Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx
Device Facts
| Record ID | K222667 |
|---|---|
| Device Name | Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx |
| Applicant | Vivachek Biotech (Hangzhou) Co., Ltd. |
| Product Code | NFT · Clinical Toxicology |
| Decision Date | Nov 10, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Indications for Use
Wisdiag Multi-Drug Urine 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, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: [Table of drugs and cutoffs]. Wisdiag Multi-Drug Urine Test Cup offers any combinations from 2 to 15 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 only. It is intended for OTC use. The tests may vield positive results for the prescription drugs Buprenorphine. Oxazepam, Secobarbital. Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be 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. Wisdiag Multi-Drug Urine Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of: [Table of drugs and cutoffs]. Wisdiag Multi-Drug Urine Test Cup Rx offers any combinations from 2 to 15 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 only. It is intended for prescription use. The tests may vield positive results for the prescription drugs Buprenorphine. Oxazepam, Secobarbital. Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be 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 Story
Single-use, lateral flow immunochromatographic urine test cup; detects 15 drugs of abuse. Urine sample added to cup; migrates via capillary action. Competitive binding principle: drug in sample competes with immobilized drug-conjugate for monoclonal antibody-coated particles. Absence of colored band at test line indicates positive result (drug concentration above cutoff); presence of band indicates negative result. Control line confirms proper test performance. Used in OTC and clinical settings; visually read by user or healthcare provider. Provides preliminary results; requires confirmatory testing via GC/MS or LC/MS for clinical decision-making.
Clinical Evidence
Bench testing only. Precision/reproducibility studies conducted over 25 days using 3 lots. Analytical specificity/interference studies evaluated cross-reactivity and potential interfering substances (pH 4-9, specific gravity 1.000-1.035). Method comparison study performed with 80 samples compared to LC-MS/MS. Lay user study with 280 participants confirmed usability and performance.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle; antigen-antibody reaction. Form factor: test cup. Connectivity: none. Stability: 2-30°C for 24 months. Materials: test strip, cup, desiccants.
Indications for Use
Indicated for qualitative, simultaneous detection of drugs of abuse in human urine. Intended for OTC and prescription use. Population: individuals requiring drug screening. Contraindications: not intended to distinguish between prescription use and abuse of drugs; results are preliminary and require 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)
Related Devices
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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
K222667
B Applicant
VivaChek Biotech (Hangzhou) Co., Ltd
C Proprietary and Established Names
Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NFT | Class II | 21 CFR 862.3100 - Amphetamine Test System | TX - Clinical Toxicology |
| NGL | Class II | 21 CFR 862.3650 - Opiate 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 |
| NGG | Class II | 21 CFR 862.3610 - Methamphetamine 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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| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| 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 |
| LCM | Unclassified | | |
## II Submission/Device Overview:
A Purpose for Submission:
New device
B Measurand:
Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana
C Type of Test:
Qualitative, lateral flow immunochromatographic assay
## III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) for Use:
Wisdiag Multi-Drug Urine 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, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, and Marijuana in human urine at the cutoff concentrations of:
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Drug (Identifier) - Cut-Off Level.
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) - 1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA) - 500 ng/mL
Morphine (MOP 300/OPI 2000) - 2000 ng/mL or 300 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
Marijuana (THC) - 50 ng/mL
Wisdiag Multi-Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under the same drug condition will be included per device. 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, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use of 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.
Wisdiag Multi-Drug Urine 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, Propoxyphene, Nortriptyline, and Cannabinoids in human urine at the cutoff concentrations of:
Drug (Identifier) - Cut-Off Level.
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) - 1000 ng/mL or 500 ng/mL
Methylenedioxymethamphetamine (MDMA) - 500 ng/mL
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Morphine (MOP 300/OPI 2000) - 2000 ng/mL or 300 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) - 50 ng/mL
Wisdiag Multi-Drug Urine Test Cup Rx offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under the same drug condition will be included per device. 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, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use of 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.
## C Special Conditions for Use Statement(s):
Rx and OTC
## D Special Instrument Requirements:
Not applicable; this is a visually read single use device.
## IV Device/System Characteristics:
### A Device Description:
The Wisdiag Multi-Drug Urine Test Cup and Wisdiag Multi-Drug Urine Test Cup Rx are rapid, single-use in vitro diagnostic devices. Each test kit contains; a drug test cup (inside foil pouch), user instruction sheet, an identification label and a specimen mailing box and bag.
### B Principle of Operation:
The immunochromatographic assays of Wisdiag Multi-Drug Urine Test Cup tests use a lateral flow, one step system for the qualitative detection of target analytes in human urine.
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
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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.
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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): | K222667 | K182701 |
| --- | --- | --- |
| Device Trade Name | Wisdiag Multi-Drug Urine Test Cup & Wisdiag Multi-Drug Urine Test Cup Rx | Wondfo T-Cup Multi-Drug Test Cup |
| General Device Characteristic Similarities | | |
| Intended Use | Qualitative detection of drugs of abuse in urine | same |
| Test Principle | Competitive binding, lateral flow immunochromatographic assay | same |
| Matrix | Urine | same |
| Test time | 5 minutes | same |
| Test drug cutoffs (ng/mL) | Amphetamine (AMP) – 1000 or 500 | same |
| | Buprenorphine (BUP) – 10 | |
| | Secobarbital (BAR) – 300 | |
| | Oxazepam (BZO) - 300 | |
| | Cocaine (COC) – 300 or 150 | |
| | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) - 300 | |
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| Device & Predicate Device(s): | K222667 | K182701 |
| --- | --- | --- |
| | Methamphetamine (MET) - 1000 or 500 | |
| | Methylenedioxymethamphetamine (MDMA) - 500 | |
| | Methadone (MTD) - 300 | |
| | Morphine (MOP 300/OPI 2000) -2000 or 300 | |
| | Oxycodone (OXY) - 100 | |
| | Phencyclidine (PCP) - 25 | |
| | Propoxyphene (PPX) - 300 | |
| | Nortriptyline (TCA) - 1,000 | |
| | Cannabinoids (THC) - 50 | |
| General Device Characteristic Differences | | |
| Conditions For Use | Rx & OTC versions available | OTC |
## VI Standards/Guidance Documents Referenced:
None referenced.
## VII Performance Characteristics (if/when applicable):
### A Analytical Performance:
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/MS. For each concentration, tests were conducted in singlicate in two (2) runs per day for twenty-five (25) days using three (3) lots of test cups. The results of all combined lots are summarized in the following tables:
| Drug | Result | +100% Cutoff | +75% Cutoff | +50% Cutoff | +25% Cutoff | Cutoff | -25% Cutoff | -50% Cutoff | -75% Cutoff | -100% Cutoff |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| BUP 10 | Neg | 0 | 0 | 0 | 0 | 74 | 150 | 150 | 150 | 150 |
| | Pos | 150 | 150 | 150 | 150 | 76 | 0 | 0 | 0 | 0 |
| | Total | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 |
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| Drug | Result | +100% Cutoff | +75% Cutoff | +50% Cutoff | +25% Cutoff | Cutoff | -25% Cutoff | -50% Cutoff | -75% Cutoff | -100% Cutoff |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| PCP 25 | Neg | 0 | 0 | 0 | 0 | 72 | 150 | 150 | 150 | 150 |
| | Pos | 150 | 150 | 150 | 150 | 78 | 0 | 0 | 0 | 0 |
| | Total | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 |
| THC 50 | Neg | 0 | 0 | 0 | 0 | 76 | 150 | 150 | 150 | 150 |
| | Pos | 150 | 150 | 150 | 150 | 74 | 0 | 0 | 0 | 0 |
| | Total | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 |
| OXY 100 | Neg | 0 | 0 | 0 | 0 | 76 | 150 | 150 | 150 | 150 |
| | Pos | 150 | 150 | 150 | 150 | 74 | 0 | 0 | 0 | 0 |
| | Total | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 |
| BAR 300 | Neg | 0 | 0 | 0 | 0 | 71 | 150 | 150 | 150 | 150 |
| | Pos | 150 | 150 | 150 | 150 | 79 | 0 | 0 | 0 | 0 |
| | Total | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 |
| BZO 300 | Neg | 0 | 0 | 0 | 0 | 76 | 150 | 150 | 150 | 150 |
| | Pos | 150 | 150 | 150 | 150 | 74 | 0 | 0 | 0 | 0 |
| | Total | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 |
| EDDP 300 | Neg | 0 | 0 | 0 | 0 | 74 | 150 | 150 | 150 | 150 |
| | Pos | 150 | 150 | 150 | 150 | 76 | 0 | 0 | 0 | 0 |
| | Total | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 |
| MTD 300 | Neg | 0 | 0 | 0 | 0 | 73 | 150 | 150 | 150 | 150 |
| | Pos | 150 | 150 | 150 | 150 | 77 | 0 | 0 | 0 | 0 |
| | Total | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 |
| MOP 300 | Neg | 0 | 0 | 0 | 0 | 73 | 150 | 150 | 150 | 150 |
| | Pos | 150 | 150 | 150 | 150 | 77 | 0 | 0 | 0 | 0 |
| | Total | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 |
| PPX 300 | Neg | 0 | 0 | 0 | 0 | 74 | 150 | 150 | 150 | 150 |
| | Pos | 150 | 150 | 150 | 150 | 76 | 0 | 0 | 0 | 0 |
| | Total | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 |
| COC 150 | Neg | 0 | 0 | 0 | 0 | 77 | 150 | 150 | 150 | 150 |
| | Pos | 150 | 150 | 150 | 150 | 73 | 0 | 0 | 0 | 0 |
| | Total | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 |
| MDMA 500 | Neg | 0 | 0 | 0 | 0 | 71 | 150 | 150 | 150 | 150 |
| | Pos | 150 | 150 | 150 | 150 | 79 | 0 | 0 | 0 | 0 |
| | Total | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 |
| TCA 1000 | Neg | 0 | 0 | 0 | 0 | 73 | 150 | 150 | 150 | 150 |
| | Pos | 150 | 150 | 150 | 150 | 77 | 0 | 0 | 0 | 0 |
| | Total | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 |
| AMP 500 | Neg | 0 | 0 | 0 | 0 | 74 | 150 | 150 | 150 | 150 |
| | Pos | 150 | 150 | 150 | 150 | 76 | 0 | 0 | 0 | 0 |
| | Total | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 |
| MET 500 | Neg | 0 | 0 | 0 | 0 | 74 | 150 | 150 | 150 | 150 |
| | Pos | 150 | 150 | 150 | 150 | 76 | 0 | 0 | 0 | 0 |
| | Total | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 |
| OPI 2000 | Neg | 0 | 0 | 0 | 0 | 74 | 150 | 150 | 150 | 150 |
| | Pos | 150 | 150 | 150 | 150 | 76 | 0 | 0 | 0 | 0 |
| | Total | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 |
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| Drug | Result | +100% Cutoff | +75% Cutoff | +50% Cutoff | +25% Cutoff | Cutoff | -25% Cutoff | -50% Cutoff | -75% Cutoff | -100% Cutoff |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| COC 300 | Neg | 0 | 0 | 0 | 0 | 77 | 150 | 150 | 150 | 150 |
| | Pos | 150 | 150 | 150 | 150 | 73 | 0 | 0 | 0 | 0 |
| | Total | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 |
| AMP 1000 | Neg | 0 | 0 | 0 | 0 | 76 | 150 | 150 | 150 | 150 |
| | Pos | 150 | 150 | 150 | 150 | 74 | 0 | 0 | 0 | 0 |
| | Total | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 |
| MET 1000 | Neg | 0 | 0 | 0 | 0 | 73 | 150 | 150 | 150 | 150 |
| | Pos | 150 | 150 | 150 | 150 | 77 | 0 | 0 | 0 | 0 |
| | Total | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 | 150 |
2. Linearity:
Not applicable.
3. Analytical Specificity/Interference:
Cross-Reactivity:
Percent cross-reactivity, provided in the below table, was calculated as the minimum concentration of analyte tested that yielded a Percent cross-reactivity that was calculated as (cut-off concentration / lowest concentration of cross reactant that gives a positive result) x 100. Compounds that did not yield a positive result at the highest concentration tested have relative cross reactivity results represented by a dash in the table below. Cross-reactivity for this device was determined through adding the potential interfering substances to drug-free urine samples.
| Drug/Cutoff ng/mL | Compound | Minimum Concentration obtaining positive result (ng/mL) | Relative Cross-reactivity (%) |
| --- | --- | --- | --- |
| BUP 10 | Buprenorphine | 10 | 100% |
| | Burprenorphine-3-D-Glucuronide | 15 | 66.7 |
| | Norbuprenorphine | 20 | 50 |
| | Norbuprenorphine-3-D-Glucuronide | 200 | 5 |
| | Morphine | 100,000 | -- |
| | Oxymorphone | 100,000 | -- |
| | Hydromorphone | 100,000 | -- |
| PCP 25 | Phencyclidine | 25 | 100% |
| | 4-Hydroxyphencyclidine | 12,500 | 0.2 |
| THC 50 | 11-nor-Δ⁹-THC-9-COOH | 50 | 100% |
| | (-)- 11-nor-9-carboxy-Δ⁹-THC | 50 | 100% |
| | 11-nor-Δ⁸-THC-9-COOH | 50 | 100% |
| | 11-nor-Δ⁹ -THC-carboxy glucuronide | 100 | 50% |
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K222667 - Page 9 of 22
| Drug/Cutoff ng/mL | Compound | Minimum Concentration obtaining positive result (ng/mL) | Relative Cross-reactivity (%) |
| --- | --- | --- | --- |
| | Cannabidiol | 100,000 | -- |
| | Cannabinol | 100,000 | -- |
| | Δ⁸-Tetrahydrocannabinol | 15,000 | 0.5% |
| | Δ⁹-Tetrahydrocannabinol | 15,000 | 0.5% |
| | 11-hydroxy-Δ⁹-Tetrahydrocannabinol | 5,000 | 1% |
| OXY 100 | Oxycodone | 100 | 100% |
| | Dihydrocodeine | 20,000 | 0.5% |
| | Hydrocodone | 80 | 125% |
| | Oxymorphone | 1,000 | 10% |
| | Codeine | 100,000 | -- |
| | Hydromorphone | 36,000 | 0.278% |
| | Morphine | 100,000 | -- |
| | Acetylmorphine | 100,000 | -- |
| | Buprenorphine | 100,000 | -- |
| | Ethylmorphine | 100,000 | -- |
| | Thebaine | 100,000 | -- |
| COC 150 | Cocaine | 375 | 40% |
| | Cocaethylene | 6,250 | 2.4% |
| | Ecgonine | 16,000 | <1% |
| | Ecgonine methyl ester | 100,000 | -- |
| | Norcocaine | 100,000 | -- |
| BAR 300 | Secobarbital | 300 | 100% |
| | Amobarbital | 300 | 100% |
| | Alphenol | 600 | 50% |
| | Aprobarbital | 200 | 150% |
| | Butabarbital | 100 | 300% |
| | Butethal | 200 | 150% |
| | Butalbital | 2,000 | 15% |
| | Cyclopentobarbital | 400 | 75% |
| | Pentobarbital | 200 | 150% |
| | Phenobarbital | 200 | 150% |
| BZO 300 | Oxazepam | 300 | 100% |
| | Alprazolam | 190 | 157.9% |
| | a-Hydroxyalprazolam | 300 | 100% |
| | Bromazepam | 500 | 60% |
| | Chlordiazepoxide | 1,500 | 20% |
| | Clobazam | 110 | 272.7% |
| | Clonazepam | 100,000 | -- |
| | Clorazepate dipotassium | 300 | 100% |
| | Delorazepam | 100,000 | -- |
| | Desalkylflurazepam | 200 | 150% |
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| Drug/Cutoff ng/mL | Compound | Minimum Concentration obtaining positive result (ng/mL) | Relative Cross-reactivity (%) |
| --- | --- | --- | --- |
| | Diazepam | 190 | 157.9% |
| | Estazolam | 5,000 | 6% |
| | Flunitrazepam | 400 | 75% |
| | Midazolam | 2,200 | 13.6% |
| | Nitrazepam | 200 | 150% |
| | Norchlordiazepoxide | 800 | 37.5% |
| | Nordiazepam | 150 | 200% |
| | Temazepam | 100 | 300% |
| | Triazolam | 6,000 | 5% |
| | Demoxepam | 2,000 | 15% |
| | Flurazepam | 100,000 | -- |
| | D,L-Lorazepam | 75,000 | 4% |
| EDDP 300 | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 | 100% |
| | Methadone | 100,000 | -- |
| | EMDP | 100,000 | -- |
| | Doxylamine | 100,000 | -- |
| | Disopyramide | 100,000 | -- |
| | LAAM (Levoo-alpha-acetylmethadol) HCl | 100,000 | -- |
| | Alpha Methadol | 100,000 | -- |
| MTD 300 | Methadone | 300 | 100% |
| | Doxylamine | 100,000 | -- |
| | EDDP | 100,000 | -- |
| | EMDP | 100,000 | -- |
| | LAAM | 100,000 | -- |
| | Alpha Methadol | 100,000 | -- |
| MOP 300 | Morphine | 300 | 100% |
| | Normorphine | 300 | 100% |
| | Codeine | 300 | 100% |
| | s-Monoacetylmorphine | 300 | 100% |
| | Ethyl morphine | 200 | 150% |
| | Heroin | 300 | 100% |
| | Hydrocodone | 700 | 42.8% |
| | Hydromorphone | 200 | 150% |
| | Morphine-3-β-d-glucuronide | 1,000 | 30% |
| | Oxycodone | 100,000 | -- |
| | Oxymorphone | 100,000 | -- |
| | Thebaine | 20,000 | 1.5% |
| | Levorphanol | 10,000 | 3% |
| | 6-Monoacetylmorphine (6-MAM) | 300 | 100% |
| | Norcodeine | 6,250 | 4.8% |
{10}
K222667 - Page 11 of 22
| Drug/Cutoff ng/mL | Compound | Minimum Concentration obtaining positive result (ng/mL) | Relative Cross-reactivity (%) |
| --- | --- | --- | --- |
| | Procaine | 100,000 | -- |
| PPX 300 | d-Propoxyphene | 300 | 100% |
| | d-Norpropoxyphene | 300 | 100% |
| MDMA 500 | 3,4-Methylenedioxymethamphetamine (MDMA) | 500 | 100% |
| | 3,4-Methylenedioxyamphetamine (MDA) | 4,000 | 12.5% |
| | 3,4-Methylenedioxyethylamphetamine (MDE) | 400 | 125% |
| | d-methamphetamine | 100,000 | -- |
| | d-amphetamine | 100,000 | -- |
| | l-methamphetamine | 100,000 | -- |
| | l-amphetamine | 100,000 | -- |
| AMP 500 | d-Amphetamine | 500 | 100% |
| | l-Amphetamine | 100,000 | -- |
| | dl-Amphetamine | 1,500 | 33.3% |
| | (+/-) 3,4-Methylenedioxyamphetamine (MDA) | 500 | 100% |
| | Phentermine | 6,000 | 8.3% |
| | Hydroxyamphetamine | 100,000 | -- |
| | d-Methamphetamine | 100,000 | -- |
| | l-Methamphetamine | 100,000 | -- |
| | (+/-) 3,4-Methylenedioxyethylamphetamine (MDE) | 100,000 | -- |
| | (+/-)3,4-Methylenedioxymethamphetamine (MDMA) | 100,000 | -- |
| | β-Phenylethylamine | 100,000 | -- |
| | Tyramine | 100,000 | -- |
| | p-Hydroxynorephedrine | 100,000 | -- |
| | Phenylpropanolamine | 100,000 | -- |
| | (+)Phenylpropanolamine | 100,000 | -- |
| | p-Hydroxyamphetamine | 100,000 | -- |
| | d/1-Norephedrine | 100,000 | -- |
| | Benzphetamine | 100,000 | -- |
| | 1-Ephedrine | 100,000 | -- |
| | 1-Epinephrine | 100,000 | -- |
| | d/1-Epinephrine | 100,000 | -- |
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K222667 - Page 12 of 22
| Drug/Cutoff ng/mL | Compound | Minimum Concentration obtaining positive result (ng/mL) | Relative Cross-reactivity (%) |
| --- | --- | --- | --- |
| | Ephedrine | 100,000 | -- |
| MET 500 | D(+)-Methamphetamine | 500 | 100% |
| | (+/-) 3,4-Methylenedioxyethylamphetamine (MDE) | 12,500 | 4% |
| | D/L-Methamphetamine | 500 | 100% |
| | p-Hydroxymethamphetamine | 15,000 | 3.3% |
| | D-Amphetamine | 100,000 | -- |
| | L-Amphetamine | 100,000 | -- |
| | Chloroquine | 50,000 | 1% |
| | (+/-)-Ephedrine | 100,000 | -- |
| | (-)-Methamphetamine | 65,000 | 0.8% |
| | (+/-) 3,4-Methylenedioxyamphetamine (MDA) | 100,000 | -- |
| | (+/-) 3,4-Methylenedioxymethamphetamine | 4,000 | 12.5% |
| | β-Phenylethylamine | 25,000 | 2% |
| | Trimethobenzamide | 10,000 | 5% |
| | D,l-Amphetamine | 100,000 | -- |
| | Mephetamine | 25,000 | 2% |
| | (1R,2S)-(-)-Ephedrine | 100,000 | -- |
| | 1-phenylephrine | 100,000 | -- |
| | L-Methamphetamine | 65,000 | 0.8% |
| TCA 1000 | Nortriptyline | 1,000 | 100% |
| | Nordoxepine | 1,000 | 100% |
| | Trimpramine | 3,000 | 33.3% |
| | Amitriptyline | 450 | 222.2% |
| | Promazine | 1,500 | 66.7% |
| | Desipramine | 200 | 500% |
| | Imipramine | 80 | 1250% |
| | Clomipramine | 1,200 | 83.3% |
| | Doxepin | 2,000 | 50% |
| | Maprotiline | 2,000 | 50% |
| | Promethazine | 100,000 | -- |
| | Cyclobenzaprine | 800 | 125% |
| | Norclomipramine | 12,500 | 8% |
| COC 300 | Benzoylecgonine | 300 | 100% |
| | Cocaine | 780 | 38.5% |
| | Cocathylene | 12,500 | 2.4% |
| | Ecgonine | 32,000 | 0.9% |
| | Ecgonine methyl ester | 100,000 | 0.3% |
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K222667 - Page 13 of 22
| Drug/Cutoff ng/mL | Compound | Minimum Concentration obtaining positive result (ng/mL) | Relative Cross-reactivity (%) |
| --- | --- | --- | --- |
| | Norcocaine | 100,000 | 0.3% |
| AMP 1000 | d-Amphetamine | 1,000 | 100% |
| | l-Amphetamine | 100,000 | -- |
| | dl-Amphetamine | 3,000 | 33.3% |
| | (+/-) 3,4-Methylenedioxyamphetamine (MDA) | 1,000 | 100% |
| | Phentermine | 6,000 | 16.7% |
| | Hydroxyamphetamine | 100,000 | -- |
| | d-Methamphetamine | 100,000 | -- |
| | l-Methamphetamine | 100,000 | -- |
| | (+/-) 3,4-Methylenedioxyethylamphetamine (MDE) | 100,000 | -- |
| | (+/-)3,4-Methylenedioxymethamphetamine (MDMA) | 100,000 | -- |
| | β-Phenylethylamine | 100,000 | -- |
| | Tyramine | 100,000 | -- |
| | p-Hydroxynorephedrine | 100,000 | -- |
| | Phenylpropanolamine | 100,000 | -- |
| | (+)Phenylpropanolamine | 100,000 | -- |
| | p-Hydroxyamphetamine | 100,000 | -- |
| | d/1-Norephedrine | 100,000 | -- |
| | Benzphetamine | 100,000 | -- |
| | 1-Ephedrine | 100,000 | -- |
| | 1-Epinephrine | 100,000 | -- |
| | d/1-Epinephrine | 100,000 | -- |
| | Ephedrine | 100,000 | -- |
| MET 1000 | D(+)-Methamphetamine | 1,000 | 100% |
| | (+/-) 3,4-Methylenedioxyethylamphetamine (MDE) | 25,000 | 4% |
| | D/L-Methamphetamine | 1,000 | 100% |
| | p-Hydroxymethamphetamine | 30,000 | 0.3% |
| | D-Amphetamine | 100,000 | -- |
| | L-Amphetamine | 100,000 | -- |
| | Chloroquine | 50,000 | 2% |
| | (+/-)-Ephedrine | 100,000 | -- |
| | (-)-Methamphetamine | 100,000 | -- |
| | (+/-) 3,4-Methylenedioxyamphetamine | 100,000 | -- |
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K222667 - Page 14 of 22
| Drug/Cutoff ng/mL | Compound | Minimum Concentration obtaining positive result (ng/mL) | Relative Cross-reactivity (%) |
| --- | --- | --- | --- |
| | (MDA) | | |
| | (+/-) 3,4-Methylenedioxymethamphetamine | 8,000 | 12.5% |
| | β-Phenylethylamine | 50,000 | 2% |
| | Trimethobenzamide | 20,000 | 5% |
| | D,l-Amphetamine | 100,000 | -- |
| | Mephetamine | 50,000 | 2% |
| | (1R,2S)-(-)-Ephedrine | 100,000 | -- |
| | 1-phenylephrine | 100,000 | -- |
| | L-Methamphetamine | 100,000 | --- |
| OPI 2000 | Morphine | 2,000 | 100% |
| | Normorphine | 50,000 | 4% |
| | Codeine | 2,000 | 100% |
| | s-Monoacetylmorphine | 2,000 | 100% |
| | Ethyl morphine | 1,500 | 133.3% |
| | Heroin | 2,000 | 100% |
| | Hydrocodone | 12,500 | 16% |
| | Hydromorphone | 3,500 | 57.1% |
| | Morphine-3-β-d-glucuronide | 2,000 | 100% |
| | Oxycodone | 25,000 | 8% |
| | Oxymorphone | 25,000 | 8% |
| | Thebaine | 50,000 | 4% |
| | Levorphanol | 75,000 | 2.7% |
| | 6-Monoacetylmorphine (6-MAM) | 2,000 | 100% |
| | Norcodeine | 12,500 | 16% |
| | Procaine | 100,000 | -- |
## Interference Study:
Potential interference from compounds chemically dissimilar to the target drugs and from endogenous agents was performed by spiking the substances into pooled urine containing target drugs at near-cutoff concentrations (at +25% and -25% of cutoff). Substances were tested for potential interference at concentrations of 100 µg/mL with the exception of albumin that was tested at 100 mg/dL, and ethanol that was tested at 1%. The following substances demonstrated no positive or negative interference on the assays encompassed in this submission.
| Acetaminophen | Acetophenetidin | Acetylsalicylic Acid |
| --- | --- | --- |
| Acyclovir | Amiodarone Hydrochloride | Apomorphine |
| Afrin | Albumin | Amlodipine Mesylate |
| Aminophylline | Amoxicillin | Aripiprazole |
| Aminopyrine | Ampicillin | Aspartame |
| Benzilic Acid | Atropine | Atomoxetine |
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K222667 - Page 15 of 22
| Benzoic Acid | Carbamazepine | Atorvastatin Calcium |
| --- | --- | --- |
| Bilirubin | Cefradine | Chloramphenicol |
| Bupropion | Cephalexin | Chlorothiazide |
| Captopril | Chloral Hydrate | Chloroquine |
| Ciprofloxacin Hydrochloride | Clonidine | Cholesterol |
| Citalopram | Clopidogrel Hydrogen Sulphate | (-) Cotinine |
| Clarithromycin | Clozapine | Chlorpheniramine |
| Deoxy- corticosterone | D,L-Tyrosine | D,L-Octopamine |
| Dextromethorphan | Digoxin | D,L-Propranolol |
| Diclofenac | Diphenhydramine | D-Norpropoxy-phene |
| Diflunisal | Dirithromycin | Domperidone |
| D-Pseudo- ephedrine | Ecgonine Methyl Ester | Doxylamine |
| Duloxetine | Effexor | Epinephrine Hydrochloride |
| Dicyclomine | Enalapril Maleate | Erythromycin |
| β-Estradiol | Fentanyl Citrate | Esomeprazole Magnesium |
| Ethanol | Fluoxetine Hydrochloride | Furosemide |
| Fenofibrate | Fluvoxamine | Gabapentin |
| Fenoprofen | Glucose | Gentisic Acid |
| Glibenclamide | Haloperidol | 3-Hydroxy-tyramine |
| Gliclazide | Hemoglobin | Isosorbide Dinitrate |
| Glipizide | Ketamine | Isoxsuprine |
| Ibuprofen | Kratom powder | Lamotrigine |
| Ketoconazole | Labetalol | Levofloxacin Hydrochloride |
| Ketoprofen | Liverite | Levonorgestrel |
| Lidocaine Hydrochloride | Loperamide | Levothyroxine Sodium |
| Lisinopril | Loratadine | Minocycline |
| Lithium Carbonate | Naproxen | Nalidixic Acid |
| Metoprolol Tartrate | Mifepristone | Niacinamide |
| Magnesium | Mirtazapine | Nifedipine |
| Meperidine | Montelukast Sodium | Nikethamide |
| Meprobamate | Phenelzine | Sulfamethazine |
| Mosapride Citrate | Pioglitazone Hydrochloride | Sulindac |
| Maprotiline | Piracetam | Tetrahydrocortisone 3 - acetate |
| Nimodipine | Pravastatin Sodium | Tetrahydrocortisone 3- (β-D-glucuronide) |
| Norethindrone | Prednisone | Tetrahydrozoline |
| N-Acetylprocain-amide | Propylthiouracil | Tetracycline |
| O-Hydroxyhippu-ric Acid | Promethazine | Thiamine |
| Olanzapine | Quetiapine Fumarate | Thioridazine |
| Omeprazole | Quinine | Topiramate |
| Oxalic Acid | Ranitidine | Tramadol Hydrochloride |
| Oxolinic Acid | Rifampicin | Trazodone Hydrochloride |
| Oxymetazoline | Risperidone | Triamterene |
| Ondansetran | Salicylic Acid | Trifluoperazine |
| Paliperidone | Serotonin | Trimethoprim |
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K222667 - Page 16 of 22
| Pantoprazole | Sertraline Hydrochloride | Uric Acid |
| --- | --- | --- |
| Papaverine | Sildenafil Citrate | Valproate |
| Paroxetine Hydrochloride | Simvastatin | Verapamil |
| Penfluridol | Sodium Valproate | Vitamin B2 |
| PenicillinV Potassium | Spironolactone | Vitamin C |
| Penicillin-G | | |
pH and Specific Gravity:
Interference by pH and specific gravity were also evaluated using pooled urine specimens containing target drugs at near-cutoff concentrations (at +25% and -25% 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:
For characterization of how the device performs analytically around the claimed cutoff concentration, please refer to section VII.A.1 (Precision study), above.
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
The device is traceable to commercially available reference materials.
6. Detection Limit:
Not applicable.
7. Assay Cut-Off:
Not applicable.
B Comparison Studies:
1. Method Comparison with Predicate Device:
The method comparison study of the Wisdiag Multi-Drug Urine Test Cup Rx was performed by three (3) operators with eighty (80) unaltered urine samples (40 negative and 40 positive). Each sample was tested in a blinded fashion by each operator and compared to LC-MS/MS results. The results are shown in the table below.
| Drug | Result | Low Neg by LC/MS, between 0 and 50% of the cutoff | Near Cutoff Neg by LC/MS, between -50% and cutoff | Near Cutoff Pos by LC/MS, between cutoff and +50% | High Pos by LC/MS, greater than +50% |
| --- | --- | --- | --- | --- | --- |
| AMP 500 | Positive | 0 | 2 | 60 | 60 |
| | Negative | 66 | 51 | 0 | 0 |
{16}
| Drug | Result | Low Neg by LC/MS, between 0 and 50% of the cutoff | Near Cutoff Neg by LC/MS, between -50% and cutoff | Near Cutoff Pos by LC/MS, between cutoff and +50% | High Pos by LC/MS, greater than +50% |
| --- | --- | --- | --- | --- | --- |
| BUP 10 | Positive | 0 | 3 | 56 | 60 |
| | Negative | 75 | 42 | 4 | 0 |
| BAR 300 | Positive | 0 | 0 | 54 | 60 |
| | Negative | 78 | 42 | 6 | 0 |
| BZO 300 | Positive | 0 | 0 | 48 | 69 |
| | Negative | 75 | 45 | 3 | 0 |
| COC 150 | Positive | 0 | 2 | 53 | 66 |
| | Negative | 75 | 40 | 1 | 0 |
| EDDP 300 | Positive | 0 | 2 | 55 | 63 |
| | Negative | 75 | 43 | 2 | 0 |
| MET 500 | Positive | 0 | 0 | 57 | 60 |
| | Negative | 75 | 45 | 3 | 0 |
| MDMA 500 | Positive | 0 | 3 | 60 | 60 |
| | Negative | 81 | 36 | 0 | 0 |
| MOP 300 | Positive | 0 | 2 | 54 | 66 |
| | Negative | 72 | 46 | 0 | 0 |
| MTD 300 | Positive | 0 | 3 | 58 | 60 |
| | Negative | 78 | 39 | 2 | 0 |
| OXY 100 | Positive | 0 | 2 | 54 | 63 |
| | Negative | 72 | 46 | 3 | 0 |
| PCP 25 | Positive | 0 | 3 | 64 | 54 |
| | Negative | 84 | 33 | 2 | 0 |
| PPX 300 | Positive | 0 | 3 | 53 | 63 |
| | Negative | 78 | 39 | 4 | 0 |
| TCA 1000 | Positive | 0 | 3 | 52 | 66 |
| | Negative | 75 | 42 | 2 | 0 |
| THC 50 | Positive | 0 | 2 | 48 | 66 |
| | Negative | 78 | 40 | 6 | 0 |
| AMP 1000 | Positive | 0 | 1 | 54 | 63 |
| | Negative | 75 | 44 | 3 | 0 |
| COC 300 | Positive | 0 | 3 | 49 | 69 |
| | Negative | 72 | 45 | 2 | 0 |
| MET 1000 | Positive | 0 | 0 | 60 | 57 |
| | Negative | 69 | 51 | 3 | 0 |
| OPI 2000 | Positive | 0 | 1 | 52 | 66 |
| | Negative | 78 | 41 | 2 | 0 |
K222667 - Page 17 of 22
{17}
Summary of Discordant Results:
| Drug Test | Sample ID | Analyte detected | LC-MS/MS Result | Device Result |
| --- | --- | --- | --- | --- |
| AMP 500 | AMP028 | Amphetamine | 477.4 | Positive |
| | AMP136* | Amphetamine | 499.0 | Positive |
| BUP 10 | BUP058* | Buprenorphine | 9.8 | Positive |
| | BUP070 | Buprenorphine | 9.9 | Positive |
| | BUP029* | Buprenorphine | 10.2 | Negative |
| | BUP055* | Buprenorphine | 10.8 | Negative |
| BAR 300 | BAR011** | Barbiturates | 303.8 | Negative |
| | BAR017* | Barbiturates | 300.9 | Negative |
| | BAR033 | Barbiturates | 312.2 | Negative |
| BZO 300 | BZO018* | Benzodiazepines | 303.6 | Negative |
| | BZO058 | Benzodiazepines | 307.2 | Negative |
| COC 150 | COC046 | Cocaine | 144.8 | Positive |
| | COC146 | Cocaine | 148.9 | Positive |
| | COC128 | Cocaine | 162.8 | Negative |
| EDDP | EDDP075* | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 290.6 | Positive |
| | EDDP010 | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 318.6 | Negative |
| | EDDP061 | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 318.5 | Negative |
| MET 500 | MET062 | Methamphetamine | 519.5 | Negative |
| | MET102* | Methamphetamine | 521.1 | Negative |
| MDMA 500 | MDMA026* | Methylenedioxymethamphetamine | 488.3 | Positive |
| | MDMA060 | Methylenedioxymethamphetamine | 492.0 | Positive |
| MOP 300 | MOP057 | Morphine | 293.2 | Positive |
| | MOP150 | Morphine | 282.8 | Positive |
| MTD 300 | MTD022 | Methadone | 298.2 | Positive |
| | MTD049* | Methadone | 289.2 | Positive |
| | MTD003 | Methadone | 309.1 | Negative |
| | MTD045 | Methadone | 301.7 | Negative |
| OXY 100 | OXY012 | Oxycodone | 96.3 | Positive |
| | OXY071 | Oxycodone | 95.2 | Positive |
| | OXY002* | Oxycodone | 101.4 | Negative |
| | OXY006 | Oxycodone | 111.0 | Negative |
| PCP 25 | PCP003 | Phencyclidine | 22.4 | Positive |
| | PCP060* | Phencyclidine | 22.7 | Positive |
| | PCP023* | Phencyclidine | 25.5 | Negative |
| PPX 300 | PPX024* | Propoxyphene | 292.5 | Positive |
| | PPX029 | Propoxyphene | 291.4 | Positive |
| | PPX043* | Propoxyphene | 300.7 | Negative |
| | PPX053 | Propoxyphene | 300.8 | Negative |
| | PPX073 | Propoxyphene | 303.4 | Negative |
K222667 - Page 18 of 22
{18}
| Drug Test | Sample ID | Analyte detected | LC-MS/MS Result | Device Result |
| --- | --- | --- | --- | --- |
| TCA 1000 | TCA005* | Nortriptyline | 991.3 | Positive |
| | TCA043 | Nortriptyline | 969.0 | Positive |
| | TCA010 | Nortriptyline | 1015.1 | Negative |
| | TCA052 | Nortriptyline | 1015.9 | Negative |
| THC 50 | THC014 | Cannabinoids | 47.8 | Positive |
| | THC054 | Cannabinoids | 46.8 | Positive |
| | THC036 | Cannabinoids | 50.5 | Negative |
| | THC062* | Cannabinoids | 50.9 | Negative |
| | THC069* | Cannabinoids | 53.5 | Negative |
| | THC076 | Cannabinoids | 53.9 | Negative |
| AMP 1000 | AMP116 | Amphetamine | 998.8 | Positive |
| | AMP095 | Amphetamine | 1035.1 | Negative |
| | AMP102* | Amphetamine | 1048.4 | Negative |
| COC 300 | COC028 | Cocaine | 296.4 | Positive |
| | COC143* | Cocaine | 283.8 | Positive |
| | COC033 | Cocaine | 317.7 | Negative |
| | COC138 | Cocaine | 318.7 | Negative |
| MET 1000 | MET123 | Methamphetamine | 1049.5 | Negative |
| | MET138* | Methamphetamine | 1068.2 | Negative |
| OPI 2000 | MOP076 | Morphine | 1943.3 | Positive |
| | MOP089 | Morphine | 2070.0 | Negative |
| | MOP139 | Morphine | 2105.7 | Negative |
*Represents samples which resulted in discordant results with two (2) different operators.
**Represents samples which resulted in discordant results with three (3) different operators.
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 280 participants from 3 sites. 66 males and 74 females used the Wisdiag Multi-Drug Urine Test Cup Configuration 1 (including AMP 500, MET 500, MOP 300, COC 150); 72 males and 68 females used the Wisdiag Multi-Drug Urine Test Cup Configuration 2 (Group 2, including AMP 1000, MET 1000,
K222667 - Page 19 of 22
{19}
MOP 2000 (OPI), COC 300). Each participant was provided one package insert, one test solution, and one test device. Test solutions were randomly assigned to participants, one solution per participant and were tested in a blinded fashion. 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 20 and over, with diverse educational backgrounds, were recruited. Results from the lay user testing are provided in the below table:
| | | Drug Concentration by LC-MS/MS | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Drug | Results | -100% Cutoff | -75% Cutoff | -50% Cutoff | -25% Cutoff | +25% Cutoff | +50% Cutoff | +75 Cutoff |
| AMP 500 | Neg | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| BUP 10 | Neg | 20 | 20 | 20 | 19 | 2 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 1 | 18 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| BAR 300 | Neg | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| BZO 300 | Neg | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| COC 150 | Neg | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| EDDP 300 | Neg | 20 | 20 | 20 | 20 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| MDMA 500 | Neg | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| MET 500 | Neg | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| MOP 300 | Neg | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| MTD 300 | Neg | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| OXY 100 | Neg | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| PCP 25 | Neg | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
K222667 - Page 20 of 22
{20}
| | | Drug Concentration by LC-MS/MS | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Drug | Results | -100% Cutoff | -75% Cutoff | -50% Cutoff | -25% Cutoff | +25% Cutoff | +50% Cutoff | +75 Cutoff |
| PPX 300 | Neg | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| TCA 1000 | Neg | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| THC 50 | Neg | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Group #2 Results | | | | | | | | |
| AMP 1000 | Neg | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| BUP 10 | Neg | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| BAR 300 | Neg | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| BZO 300 | Neg | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| COC 300 | Neg | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| EDDP 300 | Neg | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| MDMA 500 | Neg | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| MET 1000 | Neg | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| MTD 300 | Neg | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| OPI 2000 | Neg | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| OXY 100 | Neg | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
K222667 - Page 21 of 22
{21}
| | | Drug Concentration by LC-MS/MS | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Drug | Results | -100% Cutoff | -75% Cutoff | -50% Cutoff | -25% Cutoff | +25% Cutoff | +50% Cutoff | +75 Cutoff |
| PCP 25 | Neg | 20 | 20 | 20 | 20 | 1 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | Toal | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| PPX 300 | Neg | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| TCA 1000 | Neg | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| THC 50 | Neg | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
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.
K222667 - Page 22 of 22
