First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana
Device Facts
| Record ID | K171695 |
|---|---|
| Device Name | First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana |
| Applicant | W.H.P.M., Inc. |
| Product Code | NFT · Clinical Toxicology |
| Decision Date | Feb 5, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Indications for Use
First Sign® Drug of Abuse Cup Test Marijuana is a qualitative lateral flow immunoassay intended for the detection of Marijuana in human urine at cut-off concentration of 20 ng/mL. The tests provide only preliminary test results. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for prescription use. First Sign® Drug of Abuse Dip Card Test Marijuana is a qualitative lateral flow immunoassay intended for the detection of Marijuana in human urine at cut-off concentration of 20 ng/mL. The tests provide only preliminary test results. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for prescription use. First Sign Multi-Drug Cup Test is a qualitative lateral flow immunoassay intended for the detection of Amphetamine, Cocaine, and Methamphetamine in human urine at cut-off concentrations of 500 ng/mL, and 500 ng/mL, respectively. The tests provide only preliminary test results. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter use. First Sign® Multi-Drug Dip Card Test is a qualitative lateral flow immunoassay intended for the detection of Amphetamine, Cocaine, and Methamphetamine in human urine at cut-off concentrations of 500 ng/mL, and 500 ng/mL, respectively. The tests provide only preliminary test results. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter use.
Device Story
Lateral flow immunochromatographic assays for qualitative detection of drugs of abuse in human urine. Input: urine sample. Principle: competitive binding; target drugs compete with drug conjugate for limited antibody binding sites on particles. Output: visual colored line in test region indicates drug concentration below cut-off; absence of line indicates concentration above cut-off. Control line confirms proper flow. Used in point-of-care or home settings by lay users or professionals. Results are preliminary; require confirmation by GC/MS. Benefits: rapid, preliminary screening for drug presence.
Clinical Evidence
Bench testing only. Precision/reproducibility studies performed across 25 days with three operators using multiple lots. Analytical specificity and cross-reactivity evaluated against various metabolites and interfering substances. Method comparison against GC/MS performed with 80 clinical samples per drug. Lay-user study conducted with 320 participants to validate performance and instruction comprehension; results showed high concordance with GC/MS and successful user interpretation.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Formats: Dip Card and Cup. Single-use. No electronic components; visually read. Stability: 4-30°C (39-86°F) for 24 months. Analyte-specific monoclonal mouse antibodies. No external energy source required.
Indications for Use
Indicated for qualitative detection of Amphetamine, Cocaine, Methamphetamine, and Marijuana in human urine. Marijuana tests are for prescription use; Multi-Drug tests are for over-the-counter use.
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
- Advin Multi-Drug Screen Test (k122809)
Related Devices
- K180255 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup · Hangzhou Clongene Biotech Co., Ltd. · Feb 28, 2018
- K190412 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup · Hangzhou Clongene Biotech Co., Ltd. · Mar 21, 2019
- 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
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k171695
B. Purpose for Submission:
New device
C. Measurand:
Amphetamine, Marijuana, Cocaine, and Methamphetamine
D. Type of Test:
Qualitative immunochromatographic assay
E. Applicant:
W.H.P.M., Inc
F. Proprietary and Established Names:
First Sign Multi-Drug Cup Test
First Sign Multi-Drug Dip Card Test
First Sign Drug of Abuse Cup Test Marijuana
First Sign Drug of Abuse Dip Card Test Marijuana
G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NFT | II | 21 CFR 862.3100, Amphetamine Test System | Toxicology (91) |
| LDJ | II | 21 CFR 862.3870, Cannabinoids Test System | Toxicology (91) |
| NFY | II | 21 CFR 862.3250, Cocaine and Cocaine Metabolites Test System | Toxicology (91) |
| NGG | II | 21 CFR 862.3610, Methamphetamine Test System | Toxicology (91) |
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H. Intended Use:
1. Intended use(s):
See Indications for Use below.
2. Indication(s) for use:
First Sign Multi-Drug Cup Test:
First Sign Multi-Drug Cup Test is a qualitative lateral flow immunoassay intended for the detection of Amphetamine, Cocaine, and Methamphetamine in human urine at cut-off concentrations of 500 ng/mL, 150 ng/mL, and 500 ng/mL respectively.
The tests provide only preliminary test results. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. It should be used particularly when the preliminary result is positive.
For in vitro diagnostic use only. The tests are intended for over-the-counter use.
First Sign Multi-Drug Dip Card Test:
First Sign Multi-Drug Dip Card Test is a qualitative lateral flow immunoassay test intended for the detection of Amphetamine, Cocaine, and Methamphetamine in human urine at cut-off concentrations of 500 ng/mL, 150 ng/mL, and 500 ng/mL, respectively.
The tests provide only preliminary test results. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. It should be used particularly when the preliminary result is positive. For in vitro diagnostic use only.
For in vitro diagnostic use only. The tests are intended for over-the-counter use.
First Sign Drug of Abuse Cup Test Marijuana:
First Sign Drug of Abuse Cup Test Marijuana is a qualitative lateral flow immunoassay intended for the detection of Marijuana in human urine at cut-off concentration of 20 ng/mL.
The tests provide only preliminary test results. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be used when you get any drug of abuse test result.
For in vitro diagnostic use only. The test is intended for prescription use.
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First Sign Drug of Abuse Dip Card Test Marijuana:
First Sign Drug of Abuse Dip Card Test Marijuana is a qualitative lateral flow immunoassay intended for the detection of Marijuana in human urine at cut-off concentration of 20 ng/mL.
The tests provide only preliminary test results. The tests provide only preliminary test results. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be used when you get any drug of abuse test result.
For in vitro diagnostic use only. The test is intended for prescription use.
3. Special conditions for use statement(s):
For over-the-counter use (Amphetamine, Cocaine, and Methamphetamine).
For prescription use only (Marijuana).
4. Special instrument requirements:
Not applicable; this is a visually read single use device.
I. Device Description:
First Sign Multi-Drug Cup Test, First Sign Multi-Drug Dip Card Test, First Sign Drug of Abuse Cup Test Marijuana, and First Sign Drug of Abuse Dip Card Marijuana are lateral flow, immunochromatographic assays. The First Sign Multi-Drug Cup Test and the First Sign Multi-Drug Dip Card Test are for the qualitative detection of Amphetamine, Cocaine, and Methamphetamine in human urine. First Sign Drug of Abuse Cup Test Marijuana, and First Sign Drug of Abuse Dip Card Marijuana are for the qualitative detection of Marijuana in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.
J. Substantial Equivalence Information:
1. Predicate device name(s):
Advin Multi-Drug Screen Test
2. Predicate 510(k) number(s):
k122809
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3. Comparison with predicate:
Similarities and differences:
| Item | Candidate Device: First Sign Multi-Drug Cup Test First Sign Multi-Drug Dip Card Test (k171695) | Predicate Device: Advin Multi-Drug Screen Test (k122809) |
| --- | --- | --- |
| Indication(s) for Use | For the qualitative determination of drugs of abuse in human urine. | Same |
| Analyte and Cut-Off Values | Amphetamine: 500 ng/ml
Cocaine: 150 ng/ml
Methamphetamine: 500 ng/ml | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Intended Use | For over-the-counter use. | For over-the-counter and prescription use |
| Configurations | Dip Card, Cup | Same |
Similarities and differences:
| Item | Candidate Device: First Sign Drug of Abuse Cup Test Marijuana First Sign Drug of Abuse Dip Card Test Marijuana (k171695) | Predicate Device: Advin Multi-Drug Screen Test (k122809) |
| --- | --- | --- |
| Indication(s) for Use | For the qualitative determination of drugs of abuse in human urine. | Same |
| Analyte and Cut-Off Values | Marijuana: 20 ng/mL | Marijuana: 50 ng/mL |
| Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same |
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| Type of Test | Qualitative | Same |
| --- | --- | --- |
| Specimen Type | Human Urine | Same |
| Intended Use | For prescription use only. | For over-the-counter and prescription use |
| Configurations | Dip Card, Cup | Same |
## K. Standard/Guidance Document Referenced (if applicable):
Not applicable.
## L. Test Principle:
Each assay test is a lateral flow chromatographic immunoassay. During testing, a urine specimen migrates upward by capillary action. If target drugs are present in the urine below its cut-off concentration, it will not saturate the binding sites of its specific antibody (monoclonal mouse antibody) coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cut-off concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
Precision studies were carried out for samples with concentrations of -100% cut-off, -75% cut-off, -50% cut-off, -25% cut-off, cut-off, +25% cut-off, +50% cut-off, +75% cut-off and +100% cut-off. The samples used in the precision studies were prepared by spiking drug into negative urine samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blind-labeled by the person who prepared the samples and who did not take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days for each format of the device in a randomized order by three operators. The results obtained are summarized in the following tables:
Amphetamine Dip Card Format:
| Lot Number | -100% cut-off | -75% cut-off | -50% cut-off | -25% cut-off | cut-off | +25% cut-off | +50% cut-off | +75% cut-off | +100% cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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Amphetamine Cup Format:
| Lot Number | -100% cut-off | -75% cut-off | -50% cut-off | -25% cut-off | cut-off | +25% cut-off | +50% cut-off | +75% cut-off | +100% cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Marijuana Dip Card Format
| Lot Number | -100% cut-off | -75% cut-off | -50% cut-off | -25% cut-off | cut-off | +25% cut-off | +50% cut-off | +75% cut-off | +100% cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Marijuana Cup Format
| Lot Number | -100% cut-off | -75% cut-off | -50% cut-off | -25% cut-off | cut-off | +25% cut-off | +50% cut-off | +75% cut-off | +100% cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 4-/46+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Cocaine Dip Card Format
| Lot Number | -100% cut-off | -75% cut-off | -50% cut-off | -25% cut-off | cut-off | +25% cut-off | +50% cut-off | +75% cut-off | +100% cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Cocaine Cup Format
| Lot Number | -100% cut-off | -75% cut-off | -50% cut-off | -25% cut-off | cut-off | +25% cut-off | +50% cut-off | +75% cut-off | +100% cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Methamphetamine Dip Card Format
| Lot Number | -100% cut-off | -75% cut-off | -50% cut-off | -25% cut-off | cut-off | +25% cut-off | +50% cut-off | +75% cut-off | +100% cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 4-/46+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
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Methamphetamine Cup Format
| Lot Number | -100% cut-off | -75% cut-off | -50% cut-off | -25% cut-off | cut-off | +25% cut-off | +50% cut-off | +75% cut-off | +100% cut-off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 3-/47+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 2-/48+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
b. Linearity/assay reportable range:
Not applicable, these devices are intended for qualitative use only.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
The stability study protocols and acceptance criteria were reviewed and found to be acceptable. A transport simulation study was performed to test extreme shipping temperatures. The manufacturer claims that the devices are stable at 4 - 30°C (39-86°F) for 24 months based on accelerated stability studies. Real time stability studies are ongoing.
d. Detection limit:
Not applicable.
e. Analytical specificity:
Cross-reactivity:
To test specificity, drug metabolites and other components that are likely to cross-react in urine samples were tested using three lots of each format of the device. The substances were added to drug-free urine and cross-reactivity was determined based on the lowest concentration that produced a positive result. There were no differences observed between the two formats.
| Amphetamine | Result
Positive/Negative at (ng/ml) | % Cross-Reactivity |
| --- | --- | --- |
| D-Amphetamine (Cut-off = 500 ng/mL) | Positive at 500 | 100% |
| L-Amphetamine | Positive at 60000 | 0.8% |
| D, L-Amphetamine | Positive at 1000 | 50% |
| Methylenedioxyamphetamine (MDA) | Positive at 600 | 83% |
| R-(-)-Apomorphine | Positive at 13000 | 4% |
| β-Phenylethylamine | Positive at 600 | 6% |
| Tyramine | Positive at 5000 | 10% |
| Tryptamine | Positive at 10000 | 0.5% |
| Hydroxyamphetamine | Positive at 600 | 83% |
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| D-Pseudoephedrine | Negative at 105 | <0.5% |
| --- | --- | --- |
| D-Methamphetamine | Negative at ≥ 105 | <0.5% |
| L-Methamphetamine | Negative at ≥ 105 | <0.5% |
| (±)-Methamphetamine | Negative at ≥ 105 | <0.5% |
| Ephedrine | Negative at ≥ 105 | <0.5% |
| 3,4-Metylenedioxymethamphetamine (MDMA) | Negative at ≥ 105 | <0.5% |
| Methylenedioxymethamphetamine (MDE) | Negative at ≥ 105 | <0.5% |
| Phentermine | Negative at ≥ 105 | <0.5% |
| Cocaine | Result Positive/Negative at (ng/ml) | % Cross-Reactivity |
| --- | --- | --- |
| Benzoylecgonine (Cut-off = 150 ng/mL) | Positive at 150 | 100% |
| Cocaine HCL | Positive at 3000 | 5% |
| Norocaine | Negative at ≥ 105 | <0.5% |
| Cocaethylene | Negative at ≥ 105 | <0.5% |
| Ecgonine | Negative at ≥ 105 | <0.5% |
| Methamphetamine | Result Positive/Negative at (ng/ml) | % Cross-Reactivity |
| --- | --- | --- |
| D-Amphetamine (Cut-off = 150 ng/mL) | Positive at 500 | 100% |
| (±)3,4-Methylenedioxy-n-ethylamphetamine (MDEA) | Positive at 20000 | 2.5% |
| (±)-Methamphetamine | Positive at 1000 | 50% |
| P-Hydroxymehtamphetamine | Positive at 16000 | 3% |
| (±)3,4-MDMA | Positive at 2000 | 25% |
| L-Methamphetamine | Positive at 5000 | 10% |
| Fenfluramine | Positive at 40000 | 1.3% |
| L-Amphetamine | Positive at 60000 | 0.8% |
| Trimethobenzamide | Negative at ≥ 105 | <0.5% |
| Chloroquine | Negative at ≥ 105 | <0.5% |
| Ephedrine | Negative at ≥ 105 | <0.5% |
| Procaine (Novocain) | Negative at ≥ 105 | <0.5% |
| Ranitidine (Zantac) | Negative at ≥ 105 | <0.5% |
| D-Amphetamine | Negative at ≥ 105 | <0.5% |
| Oxazepame | Negative at ≥ 105 | <0.5% |
| Morphine | Negative at ≥ 105 | <0.5% |
| (±)3,4-MDA | Negative at ≥ 105 | <0.5% |
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Interference:
Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and urine with target drug concentrations at 25% below and 25% above cut-off levels. These urine samples were tested using three lots of each device. The compounds in the following table were tested at a concentration of 100 µg/mL, and did not show positive or negative interference. There were no differences observed for different device formats.
| Acetaminophen (4-Acetamidophenol) | Erythromycin | Oxazepam |
| --- | --- | --- |
| Acetophenetidin | β-Estradiol | Oxalic acid |
| N-Acetylprocainamide | Fenoprofen | Oxolinic acid |
| Acetylsalicylic acid | Furosemide | Oxymetazoline |
| Aminopyrine | Gentisic acid | Papaverine |
| Amoxicillin | Hydralazine | Penicillin-G |
| Ampicillin | Hydrochlorothiazide | Pentobarbital |
| Aspartame | Hydrocodone | Perphenazine |
| Ascorbic Acid | Hydrocortisone | Phenelzine |
| Apomorphine | O-Hydroxyhippuric acid | Phencyclidine |
| Atropine | 3-Hydroxytyramine | Prednisone |
| Benzilic acid | Ibuprofen | Procaine |
| Benzoic acid | D,L-Isoproterenol | DL-Propranolol |
| Bilirubin | Isoxsuprine | D-Propocyphene |
| Cannabidiol | Ketamine | D-Pseudoephedrine |
| Chloralhydrate | Ketoprofen | Quinine |
| Chloramphenicol | Labetalol | Ranitidine |
| Chlorothiazide | Loperamide | Salicylic acid |
| Chlorpromazine | Meprobamate | Secobarital |
| Chloroquine | Maprotiline | Serotonin (5- |
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| | | Hydroxytyramine) |
| --- | --- | --- |
| Cholesterol | Meperidine | Sulfamethazine |
| Clonidine | Methadone | Sulindac |
| Codeine | Methoxyphenamine | Tetrahydrocortisone 3-(β-D glucuronide) |
| Cortisone | Morphine-3-β-d-glucuronide | Tetrahydrozoline |
| (-) Cotinine | Nalidixic acid | Thiamine |
| Creatinine | Naloxone | Thioridazine |
| Deoxycorticosterone | Naltrexone | Triamterene |
| Dextromethorphan | Naproxen | DL-Tyrosine |
| Diclofenac | Niacinamide | Trifluoperazine |
| Diflunisal | Nifedipine | Trimethoprim |
| Digoxin | Norethindrone | D L-Tryptophan |
| Diphenhydramine | Norocodeine | Uric acid |
| Ecgonine methyl ester | Noscapine | Verapamil |
| EMDP | D,L-Octopamine | Zomepirac |
| Hemoglobin (1 mg/dL) | Albumin (1 mg/dL) | |
Effect of Urine Specific Gravity and Urine pH:
To investigate the effect of urine specific gravity and urine pH, urine samples with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 in increments of 1 pH unit were spiked with target drugs at 25% below and 25% above cut-off levels. These samples were tested using three lots of each device. For all devices, results were all positive for samples at 25% above cut-off and all negative for samples at 25% below cut-off.
f. Assay cut-off:
Characterization of how the device performs analytically around the claimed cut-off concentration appears in the precision/reproducibility section above (M.1.a.).
2. Comparison studies:
a. Method comparison with predicate device:
Method comparison studies were performed in-house with three laboratory assistants for each device format. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to GC/MS results. The results are presented in the tables below:
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Amphetamine Dip Card Format
| Dip Card | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 13 | 26 |
| | Negative | 10 | 10 | 19 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 13 | 26 |
| | Negative | 10 | 10 | 20 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 13 | 26 |
| | Negative | 10 | 10 | 19 | 1 | 0 |
Discordant Results of Amphetamine Dip Card Format
| Viewer | Sample Number | GC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 94912062 | 496 | Positive |
| Viewer C | 94911565 | 474 | Positive |
| Viewer A | 94912145 | 546 | Negative |
| Viewer B | 94912089 | 528 | Negative |
| Viewer C | 94912145 | 546 | Negative |
Amphetamine Cup Format
| Cup | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 13 | 26 |
| | Negative | 10 | 10 | 20 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 13 | 26 |
| | Negative | 10 | 10 | 19 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 14 | 26 |
| | Negative | 10 | 10 | 19 | 0 | 0 |
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Discordant Results of Amphetamine Cup Format
| Viewer | Sample Number | GC/MS Result | Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer B | 94911565 | 474 | Positive |
| Viewer C | 94912058 | 481 | Positive |
| Viewer A | 94912089 | 528 | Negative |
| Viewer B | 94912145 | 546 | Negative |
Cocaine Dip Card Format
| Dip Card | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 0 | 13 | 26 |
| | Negative | 10 | 10 | 20 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 13 | 26 |
| | Negative | 10 | 10 | 20 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 13 | 26 |
| | Negative | 10 | 10 | 19 | 1 | 0 |
Discordant Results for Cocaine Dip Card Format
| Viewer | Sample Number | GC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer C | 94911516 | 149 | Positive |
| Viewer A | 94912178 | 151 | Negative |
| Viewer B | 94911045 | 168 | Negative |
| Viewer C | 94911339 | 160 | Negative |
Cocaine Cup Format
| Cup | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 14 | 26 |
| | Negative | 10 | 10 | 19 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 13 | 26 |
| | Negative | 10 | 10 | 19 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 13 | 26 |
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13
| Cup | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| C | Negative | 10 | 10 | 20 | 1 | 0 |
Discordant Results Cocaine Cup Format
| Viewer | Sample Number | GC/MS Result | Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 94911516 | 149 | Positive |
| Viewer B | 94911033 | 139 | Positive |
| Viewer B | 94912178 | 151 | Negative |
| Viewer C | 94911339 | 160 | Negative |
Methamphetamine Dip Card Format
| Dip Card | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 13 | 26 |
| | Negative | 10 | 10 | 19 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 13 | 26 |
| | Negative | 10 | 10 | 20 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 13 | 26 |
| | Negative | 10 | 10 | 19 | 1 | 0 |
Discordant Results for Methamphetamine Dip Card
| Viewer | Sample Number | GC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 94911195 | 495 | Positive |
| Viewer B | 94912082 | 448 | Positive |
| Viewer A | 94912048 | 514 | Negative |
| Viewer B | 94912073 | 533 | Negative |
| Viewer C | 94912048 | 514 | Negative |
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Methamphetamine Cup Format
| Cup | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 13 | 26 |
| | Negative | 10 | 10 | 19 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 13 | 26 |
| | Negative | 10 | 10 | 20 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 13 | 26 |
| | Negative | 10 | 10 | 19 | 1 | 0 |
Discordant Results for Methamphetamine Cup
| Viewer | Sample Number | GC/MS Result | Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 94912072 | 445 | Positive |
| Viewer C | 94912082 | 448 | Positive |
| Viewer A | 94912073 | 533 | Negative |
| Viewer B | 94912073 | 533 | Negative |
| Viewer C | 94912048 | 514 | Negative |
Marijuana Dip Card Format
| Dip Card | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 13 | 26 |
| | Negative | 10 | 10 | 19 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 13 | 26 |
| | Negative | 10 | 10 | 19 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 13 | 26 |
| | Negative | 10 | 10 | 20 | 1 | 0 |
Discordant results Marijuana Dip Card
| Viewer | Sample Number | GC/MS Result | Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 94912036 | 18 | Positive |
| Viewer B | 94911685 | 17.8 | Positive |
| Viewer A | 94911819 | 22.6 | Negative |
| Viewer B | 94912007 | 21.3 | Negative |
| Viewer C | 94911788 | 22 | Negative |
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Marijuana Cup Format
| Cup | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cut-off) | Near Cutoff Positive by GC/MS (Between the cut-off and +50%) | High Positive by GC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 1 | 13 | 26 |
| | Negative | 10 | 10 | 19 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 13 | 26 |
| | Negative | 10 | 10 | 19 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 13 | 26 |
| | Negative | 10 | 10 | 19 | 1 | 0 |
Discordant results Marijuana Cup
| Viewer | Sample Number | GC/MS Result | Cup Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 94911691 | 19.7 | Positive |
| Viewer B | 94911686 | 17 | Positive |
| Viewer C | 94911685 | 17.8 | Positive |
| Viewer A | 94911788 | 22 | Negative |
| Viewer C | 94911819 | 22.6 | Negative |
b. Matrix comparison:
Not applicable. These devices are for use with urine samples only.
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 at three intended user sites with 320 lay persons using the First Sign Multi-Drug Cup Test and the First Sign Multidrug Dip Card Test. The lay users had diverse educational and professional backgrounds and ranged in age from 21 to >50 years. Urine samples were prepared at the following concentrations; +/-100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug-free pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and was blind labeled. Each participant was
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provided with the package insert, one blind labeled sample and one device. The results are summarized below:
Comparison between GC/MS and Lay Person Results for Amphetamine Dip Card:
| % of Cut-off | Number of samples | Drug Concentration by GC/MS (ng/mL) | Lay person Results | |
| --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative |
| -100% Cut-off | 20 | 0 | 0 | 20 |
| -75% Cut-off | 20 | 130 | 0 | 20 |
| -50% Cut-off | 20 | 245 | 0 | 20 |
| -25% Cut-off | 20 | 374 | 1 | 19 |
| +25% Cut-off | 20 | 649 | 20 | 0 |
| +50% Cut-off | 20 | 768 | 20 | 0 |
| +75% Cut-off | 20 | 857 | 20 | 0 |
| +100% Cut-off | 20 | 1019 | 20 | 0 |
Comparison between GC/MS and Lay Person Results for Cocaine Dip Card
| % of Cut-off | Number of samples | Drug Concentration by GC/MS (ng/mL) | Lay person Results | |
| --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative |
| -100% Cut-off | 20 | 0 | 0 | 20 |
| -75% Cut-off | 20 | 37 | 0 | 20 |
| -50% Cut-off | 20 | 73 | 0 | 20 |
| -25% Cut-off | 20 | 109 | 0 | 20 |
| +25% Cut-off | 20 | 178 | 18 | 2 |
| +50% Cut-off | 20 | 223 | 20 | 0 |
| +75% Cut-off | 20 | 258 | 20 | 0 |
| +100% Cut-off | 20 | 301 | 20 | 0 |
Comparison between GC/MS and Lay Person Results for Methamephetamine Dip Card:
| % of Cut-off | Number of samples | Drug Concentration by GC/MS (ng/mL) | Lay person Results | |
| --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative |
| -100% Cut-off | 20 | 0 | 0 | 20 |
| -75% Cut-off | 20 | 129 | 0 | 20 |
| -50% Cut-off | 20 | 259 | 0 | 20 |
| -25% Cut-off | 20 | 393 | 1 | 19 |
| +25% Cut-off | 20 | 669 | 20 | 0 |
| +50% Cut-off | 20 | 730 | 20 | 0 |
| +75% Cut-off | 20 | 930 | 20 | 0 |
| +100% Cut-off | 20 | 1028 | 20 | 0 |
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Comparison between GC/MS and Lay Person Results for Amphetamine Cup:
| % of Cut-off | Number of samples | Drug Concentration by GC/MS (ng/mL) | Lay person Results | |
| --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative |
| -100% Cut-off | 20 | 0 | 0 | 20 |
| -75% Cut-off | 20 | 130 | 0 | 20 |
| -50% Cut-off | 20 | 245 | 0 | 20 |
| -25% Cut-off | 20 | 374 | 0 | 20 |
| +25% Cut-off | 20 | 649 | 19 | 1 |
| +50% Cut-off | 20 | 768 | 20 | 0 |
| +75% Cut-off | 20 | 857 | 20 | 0 |
| +100% Cut-off | 20 | 1019 | 20 | 0 |
Comparison between GC/MS and Lay Person Results for Cocaine Cup
| % of Cut-off | Number of samples | Drug Concentration by GC/MS (ng/mL) | Lay person Results | |
| --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative |
| -100% Cut-off | 20 | 0 | 0 | 20 |
| -75% Cut-off | 20 | 37 | 0 | 20 |
| -50% Cut-off | 20 | 73 | 0 | 20 |
| -25% Cut-off | 20 | 109 | 1 | 19 |
| +25% Cut-off | 20 | 178 | 20 | 0 |
| +50% Cut-off | 20 | 223 | 20 | 0 |
| +75% Cut-off | 20 | 258 | 20 | 0 |
| +100% Cu-toff | 20 | 301 | 20 | 0 |
Comparison between GC/MS and Lay Person Results for Methamphetamine Cup:
| % of Cut-off | Number of samples | Drug Concentration by GC/MS (ng/mL) | Lay person Results | |
| --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative |
| -100% Cut-off | 20 | 0 | 0 | 20 |
| -75% Cut-off | 20 | 129 | 0 | 20 |
| -50% Cut-off | 20 | 259 | 0 | 20 |
| -25% Cut-off | 20 | 393 | 1 | 19 |
| +25% Cut-off | 20 | 669 | 20 | 0 |
| +50% Cut-off | 20 | 730 | 20 | 0 |
| +75% Cut-off | 20 | 930 | 20 | 0 |
| +100% Cut-off | 20 | 1028 | 20 | 0 |
Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed.
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A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading grade level of 7.
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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