QuickScreen Pro Multi Drug Screening Test, Model 9395Z
Device Facts
| Record ID | K181945 |
|---|---|
| Device Name | QuickScreen Pro Multi Drug Screening Test, Model 9395Z |
| Applicant | Phamatech, Inc. |
| Product Code | DKZ · Clinical Toxicology |
| Decision Date | Oct 18, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Indications for Use
The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a screening test for the qualitative detection of amphetamines, barbiturates, benzodiazepines, cocaine, ecstasy, methadone, methamphetamine, opiates, oxycodone, phencyclidine, marijuana, tricyclic antidepressants (imipramine) and buprenorphine in urine at the cut-off concentrations listed below. Test for barbiturates, benzodiazepine, oxycodone, buprenorphine and tricyclic antidepressants (imipramine) cannot distinguish between abused drugs and certain prescription medications. The test is intended for professional use only.
Device Story
Single-use, cup-format lateral flow immunoassay; detects drugs of abuse in urine. Input: urine sample; mechanism: competitive immunoassay using monoclonal/polyclonal antibodies on porous membrane; drug/metabolites compete with drug/protein conjugate for binding sites. Output: visual qualitative result indicated by self-timer. Used in professional point-of-care settings; interpreted by healthcare professionals. Provides preliminary results; requires confirmation via GC/MS or other methods. Benefits: rapid screening for clinical decision-making.
Clinical Evidence
No clinical studies performed. Evidence consists of analytical performance data including precision/reproducibility studies (n=80 per level) and method comparison studies against GC/MS reference method. Method comparison conducted at multiple POC sites using unaltered clinical urine samples. Results demonstrated high concordance with GC/MS; discrepant results were observed near the cut-off concentrations. Analytical specificity (cross-reactivity and interference) and stability (22-month claim) were also evaluated.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Materials: monoclonal anti-drug antibody/colloidal gold conjugate, drug derivative/protein conjugate, goat anti-rabbit antibody. Format: single-use disposable cup with 12 test strips. No external controls. No electronic components; visual readout.
Indications for Use
Indicated for professional, prescription-only qualitative screening of urine for amphetamines, barbiturates, benzodiazepines, cocaine, ecstasy (MDMA), methadone, methamphetamine, opiates, oxycodone, phencyclidine, marijuana, tricyclic antidepressants (Imipramine), and buprenorphine.
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
- At Home Drug Test 12: Model 9308Z (k070009)
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k181945
B. Purpose for Submission:
Modification of a previously cleared device to add Imipramine and Buprenorphine to the test panel.
C. Measurand:
Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Ecstasy (MDMA), Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, Marijuana, Imipramine, Buprenorphine
D. Type of Test:
Qualitative lateral flow immunoassay
E. Applicant:
Phamatech, Inc.
F. Proprietary and Established Names:
QuickScreen Pro Multi Drug Screening Test, Model 9395Z
G. Regulatory Information:
1. Regulation section:
| Product Code | Regulation Number | Regulation Description |
| --- | --- | --- |
| DKZ | 862.3100 | Amphetamine test system |
| DIS | 862.3150 | Barbiturate test system |
| JXM | 862.3170 | Benzodiazepine test system |
| DIO | 862.3250 | Cocaine and cocaine metabolite test system |
| DJC | 862.3610 | Methamphetamine test system |
| DJR | 862.3620 | Methadone test system |
| DJG | 862.3650 | Opiate test system |
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| Product Code | Regulation Number | Regulation Description |
| --- | --- | --- |
| LCM | Unclassified | Phencyclidine |
| LDJ | 862.3870 | Cannabinoid test system |
| LFG | 862.3910 | Tricyclic antidepressant drugs test system |
2. Classification:
Class II
4. Panel:
Toxicology
H. Intended Use:
1. Intended use(s):
See indications for use below.
2. Indication(s) for use:
The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a screening test for the qualitative detection of amphetamines, barbiturates, benzodiazepines, cocaine, ecstasy (MDMA), methadone, methamphetamine, opiates, oxycodone, phencyclidine, marijuana, tricyclic antidepressants (Imipramine) and buprenorphine in urine at the cut-off concentrations listed below. Test for barbiturates, benzodiazepine, oxycodone, buprenorphine and tricyclic antidepressants (Imipramine) cannot distinguish between abused drugs and certain prescription medications. The test is intended for professional use only.
| Analyte | Abbreviation | Cut-off Concentration (ng/ml) |
| --- | --- | --- |
| Amphetamines | AMP | 1000 |
| Barbiturates | BAR | 200 |
| Benzodiazepines | BZD | 200 |
| Cocaine | COC | 300 |
| Ecstasy | MDMA | 500 |
| Methadone | MTD | 300 |
| Methamphetamine | MET | 500 |
| Opiates | OPI | 300 |
| Oxycodone | OXY | 100 |
| Phencyclidine | PCP | 25 |
| Marijuana | THC | 50 |
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| Analyte | Abbreviation | Cut-off Concentration (ng/ml) |
| --- | --- | --- |
| Tricyclic Antidepressants (Imipramine) | TCA (Imipramine) | 1000 |
| Buprenorphine | BUP | 10 |
This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed.
3. Special conditions for use statement(s):
For prescription use only
4. Special instrument requirements:
Not applicable. These devices are single use and disposable.
I. Device Description:
The QuickScreen™ Pro Multi Drug Screening Test, Model 9395Z is a competitive immunoassay that is used to screen for the presence of the following drugs of abuse in urine: Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Ecstasy, Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, Marijuana, Imipramine, and Buprenorphine. The device is single-use utilizing a cup format. Each kit consists of the following materials:
- Twelve separate test strips for the 13 target drugs. Each test strip device includes monoclonal anti-drug antibody/colloidal gold conjugate specific to each drug coated in the sample path, drug derivative/protein conjugate immobilized as a line in the Test Region (T), and goat anti-rabbit antibody immobilized as a line in the Control Region (C).
- Instructional insert
- Urine sample collection cup
- Built-in timer to identify when test test results should be read
J. Substantial Equivalence Information:
1. Predicate device name(s):
At Home Drug Test 12: Model 9308Z
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2. Predicate 510(k) number(s): k070009
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | QuickScreen™ Pro Multi Drug Screening Test, Model 9395Z | At Home Drug Test 12: Model 9308Z (k070009) Predicate Device |
| Indications for use | The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is an screening test for the qualitative detection of amphetamines, barbiturates, benzodiazepines, cocaine, ecstasy, methadone, methamphetamine, opiates, oxycodone, phencyclidine, marijuana, tricyclic antidepressants (Imipramine) and buprenorphine in urine at the cut-off concentrations listed. | Same |
| Methodology | Lateral flow immunoassay based on the principle of antigen and antibody immunochemistry | Same |
| Results | Qualitative | Same |
| Analyte Cut-off | Amphetamines (AMP): 1000 ng/ml
Barbiturates (BAR): 200 ng/ml
Benzodiazepines: (BZD): 200 ng/ml
Cocaine (COC): 300 ng/ml
Ecstasy (MDMA): 500 ng/ml
Methadone (MTD): 300 ng/ml
Methamphetamine (MET): 500 ng/ml
Opiates (OPI): 300 ng/ml
Oxycodone (OXY): 100 ng/ml
Phencyclidine (PCP): 25 | Same for shared analytes |
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| Similarities | | |
| --- | --- | --- |
| Item | QuickScreen™Pro Multi Drug Screening Test, Model 9395Z | At Home Drug Test 12: Model 9308Z (k070009) Predicate Device |
| | ng/ml
Marijuana (THC): 50
ng/ml
Tricyclic Antidepressants (TCA): 1000 ng/ml
Buprenorphine (BUP): 10
ng/ml | |
| Configuration | Cup | Same |
| Specimen Type | Urine | Same |
| Use | Single-use | Same |
| Differences | | |
| --- | --- | --- |
| Item | QuickScreen™Pro Multi Drug Screening Test Model 9395Z | At Home Drug Test 12: Model 9308Z (k070009) Predicate Device |
| Use Setting | Prescription | OTC |
# K. Standard/Guidance Document Referenced (if applicable):
None referenced.
# L. Test Principle:
TheQuickScreen™ Pro Multi Drug Screening Test, Model 9395Z device employs lateral flow immunochromatographic technology, which involves the recognition and formation of a specific antibody/target drug complex. Drug in the sample and drug-labeled conjugate compete for antibody binding sites. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific 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 (T). The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. The control line (C) serves as an internal quality control to ensure proper sample volume has been added to the test and that the sample has correctly migrated up the test strip.
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M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
A precision/reproducibility study was performed using the QuickScreen™ Pro Multi Drug Screening Test Model 9395Z device at three separate point of care (POC) sites. Multiple replicates of each of the nine drug concentrations (prepared by spiking negative urine samples with buprenorphine or TCA (Imipramine)) was assayed over a minimum of 5 days. The tests were done in accordance with the package insert instructions using one lot of the device, and a summary of the results are provided in the table below. Precision performance for Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Ecstasy, Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, and Marijuana, was reviewed in k070098.
| Test Results for BUP | | | | |
| --- | --- | --- | --- | --- |
| Level | BUP Conc. (ng/ml) | % of cutoff | Result (Neg/Pos) | % Correct |
| 1 | 0.00 | 0 | 80/0 | 100% |
| 2 | 2.58 | - 75% | 80/0 | 100% |
| 3 | 5.62 | - 50% | 80/0 | 100% |
| 4 | 7.13 | - 25% | 80/0 | 100% |
| 5 | 10.42 | cutoff | 0/80 | 100% |
| 6 | 12.27 | + 25% | 0/80 | 100% |
| 7 | 16.83 | + 50% | 0/80 | 100% |
| 8 | 17.69 | + 75% | 0/80 | 100% |
| 9 | 20.43 | +100% | 0/80 | 100% |
| Test Results for TCA (Imipramine) | | | | |
| --- | --- | --- | --- | --- |
| Level | TCA Conc. (ng/ml) | % of cutoff | Result (Neg/Pos) | % Correct |
| 1 | 0.00 | 0 | 80/0 | 100% |
| 2 | 249.53 | - 75% | 80/0 | 100% |
| 3 | 547.65 | - 50% | 80/0 | 100% |
| 4 | 767.56 | - 25% | 80/0 | 100% |
| 5 | 1026.32 | cutoff | 0/80 | 100% |
| 6 | 1267.91 | + 25% | 0/80 | 100% |
| 7 | 1589.23 | + 50% | 0/80 | 100% |
| 8 | 1789.60 | + 75% | 0/80 | 100% |
| 9 | 2089.3 | +100% | 0/80 | 100% |
b. Linearity/assay reportable range:
Not applicable.
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c. Traceability, Stability, Expected values (controls, calibrators, or methods):
There are no external controls supplied with the device.
Real time stability tests were conducted over 24 months. Protocol and acceptance criteria were found to be acceptable. The manufacturer claims that the devices are stable for 22 months.
d. Detection limit:
See precision data in Section M.1.a., above, for assay performance around the claimed cutoff concentrations.
e. Analytical specificity:
Cross-reactivity: Cross-reactivity studies for BUP and Imipramine were conducted for the QuickScreen™ Pro Multi Drug Screening Test Model 9395Z device (BUP and TCA) by testing structurally similar compounds. The compounds in the below table were tested for cross reactivity, and the lowest concentration causing a positive result was determined to calculate the percentage of cross-reactivity. Cross-reactivity performance for Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Ecstasy, Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, and Marijuana, was reviewed in k070098.
| BUP Cross Reactivity | | |
| --- | --- | --- |
| Compound | Lowest conc. resulting in positive result | % cross reactivity |
| Norbuprenorphine | 20 ng/ml | 50% |
| Morphine | N/A | <0.01% |
| Buprenorphine-3-β-D-Glucuronide | 10 μg/ml | 0.1% |
| Norbuprenorphine-3-β-D-Glucuronide | 20 μg/ml | 0.2% |
| Oxymorphone | N/A | <0.01% |
| Hydromorphone | N/A | <0.01% |
| TCA Cross Reactivity | | |
| Compound | Lowest conc. resulting in positive result | % cross reactivity |
| Amitriptyline | 250 ng/ml | 400% |
| N-Desmethylclomipramine | 100 mg/ml | 1% |
| N-Desmethyltrimipramine-maleate | 100 mg/ml | 1% |
| Cyclobenzaprine | 500 ng/ml | 200% |
| Cyproheptadine | 100 mg/ml | 1% |
| Desiprimine | 250 ng/ml | 400% |
| Doxepin | 100 ng/ml | 1000% |
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Interference: The following compounds did not show interference with the QuickScreen™ Pro Multi Drug Screening Test Model 9395Z device (for BUP and Imipramine) when tested at BUP and Imipramine concentration of 50% and 150% of cut-off values. Interference performance for Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Ecstasy, Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, and Marijuana, was reviewed in k070098.
| Compound | Conc. tested (μg/ml) | Compound | Conc. tested (μg/ml) |
| --- | --- | --- | --- |
| 6-Acetylcodeine | 100 | Ketamine | 100 |
| 6-Acetylmorphine | 100 | Levallorphan Tartrate | 100 |
| Acetaminophen | 100 | Lidocaine | 100 |
| Acetaminophen | 500 | Lormetazepam | 100 |
| Acetylsalicylic Acid (Aspiring) | 500 | Lysergic Acid Diethylamide | 100 |
| Acetylsalicylic Acid (Aspiring) | 1000 | MDEA | 100 |
| Alprazolam | 100 | d-Methamphetamine | 100 |
| α-Hydroxyaprazolam | 100 | I-Methamphetamine | 100 |
| Aminogluthethimide | 100 | Metanphrine | 100 |
| Amobarbital | 100 | Methaqualone | 100 |
| S(+) Amphetamine | 100 | Metoprolol | 100 |
| Aprobarbital | 100 | Methylenedioxyamphetamine (MDA) | 100 |
| Apromorphine | 100 | Methylphenidate | 100 |
| Ascorbic Acid | 10,000 | Methylphenidate | 500 |
| Ascorbic Acid | 15,000 | Methylphenidate | 1000 |
| Ampicillin | 100 | Metoclopramide | 150 |
| Amoxicillin | 100 | Metoclopramide | 300 |
| Barbituric Acid | 100 | Morphine | 100 |
| Benzoylecgonine | 100 | Morphine-3-β-D Glucuronide | 100 |
| Oxalic Acid | 100 | Nafcillin | 100 |
| Benzphetamine | 100 | Nalbuphine | 100 |
| Benztropine Methane Sulfonate | 100 | Naloxone | 100 |
| Bilirubin | 100 | Naltrexone | 100 |
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| Compound | Conc. tested (μg/ml) | Compund | Conc. tested (μg/ml) |
| --- | --- | --- | --- |
| Bromazepam | 100 | Naphazoline | 100 |
| Brompheniramine | 100 | Netilmicin | 100 |
| Butabarbital | 100 | Nifedipine | 100 |
| Butabital | 100 | Nitrazepam | 100 |
| Butalbital | 100 | Norbuprenorphine | 100 |
| N-Desmethylimipramine | 100 | Norcodeine | 100 |
| Caffeine | 100 | Nordoxepin | 100 |
| Caffeine | 500 | Normorphine | 100 |
| Cannabidiol | 100 | Noroxymorphone | 100 |
| Cannabidiol | 100 | Nylidren | 100 |
| Cannabinol Delta 9 | 5 | Oxazepam | 100 |
| Chlordiazepoxide | 100 | Oxycodone | 100 |
| Chlorpropamide | 100 | Oxymetazoline | 100 |
| Chloroprothixene | 100 | Penicillin-G | 100 |
| Chloroquine | 100 | Pentazocine | 100 |
| Chlorpheniramine | 100 | Pentobarbital | 100 |
| Clamastine | 100 | Phencyclidine | 100 |
| Clorimpramine | 100 | Phenylephrine | 100 |
| Clonazepam | 100 | Phenylbutazone | 100 |
| Codeine | 100 | Phenylcyclopropylamine HCl | 100 |
| Cotinine | 100 | Phenylethylamine | 100 |
| Creatinine | 2500 | Terbutaline | 100 |
| Creatinine | 5000 | Phenytoin | 100 |
| Cyclizine | 100 | Prazepam | 100 |
| Cyclosporin | 100 | Prednisolone | 100 |
| Desalkylflurazepam | 100 | Primadone | 100 |
| Dextromethorphan | 100 | Procainamide | 100 |
| Diazepam | 100 | Promethazine | 100 |
| Dihydrocodeine | 100 | Promazine | 100 |
| Dipehnylhydantoin | 100 | Proproxyphine | 100 |
| Dipehnylhydantoin | 2500 | S, S (+)-Pseudoephedrine | 100 |
| Dipehnylhydantoin | 5000 | Pyrilamine | 100 |
| Doxylamine | 100 | Quinidine | 100 |
| Ecgonine | 100 | Ranitidine | 100 |
| Ecgonine Methyl Ester | 100 | Salicylic Acid | 100 |
| Efavirenz | 100 | Scopolamine | 100 |
| Ephedrine | 100 | Secobarbital | 100 |
| Epinephrine | 100 | Temazepam | 100 |
| Erythromycin | 100 | Thioridazine | 250 |
| Ethanol | 10,000 | Thioridazine | 500 |
| Ethanol | 25,000 | Thiothixene | 100 |
| Ethanol | 50,000 | Traylcyromine | 100 |
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| Compound | Conc. tested (μg/ml) | Compound | Conc. tested (μg/ml) |
| --- | --- | --- | --- |
| Ethylmorphine | 100 | Triampterene | 100 |
| Fenfluramine | 100 | Triazolam | 100 |
| Fentanyl | 100 | α-Hydroxytriazolam | 100 |
| Flunitrazepam | 100 | Triflupromazine | 100 |
| Griseofuvin | 100 | Trimipramine | 100 |
| Hydrocodone | 100 | Tyramine | 100 |
| Hydromorphine | 100 | Urea | 10,000 |
| Hexabarbital | 100 | Urea | 30,000 |
| Ibuprofen | 50 | Urea | 60,000 |
| Ibuprofen | 100 | Uric Acid | 100 |
| Indomethacin | 100 | Verapamil | 100 |
| Isoxsuprine | 100 | Verapamil | 500 |
| Kanamycin | 100 | Verapamil | 1000 |
| MDMA | 100 | Naproxime | 100 |
| Mephentermine | 100 | | |
pH sensitivity: Testing was conducted for BUP and Imipramine with the QuickScreen™ Pro Multi Drug Screening Test Model 9395Z device to determine the influence of sample pH on test results. Samples were tested in triplicate at a pH of 4.0, 4.5, 5.5, 6.5, 7.5, 8.5 and 9.0. No interference was observed for any pH test conditions. pH interference performance for Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Ecstasy, Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, and Marijuana, was reviewed in k070098.
Specific Gravity: Testing was conducted for BUP and Imipramine with the QuickScreen™ Pro Multi Drug Screening Test Model 9395Z device to determine the influence of sample specific gravity on test results. Four samples were tested, spanning a range of specific gravity from 1.002 to 1.040. All were tested in quadruplicate. No interference was observed for any specific gravity test conditions. Specific gravity interference performance for Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Ecstasy, Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, and Marijuana, was reviewed in k070098.
f. Assay cut-off:
Characterization of how the device performed analytically around the claimed cutoff concentration appears in the precision section M.1.a., above.
2. Comparison studies:
a. Method comparison with predicate device:
Method comparison studies were conducted for BUP and Imipramine at four different
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sites for the detection of BUP and two sites for the detection of Imipramine, using the QuickScreen™ Pro Multi Drug Screening Test Model 9395Z device. All tests were conducted using unaltered urine clinical samples. Accuracy performance for Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Ecstasy, Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, and Marijuana, was reviewed in k070098.
## Method Comparison Site #1
| Candidate Device Results | Zero Value Samples by GC/MS | Below 50% cutoff by GC/MS | Near Cutoff Negative (Between 50% below cutoff and cutoff concentration) by GC/MS | Near Cutoff Positive (between cutoff and 150%) by GC/MS | High Positive (above 150%) by GC/MS |
| --- | --- | --- | --- | --- | --- |
| BUP | | | | | |
| QuickScreen | | | | | |
| Positive | 0 | 0 | 3 | 5 | 35 |
| Negative | 40 | 32 | 5 | 0 | 0 |
| | | | | | |
| TCA (Imipramine) | | | | | |
| QuickScreen | | | | | |
| Positive | 0 | 0 | 1 | 23 | 17 |
| Negative | 22 | 20 | 19 | 0 | 0 |
## Discrepant results
| Sample | Analyte Detected | Subject Device Result | GC/MS Result (ng/ml) |
| --- | --- | --- | --- |
| 82 | Buprenophine | Positive | 8.21 |
| 40 | Buprenophine | Positive | 9.04 |
| 17 | Buprenophine | Positive | 9.29 |
| 62 | Imipramine | Positive | 995.9 |
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Method Comparison POC Site 1
| Candidate Device Results | Zero Value Samples | Below 50% cutoff | Near Cutoff Negative (Between 50% below cutoff and cutoff concentration) | Near Cutoff Positive (between cutoff and 150%) | High Positive (above 150%) |
| --- | --- | --- | --- | --- | --- |
| BUP | | | | | |
| QuickScreen | | | | | |
| Positive | 0 | 0 | 3 | 5 | 35 |
| Negative | 40 | 32 | 5 | 0 | 0 |
| | | | | | |
| TCA (Imipramine) | | | | | |
| QuickScreen | | | | | |
| Positive | 0 | 0 | 1 | 23 | 17 |
| Negative | 22 | 20 | 19 | 0 | 0 |
Discrepant Results
| Sample | Analyte Detected | Subject Device Result | GC/MS Result (ng/ml) |
| --- | --- | --- | --- |
| 82 | Buprenophine | Positive | 8.21 |
| 40 | Buprenophine | Positive | 9.04 |
| 17 | Buprenophine | Positive | 9.29 |
| 62 | Imipramine | Positive | 995.9 |
Method Comparison POC Site 2
| Candidate Device Results | Zero Value Samples | Below 50% cutoff | Near Cutoff Negative (Between 50% below cutoff and cutoff concentration) | Near Cutoff Positive (between cutoff and 150%) | High Positive (above 150%) |
| --- | --- | --- | --- | --- | --- |
| BUP | | | | | |
| QuickScreen | | | | | |
| Positive | 0 | 0 | 3 | 5 | 35 |
| Negative | 40 | 32 | 5 | 0 | 0 |
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Discrepant Results
| Sample | Analyte Detected | Subject Device Result | GC/MS Result (ng/ml) |
| --- | --- | --- | --- |
| 82 | Buprenophine | Positive | 8.21 |
| 40 | Buprenophine | Positive | 9.04 |
| 17 | Buprenophine | Positive | 9.29 |
Method Comparison POC Site 3
| Candidate Device Results | Zero Value Samples | Below 50% cutoff | Near Cutoff Negative (Between 50% below cutoff and cutoff concentration) | Near Cutoff Positive (between cutoff and 150%) | High Positive (above 150%) |
| --- | --- | --- | --- | --- | --- |
| BUP | | | | | |
| QuickScreen | | | | | |
| Positive | 0 | 0 | 4 | 5 | 35 |
| Negative | 40 | 32 | 4 | 0 | 0 |
Discrepant Results
| Sample | Analyte Detected | Subject Device Result | GC/MS Result (ng/ml) |
| --- | --- | --- | --- |
| 52 | Buprenophine | Positive | 6.85 |
| 82 | Buprenophine | Positive | 8.21 |
| 40 | Buprenophine | Positive | 9.04 |
| 17 | Buprenophine | Positive | 9.29 |
b. Matrix comparison:
N/A
3. Clinical studies:
a. Clinical Sensitivity:
N/A
b. Clinical specificity:
N/A
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c. Other clinical supportive data (when a. and b. are not applicable):
N/A
4. Clinical cut-off:
N/A
5. Expected values/Reference range:
N/A
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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