WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST
Device Facts
| Record ID | K121557 |
|---|---|
| Device Name | WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST |
| Applicant | Guangzhou Wondfo Biotech Co., Ltd. |
| Product Code | LDJ · Clinical Toxicology |
| Decision Date | Jul 25, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3870 |
| Device Class | Class 2 |
Indications for Use
Wondfo Cannabinoids Urine Test is an immunochromatographic assay for the qualitative determination of 11-nor-Δ9-THC-9-COOH (major metabolite of Cannabinoids) in human urine at a cutoff concentration of 50 ng/mL. The test is available in a dip card format and a cup format. It is intended for prescription use and over the counter use. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. Wondfo Propoxyphene Urine Test is an immunochromatographic assay for the qualitative determination of d-Propoxyphene in human urine at a cutoff concentration of 300 ng/mL. The test is available in a dip card format and a cup format. It is intended for prescription use. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Device Story
Wondfo Cannabinoids and Propoxyphene Urine Tests are single-use, lateral flow immunochromatographic assays; detect drug metabolites in human urine. Input: urine sample; mechanism: competitive binding using mouse monoclonal antibody-dye conjugate with gold chloride and fixed drug-protein conjugate on membrane. Output: visual colored line indicating presence or absence of drug. Used in clinical or home settings; operated by healthcare professionals or lay users (Cannabinoids). Results are preliminary; require confirmation via GC/MS. Provides rapid screening to assist clinical decision-making regarding drug use.
Clinical Evidence
No clinical data provided. Bench testing only.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Components: mouse monoclonal antibody-dye conjugate, gold chloride, fixed drug-protein conjugate, anti-mouse IgG polyclonal antibody. Formats: dip card and cup. Visual read; no instrumentation required. Storage: 4-30°C; 18-month shelf life.
Indications for Use
Indicated for qualitative detection of 11-nor-Δ9-THC-9-COOH (Cannabinoids) at 50 ng/mL or d-propoxyphene at 300 ng/mL in human urine. Intended for prescription use (both) and OTC use (Cannabinoids only). Provides preliminary results; requires confirmatory testing (e.g., GC/MS).
Regulatory Classification
Identification
A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.
Special Controls
*Classification.* Class II (special controls). A cannabinoid 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
- ACON One Step Drug Screen Test (k020771)
- ACON One Step Propoxyphene Test Strip and Device (k040445)
Related Devices
- K233019 — AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx · Hangzhou AllTest Biotech Co., Ltd. · Dec 13, 2023
- K210327 — First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup · W.H.P.M., Inc. · Aug 12, 2021
- K190412 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup · Hangzhou Clongene Biotech Co., Ltd. · Mar 21, 2019
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k121557
B. Purpose for Submission:
New device
C. Measurand:
Cannabinoids and Propoxyphene
D. Type of Test:
Qualitative immunochromatographic assay
E. Applicant:
Guangzhou Wondfo Biotech Co., Ltd.
F. Proprietary and Established Names:
Wondfo Cannabinoids Urine Test
Wondfo Propoxyphene Urine Test
G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| LDJ | II | 862.3870 Cannabinoids test system | 91, Toxicology |
| LFG | II | 862.3700 Propoxyphene test system | 91, Toxicology |
H. Intended Use:
1. Intended use(s):
See indication for use below
2. Indication(s) for use:
Wondfo Cannabinoids Urine Test
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Wondfo Cannabinoids Urine Test is an immunochromatographic assay for the qualitative determination of 11-nor-Δ9-THC-9-COOH (major metabolite of Cannabinoids) in human urine at a cutoff concentration of 50 ng/mL. The test is available in a dip card format and a cup format. It is intended for prescription use and over the counter use.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
## Wondfo Propoxyphene Urine Test
Wondfo Propoxyphene Urine Test is an immunochromatographic assay for the qualitative determination of d-Propoxyphene in human urine at a cutoff concentration of 300 ng/mL. The test is available in a dip card format and a cup format. It is intended for prescription use.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
3. Special conditions for use statement(s):
For prescription and over the counter use for Cannabinoids.
For prescription use for Propoxyphene. Propoxyphene has not been evaluated for Point-of-care use.
4. Special instrument requirements:
Not applicable, as the device is a visually-read single-use device
I. Device Description:
The devices are for use in human urine in dip card and cup formats. The Dip Card and Cup Tests are single-test test strips. The Dip Card and Cup Tests contain test dip card or cup and package insert (instructions for use). Both devices are single-use and visually read.
J. Substantial Equivalence Information:
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1. Predicate device name(s):
ACON One Step Drug Screen Test, Acon Laboratories
ACON One Step Propoxyphene Test Strip and Device, Acon Laboratories
2. Predicate 510(k) number(s):
k020771 and k040445 respectively
3. Comparison with predicate:
| Similarities and Differences | | |
| --- | --- | --- |
| Item | Device | Predicates (k020771) |
| Indications for Use | For the qualitative determination of Cannabinoids in individual human urine. | Same (different number of drugs detected) |
| Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen-antibody immunochemistry | Same |
| Type of Test | Immunoassay principles that rely on antigen-antibody interactions to indicate positive or negative result | Same |
| Calibrator | 11-nor-Δ9-THC-9-COOH | Same |
| Specimen Type | Human Urine | Same |
| Cut Off Value | Cannabinoids: 50 ng/ml | Same |
| Configurations | Cup, Dip Card | Card, dip card with integrated cup (same) |
| Intended Use | OTC Use & Prescription Use | Prescription Use |
| Similarities and Differences | | |
| --- | --- | --- |
| Item | Device | Predicates (k040445) |
| Indications for Use | For the qualitative determination of Propoxyphene in individual human urine. | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen-antibody immunochemistry | Same |
| Type of Test | Immunoassay principles that rely on antigen-antibody interactions to indicate positive or negative result | Same |
| Calibrator | d-Propoxyphene | Same |
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| Specimen Type | Human Urine | Same |
| --- | --- | --- |
| Cut Off Value | Propoxyphene 300 ng/mL | Same |
| Configurations | Cup, Dip Card | Strip, device |
| Intended Use | Prescription Use | Prescription Use |
## K. Standard/Guidance Document Referenced (if applicable):
None were referenced
## L. Test Principle:
The Wondfo Cannabinoids Urine Test and Wondfo Propoxyphene Urine Test are immunochromatographic assay for Cannabinoids and Propoxyphene Urine test using a lateral flow, one step system for the qualitative detection of 11-nor-Δ9-THC-9-COOH and d-Propoxyphene in human urine. Each assay uses a mouse monoclonal antibody-dye conjugate against drug with gold chloride and fixed drug-protein conjugate and anti-mouse IgG polyclonal antibody in membrane.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
Precision studies were performed using drug free urine spiked to the following concentrations: 0, +100%, +/-75% of cutoff, +/-50% of cutoff, +/-25% of cutoff for each analyte and each device. The samples were aliquots, coded, randomized and blinded. Testing was performed twice a day for twenty-five days by three operators. Three different lot numbers for each device were used for the study. A total of 50 determinations were made at each concentration and each lot. Sample concentrations were confirmed by GC/MS. The results are displayed in the tables below:
Cannabinoids
| | Concentration of sample ng/mL | Number of determinations | Dip Card Results #Neg/#Pos | Cup Results #Neg/#Pos |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 50 | 50/0 | 50/0 |
| | -75% | 50 | 50/0 | 50/0 |
| | -50% | 50 | 50/0 | 50/0 |
| | -25% | 50 | 50/0 | 50/0 |
| | cutoff | 50 | 5/45 | 4/46 |
| | +25% | 50 | 0/50 | 0/50 |
| | +50% | 50 | 0/50 | 0/50 |
| | +75% | 50 | 0/50 | 0/50 |
| | +100% | 50 | 0/50 | 0/50 |
| Lot 2 | Negative | 50 | 50/0 | 50/0 |
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| | -75% | 50 | 50/0 | 50/0 |
| --- | --- | --- | --- | --- |
| | -50% | 50 | 50/0 | 50/0 |
| | -25% | 50 | 50/0 | 50/0 |
| | cutoff | 50 | 6/44 | 4/46 |
| | +25% | 50 | 0/50 | 0/50 |
| | +50% | 50 | 0/50 | 0/50 |
| | +75% | 50 | 0/50 | 0/50 |
| | +100% | 50 | 0/50 | 0/50 |
| Lot 3 | Negative | 50 | 50/0 | 50/0 |
| | -75% | 50 | 50/0 | 50/0 |
| | -50% | 50 | 50/0 | 50/0 |
| | -25% | 50 | 50/0 | 50/0 |
| | cutoff | 50 | 5/45 | 5/45 |
| | +25% | 50 | 0/50 | 0/50 |
| | +50% | 50 | 0/50 | 0/50 |
| | +75% | 50 | 0/50 | 0/50 |
| | +100% | 50 | 0/50 | 0/50 |
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Propoxyphene
| | Concentration of sample ng/mL | Number of determinations | Dip Card Results #Neg/#Pos | Cup Results #Neg/#Pos |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 50 | 50/0 | 50/0 |
| | -75% | 50 | 50/0 | 50/0 |
| | -50% | 50 | 50/0 | 50/0 |
| | -25% | 50 | 50/0 | 50/0 |
| | cutoff | 50 | 6/44 | 5/45 |
| | +25% | 50 | 0/50 | 0/50 |
| | +50% | 50 | 0/50 | 0/50 |
| | +75% | 50 | 0/50 | 0/50 |
| | +100% | 50 | 0/50 | 0/50 |
| Lot 2 | Negative | 50 | 50/0 | 50/0 |
| | -75% | 50 | 50/0 | 50/0 |
| | -50% | 50 | 50/0 | 50/0 |
| | -25% | 50 | 50/0 | 50/0 |
| | cutoff | 50 | 5/45 | 4/46 |
| | +25% | 50 | 0/50 | 0/50 |
| | +50% | 50 | 0/50 | 0/50 |
| | +75% | 50 | 0/50 | 0/50 |
| | +100% | 50 | 0/50 | 0/50 |
| Lot 3 | Negative | 50 | 50/0 | 50/0 |
| | -75% | 50 | 50/0 | 50/0 |
| | -50% | 50 | 50/0 | 50/0 |
| | -25% | 50 | 50/0 | 50/0 |
| | cutoff | 50 | 4/46 | 7/43 |
| | +25% | 50 | 0/50 | 0/50 |
| | +50% | 50 | 0/50 | 0/50 |
| | +75% | 50 | 0/50 | 0/50 |
| | +100% | 50 | 0/50 | 0/50 |
b. Linearity/assay reportable range:
Not applicable, the devices are intended for qualitative use.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
External control standards are not supplied with this device; however, this device has internal process controls. A colored line appearing in the control region confirms sufficient sample volume and adequate membrane wicking. Users are informed that the test is invalid if a line fails to appear in the control region.
Stability
Accelerated and real time studies have been conducted. Protocols and
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acceptance criteria were described and found to be acceptable. The manufacturer claims the following expiration date: The Wondfo Cannabinoids Urine Test and Wondfo Propoxyphene Urine Test unopened stability is 18 months for both formats (cup and dip card) when stored at 4-30° C.
d. Detection limit:
Analytical performance of the device around the cutoff is described in Section f. (Assay cut-off) below.
e. Analytical specificity:
Cross-reactivity was established by spiking similarly structured compounds into drug free urine at various concentrations. These solutions were tested using 3 lots/device (dip card and cup). Results are expressed as a minimum concentration of metabolite or compound required to produce a response approximately equivalent to the cutoff concentration of the assay. Both devices produced similar results. The percent cross-reactivity of those compounds are presented below:
| Compound | Tested Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| THC (Cannabinoids) 11-nor-Δ9-THC-9-COOH | 50 | 100% |
| 11-nor-Δ8-THC-9-COOH | 30 | 167% |
| 11-hydroxy-Δ9-Tetrahydrocannabinol | 2500 | 2% |
| Δ8-Tetrahydrocannabinol | 7500 | <1% |
| Δ9-Tetrahydrocannabinol | 10000 | <1% |
| Cannabinol | 100000 | <1% |
| Cannabidiol | 100000 | <1% |
| Compound | Tested Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| d-Propoxyphene | 300 | 100% |
| d-Norpropoxyphene | 300 | 100% |
Structurally un-related and interference
The following unrelated compounds were found not to cross-react when tested spiked (100 µg/mL) into urine spiked with ± 25% of the cut-off concentration of cannabinoids individually:
4-Acetamidphenol, Acetophenetidin, N-acetylprocainamide, Acetylsalicylic acid, Aminopyrine, Amitryptyline, Amobarbital, Amoxicillin, Ampicillin,
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Ascorbic Acid, D,L- Amphetamine, L-Amphetamine, Apomorphine, Aspartame, Atropine, Benzilic acid, Benzoic acid, Benzoylecgonine, Benzphetamine, Bilirubin, Brompheniramine, Caffeine, Chloralhydrate, Chloramphenicol, Chlordiazepoxide, Chlorothiazide, $(\pm)$ Chlolrpheniramine, Chlorpromazine, Chlorquine, Cholesterol, Clomipramine, Clonidine, Cocaine hydrochloride, Codeine, Cortisone, $(-)$ Cotinine, Creatinine, Deoxycorticosterone, Dextromethorphan, Diazepam, Diclofenac, Diflunisal, Digoxin, Diphenhydramine, Doxylamine, Ecgonine hydrochloride, Ecgonine methylester, $(-)$ Y Ephedrine, Erythromycin, $\beta$-Estradiol, Estrone-3-sulfate, Ethyl-p-aminobenzoate, Fenoprofen, Furosemide, Gentisic acid, Hemoglobin, Hydralazine, Hydrochlorothiazide, Hydrocodone, Hydrocortisone, O-Hydroxyhippuric, 3-Hydroxytyramine, Ibuprofen, Imipramine, Iproniazid, $(+/-)$ Isoproterenol, Isoxsuprine, Ketamine, Ketoprofen, Labetalol, Levorphanol, Loperamide, Maprotiline, Meprobamate, Methadone, Methoxyphenamine, $(+)$ 3,4 Methylenedioxyamphetamine, $(+)$ 3,4 Methylenedioxy methamphetamine, Methylphenidate, Methyprylon, Morphine-3- $\beta$-D glucuronide, Nalorphine, Naloxone, Nalidixic Acid, Naltrexone, Naproxen, Niacinamide, Nifedipine, Norcodein, Norethindrone, D-Norpropoxphene, Noscapine, D,L-Octopamine, Oxalic Acid, Oxazepam, Oxolinic acid, Oxycodone, Oxymetazoline, p-Hydroxymethamphetamine, Papaverine, Penicillin-G, Pentazocine, Pentobarbital, Perphenazine, Phencyclidine, Phenelzine, Phenobarbital, Phentermine, L-Phenylephrine, $\beta$-Phenylethlamine, $\beta$-Phenyliethylamine, Phenylopropanolamine, Prednisolone, Prednisone, Procaine, Promazine, Promethazine, D,L- Propranolol, D-Propoxphene, D-Pseudophedrine, Quinidine, Quinine, Ranitidine Salicylic Acid, Secobarbital, Serotonin (5-Hydroxytyramine), Sulfamethazine, Sulindac, Temazepam, Tetracycline, Tetrahydrocortisone, 3 acetate, Tetrahydrocortisone3 (5-Dglucuronide), Tetrahydoizoline, Thebaine, Thiamine, Thioridazine, D, L-Thyroxine, Tolbutamide, Triamterene, Trifluoperazine, Trimethoprim, Trimipramine, Tryptamine, D,L-Tryptophan, Tyamine, PrD, L-Tyrosine, Uric Acid, Verapamil, Zomepirac
The following unrelated compounds were found not to cross-react when tested spiked $(100\ \mu\mathrm{g/mL})$ into urine spiked with $\pm 25\%$ of the cut-off concentration of propoxyphene individually:
Acetophenetidin, Acetylsalicylic acid, Aminopyrine, Amoxicillin, Ampicillin, Apomorphine, Aspartame, Atropine, Benzilic acid, Benzoic acid, Benzphetamine, Bilirubin, Caffeine, Chloralhydrate, Chloramphenicol, Chlorothiazide, D,L-Chlolrpheniramine, Chlorpromazine, Chlorquine, Cholesterol, Clonidine, L-Cotinine, Cortisone, Creatinine, D-Pseudoephedrine, Dextromethorphan, $\beta$-D-glucuronide, Diclofenac, Diflunisal, Digoxin, Diphenhydramine, Ecgonine methylester, L-Ephedrine, Erythromycin, $\beta$-Estradiol, Estrone-3-sulfate, Ethyl-p-aminobenzoate, Fenoprofen, Furosemide, Gentisic acid, Hemoglobin, Hydralazine
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Hydrochlorothiazide, Hydrocortisone, O-Hydroxyhippuric, 3-Hydroxytyramine, IsoxsuprineD, L-Isoproterenol, Ketoprofen, Labetalol, Loperamide, Meprobamate, Methoxyphenamine, Morphine-3-β-D-glucuronide, Naloxone, Nalidixic Acid, Naltrexone, Naproxen, Niacinamide, Nifedipine, Norethindrone, , Noscapine, D,L-Octopamine, Oxalic Acid, Oxolinic acid, Oxymetazoline, Papaverine, Penicillin-G, Perphenazine, Phenelzine, L-Phenylephrine, β-Phenylethlamine, Phenylopropanolamine, , Prednisone, D,L- Propranolol, Quinidine, Quinine, Ranitidine Salicylic Acid, Serotonin, Sulfamethazine, Sulindac, Tetracycline, Tetrahydrocortisone, Tetrahydrozoline, Thiamine, Thioridazine, D, L-Thyrosine, Tolbutamide, Triamterene, Trifluoperazine, Trimethoprim, D,L-Tryptophan, Tyamine, Uric Acid, Verapamil, Zomepirac
Evaluation of SG and pH on test results:
To evaluate the effect of pH value on the test results, a negative urine sample were adjusted to pH levels 4.0, 5.0, 6.0, 7.0, 8.0 and 9.0. The samples were then spiked with each drug at +/-25% of the cutoff values. Testing was performed on 3 lots/device (dip card and cup).
To evaluate the effect of specific gravity, 12 urine samples having specific gravities of 1.000, 1.003, 1.007, 1.008, 1.017, 1.019, 1.020, 1.025, and 1.030, 1.031, 1.033 and 1.035 were spiked with each drug at +/-25% of the cut-off values. Testing was performed on 3 lots/device (dip card and cup).
The testing results demonstrate that varying pHs and specific gravities do not affect urine testing results around each analyte cut-off.
f. Assay cut-off:
Cutoff studies were performed for cannabinoids and propoxyphene using a combination of clinical and spiked samples for each drug (n=150 per drug). The testing protocol was identical for each drug.
25 clinical samples were collected for each drug. Concentrations of cannabinoids and propoxyphene in the samples were determined by GC/MS.
An additional 125 drug free negative samples were obtained for each drug and spiked with either cannabinoids and propoxyphene at -50% cutoff, -25% cutoff, cutoff, +25% cutoff, and +50% cutoff. 5 clinical samples and 25 spiked samples were tested at each concentration for each drug in replicates of 30 using three lots and 3 operators (n=270). Results are summarized below:
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Cannabinoids
| | Concentration of sample ng/mL | Number of determinations | Dip Card Results #Neg/#Pos | Cup Results #Neg/#Pos |
| --- | --- | --- | --- | --- |
| Lot 1 | -50% cutoff | 90 | 90/0 | 90/0 |
| | -25% cutoff | 90 | 90/0 | 90/0 |
| | Cutoff | 90 | 9/81 | 11/79 |
| | +25% cutoff | 90 | 0/90 | 0/90 |
| | +50% cutoff | 90 | 0/90 | 0/90 |
| Lot 2 | -50% cutoff | 90 | 90/0 | 90/0 |
| | -25% cutoff | 90 | 90/0 | 90/0 |
| | Cutoff | 90 | 12/78 | 10/80 |
| | +25% cutoff | 90 | 0/90 | 0/90 |
| | +50% cutoff | 90 | 0/90 | 0/90 |
| Lot 3 | -50% cutoff | 90 | 90/0 | 90/0 |
| | -25% cutoff | 90 | 90/0 | 90/0 |
| | Cutoff | 90 | 11/79 | 8/82 |
| | +25% cutoff | 90 | 0/90 | 0/90 |
| | +50% cutoff | 90 | 0/90 | 0/90 |
Propoxyphene
| | Concentration of sample ng/mL | Number of determinations | Dip Card Results #Neg/#Pos | Cup Results #Neg/#Pos |
| --- | --- | --- | --- | --- |
| Lot 1 | -50% cutoff | 90 | 90/0 | 90/0 |
| | -25% cutoff | 90 | 90/0 | 90/0 |
| | Cutoff | 90 | 10/80 | 9/81 |
| | +25% cutoff | 90 | 0/90 | 0/90 |
| | +50% cutoff | 90 | 0/90 | 0/90 |
| Lot 2 | -50% cutoff | 90 | 90/0 | 90/0 |
| | -25% cutoff | 90 | 90/0 | 90/0 |
| | Cutoff | 90 | 8/82 | 10/80 |
| | +25% cutoff | 90 | 0/90 | 0/90 |
| | +50% cutoff | 90 | 0/90 | 0/90 |
| Lot 3 | -50% cutoff | 90 | 90/0 | 90/0 |
| | -25% cutoff | 90 | 90/0 | 90/0 |
| | Cutoff | 90 | 9/81 | 10/80 |
| | +25% cutoff | 90 | 0/90 | 0/90 |
| | +50% cutoff | 90 | 0/90 | 0/90 |
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2. Comparison studies:
a. Method comparison with predicate device:
The method comparison for the Wondfo Cannabinoids Urine Test and Wondfo Propoxyphene Urine Test was performed in-house with three laboratory assistants with relevant experience and a lay person with no experience other than reading the instructions for use. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to GC/MS results. The results are presented in the table below:
Cannabinoids
| Cup format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 2 | 18 | 22 |
| | Negative | 10 | 12 | 16 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 18 | 22 |
| | Negative | 10 | 12 | 17 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 18 | 22 |
| | Negative | 10 | 12 | 17 | 0 | 0 |
| Lay Person | Positive | 0 | 0 | 2 | 18 | 22 |
| | Negative | 10 | 12 | 16 | 0 | 0 |
Cannabinoids
| Dip Card format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 18 | 22 |
| | Negative | 10 | 12 | 17 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 18 | 22 |
| | Negative | 10 | 12 | 17 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 18 | 22 |
| | Negative | 10 | 12 | 17 | 0 | 0 |
| Lay Person | Positive | 0 | 0 | 1 | 18 | 22 |
| | Negative | 10 | 12 | 17 | 0 | 0 |
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Discordant table:
| Viewer | Sample number | GC/MS result | Cup format Viewer result |
| --- | --- | --- | --- |
| Viewer A | GDA 19 | 47 | positive |
| Viewer A | GDA 20 | 49 | positive |
| Viewer B | GDA 20 | 49 | positive |
| Viewer C | GDA 19 | 47 | positive |
| Lay person | GDA 19 | 47 | positive |
| Lay person | GDA 20 | 49 | positive |
| Viewer | Sample number | GC/MS result | Dip Card format viewer results |
| --- | --- | --- | --- |
| Viewer A | GDA 20 | 49 | positive |
| Viewer B | GDA 19 | 47 | positive |
| Viewer C | GDA 19 | 47 | positive |
| Lay person | GDA 20 | 49 | positive |
Propoxyphene
| Cup format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 25 | 15 |
| | Negative | 10 | 18 | 11 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 25 | 15 |
| | Negative | 10 | 18 | 10 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 25 | 15 |
| | Negative | 10 | 18 | 11 | 0 | 0 |
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# Propoxyphene
| Dip Card format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 25 | 15 |
| | Negative | 10 | 18 | 11 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 25 | 15 |
| | Negative | 10 | 18 | 11 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 25 | 15 |
| | Negative | 10 | 18 | 11 | 0 | 0 |
# Discordant result
| Viewer | Sample number | GC/MS result | Cup format Viewer result |
| --- | --- | --- | --- |
| Viewer A | PPX317 | 297.4 | positive |
| Viewer B | PPX63 | 295.6 | positive |
| Viewer B | PPX318 | 293.8 | positive |
| Viewer C | PPX63 | 295.6 | positive |
| Viewer | Sample number | GC/MS result | Dip Card format viewer results |
| --- | --- | --- | --- |
| Viewer A | PPX318 | 293.8 | positive |
| Viewer B | PPX317 | 297.4 | positive |
| Viewer C | PPX317 | 297.4 | positive |
# Lay-user study for Cannabinoids
# Test Cup format:
A lay user study was performed at three intended user sites with 140 lay persons. Participants in the study were 66 females and 74 males tested the cannabinoids samples. They had diverse educational and professional backgrounds and ranged in age from 21 to $>50$ . Urine samples were prepared at the following concentrations; negative, $+/-75\%$ , $+/-50\%$ , $+/-25\%$ of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled samples and a device. The results are summarized below.
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| Cup format | | Number of samples | OTC user | | %Agreement With GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Cannabinoids | Negative | 20 | 20 | 0 | 100% |
| | -75% | 20 | 20 | 0 | 100% |
| | -50% | 20 | 20 | 0 | 100% |
| | -25% | 20 | 19 | 1 | 85% |
| | +25% | 20 | 1 | 19 | 90% |
| | +50% | 20 | 0 | 20 | 100% |
| | +75% | 20 | 0 | 20 | 100% |
Dip Card format:
A lay user study was performed at three intended user sites with 140 lay persons. Participants in the study were 63 females and 77 males tested the cannabinoids samples. They had diverse educational and professional backgrounds and ranged in age from 21 to $>50$ . Urine samples were prepared at the following concentrations; negative, $+/-75\%$ , $+/-50\%$ , $+/-25\%$ of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled samples and a device. The results are summarized below.
| Dip Card format | | Number of samples | OTC user | | %Agreement With GC/MS |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| Cannabinoids | Negative | 20 | 20 | 0 | 100% |
| | -75% | 20 | 20 | 0 | 100% |
| | -50% | 20 | 20 | 0 | 100% |
| | -25% | 20 | 18 | 2 | 85% |
| | +25% | 20 | 0 | 20 | 95% |
| | +50% | 20 | 0 | 20 | 100% |
| | +75% | 20 | 0 | 20 | 100% |
All study participants completed questionnaires after the performed the test and recorded their results. The questionnaires covered evaluation of the package insert regarding expiration date of the device, storage, the directions for performing the test, the ease of performing the test, directions for interpreting the results, and ease of interpretation of the results. These questionnaires demonstrated that the test instructions were easy to understand and that the testing procedure was easy to perform and the results were easy to read.
b. Matrix comparison:
Not applicable
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3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
Not applicable
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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