QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST
Device Facts
| Record ID | K130275 |
|---|---|
| Device Name | QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST |
| Applicant | Tianjin New Bay Bioresearch Co., Ltd. |
| Product Code | DJG · Clinical Toxicology |
| Decision Date | Sep 26, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3650 |
| Device Class | Class 2 |
Indications for Use
The QuikScreen™ Multi (MDMA and OPI) Drug Cup Test consists of competitive binding, lateral flow immunochromatographic assays and provides a simple and rapid analytical screening procedure to simultaneously detect the drugs of abuse MDMA at or above the cutoff level of 500 ng/ml and OPI at or above the cutoff level of 300 ng/ml in human urine. The device is intended for prescription use and Over-The-Counter settings.
Device Story
The QuikScreen Multi (MDMA and OPI) Drug Cup Test is a lateral flow immunochromatographic device for qualitative drug screening in human urine. The device consists of a specimen collection cup with integrated test strips. The membrane is coated with goat anti-mouse antibody and drug-bovine serum albumin conjugate; the sample pad contains colloidal gold-labeled mouse monoclonal anti-drug antibodies. In the presence of drugs, the gold-labeled antibody binds to the drug in the urine, preventing the formation of a magenta band in the test zone (positive result). In the absence of drugs, the gold-labeled antibody binds to the drug-protein conjugate on the membrane, producing a magenta band (negative result). The device is intended for use by lay users in OTC settings or by clinicians. Results are visually interpreted within five minutes. The test provides preliminary results that require confirmation by GC/MS or LC/MS. It does not distinguish between therapeutic use and abuse.
Clinical Evidence
No clinical diagnostic studies were performed. Evidence includes analytical performance (precision, cross-reactivity, interference, and cutoff characterization) and a lay-user study. The lay-user study (n=104) demonstrated high agreement with reference methods (GC/MS) across various drug concentrations. Method comparison against GC/MS/LC-MS using 290 clinical urine specimens showed high agreement (OPI: 96.3% negative, 100% positive; MDMA: 96.1% negative, 98.1% positive).
Technological Characteristics
Lateral flow immunochromatographic competitive binding assay. Materials: membrane coated with goat anti-mouse antibody and drug-bovine serum albumin conjugate; sample pad with colloidal gold-labeled mouse monoclonal anti-drug antibody. Form factor: specimen collection cup with integrated test strips. Visual readout. No electronic components or software.
Indications for Use
Indicated for the qualitative, simultaneous screening of MDMA (cutoff 500 ng/mL) and Opiates (cutoff 300 ng/mL) in human urine. Intended for prescription and Over-The-Counter (OTC) use. Provides preliminary analytical results; requires confirmation via GC/MS or LC/MS.
Regulatory Classification
Identification
An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Predicate Devices
- Wondfo Multi-Drug Urine Test Cup (k121166)
- Wondfo Multi-Drug Urine Test Panel (k121166)
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k130275
B. Purpose for Submission:
New device
C. Measurand:
3,4 Methylene-dioxy-methamphetamine (MDMA) & Opiates
D. Type of Test:
Qualitative lateral flow immunochromatographic competitive binding assay
E. Applicant:
Tianjin New Bay Bioresearch
F. Proprietary and Established Names:
QuikScreen Multi (MDMA and OPI) Drug Cup Test
G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DJG | Class II | 21CFR862.3650, Opiate test system | 91-Toxicology |
| LAF | Class II | 21CFR862.3610, Methamphetamine test system | 91-Toxicology |
H. Intended Use:
1. Intended use(s):
See Indications for Use
2. Indication(s) for use:
The QuikScreen™ Multi (MDMA and OPI) Drug Cup Test consists of competitive binding, lateral flow immunochromatographic assays and provides
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a simple and rapid analytical screening procedure to simultaneously detect the drugs of abuse MDMA at or above the cutoff level of 500 ng/ml and OPI at or above the cutoff level of 300 ng/ml in human urine. The device is intended for prescription use and Over-The-Counter settings.
| Test | Calibrator | Cutoff |
| --- | --- | --- |
| Opiate | Morphine | 300 ng/ml |
| MDMA | (+/-)-3,4Methylene-dioxymethamphetamine | 500 ng/ml |
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. Clinical and professional judgment should be exercised with any drug of abuse test result, particularly when preliminary results are used. The assay does not distinguish whether OPI or MDMA is being taken therapeutically or abused.
3. Special conditions for use statement(s):
For Over-The-Counter (OTC) and prescription use
For in vitro diagnostic (IVD) use only.
4. Special instrument requirements: Not applicable
I. Device Description:
The QuikScreen Multi (MDMA and OPI) Drug Cup Test is a device consisting of a specimen collection cup with a built-in strip holder which is able to hold MDMA and OPI test strips. The membrane of the drug test strip is coated with goat anti-mouse antibody and drug-bovine serum albumin conjugate. The sample pad of test strip contains a colloidal gold-labeled mouse monoclonal anti-drug (OPI or MDMA) antibody.
J. Substantial Equivalence Information:
1. Predicate device name(s): Wondfo Multi-Drug Urine Test Cup
Wondfo Multi-Drug Urine Test Panel
2. Predicate K number(s): k121166
3. Comparison with predicate:
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| | Candidate
QuikScreen Multi (MDMA and OPI) Drug Cup Test | Predicate
Wondfo Multi- Drug Urine Test Cup and Test Panel(k121166) |
| --- | --- | --- |
| Indications for Use | Same | Guanzhou Wondfo Biotech Co Multi-Drug Urine Test Cup and Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of drugs of abuse in human urine |
| Sample Type | Same. | Urine |
| Type of Test | Same | Qualitative lateral flow immunochromatographic competitive binding assay |
| Test Format | Cup | Cup and Panel |
| Analyte and Cut-off | Same for MDMA and OPI | Multiple drugs of abuse analytes including MDMA (300 ng/mL) and OPI (500 ng/mL) |
K. Standard/Guidance Document Referenced (if applicable):
None
L. Test Principle:
The assay is based on lateral flow immunochromatographic technology. Drug (OPI or MDMA) in the urine sample competes with the colloidal gold labeled goat anti-mouse monoclonal antibody -conjugated for binding to drug protein conjugate in the test zone area.
If drug (OPI or MDMA) is present in the sample, the test sample flows through the absorbent device, and the colloidal gold labeled antibody-conjugate binds to the free drug in the specimen forming an antibody-conjugate in the test reaction zone
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and will not produce a magenta color band when the drug is above the detection level (positive result). In the absence of drug (OPI or MDMA) in the sample, the drug-protein conjugate binds to labeled antibody and produces a magenta band in the test zone area (negative result).
The device also has an internal process control which indicates that adequate volume of sample has been added and that the immune-chromatographic device is intact. A goat anti-mouse antibody is also employed in the control line system. A negative specimen produces two distinct color bands in both the test line and control area. A positive specimen produces only one color band in the control area.
The absence or presence of a line is determined visually by the user. The tester will obtain a result in five minutes.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
The precision (within lot) of the QuikScreen Multi (MDMA and OPI) Drug Cup Test was tested with one lot of the test device by one operator on one day. This consists of (90) replicates for each level of each drug standard (negative), -75% cutoff, -50% cutoff, -25% cutoff, cutoff, +25% cutoff, +50% cutoff, +75% cutoff and +100% of cutoff concentrations.
Within -lot precision for MDMA
| MDMA Level (ng/mL) | Cut-off level | N | Expected | Percent Correct (%) |
| --- | --- | --- | --- | --- |
| 0 | Neg | 30 | Negative | 100 |
| 125 | -75% | 30 | Negative | 100 |
| 250 | -50% | 30 | Negative | 100 |
| 375 | -25% | 30 | Negative | 86.6 |
| 500 | Cut-off | 30 | Positive | 100 |
| 625 | +25% | 30 | Positive | 100 |
| 750 | +50% | 30 | Positive | 100 |
| 875 | +75% | 30 | Positive | 100 |
| 1000 | +100% | 30 | Positive | 100 |
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Within lot precision for OPI
| OPI Level ng/ml | Cut-off level | N | Expected | Percent Correct (%) |
| --- | --- | --- | --- | --- |
| 0 | Neg | 30 | Negative | 100 |
| 75 | -75% | 30 | Negative | 100 |
| 150 | -50% | 30 | Negative | 100 |
| 225 | -25% | 30 | Negative | 90 |
| 300 | Cut-off | 30 | Positive | 100 |
| 375 | +25% | 30 | Positive | 100 |
| 450 | +50% | 30 | Positive | 100 |
| 525 | +75% | 30 | Positive | 100 |
| 600 | +100% | 30 | Positive | 100 |
An inter lot precision test was performed on the three different lots of QuikScreen Multi (MDMA and OPI) Drug Cup Test Devices. Three lots of test devices were used by three different operators on 3 different days. This consists of (30) replicates of each level of each drug standards (0, -75% cutoff, -50% cutoff, -25% cutoff, cutoff, +25% cutoff, +50% cutoff, +75% cutoff and +100% cutoff) and performed by 3 operators at multiple day period.
Inter lot study for MDMA:
| MDMA Conc. | Lot1 | | | | Lot 2 | | | | Lot 3 | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | N | + | - | Correct % | N | + | - | Correct % | N | + | - | Correct % |
| 0 ng/ml | 30 | 0 | 30 | 100 | 30 | 0 | 30 | 100 | 30 | 0 | 30 | 100 |
| 125 ng/ml | 30 | 0 | 30 | 100 | 30 | 0 | 30 | 100 | 30 | 0 | 30 | 100 |
| 250 ng/ml | 30 | 0 | 30 | 100 | 30 | 0 | 30 | 100 | 30 | 0 | 30 | 100 |
| 375 ng/ml | 30 | 4 | 26 | 86.6 | 30 | 4 | 26 | 86.6 | 30 | 2 | 28 | 93.3 |
| 500 ng/ml (Cut-off) | 30 | 29 | 1 | 96.6 | 30 | 29 | 1 | 96.6 | 30 | 28 | 2 | 93.3 |
| 625 ng/ml | 30 | 30 | 0 | 100 | 30 | 30 | 0 | 100 | 30 | 30 | 0 | 100 |
| 750 ng/ml | 30 | 30 | 0 | 100 | 30 | 30 | 0 | 100 | 30 | 30 | 0 | 100 |
| 875 ng/ml | 30 | 30 | 0 | 100 | 30 | 30 | 0 | 100 | 30 | 30 | 0 | 100 |
| 1000 ng/ml | 30 | 30 | 0 | 100 | 30 | 30 | 0 | 100 | 30 | 30 | 0 | 100 |
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Inter- lot study for OPI
| OPI Conc | Lot1 | | | | Lot 2 | | | | Lot 3 | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | N | + | - | Correct % | N | + | - | Correct % | N | + | - | Correct % |
| 0 ng/ml | 30 | 0 | 30 | 100 | 30 | 0 | 30 | 100 | 30 | 0 | 30 | 100 |
| 75 ng/ml | 30 | 0 | 30 | 100 | 30 | 0 | 30 | 100 | 30 | 0 | 30 | 100 |
| 150 ng/ml | 30 | 0 | 30 | 100 | 30 | 0 | 30 | 100 | 30 | 0 | 30 | 100 |
| 225 ng/ml | 30 | 3 | 27 | 90.0 | 30 | 4 | 26 | 86.6. | 30 | 1 | 29 | 96.6 |
| 300 ng/ml (Cut-off) | 30 | 30 | 0 | 100 | 30 | 30 | 0 | 100 | 30 | 29 | 1 | 96.6 |
| 375 ng/ml | 30 | 30 | 0 | 100 | 30 | 30 | 0 | 100 | 30 | 30 | 0 | 100 |
| 450 ng/ml | 30 | 30 | 0 | 100 | 30 | 30 | 0 | 100 | 30 | 30 | 0 | 100 |
| 525 ng/ml | 30 | 30 | 0 | 100 | 30 | 30 | 0 | 100 | 30 | 30 | 0 | 100 |
| 600 ng/ml | 30 | 30 | 0 | 100 | 30 | 30 | 0 | 100 | 30 | 30 | 0 | 100 |
b. Linearity/assay reportable range:
Not applicable, the device is intended for qualitative use
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Stability protocols and acceptance criteria for the test device were reviewed and found acceptable. The sponsor demonstrated the MDMA and OPI drug cup device is stable for 24 months at 2-8 °C and 37 °C using accelerated and real time studies.
Commercially available quality controls are recommended for use in the labeling.
d. Detection limit:
Not applicable.
e. Analytical specificity:
Cross-reactivity was evaluated by spiking various concentrations of similarly structured drug compounds into drug-free urine. 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. The percent cross-reactivity of those compounds is presented below:
Concentration of Opiate-related compounds that yield positive
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results approximately equivalent to the Opiate 300 cutoff set for the test.
| Minimum Concentration of Opiate Related Compounds Require to yield the positive result as cut off concentration | Test Result After Add drug related compounds to Drug free Urine | % of Cross reactivity |
| --- | --- | --- |
| Morphine | 300 ng/ml | 100% |
| 6-Acetylmorphine | 300 ng/ml | 100% |
| Codeine | 300 ng/ml | 100% |
| Ethylmorphine | 5000 ng/ml | 0.06% |
| Hydromorphone | 6000 ng/ml | 0.05% |
| Hydrocodone | 6000 ng/ml | 0.05% |
Concentration of MDMA-related compounds that yield positive results approximately equivalent to the MDMA 500 cutoff set for the test.
| Minimum Concentration of Opiate Related Compounds Require to Yield the Positive Result as Cut Off Concentration | Test Result After Add drug Related Compounds to Drug free Urine ng/ml | % of Cross Reactivity |
| --- | --- | --- |
| 3,4-Methylenedioxymethamphetamine (MDMA) | 500 | 100% |
| D-Amphetamine | 1x10^{6} | 0.005% |
| (D)-Methamphetamine | 5 x 10^{5} | 0.01% |
| L-Methamphetamine | 5 x 10^{5} | 0.01% |
| 3,4-Mthylenedioxyethylamphetamine(MDEA) | 5000 | 0.005% |
| 3,4-Methylenedioxyamphetamine(MDA) | 5000 | 0.005% |
| p-Methoxyamphetamine (PMA) | 5x10^{5} | 0.01% |
In order to examine potential naturally occurring interfering substances in urine, drug negative urine (-25 % cutoff) and drug positive urine (+25 % cutoff) were spiked with various potentially interfering substances. Both aliquots were tested with QuikScreen™ Multi (MDMA and OPI) Drug Cup Test Device. There was no interference from the following substances at the concentration listed in Table below:
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The effect on OPI and MDMA test device with natural occurring endogenous substances
| Interfering Substances | Final Concentration | OPI | | MDMA | |
| --- | --- | --- | --- | --- | --- |
| | | 225 ng/ml Results | 375 ng/ml Result | 375 ng/ml Results | 625 ng/ml Result |
| Ascorbic Acid | 300 mg/dl | - | + | - | + |
| Bilirubin | 1.0 mg/dl | - | + | - | + |
| Creatine | 500 mg/dl | - | + | - | + |
| Glucose | 1500 mg/dl | - | + | - | + |
| Hemoglobin | 300 mg/dl | - | + | - | + |
| Potassium | 110 mEq/dl | - | + | - | + |
| Human Serum Albumin | 500 mg/dl | - | + | - | + |
| Globulin | 1500 mg/dl | - | + | - | + |
| Sodium chloride | 6000 mg/dl | - | + | - | + |
| Uric Acid | 23 mg/dl | - | + | - | + |
| Cholesterol | 500 mg/dl | - | + | - | + |
A study was conducted with QuikScreen™ Multi (MDMA and OPI) drug cup to determine the cross-reactivity of non-drug related compounds with the test at concentrations much higher than normally found in the urine of people using or abusing drugs. No related compounds (100μg/ml) were spiked into the urine containing -25% cutoff of drug (negative) and +25% cutoff of drug (positive). No cross reactivity with MDMA or OPI device were detected with the substances spiked in the either negative or positive urine in the table below:
Compounds tested and found not to cross react with the test at a 100μg/ml concentration in urine:
| Acetaminophen | Methylphenidate | Phenylpropanolamine |
| --- | --- | --- |
| Acetylsalicylic Acid | Histamine | l-Phenylephrine |
| Amikacin | *2-Ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolioline. | Pentobarbital |
| Amitriptyline | Hydrochlorothiazide | d-Propoxyphene |
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The sponsor provided studies to show that the QuikScreen™ Multi (MDMA and OPI) Drug Cup Test device performance at the cutoff level is not affected by any urine samples with a pH ranging from 4.0 to 8.5 and specific gravity ranging from 1.005 to 1.030. The protocols and data were reviewed and found to be acceptable.
f. Assay cut-off:
The assay cutoff characterization study was performed by using QuikScreen Multi (MDMA and OPI) Drug Cup Test. The study samples were made by using OPI or MDMA stock solution confirmed by GC/MS and diluting in drug-free urine. Results are shown in the tables below:
| OPI (ng/ml) | QuikScreen OPI Drug Cup Test Results | |
| --- | --- | --- |
| | No. of positive /Total sample | % Positive Urine |
| 0 | 0/15 | 0.0 % |
| 75 (-75 % ) | 0/15 | 0.0 % |
| 150(-50 % ) | 0/15 | 0.0% |
| 225(-25%) | 2/15 | 13.3% |
| 270 (-10 %) | 7/15 | 46.6 % |
| 300 (Cutoff) | 15/15 | 100 % |
| 330 (+10 %) | 15/15 | 100% |
| 375 (+25 %) | 15/15 | 100 % |
| 450 (+50%) | 15/15 | 100 % |
| 525 (+75%) | 15/15 | 100 % |
| 600 (+100%) | 15/15 | 100 % |
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| MDMA (ng/ml) | QuikScreen MDMA Drug Cup Test Results | |
| --- | --- | --- |
| | No. of positive /Total sample | % Positive Urine |
| 0 | 0/15 | 0.0 % |
| 125 (-75 %) | 0/15 | 0.0 % |
| 250(-50 %) | 0/15 | 0.0% |
| 375(-25%) | 1/15 | 6.6% |
| 450(-10 %) | 8/15 | 53.3% |
| 500 (Cutoff) | 15/15 | 100 % |
| 550 (+10 %) | 15/15 | 100% |
| 625 (+25 %) | 15/15 | 100 % |
| 750 (+50%) | 15/15 | 100 % |
| 875 (+75%) | 15/15 | 100 % |
| 1000 (+100%) | 15/15 | 100 % |
2. Comparison studies:
a. Method comparison with predicate device:
A method comparison study was performed using positive and negative unaltered clinical urine specimens. Samples were collected from 80 negative drug free urine specimens, 80 OPI positive patient's urine specimens, and 130 MDMA positive specimens. Each urine specimen was tested with the QuikScreen Multi (MDMA and OPI) Drug Cup Test and the reference method (GC-MS or LC-MS). The results are summarized as follows:
Agreement between QuikScreen™ One Step OPI Drug Cup Test Results to Reference Methods Results are shown in the table below:
| Drug Test | Drug free patient Urine Negative | Negative To <-50% | Near cutoff Negative. (-50% to Cutoff | Near cutoff Positive (+50% to Cutoff) | Positive (>+50% Cutoff | %Agreement with Reference Methods | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | 0 ng/ml | 0 to 150 ng/ml | 150 – 300 ng/ml | 300 – 450 ng/ml | >450 ng/ml | Negative (-) | Positive (+) |
| QuikScreen OPI Drug Cup test | Positive (+) | 0 | 0 | 5 | 17 | 43 | 96.3 % | 100% |
| | Negative (-) | 80 | 10 | 15 | 0 | 0 | | |
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Discordant Patient Specimens of Morphine Drug test from QuikScreen ( MDMA and Morphine ) Cup test is summarized as follows:
| Patients ID # | Morphine Reference value ng/ml | QuikScreen Cup test Result Positive/Negative Cutoff Value 300 ng/ml | |
| --- | --- | --- | --- |
| | | Expected | Observed |
| Patient 104 (M4) | 261 ng/ml | Negative | Positive |
| Patient 105 (M15) | 265 ng/ml | Negative | Positive |
| Patient 106 (M27) | 267 ng/ml | Negative | Positive |
| Patient 107 (M30) | 273 ng/ml | Negative | Positive |
| Patient 168 | 293 ng/ml | Negative | Positive |
Agreement between QuikScreen™ One Step MDMA Drug Cup Test Results to reference methods Results are shown in the table below:
| Drug Test | Drug Free Patient Urine Negative | Negative To <-50% | Near cutoff Negative. (-50% to Cutoff | Near cutoff Positive (+50% to Cutoff) | Positive (>+50% Cutoff | %Agreement With Reference Methods | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | 0 ng/ml | 0 to 250 ng/ml | 250 – 500 ng/ml | 500 – 750 ng/ml | >750 ng/ml | Negative (-) | Positive (+) |
| QuikScreen MDMA Drug Cup test | Positive (+) | 0 | 0 | 6 | 10 | 43 | 96.1 % | 98.1% |
| | Negative (-) | 80 | 51 | 19 | 1 | 0 | | |
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Discordant Patient Specimens of MDMA Drug test from QuikScreen (MDMA and Morphine) Cup test is summarized as follows:
| Patients ID # | MDMA Reference Test Results ng/ml | QuikScreen Cup test Result Positive/Negative Cutoff Value 500 ng/ml | |
| --- | --- | --- | --- |
| | | Expected | Observed |
| Patient 150 (AA021) | 422.8 ng/ml | Negative | Positive |
| Patient 153 (AA020) | 441.4 ng/ml | Negative | Positive |
| Patient 154 (AA033) | 445.4 ng/ml | Negative | Positive |
| Patient 155 (AA034) | 470.8 ng/ml | Negative | Positive |
| Patient 156 (AA028) | 472.5 ng/ml | Negative | Positive |
| Patient 157 (AA036) | 478.7 ng/ml | Negative | Positive |
| Patient 158 (AA038) | 510.5 ng/ml | Positive | Negative |
b. Matrix comparison:
Not applicable
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):
A lay user study was performed with 104 lay persons. Participants in the study (65 females and 39 Males) tested the MDMA and Opiate samples. They had diverse educational and professional backgrounds and ranged in age from 26 to 66. Urine samples were prepared at the following concentrations; negative, +/-
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75%, +/-50%, and +/-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 aliquotted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample, and a device. The results are summarized below.
| | | Number of samples | OTC user | | %Agreement With Reference Test |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| MDMA | Negative | 104 | 104 | 0 | 100 % |
| | -75 % | 104 | 104 | 0 | 100 % |
| | -50% | 104 | 104 | 0 | 100 % |
| | -25% | 104 | 93 | 11 | 89.4 % |
| | Cutoff | 104 | 4 | 100 | 96.1 % |
| | +25% | 104 | 0 | 104 | 100 % |
| | +50% | 104 | 0 | 104 | 100 % |
| | +75% | 104 | 0 | 104 | 100 % |
| | +100% | 104 | 0 | 104 | 100 % |
| | | Number of samples | OTC user | | %Agreement With Reference Test |
| --- | --- | --- | --- | --- | --- |
| Drug | Concentration | | Negative | Positive | |
| OPI | Negative | 104 | 104 | 0 | 100 % |
| | -75 % | 104 | 104 | 0 | 100 % |
| | -50% | 104 | 104 | 0 | 100 % |
| | -25% | 104 | 93 | 11 | 89.4 % |
| | Cutoff | 104 | 1 | 103 | 99 % |
| | +25% | 104 | 0 | 104 | 100 % |
| | +50% | 104 | 0 | 104 | 100 % |
| | +75% | 104 | 0 | 104 | 100 % |
| | +100% | 104 | 0 | 104 | 100 % |
The labeling is rated at 8.3 grade reading level per Flesch-Kincaid methodology. All participants(100%) indicated on the questionnaire that the instructions are clear and that they do not find the QuikScreenTM Multi (MDMA and OPI) Drug Cup Test difficult to operate.
4. Clinical cut-off:
Not applicable
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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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