Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test
Device Facts
| Record ID | K232736 |
|---|---|
| Device Name | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test |
| Applicant | Chemtron Biotech, Inc. |
| Product Code | DJG · Clinical Toxicology |
| Decision Date | Dec 20, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3650 |
| Device Class | Class 2 |
Indications for Use
The Chemtrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Norfentanyl, Marijuana, Methamphetamine, Morphine, Opiates, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene , Tramadol and Trivyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the tests are calibrated to are as follows: [Table omitted for brevity]. The multi test panels can consist of any analytes listed above in any combination. Only one cut-off concentration will be included per analyte per device. The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants.
Device Story
Rapid lateral flow immunoassays for qualitative detection of drugs of abuse in human urine. Device formats include Dip Card and Cup. Principle: competitive binding immunoassay; drug-protein conjugates on test strip compete with drugs in urine for limited anti-drug antibody-colloidal gold conjugates. Presence of drug in urine above cutoff prevents formation of visible line at test region (T); absence of drug allows line formation. Control line (C) indicates proper flow. Used in point-of-care or home settings by lay-users or professionals. Results are preliminary; require confirmation via GC/MS or LC/MS. Provides rapid screening to assist in clinical decision-making regarding drug use.
Clinical Evidence
Consumer study with 140 untrained lay-users across 3 sites. Evaluated ability to interpret results using package insert. Samples included negative, 50%, 75%, 125%, and 150% of cutoff concentrations. Results showed high agreement with LC/MS reference method across all analytes.
Technological Characteristics
Colloidal gold-based lateral flow immunoassay. Single-use, in vitro diagnostic. Formats: Dip Card or Cup. Principle: competitive binding. No electronic components or software algorithms.
Indications for Use
Indicated for qualitative detection of drugs of abuse (Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Norfentanyl, Marijuana, Methamphetamine, Morphine, Opiates, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene, Tramadol, TCA) in human urine. Intended for OTC and prescription use. Not intended to differentiate between illicit and prescription use of specific drugs.
Regulatory Classification
Identification
An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Predicate Devices
- Chemtrue® Multi-Panel Drug Screen Cup/Dip Card Tests (k153192)
Related Devices
- K152590 — ACCU NEWS Drug Screening Test Card/Urine Cup · Coretests, Inc. · Apr 15, 2016
- K232604 — LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette) · Hangzhou Laihe Biotech Co., Ltd. · Jan 10, 2024
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY ONLY
## I Background Information:
A 510(k) Number
K232736
B Applicant
Chemtron Biotech, Inc.
C Proprietary and Established Names
Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test.
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DJG | Class II | 21 CFR 862.3650 - Opiate Test System | TX - Clinical Toxicology |
| DKZ | Class II | 21 CFR 862.3100 - Amphetamine test system | TX - Clinical Toxicology |
| DIS | Class II | 21 CFR 862.3150 - Barbiturate test system | TX - Clinical Toxicology |
| JXM | Class II | 21 CFR 862.3170 - Benzodiazepine test system | TX - Clinical Toxicology |
| DIO | Class II | 21 CFR 862.3250 - Cocaine and cocaine metabolite test system | TX - Clinical Toxicology |
| DJC | Class II | 21 CFR 862.3610 - Methamphetamine test system | TX - Clinical Toxicology |
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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| LDJ | Class II | 21 CFR 862.3870 - Cannabinoid test system | TX - Clinical Toxicology |
| --- | --- | --- | --- |
| LAF | Class II | 21 CFR 862.3610 - Methamphetamine test system | TX - Clinical Toxicology |
| DJR | Class II | 21 CFR 862.3620 - Methadone test system | TX - Clinical Toxicology |
| DNK | Class II | 21 CFR 862.3640 - Morphine test system | TX - Clinical Toxicology |
| LCM | Unclassified | | |
| LFG | Class II | 21 CFR 862.3910 - Tricyclic antidepressant drugs test system | TX - Clinical Toxicology |
## II Submission/Device Overview:
### A Purpose for Submission:
New device
### B Measurand:
d-Amphetamine, Secobarbital/Pentobarbital, Oxazepam, Buprenorphine, Benzoylecgonine, d,l-Methylenedioxy methamphetamine, Norfentanyl, d-Methamphetamine, 11-nor-Δ9-THC-9-COOH, Methadone, Morphine, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Tramadol
### C Type of Test:
Qualitative
## III Intended Use/Indications for Use:
### A Intended Use(s):
See Indications for Use below.
### B Indication(s) for Use:
The Chemtrue® Drug Screen Fentanyl / Tramadol Dip Card Test is a rapid lateral flow immunoassay for the qualitative detection of Norfentanyl (FYL) 5 and Tramadol (TML) 100 drugs in human urine. It is an in vitro diagnostic device. The test cut-off concentrations and calibrators are listed below:
Analyte
Abbreviation
Calibrator
Cutoff Concentration (ng/mL)
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| Norfentanyl | FYL | Norfentanyl | 5 |
| --- | --- | --- | --- |
| Tramadol | TML | Tramadol | 100 |
The Chemtrue® Drug Screen Fentanyl / Tramadol Dip Card Test detects and is calibrated against norfentanyl, the major metabolite of fentanyl in human urine. The test is available in Single and multi-panels.
The test provides only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to the drug test result, particularly when preliminary positive result is indicated.
The test is not intended to differentiate between drugs of abuse and prescription use of Fentanyl/ Tramadol. The test is for in vitro diagnostic use only.
The Chemtrue® Drug Screen Fentanyl / Tramadol Cup Test is a rapid lateral flow immunoassay for the qualitative detection of Norfentanyl (FYL) 5 and Tramadol (TML) 100 drugs in human urine. It is an in vitro diagnostic device. The test cut-off concentrations and calibrators are listed below:
| Analyte | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) |
| --- | --- | --- | --- |
| Norfentanyl | FYL | Norfentanyl | 5 |
| Tramadol | TML | Tramadol | 100 |
The Chemtrue® Drug Screen Fentanyl / Tramadol Cup Test detects and is calibrated against norfentanyl, the major metabolite of fentanyl in human urine. The test is available in Single and multi-panels.
The test provides only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to the drug test result, particularly when preliminary positive result is indicated.
The test is not intended to differentiate between drugs of abuse and prescription use of Fentanyl/ Tramadol. The test is for in vitro diagnostic use only.
The Chemtrue® Multi-Panel Drug Screen Dip Card Test is a rapid lateral flow immunoassay for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Ecstasy, Norfentanyl, Marijuana, Methamphetamine, Methadone, Morphine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, Tramadol and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
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| Analyte | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) |
| --- | --- | --- | --- |
| Amphetamine | AMP | d-Amphetamine | 300 |
| Amphetamine | AMP | d-Amphetamine | 500 |
| Amphetamine | AMP | d-Amphetamine | 1,000 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 200 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Benzodiazepines | BZO | Oxazepam | 200 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Buprenorphine | BUP | Buprenorphine | 10 |
| Cocaine | COC | Benzoylecgonine | 150 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxy methamphetamine | 500 |
| Norfentanyl | FYL | Norfentanyl | 5 |
| Methamphetamine | MET | d-Methamphetamine | 300 |
| Methamphetamine | MET | d-Methamphetamine | 500 |
| Methamphetamine | MET | d-Methamphetamine | 1,000 |
| Marijuana | THC | 11-nor-Δ9-THC-9-COOH | 50 |
| Methadone | MTD | Methadone | 300 |
| Morphine | MOR | Morphine | 300 |
| Opiates | OPI | Morphine | 2,000 |
| Oxycodone | OXY | Oxycodone | 100 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Propoxyphene | PPX | Propoxyphene | 300 |
| Tricyclic Antidepressants | TCA | Nortriptyline | 1,000 |
| Tramadol | TML | Tramadol | 100 |
The multi test panels can consist of any drug analytes listed above in any combination. Only one cut-off concentration will be included per analyte per device.
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The test provides only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants.
The Chemtrue® Multi-Panel Drug Screen Cup Test is a rapid lateral flow immunoassay for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Ecstasy, Norfentanyl, Marijuana, Methamphetamine, Methadone, Morphine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, Tramadol and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Analyte | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) |
| --- | --- | --- | --- |
| Amphetamine | AMP | d-Amphetamine | 300 |
| Amphetamine | AMP | d-Amphetamine | 500 |
| Amphetamine | AMP | d-Amphetamine | 1,000 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 200 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Benzodiazepines | BZO | Oxazepam | 200 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Buprenorphine | BUP | Buprenorphine | 10 |
| Cocaine | COC | Benzoylecgonine | 150 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxy methamphetamine | 500 |
| Norfentanyl | FYL | Norfentanyl | 5 |
| Methamphetamine | MET | d-Methamphetamine | 300 |
| Methamphetamine | MET | d-Methamphetamine | 500 |
| Methamphetamine | MET | d-Methamphetamine | 1,000 |
| Marijuana | THC | 11-nor-Δ9-THC-9-COOH | 50 |
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| Methadone | MTD | Methadone | 300 |
| --- | --- | --- | --- |
| Morphine | MOR | Morphine | 300 |
| Opiates | OPI | Morphine | 2,000 |
| Oxycodone | OXY | Oxycodone | 100 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Propoxyphene | PPX | Propoxyphene | 300 |
| Tricyclic Antidepressants | TCA | Nortriptyline | 1,000 |
| Tramadol | TML | Tramadol | 100 |
The multi test panels can consist of any drug analytes listed above in any combination. Only one cut-off concentration will be included per analyte per device.
The test provides only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants.
## C Special Conditions for Use Statement(s):
OTC - Over The Counter
## D Special Instrument Requirements:
Not applicable
## IV Device/System Characteristics:
### A Device Description:
The devices are colloidal gold-based lateral flow immunoassays for the rapid, qualitative detection of drugs of abuse in human urine. The tests are single-use, in vitro diagnostic devices, which come in Dip Card or Cup formats, as indicated by the test name.
### B Principle of Operation:
These devices are rapid lateral flow immunoassays in which chemically modified drugs (drug-protein conjugates) compete with drugs that may be present in urine. On each test strip, a drug-protein conjugate is striped on the test band of the membrane - known as the test region (T) and
K232736 - Page 6 of 17
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the anti-drug antibody-colloidal gold conjugate pads are placed at the forward end of the membrane. If target drugs are present in the urine specimen below its cut-off concentration, the solution of the colored antibody-colloidal gold conjugates moves along with the sample solution by capillary action across the membrane to the immobilized drug-protein conjugate zone on the test band region. The colored antibody-gold conjugates then complexes with the drug-protein conjugates to form visible lines. Therefore, the formation of the visible precipitant in the test band indicates a negative result. If the target drug level exceeds its cut-off concentration, the drug/metabolite antigen competes with drug-protein conjugates on the test band region for the limited antibody on the colored drug antibody-colloidal gold conjugate pad. The drug will saturate the limited antibody binding sites and the colored antibody-colloidal gold conjugate cannot bind to the drug-protein conjugate at the test region of the test strip. Therefore, absence of the color band on the test region indicates a preliminary positive result.
A band should form in the control region (C) of the devices regardless of the presence of drug in the sample to indicate that the test has been performed properly.
V Substantial Equivalence Information:
A Predicate Device Name(s):
Chemtrue® Multi-Panel Drug Screen Cup/Dip Card Tests
B Predicate 510(k) Number(s):
K153192
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K232736 | K153192 |
| --- | --- | --- |
| Device Trade Name | Chemtrue® Drug Screen Fentanyl/Tramadol Cup/Dip Card Tests
Chemtrue® Multi-Panel Drug Screen Cup/ Dip Card Tests | Chemtrue® Multi-Panel Drug Screen Cup/Dip Card Tests |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Same | Drugs of abuse testing in human urine |
| General Device Characteristic Differences | | |
| Analytes | Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, | Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, |
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| | Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene, Tricyclic Antidepressants (TCA), Norfentanyl, and Tramadol | Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene and Tricyclic Antidepressants (TCA) |
| --- | --- | --- |
## VI Standards/Guidance Documents Referenced:
Not applicable
## VII Performance Characteristics (if/when applicable):
### A Analytical Performance:
#### 1. Precision/Reproducibility:
Precision/reproducibility studies were carried out for Norfentanyl- and Tramadol-spiked urine controls with LC/MS confirmed concentrations of 0%, -50%, -25%, 100%, +25% and +50% of the drug cutoff. The samples were blind coded and randomly assigned to 3 operators over 5 days of testing.
Precision performance for the remaining drugs (d-Amphetamine, Secobarbital/Pentobarbital, Oxazepam, Buprenorphine, Benzoylecgonine, d,l-Methylenedioxy methamphetamine, d-Methamphetamine, 11-nor-Δ9-THC-9-COOH, Methadone, Morphine, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline) was established in k142396 and k153192.
### Dip Card Format
| Test | Concentration Tested | Lot 1 Neg/Pos | Lot 2 Neg/Pos | Lot 3 Neg/Pos | Total Neg/Pos |
| --- | --- | --- | --- | --- | --- |
| FYL | Negative | 10/0 | 10/0 | 10/0 | 30/0 |
| | 50% of cutoff | 10/0 | 10/0 | 10/0 | 30/0 |
| | 75% of cutoff | 10/0 | 10/0 | 10/0 | 30/0 |
| | Cutoff | 2/8 | 1/9 | 2/8 | 5/25 |
| | 125% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| | 150% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| TML | Negative | 10/0 | 10/0 | 10/0 | 30/0 |
| | 50% of cutoff | 10/0 | 10/0 | 10/0 | 30/0 |
| | 75% of cutoff | 10/0 | 10/0 | 10/0 | 30/0 |
| | Cutoff | 1/9 | 3/7 | 1/9 | 5/25 |
| | 125% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| | 150% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
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Cup Format
| Test | Concentration Tested | Lot 1 Neg/Pos | Lot 2 Neg/Pos | Lot 3 Neg/Pos | Total Neg/Pos |
| --- | --- | --- | --- | --- | --- |
| FYL | Negative | 10/0 | 10/0 | 10/0 | 30/0 |
| | 50% of cutoff | 10/0 | 10/0 | 10/0 | 30/0 |
| | 75% of cutoff | 10/0 | 10/0 | 10/0 | 30/0 |
| | Cutoff | 1/9 | 1/9 | 2/8 | 4/26 |
| | 125% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| | 150% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| TML | Negative | 10/0 | 10/0 | 10/0 | 30/0 |
| | 50% of cutoff | 10/0 | 10/0 | 10/0 | 30/0 |
| | 75% of cutoff | 10/0 | 10/0 | 10/0 | 30/0 |
| | Cutoff | 1/9 | 3/7 | 2/8 | 6/24 |
| | 125% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| | 150% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
2. Linearity:
Not applicable. These devices are intended for qualitative use only.
3. Analytical Specificity/Interference:
For each drug and cutoff, specificity was evaluated by spiking various concentrations of similarly structured drug compounds into drug-free urine. Results are expressed as a minimum concentration of metabolite or compound required to produce a response approximately equivalent to the cutoff concentration of the assay. The percent cross reactivity of those compounds is listed below (if no cross reactivity was observed, the highest concentration tested is shown as <1%):
Norfentanyl-related compounds:
| Substances | Concentration ng/mL | % Cross Reactivity |
| --- | --- | --- |
| Norfentanyl | 5 | 100 |
| Fentanyl | 10 | 100 |
| 4-Fluoro-isobutyryl Fentanyl | >20,000 | <1 |
| 9-HydroxyRisperidone | 10,000 | <1 |
| Acetyl Fentanyl | 200 | 2.5 |
| Acetyl Norfentanyl | 200 | 2.5 |
| (±)-β-Hydroxythiofentanyl HCl | 20 | 25 |
| Acryl Fentanyl | 30 | 16.7 |
| Alfentanil | 1,000 | <1 |
| Butyryl Fentanyl | 15 | 33.3 |
| Carfentanil Oxalate | >10,000 | <1 |
| Cis-d, I 3-Methylfentanyl | 70 | 7.1 |
| Despropionylfentanyl (4-ANPP) | >20,000 | <1 |
| Furanyl Fentanyl | 80 | 6.25 |
| Isobutyryl Fentanyl | 5,000 | <1 |
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| Labetalol Hydrochloride | >100,000 | <1 |
| --- | --- | --- |
| MT-45 | 7,500 | <1 |
| Norcarfentail Oxalate | >20,000 | <1 |
| Ocfentanil | 1,000 | <1 |
| Para-fluoro butyrl Fentanyl (P-FBF) | 20 | 25 |
| para-Fluorofentanyl | 10 | 50 |
| Remifentanil | >20,000 | <1 |
| Risperidone | 10,000 | <1 |
| Sufentanil | 3,000 | <1 |
| Thienyl Fentanyl | 40 | 12.5 |
| Trans-d, I 3-Methylfentanyl | 30 | 16.7 |
| Trazodone | >100,000 | <1 |
| U-47700 | >100,000 | <1 |
| Valeryl Fentanyl | >100,000 | <1 |
Tramadol related compounds:
| Substances | Concentration ng/mL | % Cross Reactivity |
| --- | --- | --- |
| Tramadol | 100 | 100 |
| n-Desmethyl Tramadol | 400 | 25 |
| o-Desmethyl Tramadol | 1,000 | 10 |
| Venlafaxine | >100,000 | <1 |
| o-Desmethyl Venlafaxine | >10,000 | <1 |
The sponsor also evaluated the potential for positive and negative interference from non-structurally related compounds, endogenous compounds, pH, and specific gravity using samples containing drugs at $\pm 25\%$ of the respective drug cutoff concentrations.
The following endogenous compounds showed no interference when tested at $100~\mu \mathrm{g / mL}$:
| Albumin | Creatinine | r-Globulin | Octopamine |
| --- | --- | --- | --- |
| Acetone | Dopamine | Hemoglobin | Riboflavin |
| Ascorbic Acid | Ethanol | Human serum Albumin | Sodium Chloride |
| Atropine | Galactose | B-Hydroxybutyric Acid(F) | Uric Acid |
| Bilirubin | Glucose | Oxalic Acid | Urea |
| Cholesterol | | | |
The following structurally unrelated compounds showed no interference when tested at 100 $\mu \mathrm{g / mL}$:
| Amlodipine besylate | I-Erythromycin | Norethindrone |
| --- | --- | --- |
| 7-Aminonitrazepam | Estradiol | Noscapine |
| Amoxicillin | Estrone | Octopamine |
| Ampicillin | Fenfluramine | Papaverine |
| Apomorphine | Fenofibrate | Penicillin-G |
| Aspirin | Fluphenazine(F) | Pentazocine |
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The following compounds showed no interference to the detection of Norfentanyl/Tramadol when tested at the following concentrations:
| Compound | Conc. (ng/mL) | Compound | Conc. (ng/mL) |
| --- | --- | --- | --- |
| Acetylsalicylic Acid | 500,000 | Metformin | 25,000 |
| 7-Aminoflunitrazepam | 25,000 | Norpseudoephedrine | 25,000 |
| Bupropion | 25,000 | Oxazepam Glucuronide | 25,000 |
| Caffeine | 500,000 | Sufentanil Citrate | 25,000 |
| Carbamazepine | 25,000 | 11-nor-9 carboxy THC | 50,000 |
| Lorazepam Glucuronide | 50,000 | L-thyroxine | 25,000 |
| LSD | 50,000 | Zolpidem Tartrate | 50,000 |
The following opioids showed no interference when tested at 100 µg/mL:
| 6-Acetylmorphine | Hydromorphone | Norcodeine |
| --- | --- | --- |
| Amphetamine | Levorphanol | Norketamine |
| Aspartame | Fotemustine | Perphenazine |
| --- | --- | --- |
| Baclofen | Furosemide | Phenelzine |
| Benzocaine6 | Gemfibrozil | Phenylethylamine |
| Benzylpiperazine | Guaiacolglyceryl ether | Phentermine |
| Benzoic Acid | Gentisic acid | Prednisone |
| 4-Bromo-2,5,Dimethoxyphenethylamine | Hexobarbital | Promazine |
| Carisoprodol | Hydralazine | Promethazine |
| Clomipramine | Hydrocortisone | Propoxyphene |
| Cetirizine | 3-Hydroxytyramine | Propranolol |
| Chloramphenicol | β-Hydroxybutyric Acid | Pyridoxine |
| Chlordiazepoxide | Ibuprofen | Pyrilamine |
| Chlorpheniramine | d,l-Isoproterenol | Pyrogallol |
| Chlorpromazine | Ketamine | Norpropoxyphene |
| Clofibrate | Lamotrigine | Quinidine |
| Clonidine | Lisinopril | Quinine |
| Cortisone | Loratidine | Quinolinic Acid |
| I-Cotinine | Maprotiline | Ranitidine |
| Creatine Hydrate | Meprobamate | Salicylic Acid |
| Cyclobenzaprine | Metoprolol | Sodium Azide |
| Cyclodextrin-r | Methapyrilene | Sulfamethazine |
| Cyproheptadine | Methylphenidate | Sulindac |
| Demoxepam | Nalidixic Acid | Tetracycline |
| Deoxycorticosterone | Naloxone | Tetrahydrozoline |
| Dextromethorphan | Naltrexone | Thiamine |
| Diclofenac | Naproxen | Thioridazine |
| Diflunisal | Niacinamide | Trifluoromethylphenyl-piperazine |
| Dimethyl-aminoantipyrine | N-desmethylapentadol | Trifluoperazine |
| Diphenhydramine | Nicotinic Acid | Tryptamine |
| Diphenylhydantoin | Nifedipine | Tyramine |
| | | Zolpidem |
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| Buprenorphine | Methadone | Normorphine |
| --- | --- | --- |
| Codeine | Morphine | Noroxycodone |
| Dihydrocodeine | Morphine-3-glucuronide | Oxycodone |
| EDDP | Naloxone | Oxymorphone |
| Fluoxetine | norbuprenorphine | Pentazocine (Talwin) |
| Heroin | Morphine | Tramadol |
| Hydrocodone | Morphine-3-glucuronide | |
The following opioid compounds/drugs showed no interference when tested at 10 µg/mL:
| Meperidine | Normeperidine | Risperidone |
| --- | --- | --- |
To evaluate the effect of pH value on the test results, urine controls at ± 25% of the cutoff value were used. Each control level was adjusted by either 1N NaOH solution or 1N HCl to pH levels of 2.0, 3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 and 9.0. Each test sample was tested in duplicate.
To evaluate the effect of specific gravity, urine controls at ± 25% of the cutoff values were spiked with deionized water or sugar to obtain specific gravities of 1.001, 1.010, 1.015, 1.020, 1.025, and 1.030. Each test sample was tested in duplicate.
The results demonstrated that pH and specific gravity do not affect the results from the device at the conditions tested.
The analytical specificity performance for the remaining drugs (d-Amphetamine, Secobarbital/Pentobarbital, Oxazepam, Buprenorphine, Benzoylecgonine, d,l-Methylenedioxy methamphetamine, d-Methamphetamine, 11-nor-Δ9-THC-9-COOH, Methadone, Morphine, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline) was established in k142396 and k153192.
4. Assay Reportable Range:
Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section VII.A.1 above.
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
All drug calibrators of the device are traceable to available commercial reference materials.
6. Detection Limit:
Characterization of how the device performs at low concentrations appears in the precision section, VII.A.1, above.
7. Assay Cut-Off:
Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section, VII.A.1, above.
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B Comparison Studies:
1. Method Comparison with Predicate Device:
The sponsor performed a method comparison study comparing the performance of the test strips to the LC/MS reference method. The results are summarized below:
| Chemtrue®
Drug Screen
Dip Card | Concentration By LC/MS (ng/mL) | | | | |
| --- | --- | --- | --- | --- | --- |
| | (-) | | | (+) | |
| | No drug present | Negative | | Near cutoff positive
(Cutoff to 150% of the cutoff) | Positive (>150% of the cutoff) |
| | | < 50% of the cutoff | 50% of the cutoff to the cutoff | | |
| FYL 5 (+) | 0 | 1* | 3 | 6 | 26 |
| (-) | 22 | 29 | 6 | 0 | 0 |
| TML100 (+) | 0 | 0 | 0 | 8 | 23 |
| (-) | 20 | 20 | 12 | 0 | 0 |
| Chemtrue®
Drug Screen
Cup | Concentration By LC/MS (ng/mL) | | | | |
| --- | --- | --- | --- | --- | --- |
| | (-) | | | (+) | |
| | No drug present | Negative | | Near cutoff positive
(Cutoff to 150% of the cutoff) | Positive (>150% of the cutoff) |
| | | < 50% of the cutoff | 50% of the cutoff to the cutoff | | |
| FYL 5 (+) | 0 | 1* | 2 | 6 | 26 |
| (-) | 22 | 29 | 7 | 0 | 0 |
| TML100 (+) | 0 | 0 | 0 | 8 | 23 |
| (-) | 20 | 20 | 12 | 0 | 0 |
*This sample was found to contain fentanyl at concentrations that contributed to the observed positive result.
The analytical accuracy of the remaining drugs (d-Amphetamine, Secobarbital/Pentobarbital, Oxazepam, Buprenorphine, Benzoylecgonine, d,l-Methylenedioxy methamphetamine, d-Methamphetamine, 11-nor-Δ9-THC-9-COOH, Methadone, Morphine, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline) was established in k142396 and k153192.
2. Matrix Comparison:
Not applicable. These devices are for use with urine samples only.
C Clinical Studies:
1. Clinical Sensitivity:
Not applicable.
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2. Clinical Specificity:
Not applicable.
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
A consumer study was performed for all analytes to evaluate the ability of untrained users to interpret the devices properly when given only the labeling (package insert) provided with the devices. Lay-users (140) participated in this study from 3 intended user sites with LC/MS confirmed urine samples in the following concentration ranges: negative, 50%, 75%, 125% and 150% of the cutoff. Samples were created by spiking drugs into drug-free urine pool. Each sample was aliquoted into an individual blind-labeled container. Each lay-user was provided with a package insert in English only, 2 blind-coded samples, and one each of the test devices (Cup/Dip Card format). The results are summarized below:
| Chemtrue® Drug Screen Dip Card | LC/MS Negative | | | LC/MS Positive | | % Agreement with LC/MS values | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | No Drug Present | 50% of the cutoff | 75% of the cutoff | 125% of the cutoff | | 150% of the cutoff |
| AMP1000 | (+) | 0 | 0 | 0 | 10 | 10 | 100% |
| | (-) | 60 | 10 | 10 | 0 | 0 | 100% |
| AMP500 | (+) | 0 | 0 | 0 | 23 | 23 | 100% |
| | (-) | 47 | 22 | 23 | 0 | 0 | 100% |
| AMP300 | (+) | 0 | 0 | 0 | 23 | 22 | 100% |
| | (-) | 47 | 24 | 22 | 0 | 0 | 100% |
| BAR300 | (+) | 0 | 0 | 0 | 10 | 10 | 100% |
| | (-) | 60 | 10 | 10 | 0 | 0 | 100% |
| BAR200 | (+) | 0 | 0 | 0 | 23 | 23 | 100% |
| | (-) | 93 | 23 | 23 | 0 | 0 | 100% |
| BUP10 | (+) | 0 | 0 | 0 | 23 | 23 | 100% |
| | (-) | 93 | 23 | 23 | 0 | 0 | 100% |
| BZO300 | (+) | 0 | 0 | 0 | 10 | 10 | 100% |
| | (-) | 60 | 10 | 10 | 0 | 0 | 100% |
| BZO200 | (+) | 0 | 0 | 0 | 23 | 23 | 100% |
| | (-) | 93 | 23 | 23 | 0 | 0 | 100% |
| COC300 | (+) | 0 | 0 | 0 | 10 | 10 | 100% |
| | (-) | 60 | 10 | 10 | 0 | 0 | 100% |
| COC150 | (+) | 0 | 0 | 0 | 23 | 23 | 100% |
| | (-) | 93 | 23 | 23 | 0 | 0 | 100% |
| FYL5 | (+) | 0 | 0 | 0 | 24 | 23 | 100% |
| | (-) | 93 | 23 | 23 | 0 | 0 | 100% |
| MDMA500 | (+) | 0 | 0 | 1 | 24 | 22 | 100% |
| | (-) | 93 | 23 | 21 | 0 | 0 | 99% |
| MET1000 | (+) | 0 | 0 | 0 | 10 | 10 | 100% |
| | (-) | 60 | 10 | 10 | 0 | 0 | 100% |
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| MET500 | (+) | 0 | 0 | 0 | 23 | 23 | 100% |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | (-) | 47 | 23 | 23 | 0 | 0 | 100% |
| MET300 | (+) | 0 | 0 | 0 | 23 | 23 | 100% |
| | (-) | 47 | 23 | 23 | 0 | 0 | 100% |
| MTD300 | (+) | 0 | 0 | 0 | 23 | 23 | 100% |
| | (-) | 93 | 23 | 23 | 0 | 0 | 100% |
| MOR300 | (+) | 0 | 0 | 0 | 23 | 22 | 100% |
| | (-) | 37 | 24 | 23 | 0 | 0 | 100% |
| OXY100 | (+) | 0 | 0 | 1 | 23 | 23 | 100% |
| | (-) | 93 | 23 | 22 | 0 | 0 | 99% |
| OPI2000 | (+) | 0 | 0 | 0 | 23 | 23 | 100% |
| | (-) | 37 | 23 | 23 | 0 | 0 | 100% |
| PCP25 | (+) | 0 | 0 | 0 | 22 | 23 | 98% |
| | (-) | 93 | 23 | 23 | 1 | 0 | 100% |
| PPX300 | (+) | 0 | 0 | 0 | 23 | 23 | 100% |
| | (-) | 93 | 23 | 23 | 0 | 0 | 100% |
| TCA1000 | (+) | 0 | 0 | 0 | 23 | 23 | 100% |
| | (-) | 93 | 23 | 23 | 0 | 0 | 100% |
| THC50 | (+) | 0 | 0 | 0 | 22 | 23 | 98% |
| | (-) | 93 | 23 | 23 | 1 | 0 | 100% |
| TML100 | (+) | 0 | 0 | 0 | 23 | 23 | 100% |
| | (-) | 93 | 24 | 24 | 0 | 0 | 100% |
| Chemtrue® Drug Screen Cup | LC/MS Negative | | | LC/MS Positive | | % Agreement with LC/MS values | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | No Drug Present | 50% of the cutoff | 75% of the cutoff | 125% of the cutoff | | 150% of the cutoff |
| AMP1000 | (+) | 0 | 0 | 0 | 10 | 10 | 100% |
| | (-) | 60 | 10 | 10 | 0 | 0 | 100% |
| AMP500 | (+) | 0 | 0 | 0 | 23 | 23 | 100% |
| | (-) | 47 | 23 | 23 | 0 | 0 | 100% |
| AMP300 | (+) | 0 | 0 | 0 | 23 | 23 | 100% |
| | (-) | 47 | 23 | 23 | 0 | 0 | 100% |
| BAR300 | (+) | 0 | 0 | 0 | 10 | 10 | 100% |
| | (-) | 60 | 10 | 10 | 0 | 0 | 100% |
| BAR200 | (+) | 0 | 0 | 0 | 23 | 23 | 100% |
| | (-) | 93 | 23 | 23 | 0 | 0 | 100% |
| BUP10 | (+) | 0 | 0 | 0 | 23 | 23 | 100% |
| | (-) | 93 | 23 | 23 | 0 | 0 | 100% |
| BZO300 | (+) | 0 | 0 | 0 | 10 | 10 | 100% |
| | (-) | 60 | 10 | 10 | 0 | 0 | 100% |
| BZO200 | (+) | 0 | 0 | 0 | 23 | 23 | 100% |
| | (-) | 93 | 23 | 23 | 0 | 0 | 100% |
| COC300 | (+) | 0 | 0 | 0 | 10 | 10 | 100% |
| | (-) | 60 | 10 | 10 | 0 | 0 | 100% |
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| COC150 | (+) | 0 | 0 | 0 | 23 | 23 | 100% |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | (-) | 93 | 23 | 23 | 0 | 0 | 100% |
| FYL5 | (+) | 0 | 0 | 0 | 22 | 23 | 100% |
| | (-) | 93 | 25 | 24 | 0 | 0 | 100% |
| MDMA500 | (+) | 0 | 0 | 1 | 24 | 22 | 100% |
| | (-) | 93 | 23 | 22 | 0 | 0 | 99% |
| MET1000 | (+) | 0 | 0 | 0 | 10 | 10 | 100% |
| | (-) | 60 | 10 | 10 | 0 | 0 | 100% |
| MET500 | (+) | 0 | 0 | 0 | 23 | 23 | 100% |
| | (-) | 47 | 23 | 23 | 0 | 0 | 100% |
| MET300 | (+) | 0 | 0 | 1 | 23 | 23 | 100% |
| | (-) | 47 | 23 | 22 | 0 | 0 | 99% |
| MTD300 | (+) | 0 | 0 | 0 | 22 | 23 | 98% |
| | (-) | 93 | 23 | 23 | 1 | 0 | 100% |
| MOR300 | (+) | 0 | 0 | 0 | 23 | 22 | 100% |
| | (-) | 37 | 24 | 23 | 0 | 0 | 100% |
| OXY100 | (+) | 0 | 0 | 1 | 23 | 23 | 100% |
| | (-) | 0 | 23 | 22 | 0 | 0 | 99% |
| OPI2000 | (+) | 0 | 0 | 0 | 23 | 23 | 100% |
| | (-) | 37 | 23 | 23 | 0 | 0 | 100% |
| PCP25 | (+) | 0 | 0 | 1 | 23 | 23 | 100% |
| | (-) | 93 | 23 | 22 | 0 | 0 | 99% |
| PPX300 | (+) | 0 | 0 | 0 | 23 | 23 | 100% |
| | (-) | 93 | 23 | 23 | 0 | 0 | 100% |
| TCA1000 | (+) | 0 | 0 | 0 | 22 | 23 | 98% |
| | (-) | 93 | 23 | 23 | 1 | 0 | 100% |
| THC50 | (+) | 0 | 0 | 0 | 23 | 23 | 100% |
| | (-) | 93 | 23 | 23 | 0 | 0 | 100% |
| TML100 | (+) | 0 | 0 | 0 | 24 | 23 | 100% |
| | (-) | 93 | 24 | 23 | 0 | 0 | 100% |
D Clinical Cut-Off:
Not applicable.
E Expected Values/Reference Range:
Not applicable.
VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
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IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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