrations.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Components: test cup, package insert, desiccant. Storage: 2-30°C. Qualitative detection. No electronic components or software.

Indications for Use

Indicated for qualitative, simultaneous detection of drugs of abuse and metabolites in human urine. Intended for OTC use to provide preliminary results. Not for distinguishing between prescription use and abuse. Requires confirmation by GC/MS or LC/MS.

Regulatory Classification

Identification

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

Special Controls

*Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Predicate Devices

• Wondfo T-Cup® Multi-Drug Urine Test Cup (K182701)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number

K252550

B Applicant

Guangzhou Wondfo Biotech Co., Ltd.

C Proprietary and Established Names

SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NFT | Class II | 21 CFR 862.3100 - Amphetamine Test System | TX - Clinical Toxicology |
| PTH | Class II | 21 CFR 862.3150 - Barbiturate test system | TX - Clinical Toxicology |
| NFV | Class II | 21 CFR 862.3170 - Benzodiazepine test system | TX - Clinical Toxicology |
| NFY | Class II | 21 CFR 862.3250 - Cocaine and cocaine metabolite test system | TX - Clinical Toxicology |
| PTG | Class II | 21 CFR 862.3620 - Methadone test system | TX - Clinical Toxicology |

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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| NGG | Class II | 21 CFR 862.3610 - Methamphetamine test system | TX - Clinical Toxicology |
| --- | --- | --- | --- |
| LCM | Unclassified | | |
| QBF | Class II | 21 CFR 862.3700 - Propoxyphene test system | TX - Clinical Toxicology |
| QAW | Class II | 21 CFR 862.3910 - Tricyclic antidepressant drugs test system | TX - Clinical Toxicology |
| NFW | Class II | 21 CFR 862.3870 - Cannabinoid test system | TX - Clinical Toxicology |
| NGL | Class II | 21 CFR 862.3650 - Opiate test system | TX - Clinical Toxicology |

## II Submission/Device Overview:

### A Purpose for Submission:

New Device (adding four additional analytes and a new cutoff of 20ng/mL for THC-COOH (Marijuana 20) to the previously cleared device under K182701).

### B Measurand:

Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Opiates, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids, 6-Monoacetylmorphine, Fentanyl, Norfentanyl, and Tramadol.

### C Type of Test:

Qualitative, lateral flow immunoassay

## III Intended Use/Indications for Use:

### A Intended Use(s):

See Indications for Use below.

### B Indication(s) for Use:

SAFElife™ T-Cup Multi-Drug Urine Test Cup:

SAFElife™ T-Cup Multi-Drug Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-

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ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Fentanyl, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Opiates, Methadone, Norfentanyl, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids and Tramadol in human urine at the cutoff concentrations of:

| Drug (Identifier) | Cutoff Level |
| --- | --- |
| 6-Monoacetylmorphine (6-MAM) | 10 ng/mL |
| Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL or 150 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Fentanyl (FTY) | 1 ng/mL |
| Methamphetamine (MET/mAMP) | 1000 ng/mL or 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP) | 300 ng/mL |
| Opiates (OPI) | 2000 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Norfentanyl (NFTY) | 5 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Cannabinoids (THC) | 50 ng/mL or 20 ng/mL |
| Tramadol (TRA) | 100 ng/mL |

SAFElife™ T-Cup Multi-Drug Urine Test Cup offers any combinations from 1 to 19 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use.

The tests may yield positive results for the prescription drugs Buprenorphine, Fentanyl, Nortriptyline, Oxazepam, Secobarbital, Oxycodone and Tramadol 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. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the recommended confirmatory method.

SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx:

SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Fentanyl, Methylenedioxymethamphetamine, Methamphetamine, Morphine, Opiates, Methadone, Norfentanyl, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids and Tramadol in human urine with below cutoff concentrations and approximate detection time:

| Drug (Identifier) | Calibrator | Cut-off Level |
| --- | --- | --- |
| 6-Monoacetylmorphine (6-MAM) | 6-Monoacetylmorphine | 10 ng/mL |
| Amphetamine (AMP500) | d-Amphetamine | 500 ng/mL |

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| Amphetamine (AMP1000) | d-Amphetamine | 1000 ng/mL |
| --- | --- | --- |
| Secobarbital (BAR) | Secobarbital | 300 ng/mL |
| Buprenorphine (BUP) | Buprenorphine | 10 ng/mL |
| Oxazepam (BZO) | Oxazepam | 300 ng/mL |
| Cocaine (COC150) | Benzoylecgonine | 150 ng/mL |
| Cocaine (COC300) | Benzoylecgonine | 300 ng/mL |
| 2-ethylidene-1,5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) | | 2-ethylidene-1,5-dimethyl-3, 3-diphenyl-pyrrolidine |
| Fentanyl (FTY) | Fentanyl | 1 ng/mL |
| Methylenedioxymethamphetamine (MDMA) 3,4-Methylenedioxymethamphetamine | | 500 ng/mL |
| Methamphetamine (MET500/mAMP500) | D(+)-Methamphetamine | 500 ng/mL |
| Methamphetamine (MET1000/mAMP1000) D(+)-Methamphetamine | | 1000 ng/mL |
| Morphine (MOP300) | Morphine | 300 ng/mL |
| Opiates (OPI2000) | Morphine | 2000 ng/mL |
| Methadone (MTD) | Methado | 300 ng/mL |
| Norfentanyl (NFTY) | Norfentanyl | 5 ng/mL |
| Oxycodone (OXY) | Oxycodone | 100 ng/mL |
| Phencyclidine (PCP) | Phencyclidine | 25 ng/mL |
| Propoxyphene (PPX) | d-Propoxyphene | 300 ng/mL |
| Nortriptyline (TCA) | Nortriptyline | 1000 ng/mL |
| Cannabinoids (THC20) | 11-nor-Δ9-THC-9-COOH | 20 ng/mL |
| Cannabinoids (THC50) | 11-nor-Δ9-THC-9-COOH | 50 ng/mL |
| Tramadol (TRA) | Tramadol | 100 ng/mL |

SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx offers any combinations from 1 to 19 drugs of abuse tests with or without on-board adulteration/specimen validity test (SVT) but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use.

The tests may yield positive results for the prescription drugs Buprenorphine, Fentanyl, Nortriptyline, Oxazepam, Secobarbital, Oxycodone and Tramadol 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. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the recommended confirmatory method.

## C Special Conditions for Use Statement(s):

OTC - Over The Counter

## D Special Instrument Requirements:

Not Applicable.

## IV Device/System Characteristics:

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# A Device Description:

The SAFElife™ T-Cup Multi-Drug Urine Test Cup and the SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx are lateral flow immunochromatographic assays for the qualitative detection of the claimed analytes in human urine at the associated cut-off concentrations. This submission (K252550) represents the following claimed analytes and associated cut off concentrations; 6-Monoacetylmorphine at 10 ng/mL, Fentanyl at 1 ng/mL, Norfentanyl at 5 ng/mL, Tramadol at 100 ng/mL, and Cannabinoids (THC) at 20 ng/mL. Each SAFElife™ T-Cup Multi-Drug Urine Test Cup or SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx device consists of a test cup and a package insert. Each test cup is sealed with one sachet of desiccant in an aluminum pouch.

# B Principle of Operation:

SAFElife T-Cup Multi-Drug Urine Test Cup is a lateral flow chromatographic immunoassay. When urine sample is added to the cup device, urine is absorbed into the test strip and migrates upwards by capillary action. If the concentration of target drug presented in the urine sample is below the cutoff level, the target drug will not saturate the binding sites of its specific monoclonal antibody-coated particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored band will be formed on the test line region. If the concentration of target is beyond the cutoff level, the target drug will saturate the binding sites of its specific monoclonal antibody-particles, thus the antibody-coated particles will not be captured by immobilized drug-conjugate hence no colored band will be formed on the test line region. A band should be formed on the control line region regardless of the presence of target drug or metabolite in the sample to indicate that the tests have been performed properly.

# V Substantial Equivalence Information:

# A Predicate Device Name(s):

Wondfo T-Cup Multi-Drug Urine Test Cup

# B Predicate 510(k) Number(s):

K182701

# C Comparison with Predicate(s):

| Device & Predicate Device(s): | K252550 | K182701 |
| --- | --- | --- |
| Device Trade Name | SAFElife™ T-Cup Multi-Drug Urine Test Cup
SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx | Wondfo T-Cup Multi-Drug Urine Test Cup |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | For the qualitative determination of drugs and drug metabolites in human urine. | Same |

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| Specimen Type | Human Urine | Same |
| --- | --- | --- |
| Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same |
| **General Device Characteristic Differences** | | |
| Analytes and Cutoff | Amphetamine (AMP)
1000 ng/mL or 500 ng/mL
Buprenorphine (BUP)
10 ng/mL
Secobarbital (BAR)
300 ng/mL
Oxazepam (BZO)
300 ng/mL
Cocaine (COC)
300 ng/mL or 150 ng/mL
2 ethylidene 1,5 dimethyl
3,3 diphenylpyrrolidine (EDDP)
300 ng/mL
Methamphetamine (MET/mAMP)
1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA)
500 ng/mL
Morphine (MOP 300)
300 ng/mL
Opiates (OPI 2000)
2000 ng/mL
Methadone (MTD)
300 ng/mL
Oxycodone (OXY)
100 ng/mL
Phencyclidine (PCP)
25 ng/mL
Propoxyphene (PPX)
300 ng/mL
Nortriptyline (TCA)
1000 ng/mL
Cannabinoids (THC) | Same except without 6-MAM 10 ng/mL
FTY 1 ng/mL
NFTY 5 ng/mL
TRA 100 ng/mL
THC 20 ng/mL |

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VI Standards/Guidance Documents Referenced:

None referenced.

VII Performance Characteristics (if/when applicable):

A Analytical Performance:
Analytical performance for Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Opiates, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids were conducted on k182701.

1. Precision/Reproducibility:

Precision studies were carried out for samples with concentrations of -100% cutoff, -75% cut off, -50% cutoff, -25% cutoff, cutoff, +25% cutoff, +50% cutoff, +75% cutoff and +100% cutoff. Samples with concentration of -100% cutoff were drug-free urines samples. Other samples were prepared by spiking target drug in drug-free urine samples. Each drug concentration was confirmed by LC/MS or GC/MS. For each concentration, tests were performed one replicate per run per lot (one operator per lot), two runs per day for 25 days in a randomized order. The results are summarized in the following table:

| Drug | Lot Number | -100% Cutoff | -75% Cutoff | -50% Cutoff | -25% Cutoff | Cutoff | +25% Cutoff | +50% Cutoff | +75% Cutoff | +100% Cutoff |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 6-MAM 10 | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 1-/49+ | 0-/50+ | 0-/50+ | 0-/50+ |
| | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 25-/25+ | 1-/49+ | 0-/50+ | 0-/50+ | 0-/50+ |
| | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 26-/24+ | 2-/48+ | 0-/50+ | 0-/50+ | 0-/50+ |
| FTY1 | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 23-/27+ | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ |
| | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 24-/26+ | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ |
| | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 25-/25+ | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ |
| NFTY5 | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 24-/26+ | 2-/48+ | 0-/50+ | 0-/50+ | 0-/50+ |

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| | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 26-/24+ | 1-/49+ | 0-/50+ | 0-/50+ | 0-/50+ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 24-/26+ | 1-/49+ | 0-/50+ | 0-/50+ | 0-/50+ |
| THC20 | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 26-/24+ | 1-/49+ | 0-/50+ | 0-/50+ | 0-/50+ |
| | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 25-/25+ | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ |
| | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 23-/27+ | 2-/48+ | 0-/50+ | 0-/50+ | 0-/50+ |
| TRA100 | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ |
| | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ |
| | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ |

2. **Linearity:**
Not applicable.

3. **Analytical Specificity/Interference:**

**Analytical specificity**

Analytical specificity was performed for this device to determine the cross-reactivity from structurally related compounds by identifying the concentration of a compound prepared in drug-free negative urine that would produce a positive response for each assay. Percent cross-reactivity, provided in the below table, was calculated as the concentration of analyte tested that yielded a positive result, divided by the cutoff concentration, multiplied by 100. The results are summarized below.

| Drug/Cutoff | Compound | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
| --- | --- | --- | --- |
| 6-MAM10 | Heroin | 60 | 16.7% |
| | Morphine | 75000 | 0.01% |
| | Normorphine | 150000 | Not detected |
| | Nalorphine HCl | 150000 | Not detected |
| | Hydrocodone | 150000 | Not detected |
| | Hydromorphone | 150000 | Not detected |
| | Chlordiazepoxide | 150000 | Not detected |
| | Clobazam | 150000 | Not detected |
| | D-Amphetamine | 150000 | Not detected |
| | (±)-Amphetamine | 150000 | Not detected |
| | Levorphanol tartrate | 150000 | Not detected |
| | Codeine | 150000 | Not detected |
| | Ethylmorphine | 150000 | Not detected |
| | Morphine3-β-D-glucuronide | 150000 | Not detected |
| | Norcodeine | 150000 | Not detected |

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| Drug/Cutoff | Compound | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
| --- | --- | --- | --- |
| | Oxycodone | 150000 | Not detected |
| Oxymorphone | 150000 | Not detected |
| Procaine hydrochloride | 150000 | Not detected |
| Thebaine | 150000 | Not detected |
| 6-Acetylcodeine | 150000 | Not detected |
| Buprenorphine | 150000 | Not detected |
| Dihydrocodeine | 150000 | Not detected |
| Dextromethorphan | 150000 | Not detected |
| Imipramine hydrochloride | 150000 | Not detected |
| Meperidine | 150000 | Not detected |
| (±)-Methadone | 150000 | Not detected |
| Mitragynine(kratom) | 150000 | Not detected |
| Morphine-6-β-D-glucuronide | 150000 | Not detected |
| Naloxone hydrochloride | 150000 | Not detected |
| Naltrexone hydrochloride | 150000 | Not detected |
| Naproxen | 150000 | Not detected |
| Norbuprenorphine | 150000 | Not detected |
| Norbuprenorphine glucuronide | 150000 | Not detected |
| Noroxycodone HCL | 150000 | Not detected |
| Noroxymorphone HCL | 150000 | Not detected |
| (+)-Norpropoxyphene maleate | 150000 | Not detected |
| Oxymorphone-3β-D-glucuronide | 150000 | Not detected |
| Tapentadol HCl | 150000 | Not detected |
| Tramadol | 150000 | Not detected |
| FTY1 | Acetyl fentanyl | 16 | 6.25% |
| Acrylfentanyl | 1 | 100.00% |
| ω-1-Hydroxyfentanyl | 20,000 | 0.005% |
| Isobutyryl fentanyl | 1 | 100.00% |
| Ocfentanil | 2.3 | 43.48% |
| Butyryl fentanyl | 2 | 50.00% |
| Furanyl fentanyl | 1 | 100.00% |
| Valeryl fentanyl | 2.5 | 40.00% |
| (±) β-hydroxythiofentanyl | 2.5 | 40.00% |
| 4-Fluoro-isobutyrylfentanyl | 3 | 33.33% |

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| Drug/Cutoff | Compound | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
| --- | --- | --- | --- |
| | Para-fluorobutyryl fentanyl | 4 | 25.00% |
| | Para-fluoro fentanyl | 2.5 | 40.00% |
| | (+)-3-cis-methyl fentanyl | 50 | 2.00% |
| | Carfentanil | 2 | 50.00% |
| | Sufentanil | 15 | 6.67% |
| | Alfentanil | 7500 | 0.01% |
| | Despropionyl fentanyl (4-ANPP) | 2,000 | 0.05% |
| | Remifentanil | 150000 | Not detected |
| | Norfentanyl | 150000 | Not detected |
| | Acetyl norfentanyl | 150000 | Not detected |
| | Norcarfentanil | 150000 | Not detected |
| | Trazodone | 25000 | 0.004% |
| NFTY5 | Fentanyl | 10 | 50% |
| | Acetyl fentanyl | 150 | 3.3% |
| | Acetyl Norfentanyl | 200 | 2.5% |
| | □ ±)-β-Hydroxythiofentanyl HCl | 2500 | 0.2% |
| | Acryl Fentanyl | 2500 | 0.2% |
| | Butyryl Fentanyl | 5000 | 0.1% |
| | Furanyl Fentanyl | 10000 | 0.05% |
| | Para-fluoro butyrl Fentanyl (P-FBF) | 80000 | 0.006% |
| | Para-fluoro Fentanyl | 40000 | 0.013% |
| | 9-HydroxyRisperidone | 10000 | 0.05% |
| | Alfentanil | 20000 | 0.025% |
| | Isobutyryl Fentanyl | 5000 | 0.1% |
| | Remifentanil | 15000 | 0.03% |
| | Valeryl Fentanyl | 20000 | 0.025% |
| | Thienyl Fentanyl | 50 | 10% |
| | (+)-3-cis-methyl fentanyl | 50 | 10% |
| | 4-Fluoro-isobutyryl Fentanyl | 30000 | Not detected |
| | Despropionyl fentanyl (4-ANPP) | 30000 | Not detected |
| | MT-45 diHCL | 150000 | Not detected |
| | Ocfentanil | 150000 | Not detected |
| | Risperidone | 150000 | Not detected |

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K252550 - Page 11 of 19
| Drug/Cutoff | Compound | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
| --- | --- | --- | --- |
| | Sufentanil | 150000 | Not detected |
| | Carfentanil | 150000 | Not detected |
| | Labetalol Hydrochloride | 150000 | Not detected |
| | Trazodone | 150000 | Not detected |
| | U-47700 | 150000 | Not detected |
| | ω-1-Hydroxyfentanyl | 30000 | Not detected |
| | 6-Acetyl morphine | 150000 | Not detected |
| | (±)-Amphetamine | 150000 | Not detected |
| | Buprenorphine | 150000 | Not detected |
| | Buprenorphine-3β-D-glucuronide | 150000 | Not detected |
| | Codeine | 150000 | Not detected |
| | Dextromethorphan | 150000 | Not detected |
| | Dihydrocodeine | 150000 | Not detected |
| | EDDP | 150000 | Not detected |
| | EMDP | 150000 | Not detected |
| | Fluoxetine | 150000 | Not detected |
| | Heroin | 150000 | Not detected |
| | Hydrocodone | 150000 | Not detected |
| | Hydromorphone | 150000 | Not detected |
| | Ketamine | 150000 | Not detected |
| | Levorphanol tartrate | 150000 | Not detected |
| | Meperidine | 150000 | Not detected |
| | (±)-Methadone | 150000 | Not detected |
| | Morphine | 150000 | Not detected |
| | Morphine-3-β-D-glucuronide | 150000 | Not detected |
| | Naloxone hydrochloride | 150000 | Not detected |
| | Naltrexone hydrochloride | 150000 | Not detected |
| | Norbuprenorphine | 150000 | Not detected |
| | Norcodeine | 150000 | Not detected |
| | Norketamine | 150000 | Not detected |
| | Normeperidine | 150000 | Not detected |
| | Normorphine | 150000 | Not detected |
| | Noroxycodone | 150000 | Not detected |
| | Oxycodone | 150000 | Not detected |
| | Oxymorphone | 150000 | Not detected |

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K252550 - Page 12 of 19

| Drug/Cutoff | Compound | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
| --- | --- | --- | --- |
| | Pentazocine (Talwin) | 150000 | Not detected |
| | Pipamperone | 150000 | Not detected |
| | Tapentadol hydrochloride | 150000 | Not detected |
| | Thioridazine | 150000 | Not detected |
| | Tilidine | 150000 | Not detected |
| | Tramadol | 150000 | Not detected |
| | O-Desmethyl -cris-Tramadol | 150000 | Not detected |
| | N-Desmethyl -cris-Tramadol | 150000 | Not detected |
| | Norcarfentanil | 150000 | Not detected |
| THC 20 | (-)-11-nor-9-carboxy-Delta8-THC | 20 | 100% |
| | (-)-11-Nor-Δ9-THC- 9-carboxylic acid glucuronide | 30 | 66.7% |
| | (±)-11-Hydroxy-Δ9-THC | 20 | 100% |
| | (-)-11-nor-9-carboxy-Δ 9-THC | 20 | 100% |
| | (-)-Δ9-THC | 6000 | 0.3% |
| | (-)-Δ8-THC | 4000 | 0.5% |
| | Cannabinol | 8000 | 0.25% |
| | Cannabidiol | 150000 | Not detected |
| TRA100 | n-Desmethyl -cris-Tramadol | 400 | 25% |
| | o-Desmethyl -cris-Tramadol | 1000 | 10% |
| | o-Desmethyl Venlafaxine | 15000 | Not detected |
| | Venlafaxine HCl | 150000 | Not detected |

## Interference

A study to evaluate potential interference from various endogenous and exogenous compounds, by spiking the substances into pooled urine containing target drugs at near-cutoff concentrations (at +50% and -50% of cutoff). Unless otherwise indicated, substances were tested for potential interference at concentrations of 100 µg/mL. The following substances demonstrated no positive or negative interference on the assays encompassed in this submission.

| Acetaminophen | Effexor | Nimodipine |
| --- | --- | --- |
| Acetophenetidin | Enalapril Maleate | Nitroglycerin |
| Acetylsalicylic Acid | Erythromycin | Norethindrone |
| Acyclovir | Esomeprazole Magnesium | N-Acetylprocainamide |

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K252550 - Page 13 of 19
| Afrin | β-Estradiol | O-Hydroxyhippuric Acid |
| --- | --- | --- |
| Albumin (100mg/dL) | 1% ethanol | Olanzapine |
| Aminophylline | Fenofibrate | Omeprazole |
| Aminopyrine | Fenoprofen | Oxalic Acid |
| Amiodarone Hydrochloride | Fentanyl Citrate | Oxolinic Acid |
| Amlodipine Mesylate | Fluoxetine Hydrochloride | Oxymetazoline |
| Amoxicillin | Fluvoxamine | Ondansetran |
| Ampicillin | Furosemide | Paliperidone |
| Apomorphine | Gabapentin | Pantoprazole |
| Aripiprazole | Gentisic Acid | Papaverine |
| Aspartame | Glibenclamide | Paroxetine Hydrochloride |
| Atomoxetine | Gliclazide | Penfluridol |
| Atorvastatin Calcium | Glipizide | PenicillinV Potassium |
| Atropine | Glucose | Penicillin-G |
| Benzilic Acid | Haloperidol | Phenelzine |
| Benzoic Acid | Hemoglobin | Pioglitazone Hydrochloride |
| Bilirubin | Hydrochlorothiazide | Piracetam |
| Bupropion | Hydrocortisone | Pravastatin Sodium |
| Captopril | 3-Hydroxytyramine | Prednisone |
| Carbamazepine | Isosorbide Dinitrate | Propylthiouracil |
| Cefradine | Isoxsuprine | Quetiapine Fumarate |
| Cephalexin | Ibuprofen | Quinine |
| Chloral Hydrate | Ketoconazole | Ranitidine |
| Chloramphenicol | Ketoprofen | Rifampicin |
| Chlorothiazide | Ketamine | Risperidone |
| Cholesterol | Kratom powder | Salicylic Acid |
| Ciprofloxacin Hydrochloride | Labetalol | Serotonin |
| Citalopram | Lamotrigine | Sertraline Hydrochloride |
| Clarithromycin | Levofloxacin Hydrochloride | Sildenafil Citrate |
| Clonidine | Levonorgestrel | Simvastatin |
| Clopidogrel Hydrogen Sulphate | Levothyroxine Sodium | Sodium Valproate |
| Clozapine | Lidocaine Hydrochloride | Spironolactone |
| Conjugated Estrogens | Lisinopril | Sulfamethazine |
| Cortisone | Lithium Carbonate | Sulindac |
| Creatinine | Liverite | Tetracycline |
| (-) Cotinine | Loperamide | Tetrahydrocortisone 3 - acetate |
| chlorpheniramine | Loratadine | Tetrahydrocortisone 3-(β-D glucuronide) |
| D,L-Octopamine | Magnesium | Tetrahydrozoline |

{13}

| D,L-Propranolol | Meperidine | Thiamine |
| --- | --- | --- |
| D,L-Tyrosine | Meprobamate | Thioridazine |
| Deoxycorticosterone | Metoprolol Tartrate | Topiramate |
| Dextromethorphan | Mifepristone | Tramadol Hydrochloride |
| Diclofenac | Mirtazapine | Trazodone Hydrochloride |
| Diflunisal | Montelukast Sodium | Triamterene |
| Digoxin | Mosapride Citrate | Trifluoperazine |
| Diphenhydramine | Minocycline | Trimethoprim |
| Dirithromycin | Nalidixic Acid | Uric Acid |
| Domperidone | Naproxen | Valproate |
| D-Pseudoephedrine | Niacinamide | Verapamil |
| Duloxetine | Nifedipine | Vitamin B2 |
| Dicyclomine | Nikethamide | Vitamin C |
| Chloroquine | Ecgonine Methyl Ester | Promethazine |

Urine Density & Urine pH

Interference by pH and specific gravity were also evaluated using pooled urine specimens containing target drugs at near-cutoff concentrations (at +50% and -50% of cutoff). The results demonstrated that pH levels of 4 to 9 and specific gravity levels of 1.000 to 1.035 do not affect the results of the assays.

4. Assay Reportable Range:

Not applicable.

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

The assay is traceable to a commercial standard from Cerilliant Corp.

6. Detection Limit:

Not applicable.

7. Assay Cut-Off:

Analytical performance of the device around the claimed cutoff is described in the precision section VII.A1. above.

B Comparison Studies:

1. Method Comparison with Predicate Device:

In this submission, the method comparison study for 6-Monoacetylmorphine (6-MAM10), Fentanyl (FTY1), Cannabinoids (THC20), Tramadol (TRA100) and Norfentanyl (NFTY5), was

K252550 - Page 14 of 19

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performed by three operators with 80 unaltered urine samples. These samples were blind labeled and compared to LC/MS or GC/MS results. The results are shown in the table below. Method comparison studies demonstrating device accuracy when measuring previously cleared analytes can be found in K182701.

| Drug | Operator | Results | Drug-free by LC/MS | Low Neg by LC/MS (less than -50%) | Near Cutoff Neg by LC/MS (Between -50% and the Cutoff) | Near Cutoff Pos by LC/MS (Between the cutoff and +50%) | High Pos by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6-MAM 10 | A | Positive | 0 | 0 | 3 | 21 | 18 |
| | | Negative | 13 | 14 | 10 | 1 | 0 |
| | B | Positive | 0 | 0 | 2 | 21 | 18 |
| | | Negative | 13 | 14 | 11 | 1 | 0 |
| | C | Positive | 0 | 0 | 1 | 21 | 18 |
| | | Negative | 13 | 14 | 12 | 1 | 0 |
| FTY 1 | A | Positive | 0 | 0 | 2 | 21 | 18 |
| | | Negative | 12 | 16 | 10 | 1 | 0 |
| | B | Positive | 0 | 0 | 1 | 20 | 18 |
| | | Negative | 12 | 16 | 11 | 2 | 0 |
| | C | Positive | 0 | 0 | 2 | 21 | 18 |
| | | Negative | 12 | 16 | 10 | 1 | 0 |
| NFTY 5 | A | Positive | 0 | 0 | 3 | 23 | 16 |
| | | Negative | 10 | 16 | 11 | 1 | 0 |
| | B | Positive | 0 | 0 | 2 | 22 | 16 |
| | | Negative | 10 | 16 | 12 | 2 | 0 |
| | C | Positive | 0 | 0 | 2 | 22 | 16 |
| | | Negative | 10 | 16 | 12 | 2 | 0 |
| THC 20 | A | Positive | 0 | 0 | 2 | 28 | 10 |
| | | Negative | 9 | 15 | 14 | 2 | 0 |
| | B | Positive | 0 | 0 | 2 | 29 | 10 |
| | | Negative | 9 | 15 | 14 | 1 | 0 |
| | C | Positive | 0 | 0 | 2 | 28 | 10 |
| | | Negative | 9 | 15 | 14 | 2 | 0 |
| TRA 100 | A | Positive | 0 | 0 | 2 | 27 | 12 |
| | | Negative | 10 | 18 | 10 | 1 | 0 |
| | B | Positive | 0 | 0 | 1 | 27 | 12 |
| | | Negative | 10 | 18 | 11 | 1 | 0 |
| | C | Positive | 0 | 0 | 1 | 27 | 12 |
| | | Negative | 10 | 18 | 11 | 1 | 0 |

Summary of Discordant Results:

K252550 - Page 15 of 19

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K252550 - Page 16 of 19
| Drug | Operator | Sample Number | LC/MS Results (ng/mL) | Device Results |
| --- | --- | --- | --- | --- |
| 6-MAM 10 | Operator A | SU25050045 | 7.867 | Positive |
| | Operator A | SU25050057 | 8.193 | Positive |
| | Operator A | SU25050075 | 9.192 | Positive |
| | Operator A | SU25050029 | 10.863 | Negative |
| | Operator B | SU25050057 | 8.193 | Positive |
| | Operator B | SU25050075 | 9.192 | Positive |
| | Operator B | SU25050074 | 10.359 | Negative |
| | Operator C | SU25050075 | 9.192 | Positive |
| | Operator C | SU25050074 | 10.359 | Negative |
| FTY 1 | Operator A | SU25050271 | 0.848 | Positive |
| | Operator A | SU25050284 | 0.965 | Positive |
| | Operator A | SU25050249 | 1.136 | Negative |
| | Operator B | SU25050284 | 0.965 | Positive |
| | Operator B | SU25050249 | 1.136 | Negative |
| | Operator B | SU25050270 | 1.184 | Negative |
| | Operator C | SU25050271 | 0.848 | Positive |
| | Operator C | SU25050284 | 0.965 | Positive |
| | Operator C | SU25050270 | 1.184 | Negative |
| NFTY 5 | Operator A | SU25060042 | 4.315 | Positive |
| | Operator A | SU25060030 | 4.765 | Positive |
| | Operator A | SU25060011 | 4.879 | Positive |
| | Operator A | SU25060065 | 5.341 | Negative |
| | Operator B | SU25060030 | 4.765 | Positive |
| | Operator B | SU25060011 | 4.879 | Positive |
| | Operator B | SU25060075 | 5.526 | Negative |
| | Operator B | SU25060073 | 5.699 | Negative |
| | Operator C | SU25060042 | 4.315 | Positive |
| | Operator C | SU25060011 | 4.879 | Positive |
| | Operator C | SU25060065 | 5.341 | Negative |
| | Operator C | SU25060073 | 5.699 | Negative |
| THC 20 | Operator A | SU25050194 | 18.614 | Positive |
| | Operator A | SU25050181 | 19.363 | Positive |
| | Operator A | SU25050167 | 20.499 | Negative |
| | Operator A | SU25050220 | 20.645 | Negative |
| | Operator B | SU25050194 | 18.614 | Positive |
| | Operator B | SU25050181 | 19.363 | Positive |
| | Operator B | SU25050167 | 20.499 | Negative |
| | Operator C | SU25050185 | 18.422 | Positive |
| | Operator C | SU25050181 | 19.363 | Positive |
| | Operator C | SU25050220 | 20.645 | Negative |
| | Operator C | SU25050230 | 21.541 | Negative |

{16}

| Drug | Operator | Sample Number | LC/MS Results (ng/mL) | Device Results |
| --- | --- | --- | --- | --- |
| TRA 100 | Operator A | SU25050130 | 98.136 | Positive |
| | Operator A | SU25050098 | 98.772 | Positive |
| | Operator A | SU25050120 | 102.471 | Negative |
| | Operator B | SU25050130 | 98.136 | Positive |
| | Operator B | SU25050144 | 108.094 | Negative |
| | Operator C | SU25050098 | 98.772 | Positive |
| | Operator C | SU25050120 | 102.471 | Negative |

# 2. Matrix Comparison:

Not applicable.

# C Clinical Studies:

# 1. Clinical Sensitivity:

Not applicable.

# 2. Clinical Specificity:

Not applicable.

# 3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):

A lay user study was performed involving a total of 140 participants from 3 sites. 76 males and 64 females tested SAFelife™ T-Cup Multi-Drug Urine Test Cup Configuration 1 (including 6-MAM10, AMP1000, BAR300, BUP10, BZO300, COC300, FTY1, MDMA500, mAMP1000, OPI2000, MTD300, NFTY5, OXY100, THC20, TRA100). Each participant was provided one package insert, one blind labeled test solution, and one test device. Test solutions were randomly assigned to participants, one for each. Following testing, users completed a study questionnaire to assess usability and user comprehension, and the results from this questionnaire were found to be acceptable. Participants aged 18 and over, with diverse educational backgrounds. Urine samples were prepared at the following concentrations: - $100\%$ , $+/-75\%$ , $+/-50\%$ , $+/-25\%$ of the cutoff by spiking drug(s) into drug free-pooled urine specimens. Results from the lay user testing are provided in the below table:

| Drug/ Cutoff | Result | Concentration | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff |
| 6-MAM10 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% |

K252550 - Page 17 of 19

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| Drug/Cutoff | Result | Concentration | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff |
| AMP1000 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| BAR300 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | Agreement (%) | 100% | 100% | 100% | 95% | 90% | 100% | 100% |
| BUP10 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| BZO300 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | Agreement (%) | 100% | 100% | 100% | 95% | 90% | 100% | 100% |
| COC300 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% |
| FTY1 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% |
| mAMP 1000 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| MDMA500 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% |
| MTD300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| NFTY5 | Negative | 20 | 20 | 20 | 18 | 2 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 2 | 18 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |

K252550 - Page 18 of 19

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| Drug/ Cutoff | Result | Concentration | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | -100% cutoff | -75% cutoff | -50% cutoff | -25% cutoff | +25% cutoff | +50% cutoff | +75% cutoff |
| | Agreement (%) | 100% | 100% | 100% | 90% | 90% | 100% | 100% |
| OPI2000 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | Agreement (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| OXY100 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% |
| THC20 | Negative | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | Agreement (%) | 100% | 100% | 100% | 95% | 90% | 100% | 100% |
| TRA100 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | Agreement (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% |

Lay users were also given surveys on the ease of understanding the package insert. All participants indicated that the device instruction is easy to understand and follow. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

D Clinical Cut-Off:

Not applicable.

E Expected Values/Reference Range:

Not applicable.

VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

K252550 - Page 19 of 19