FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST
Device Facts
| Record ID | K061617 |
|---|---|
| Device Name | FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST |
| Applicant | Tianjin New Bay Bioresearch Co., Ltd. |
| Product Code | DKZ · Clinical Toxicology |
| Decision Date | Nov 22, 2006 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Indications for Use
Forsure One Step Dip & Read Drug Screen Test of Amphetamine, Methamphetamine, Benzoylecgonine, Benzodiazepine, Marijuana, Morphine, Phencyclidine, Methadone , Oxycodone, Tricyclic Antidepressant, Barbiturates and Propoxyphene Test device are a Chromatographic immunoassay for qualitative determination of the presence of Amphetamine at a cutoff concentration of 1000 ng/ml, Methamphetamine at a cutoff concentration of 1000 ng/ml, THC at a cutoff concentration of 50 ng/ml, Morphine at a cutoff concentration of 2000 ng/ml, Benzoylecgonine at a cutoff concentration of 300 ng/ml , Phencyclidine at a cutoff concentration of 25 ng/ml, Benzodiazepine at cutoff concentration of 300 ng/ml, Methadone at cutoff concentration of 300 ng/ml, Oxycodone at cutoff concentration of 100 ng/ml, Tricyclic Antidepressant at cutoff concentration of 1000 ng/ml, Barbiturates at cutoff concentration of 300 ng/ml, and Propoxyphene at cutoff concentration of 300 ng/ml. The assay provides a simple and rapid analytical screening procedure to detect Amphetamine, THC, Morphine, Methamphetamine, Benzoylecognine, Phencyclidine, Benzodiazepine, Methadone, Oxycodone, Tricyclic Antidepressant, Barbiturates and Propoxyphene in human urine. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.
Device Story
Lateral flow immunochromatographic test; detects drugs/metabolites in human urine. Device consists of up to 12 absorbent strips; each strip contains colloidal gold-labeled mouse monoclonal anti-drug antibodies and immobilized drug-protein conjugates. Principle: competitive binding; drug in sample competes with immobilized conjugate for antibody sites. Result: presence of drug prevents line formation (preliminary positive); absence of drug allows line formation (negative). Used in central laboratories by professionals; visually read. Provides preliminary results; requires GC/MS confirmation for clinical decision-making.
Clinical Evidence
No clinical studies performed. Analytical performance established via bench testing. Method comparison conducted using 93-110 clinical urine samples per analyte, compared against GC/MS. Results showed high agreement (93-100%) across all analytes. Precision and reproducibility studies confirmed performance at 75%, 100%, and 125% of cutoff concentrations.
Technological Characteristics
Lateral flow immunochromatographic assay; colloidal gold-labeled antibody-antigen complex; porous membrane support; visual read; standalone single-use device; no instrumentation required; storage below 28°C.
Indications for Use
Indicated for professional use in central laboratories for qualitative screening of Amphetamine, Methamphetamine, Benzodiazepine, Barbiturate, Cocaine, Cannabinoids, Opiates, Phencyclidine, Methadone, Oxycodone, Tricyclic Antidepressant, and Propoxyphene in human urine. Prescription use only.
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
- UCP Bioscience Rapid Drug Screening Test Strips (K050540)
- TNB Forsure One Step Drug Screen Test Cup Device (K052882)
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k061617
B. Purpose for Submission:
New device
C. Measurand:
Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Benzoylecgonine, Morphine, Tetrahydrocannabinol (THC), Phencyclidine (PCP), Methadone, Oxycodone, Tryicyclic Antidepressant (TCA), and Propoxyphene in urine.
D. Type of Test:
Qualitative lateral flow immunochromatographic test
E. Applicant:
Tianjin New Bay Bioresearch Co., Ltd.
F. Proprietary and Established Names:
Forsure One Step Dip & Read Drug Screen Test
G. Regulatory Information:
1. Regulation section:
21 CFR 862.3100, Amphetamine Test System
21 CFR 862.3150, Barbiturate Test System
21 CFR 862.3170, Benzodiazepine Test System
21 CFR 862.3250, Cocaine and Cocaine Metabolite Test System
21 CFR 862.3610, Methamphetamine Test System
21 CFR 862.3620, Methadone Test System
21 CFR 862.3650, Opiates and Test System
21 CFR 862.3700, Propoxyphene Test System
21 CFR 862.3870, Cannabinoids Test System
21 CFR 862.3910, Tricyclic Antidepressant
21 CFR 862.3200, Clinical Toxicology Calibrator
21 CFR 862.3280, Clinical Toxicology Control Material Unclassified, Phencyclidine
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2. Classification:
Class II
3. Product code:
DKZ, DIS, JXM, DIO, DJC, DJR, DJG, JXN, LDJ, LFG, and LCM
4. Panel:
Toxicology (91)
H. Intended Use:
1. Intended use(s):
Refer to the Indications for use.
2. Indication(s) for use:
Forsure One Step Dip & Read Drug Screen Test is a prescription assay intended for professional use in central laboratories only. It provides qualitative screening results for Amphetamine (AMP), Methamphetamine (MET), Benzodiazepine (BZD), Barbiturate (BAR), Cocaine (COC), Cannibinoids (THC), Opiates (OPI), Phencyclidine (PCP), Methadone (MTD), Oxycodone (OXY), Tricyclic Antidepressant (TCA) and Propoxyphene (PPX) in human urine at the following cutoff levels:
| Test | Calibrator | Cutoff |
| --- | --- | --- |
| Amphetamine | D-Amphetamine | 1000 ng/mL |
| Methamphetamine | D-Methamphetamine | 1000 ng/mL |
| Benzodiazepine | Oxazepam | 300 ng/mL |
| Barbiturate | Secobarbital | 300 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Cannabinoids | 11-norΔ9-THC-9 COOH | 50 ng/mL |
| Opiates | Morphine | 2000 ng/mL |
| Phencyclidine | Phencyclidine | 25 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Tricyclic Antidepressant | Nortriptyline | 1000 ng/mL |
| Propoxyphene | Propoxyphene | 300 ng/mL |
The assay provides only preliminary analytical test results. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly in evaluating a preliminary positive. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.
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3. Special conditions for use statement(s):
This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly in evaluating a preliminary positive. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.
For prescription use only.
4. Special instrument requirements:
Not applicable; the device is a visually-read single-use device.
I. Device Description:
Forsure One Step Dip & Read Drug Screen Test contains up to twelve individual chromatographic absorbent strips in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. The method employs unique monoclonal and polyclonal antibodies to selectively identify the drug or drug metabolite in the sample. The membrane on the strip is coated with goat anti-mouse antibody and a specific drug-protein conjugate. The sample pad contains a colloidal gold labeled mouse monoclonal anti specific drug antibody. The device is for single-use and is visually read.
J. Substantial Equivalence Information:
1. Predicate device name(s):
Forsure Rapid One Step Multiple (X) Abuse Drug Screen Test Cup Device
2. Predicate 510(k) number(s):
k052882
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use | Qualitative determination of drugs in human urine | Same |
| Matrix | Human Urine | Same |
| Test Principle | Immunochromatographic, lateral flow | Same |
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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Analytes | Amphetamine
Methamphetamine
Benzodiazepine,
Barbiturate, Cocaine,
Cannibinoids , Opiates
PCP, Methadone,
Oxycodone, TCA and
Propoxyphene | Same |
K. Standard/Guidance Document Referenced (if applicable):
None referenced
L. Test Principle:
The test employs lateral flow immunochromatographic technology. Drug in the sample and drug-labeled conjugate (containing a chromagen) compete for antibody binding sites in the test area of the test strip. Binding of drug in the sample causes the absence of a line at the test area, i.e., a preliminary positive result. When drug is not present in the sample, the drug-labeled conjugate binds at the test line, resulting in formation of a line, i.e., a negative result. The absence or presence of the line is determined visually by the operator.
The device also has an internal process control which indicates that an adequate volume of sample has been added and that the immunochromatographic strip is intact.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Precision studies were performed using in house drug standards. The standard was diluted in drug-free urine to give drug concentrations at the following levels: 0, 50%, 75%, 100%, 125% and 150% of the cutoff. A total of 15 determinations were made at each concentration for each analyte. Testing was performed on one day by one operator. All samples at 0 and -50% yielded negative results and all samples 150% yielded positive results. Within lot precision study data for 75%, 100% and 125% is summarized below:
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| 75% Cutoff | AMP | MET | MOR | BEG | BAR | BZD | THC | PCP | MAD | OXY | TCA | PPX |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Total # determinations | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 |
| Concentration (ng/mL) | 750 | 750 | 1500 | 150 | 225 | 225 | 37.5 | 18.75 | 225 | 75 | 750 | 225 |
| #NEG/#POS | 12/3 | 12/3 | 13/2 | 12/3 | 14/1 | 13/2 | 12/3 | 11/4 | 13/2 | 10/5 | 11/4 | 12/3 |
| Precision | 80% | 80% | 87% | 80% | 93% | 87% | 80% | 73% | 87% | 67% | 73% | 80% |
| 100% Cutoff | AMP | MET | MOR | BEG | BAR | BZD | THC | PCP | MAD | OXY | TCA | PPX |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Total # determinations | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 |
| Concentration (ng/mL) | 1000 | 1000 | 2000 | 300 | 300 | 300 | 50 | 25 | 300 | 100 | 1000 | 300 |
| #NEG/#POS | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 |
| Precision | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% |
| 125% Cutoff | AMP | MET | MOR | BEG | BAR | BZD | THC | PCP | MAD | OXY | TCA | PPX |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Total # determinations | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 |
| Concentration (ng/mL) | 1250 | 1250 | 2500 | 375 | 375 | 375 | 62.5 | 31.25 | 375 | 125 | 1250 | 375 |
| #NEG/#POS | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 |
| Precision | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% |
## Inter Lot Reproducibility
To test inter lot precision, drug-free urine was spiked with commercially available drug standard to the following levels: 0, 50%, 75%, 100%, 125% and 150% of cutoff. Testing was performed using three different lot numbers, 15 samples of each lot were run at each of the concentrations for each drug over 20 days. All samples tested at 0, -50% yielded negative results and all samples at 150% yielded positive results. Inter lot Precision Study data for 75%, 100% and 125% of cutoff is summarized below:
| 75% Cutoff | Total # determination | | | # Negative/# Positive | | | inter Lot Precision (%) | | | Average Lot |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Precision |
| AMP | 15 | 15 | 15 | 14/1 | 13/2 | 13/2 | 93% | 87% | 87% | 89% |
| MET | 15 | 15 | 15 | 11/4 | 14/1 | 11/4 | 73% | 93% | 73% | 80% |
| MOR | 15 | 15 | 15 | 14/1 | 12/3 | 12/3 | 93% | 80% | 80% | 84% |
| BEG | 15 | 15 | 15 | 13/2 | 14/1 | 14/1 | 87% | 93% | 93% | 91% |
| BAR | 15 | 15 | 15 | 14/1 | 13/2 | 14/1 | 93% | 87% | 93% | 91% |
| BZD | 15 | 15 | 15 | 12/3 | 13/2 | 11/4 | 80% | 87% | 73% | 80% |
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| 100% Cutoff | Total # determination | | | # Negative/# Positive | | | inter Lot Precision (%) | | | Average Lot |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Precision |
| AMP | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100% |
| MET | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100% |
| MOR | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100% |
| BEG | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100% |
| BAR | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100% |
| BZD | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100% |
| THC | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100% |
| PCP | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100% |
| MTD | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100% |
| OXY | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100% |
| TCA | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100% |
| PPX | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100% |
| 125% Cutoff | Total # determination | | | # Negative/# Positive | | | inter Lot Precision (%) | | | Average Lot |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Precision |
| AMP | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100% |
| MET | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100% |
| MOR | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100% |
| BEG | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100% |
| BAR | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100% |
| BZD | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100% |
| THC | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100% |
| PCP | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100% |
| MTD | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100% |
| OXY | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100% |
| TCA | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 | 100% | 100% | 100% | 100% |
b. Linearity/assay reportable range:
Not applicable. The assay is intended for qualitative use.
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c. Traceability, Stability, Expected values (controls, calibrators, or methods):
The device has an internal procedural control. A magenta line appearing in the control region (C) is considered as an internal procedural control. It confirms sufficient specimen volume and adequate membrane wicking.
External control materials are not supplied with these tests; however it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance. User should follow local, state and federal guidelines for testing QC material.
**Stability**
Real time and accelerated studies have been conducted. Protocols and acceptance criteria were described and found to be acceptable. The manufacturer claims the following expiration date:
When stored at 2 – 30°C product is good until expiration date which is 18 months.
d. Detection limit:
A drug-free urine pool was spiked with specific drug at the following concentrations: 25% and 50% below the cutoff, cutoff and 25% above the cutoff. The results are presented in the table below:
| | AMP | MET | BZD | BAR | BEG | THC | MOR | PCP | MAD | OXY | TCA | PPX |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Total # determinations | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 | 15 |
| -50% of cutoff/concentration ng/mL | 500 | 500 | 150 | 150 | 150 | 25 | 1000 | 12.5 | 150 | 50 | 500 | 150 |
| #NEG/#POS | 15/0 | 15/0 | 15/0 | 15/0 | 15/0 | 15/0 | 15/0 | 15/0 | 15/0 | 15/0 | 15/0 | 15/0 |
| | | | | | | | | | | | | |
| -25% of cutoff/concentration ng/mL | 750 | 750 | 225 | 225 | 750 | 225 | 1500 | 75 | 18.75 | 225 | 750 | 37.5 |
| #NEG/#POS | 12/3 | 11/4 | 11/4 | 11/4 | 11/4 | 9/6 | 12/3 | 11/4 | 10/5 | 10/5 | 13/2 | 10/5 |
| | | | | | | | | | | | | |
| Cutoff/concentration ng/mL | 1000 | 300 | 300 | 300 | 1000 | 300 | 2000 | 100 | 25 | 300 | 1000 | 50 |
| NEG/#POS | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 |
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| | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| +25% of cutoff/concentration ng/mL | 1250 | 375 | 375 | 375 | 1250 | 375 | 2500 | 125 | 31.25 | 375 | 1250 | 62.5 |
| #NEG/#POS | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 |
e. Analytical specificity:
Cross-reactivity was established by spiking various concentrations of similarly structured drug compounds into normal human urine. By analyzing various concentration of each compound the sponsor determined the concentration of the drug that produced a response approximately equivalent to the cutoff concentration of the assay. Results of those studies appear in the tables below:
| Amphetamine | |
| --- | --- |
| Drug Compound | Response equivalent to cutoff in ng/mL |
| d-amphetamine | 1000 |
| l-amphetamine | 25,000 |
| d-l-amphetamine | 10,000 |
| B-Phenylethylamine | 180,000 |
| Tyramin | 100000 |
| (±)3,4-Methylenedioxyamphetamine ((±)3,4-MDA) | 1200 |
| (±)3,4-Methylenedioxyethylamphetamine ((±)3,4-MDA) | 100000 |
| Methamphetamine | |
| --- | --- |
| Drug Compound | Response equivalent to cutoff in ng/mL |
| d-Amphetamine | 200000 |
| l-Amphetamine | 200,000 |
| d-Methamphetamine | 1000 |
| (±)3,4-Methylenedioxyamphetamine ((±)3,4-MDA) | 1000 |
| (±)3,4-Methylenedioxyethylamphetamine ((±)3,4-MDA) | 500 |
| Morphine | |
| --- | --- |
| Drug compound | Response equivalent to cutoff in ng/mL |
| Morphine | 2000 |
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| Morphine | |
| --- | --- |
| Drug compound | Response equivalent to cutoff in ng/mL |
| Morphine-3-β-D glucuronide | 2000 |
| Codeine | 2000 |
| Heroin | 2000 |
| Levorphanol | 4000 |
| 6-Monoacetylmorphine | 50 |
| Hydromorphone | 5000 |
| Hydrocodone | 20000 |
| Oxycodone | 60000 |
| Ethylmorphine | 50 |
| Cocaine | |
| --- | --- |
| Compound | Response equivalent to cutoff in ng/mL |
| Benzoylecgonine | 300 |
| Cocaine | 300 |
| Cocaethylene | 50 |
| Cannabinoids (THC) | |
| --- | --- |
| Compound | Response equivalent to cutoff in ng/mL |
| Cannabinol | 10000 |
| 11-Nor-Δ8-Tetrahydrocannabinol carboxylic acid | 50 |
| 11-Nor-Δ9-Tetrahydrocannabinol carboxylic acid | 50 |
| Δ8-Tetrahydrocannabinol | 7500 |
| Δ9-Tetrahydrocannabinol | 10000 |
| 11-hydroxy-Δ9-Tetrahydrocannabinol | 2500 |
| Phencyclidine | |
| --- | --- |
| Compound | Response equivalent to cutoff in ng/mL |
| Tenocyclidine | 2000 |
| Phencyclidine | 25 |
| 4-Hydroxyphencyclidine | 1000 |
| Phencyclidine Morphine | 5 |
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| Barbiturates | |
| --- | --- |
| Compound | Response equivalent to cutoff in ng/mL |
| Secobarbital | 300 |
| Allobarbital | 600 |
| Amobarbital | 600 |
| Barbital | 300 |
| Butabarbital | 300 |
| Butalbital | 300 |
| Pentobarbital | 300 |
| Phenobarbital | 300 |
| Benzodiazepines | |
| --- | --- |
| Compound | Response equivalent to cutoff in ng/mL |
| Alprazolam | 600 |
| Chlordiazepoxide | 300 |
| Diazepam | 300 |
| Oxazepam | 300 |
| Clonazepam | 300 |
| Flunitrazepam | 300 |
| Nitrazepam | 250 |
| Bromazepam | 100 |
| Clobazam | 300 |
| Estazolam | 300 |
| Flurazepam | 150 |
| Lorazepam | 500 |
| Lormetazepam | 500 |
| Clorazepate | 200 |
| Nordiazepam | 150 |
| Prazepam | 1500 |
| Temazepam | 150 |
| Delorazepam | 3000 |
| Triazolam | 200 |
| Methadone | |
| --- | --- |
| Compound | Response equivalent to cutoff in ng/mL |
| Methadone | 300 |
| Doxylamine | 50000 |
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| Methadone | |
| --- | --- |
| Compound | Response equivalent to cutoff in ng/mL |
| EDDP | 100000 |
| Methadol | 25000 |
| Perphenazine | 75000 |
| Protriptyline | 2000 |
| Trimipramine | 10000 |
| Propoxyphene | |
| --- | --- |
| Compound | Response equivalent to cutoff in ng/mL |
| Propoxyphene | 300 |
| Norpropoxphene | 1000 |
| Methadone | 1350000 |
| 2-ethyl-1,5-dimethyl 3,3-diphenylpyrroline | 200000 |
| Oxycodone | |
| --- | --- |
| Compound | Response equivalent to cutoff in ng/mL |
| Oxycodone-HCL | 100 |
| Morphine-Sulfate | 7000 |
| Codeine | 700 |
| Morphine 3-β-D glucuronide | 40000 |
| Hydromorphone | 1500 |
| Norcodeine | 40000 |
| Oxymorphone | 300 |
| Hydrocodone | 500 |
| Tricyclic Antidepressant (TCA) | |
| --- | --- |
| Compound | Response equivalent to cutoff in ng/mL |
| Amitriptyline | 1000 |
| Cyclobenzaprine | 1500 |
| Clomipramine | 5000 |
| Desipramine | 600 |
| Doxepin | 1000 |
| Imipramine | 600 |
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| Tricyclic Antidepressant (TCA) | |
| --- | --- |
| Compound | Response equivalent to cutoff in ng/mL |
| Nortriptyline | 1000 |
| Nordoxepin | 1000 |
The following compounds were evaluated for potential positive and/or negative interference with the assay. To evaluate for interference the sponsor added potentially interfering compounds to drug-free urine (to test for positive interference) and to urine samples at the cutoff concentration (to test for negative interference). All potential interferents were added at a concentration of 100 $\mu \mathrm{g} / \mathrm{mL}$ . There were no deviations from the expected results.
| Common Substances | | |
| --- | --- | --- |
| Acetaminophen | Diphenhydramine | (+/-) Naproxen |
| Acetone | 5,5-Diphenylhydantoin | Nicotine |
| Acetylsalicylic Acid | Dopamine | Nor-Bupreorphine |
| Amikacin | EDDP | Noscapine Hydrochloride |
| Amitriptyline | + Ephedrine | Oxalic Acid |
| Ampicillin | - Ephedrine | Omega-3-fatty acid |
| l-Ascorbic Acid | +/- Epinephrine | Penicillin-G |
| Aspartame | Erythromycin | Phenalzine |
| Aspirin | Ethanol | l-Phenylephrine |
| Atropine | Fentanyl | (+/-) Phenylpropanolamine |
| Benzocaine | Fluoxetine | Promathazine |
| Benzoic Acid | Furosemide | Pseudoephedrine |
| Buprenophine-3-β-D-glucuronide | Glucosamine | Quinine |
| (+)-Brompheniramine | Guaiacol Glyceryl Ether | Quinidine |
| Buprenorphine | Hydrochlorothiazide | Salicylic Acid |
| --- | --- | --- |
| Caffeine | Hydrocodone | Sustiva |
| (+)-Chlorpheniramine | Ibuprofen | Sulindac |
| (+/-)- Chlorpheniramine | Ketamine | Theophyline |
| Chlorpromazine | Lidocaine | Thioridazine |
| Cortisone | Maprotiline | Tramandol |
| (-)-Cotinin | Meperidine | d(+)-Trehalose |
| Creatinine | Methanol | Trifluoperazine |
| Dextromethorphan | Methylphenidate | |
| 4-Dimethylaminoantipyrine | Naltrexone | |
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The following endogenous compounds were evaluated for potential positive and/or negative interference with the assay. To evaluate for interference the sponsor added potentially interfering compounds to drug-free urine (to test for positive interference) and to urine samples at the cutoff concentration plus 25% (to test for negative interference). There were no deviations from the expected results.
| Substances | |
| --- | --- |
| Bilirubin | 1.0 mg/dL |
| Creatinine | 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 |
There is the possibility that other substances and/or factors not listed above may interfere with the test and cause false results, e.g., technical or procedural errors.
## Specific Gravity
Two drug free urine samples, one with a specific gravity of 1.030 and the other 1.003 were prepared. The samples were divided into two and one was spiked with drug concentration at 25% above the cutoff for all the analytes. Each sample was run in duplicate. The results demonstrate that a specific gravity range of 1.003 – 1.030 did not affect the expected or accuracy of the results.
## pH
The pH of an aliquot negative urine pool was adjusted to a pH range of 4 to 9 in 1 pH increments for a total of six samples. Each of the samples was split into two samples to form a pair for each pH level. One of the paired samples from each set was spiked with drug concentration at 25% above the cutoff for all the analytes. Each sample was run on the device and the results demonstrate that varying ranges of pH dose not interfere with the performance of the test.
## f. Assay cut-off:
The identified cutoff concentrations for amphetamine, cocaine, methamphetamine, opiates 2000, Phencyclidine and THC are those recommended by the Substance Abuse and Mental Health Services Administration (SAMHSA). SAMHSA has not recommended a cutoff concentration for Barbiturate, Benzodiazepine, Oxycodone, Propoxyphene and Tricyclic Antidepressant (TCA).
13
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Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision and detection sections above.
# 2. Comparison studies:
# a. Method comparison with predicate device:
93-110 unaltered clinical urine samples, depending on the drug type, were evaluated. Specimens obtained from a reference laboratory were tested using the Forsure One Step Dip & Read Drug Screen Test and Gas Chromatography/Mass Spectrometry (GC/MS). Approximately $10\%$ of samples had drug concentration between $50\%$ below the cutoff and the cutoff concentration, another $10\%$ of samples had drug concentration between the cutoff and $50\%$ above the cutoff concentration.
| | Candidate Device Results | Negative by GC/MS | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) | % Agreement (among positives and negatives) |
| --- | --- | --- | --- | --- | --- | --- |
| AMP | Positive | 0 | 2 | 5 | 42 | 100% |
| | Negative | 58 | 3 | 0 | 0 | 96.8% |
| MET | Positive | 0 | 1 | 10 | 31 | 100% |
| | Negative | 55 | 4 | 0 | 0 | 98.3% |
| BEG | Positive | 0 | 1 | 17 | 25 | 100% |
| | Negative | 49 | 4 | 0 | 0 | 98.1% |
| THC | Positive | 0 | 1 | 6 | 36 | 100% |
| | Negative | 50 | 3 | 0 | 0 | 98% |
| MOR | Positive | 0 | 1 | 17 | 24 | 100% |
| | Negative | 50 | 4 | 0 | 0 | 98% |
| PCP | Positive | 0 | 4 | 16 | 24 | 100% |
| | Negative | 50 | 3 | 0 | 0 | 93% |
| BZD | Positive | 0 | 0 | 15 | 28 | 100% |
| | Negative | 49 | 4 | 0 | 0 | 100% |
| MAD | Positive | 0 | 0 | 9 | 33 | 100% |
| | Negative | 48 | 4 | 0 | 0 | 100% |
| OXY | Positive | 0 | 1 | 5 | 50 | 100% |
| | Negative | 39 | 4 | 0 | 0 | 98% |
| TCA | Positive | 0 | 1 | 18 | 23 | 100% |
| | Negative | 38 | 4 | 0 | 0 | 98% |
| BAR | Positive | 0 | 2 | 19 | 20 | 100% |
| | Negative | 49 | 3 | 0 | 0 | 96% |
{14}
| | Candidate Device Results | Negative by GC/MS | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) | % Agreement (among positives and negatives) |
| --- | --- | --- | --- | --- | --- | --- |
| PPX | Positive | 0 | 2 | 19 | 24 | 100% |
| | Negative | 53 | 2 | 0 | 0 | 96.3% |
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):
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.
