Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests
Device Facts
| Record ID | K153192 |
|---|---|
| Device Name | Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests |
| Applicant | Chemtron Biotech, Inc. |
| Product Code | DJG · Clinical Toxicology |
| Decision Date | Apr 18, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3650 |
| Device Class | Class 2 |
Indications for Use
The Chemtrue® Multi-Panel Drug Screen Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene and Tricyclic Antidepressants (TCA) drugs in human urine. The tests are intended for prescription and Over-The-Counter (OTC) use. The tests provide 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. There are no uniformly recognized cut-off concentration levels for these drugs in urine.
Device Story
Rapid lateral flow immunoassay for qualitative detection of drugs of abuse in human urine; utilizes competitive binding principle with drug-protein conjugates and anti-drug antibody-colloidal gold conjugates. Available in Dip Card or Cup formats. User (clinician or lay-user) collects urine; sample migrates via capillary action across membrane. Presence of drug above cutoff prevents formation of visible test line (preliminary positive); absence of drug allows formation of visible line (negative). Control line indicates proper test performance. Results are visual; intended for preliminary screening only. Confirmatory testing via GC/MS or LC/MS required for positive results. Clinical judgment required for interpretation.
Clinical Evidence
Consumer study with 130 lay-users across three sites; evaluated ability to interpret results using provided package insert; samples included negative, 50%, 75%, 125%, and 150% of cutoff concentrations; results showed high agreement with GC/MS reference method across all analytes.
Technological Characteristics
Lateral flow chromatographic immunoassay; visual readout; single-use test cup or dip card with 1-14 drug test strips; competitive binding principle; stable for 24 months at 2-30°C; no instrumentation required.
Indications for Use
Indicated for qualitative detection of drugs of abuse (Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene, TCA) in human urine. Intended for prescription and OTC use. Not for differentiating 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
- Innovacon Spectrum II Test Card with Integrated Cups (k061718)
- QuickScreen™ Test (k103295)
- ONSite CupKit™ (k060896)
Related Devices
- K143599 — Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000 · Chemtron Biotech, Inc. · Apr 17, 2015
- K232736 — 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 · Chemtron Biotech, Inc. · Dec 20, 2023
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY ONLY TEMPLATE
A. 510(k) Number:
k153192
B. Purpose for Submission:
New device
C. Measurands:
Amphetamine, barbiturates, benzodiazepines, buprenorphine, cocaine, marijuana, methadone, methamphetamine, methylenedioxymethamphetamine (MDMA), morphine, opiates, oxycodone, phencyclidine, propoxyphene, and tricyclic antidepressants.
D. Type of Test:
Qualitative lateral flow chromatographic immunoassay
E. Applicant:
Chemtron Biotech, Inc.
F. Proprietary and Established Names:
Chemtrue® Multi-Panel Drug Screen Cup Tests
Chemtrue® Multi-Panel Drug Screen Cup with OPI2000 Tests
Chemtrue® Multi-Panel Drug Screen Dip Card Tests
Chemtrue® Multi-Panel Drug Screen Dip Card with OPI2000 Tests
G. Regulatory Information:
| Assay | Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- | --- |
| Amphetamine | DKZ | Class II | 21CFR 862.3100, Amphetamine Test System | Toxicology (91) |
| Barbiturates | DIS | Class II | 21 CFR 862.3150, Barbiturates Test System | Toxicology (91) |
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| Assay | Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- | --- |
| Benzodiazepines | JXM | Class II | 21 CFR 862.3170, Benzodiazepines Test System | Toxicology (91) |
| Buprenorphine | DJG | Class II | 21 CFR 862.3650, Opiate test system | Toxicology (91) |
| Cocaine | DIO | Class II | 21 CFR 862.3250, Cocaine and metabolites Test System | Toxicology (91) |
| Marijuana | LDJ | Class II | 21 CFR 862.3870, Cannabinoids Test System | Toxicology (91) |
| Methadone | DJR | Class II | 21 CFR 862.3620, Methadone Test System | Toxicology (91) |
| Methamphetamine | LAF | Class II | 21 CFR 862.3610, Methamphetamine Test System | Toxicology (91) |
| MDMA | DJC | Class II | 21 CFR 862.3610, Methamphetamine Test System | Toxicology (91) |
| Morphine | DNK | Class II | 21 CFR 862.3640, Morphine Test System | Toxicology (91) |
| Opiates | DJG | Class II | 21 CFR 862.3650, Opiate Test System | Toxicology (91) |
| Oxycodone | DJG | Class II | 21 CFR 862.3650, Opiate Test System | Toxicology (91) |
| Phencyclidine | LCM | Class II | Unclassified, Enzyme immunoassay Phencyclidine | Toxicology (91) |
| Propoxyphene | JXN | Class II | 21 CFR 862.3700 Propoxyphene test system | Toxicology (91) |
| Tricyclic Antidepressants | LFG | Class II | 21 CFR 862.3910, Tricyclic antidepressant drugs test system | Toxicology (91) |
# H. Intended Use:
1. Intended use(s):
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Refer to Indications for Use below
## 2. Indication(s) for use:
### Chemtrue® Multi-Panel Drug Screen Dip Card Tests
The Chemtrue® Multi-Panel Drug Screen Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene 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 | 1000 |
| 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-Methylenedioxymethamphetamine | 500 |
| Methamphetamine | MAMP | d-Methamphetamine | 300 |
| Methamphetamine | MAMP | d-Methamphetamine | 500 |
| Methamphetamine | MAMP | d-Methamphetamine | 1000 |
| Marijuana | THC | 11-nor-Δ⁹-THC-9-COOH | 50 |
| Methadone | MTD | Methadone | 300 |
| Morphine | MOR | Morphine | 300 |
| Oxycodone | OXY | Oxycodone | 100 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Propoxyphene | PPX | Propoxyphene | 300 |
| Tricyclic Antidepressants | TCA | Nortriptyline | 1000 |
The multi test panels can consist of up to fourteen (14) of the above listed analytes in any combination. Only one cutoff concentration will be included per analyte per device. The tests are intended for prescription and Over-The-Counter (OTC) use.
The tests provide 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
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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. There are no uniformly recognized cut-off concentration levels for these drugs in urine.
# Chemtrue® Multi-Panel Drug Screen Dip Card with OPI2000 Tests
The Chemtrue® Multi-Panel Drug Screen Dip Card with OP2000 Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Opiates, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene 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 | 1000 |
| 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-Methylenedioxymethamphetamine | 500 |
| Methamphetamine | MAMP | d-Methamphetamine | 300 |
| Methamphetamine | MAMP | d-Methamphetamine | 500 |
| Methamphetamine | MAMP | d-Methamphetamine | 1000 |
| Marijuana | THC | 11-nor-Δ9-THC-9-COOH | 50 |
| Methadone | MTD | Methadone | 300 |
| Opiates | OPI | Morphine | 2000 |
| Oxycodone | OXY | Oxycodone | 100 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Propoxyphene | PPX | Propoxyphene | 300 |
| Tricyclic Antidepressants | TCA | Nortriptyline | 1000 |
The multi test panels can consist of up to fourteen (14) of the above listed analytes in any combination. Only one cutoff concentration will be included per analyte per device. The tests are intended for prescription and Over-The-Counter (OTC) use.
The tests provide only a preliminary result. A more specific alternative chemical method
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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. There are no uniformly recognized cut-off concentration levels for these drugs in urine.
# Chemtrue® Multi-Panel Drug Screen Cup Tests
The Chemtrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene 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 | 1000 |
| 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-Methylenedioxymethamphetamine | 500 |
| Methamphetamine | MAMP | d-Methamphetamine | 300 |
| Methamphetamine | MAMP | d-Methamphetamine | 500 |
| Methamphetamine | MAMP | d-Methamphetamine | 1000 |
| Marijuana | THC | 11-nor-Δ9-THC-9-COOH | 50 |
| Methadone | MTD | Methadone | 300 |
| Morphine | MOR | Morphine | 300 |
| Oxycodone | OXY | Oxycodone | 100 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Propoxyphene | PPX | Propoxyphene | 300 |
| Tricyclic Antidepressants | TCA | Nortriptyline | 1000 |
The multi test panels can consist of up to fourteen (14) of the above listed analytes in any combination. Only one cutoff concentration will be included per analyte per device. The
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tests are intended for prescription and Over-The-Counter (OTC) use.
The tests provide 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. There are no uniformly recognized cut-off concentration levels for these drugs in urine.
# Chemtrue® Multi-Panel Drug Screen Cup with OPI2000 Tests
The Chemtrue® Multi-Panel Drug Screen Cup with OPI2000 Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Opiates, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene 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 | 1000 |
| 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-Methylenedioxymethamphetamine | 500 |
| Methamphetamine | MAMP | d-Methamphetamine | 300 |
| Methamphetamine | MAMP | d-Methamphetamine | 500 |
| Methamphetamine | MAMP | d-Methamphetamine | 1000 |
| Marijuana | THC | 11-nor-Δ9-THC-9-COOH | 50 |
| Methadone | MTD | Methadone | 300 |
| Opiates | OPI | Morphine | 2000 |
| Oxycodone | OXY | Oxycodone | 100 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Propoxyphene | PPX | Propoxyphene | 300 |
| Tricyclic Antidepressants | TCA | Nortriptyline | 1000 |
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The multi test panels can consist of up to fourteen (14) of the above listed analytes in any combination. Only one cutoff concentration will be included per analyte per device. The tests are intended for prescription and Over-The-Counter (OTC) use.
The tests provide 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. There are no uniformly recognized cut-off concentration levels for these drugs in urine.
3. Special conditions for use statement(s):
For in vitro diagnostic use only.
4. Special instrument requirements:
Not applicable, as the devices are visually-read single-use devices.
I. Device Description:
The devices consist of:
- A test cup or a test card with 1 to 14 drug test strips
- Transport vial, transport bag, and mailing box (for confirmation testing)
- Package insert (instructions for use)
J. Substantial Equivalence Information:
1. Predicate device name(s):
Innovacon Spectrum II Test Card, Innovacon Spectrum II Test Card with Integrated Cups Phamatech QuickScreen Cocaine 150 Test
2. Predicate 510(k) number(s):
k061718
k103295
3. Comparison with predicate:
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| Similarities - k103295 | | |
| --- | --- | --- |
| Item | Candidate Devices
Chemtrue® Drug Screen Dip Card Tests, Chemtrue® Drug Screen Dip Card with OPI2000 Tests, Chemtrue® Multi-Panel Drug Screen Cup Tests, Chemtrue® Multi-Panel Drug Screen Cup Tests with OPI2000 Tests | Predicate - k103295
Phamatech QuickScreen Cocaine 150 Test |
| Indications for Use | Same | Qualitative detection of drugs of abuse in urine |
| Analytes | Same | COC at 150 ng/mL |
| Methodology | Same | Qualitative lateral flow chromatographic immunoassay |
| Similarities - k061718 | | |
| --- | --- | --- |
| Item | Candidate Devices
Chemtrue® Drug Screen Dip Card Tests, Chemtrue® Drug Screen Dip Card with OPI2000 Tests, Chemtrue® Multi-Panel Drug Screen Cup Tests, Chemtrue® Multi-Panel Drug Screen Cup Tests with OPI2000 Tests | Predicate - k061718
Innovacon Spectrum II Test Card, Innovacon Spectrum II Test Card with Integrated Cups |
| Indications for Use | Same | Qualitative detection of drugs of abuse in urine |
| Analytes | Same | AMP at 300, 500, and 1000 ng/mL
BAR at 200 and 300 ng/mL
BZO at 200 and 300 ng/mL
BUP at 10 ng/mL
COC at 300 ng/mL
MDMA at 500 ng/mL
MET at 300, 500, and 1000 ng/mL
THC at 50 ng/mL
MTD at 300 ng/mL
MOR at 300 ng/mL
OPI at 2000 ng/mL
OXY at 100 ng/mL
PCP at 25 ng/mL
PPX at 300 ng/mL
TCA at 1000 ng/mL |
8
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| Similarities – k061718 | | |
| --- | --- | --- |
| Item | Candidate Devices Chemtrue® Drug Screen Dip Card Tests, Chemtrue® Drug Screen Dip Card with OPI2000 Tests, Chemtrue® Multi-Panel Drug Screen Cup Tests, Chemtrue® Multi-Panel Drug Screen Cup Tests with OPI2000 Tests | Predicate – k061718 Innovacon Spectrum II Test Card, Innovacon Spectrum II Test Card with Integrated Cups |
| Methodology | Same | Qualitative lateral flow chromatographic immunoassay |
| Differences – k103295 | | |
| --- | --- | --- |
| Item | Candidate Devices Chemtrue® Drug Screen Dip Card Tests, Chemtrue® Drug Screen Dip Card with OPI2000 Tests, Chemtrue® Multi-Panel Drug Screen Cup Tests, Chemtrue® Multi-Panel Drug Screen Cup Tests with OPI2000 Tests | Predicate - k103295 Phamatech QuickScreen Cocaine 150 Test |
| Intended Use | For prescription and Over-The-Counter (OTC) | For prescription and point-of-care use only |
| Differences - k061718 | | |
| --- | --- | --- |
| Item | Candidate Devices Chemtrue® Drug Screen Dip Card Tests, Chemtrue® Drug Screen Dip Card with OPI2000 Tests, Chemtrue® Multi-Panel Drug Screen Cup Tests, Chemtrue® Multi-Panel Drug Screen Cup Tests with OPI2000 Tests | Predicate – k061718 Innovacon Spectrum II Test Card, Innovacon Spectrum II Test Card with Integrated Cups |
| Intended Use | For prescription and Over-The-Counter (OTC) | For prescription use only |
K. Standard/Guidance Document Referenced (if applicable):
Guidance for Industry and Food and Drug Administration Staff: Design Considerations for Devices Intended for Home Use, November 24, 2014
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L. Test Principle:
The devices are rapid lateral flow immunoassays in which drug-protein conjugates in the test device compete with drugs or drug metabolites that may be present in urine. On each test strip, a drug-protein conjugate is added to the test band of the membrane – known as the test region (T), and 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.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Dipcard format
| Drug | Concentration Tested | Operator 1/Lot 1 | Operator 2/Lot 2 | Operator 3/Lot 3 | Total of the three operators |
| --- | --- | --- | --- | --- | --- |
| | | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos |
| AMP 300 | 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 | 5/5 | 4/6 | 5/5 | 14/16 |
| | 125% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| | 150% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| BAR 200 | 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 | 5/5 | 5/5 | 6/4 | 16/14 |
| | 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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| BZO 200 | 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 | 3/6 | 5/4 | 6/6 | 14/16 |
| | 125% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| | 150% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| COC 150 | 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 | 3/4 | 4/7 | 7/5 | 14/16 |
| | 125% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| | 150% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| MAMP 300 | 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 | 6/4 | 4/5 | 6/5 | 16/14 |
| | 125% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| | 150% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| AMP 500 | 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 | 4/3 | 4/6 | 8/5 | 16/14 |
| | 125% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| | 150% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| MAMP 500 | 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 | 4/5 | 3/4 | 9/5 | 16/14 |
| | 125% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| | 150% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| PPX 300 | 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 | 4/5 | 4/5 | 7/5 | 15/15 |
| | 125% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| | 150% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
Cup format
| AMP 300 | 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 | 1/4 | 7/5 | 9/4 | 17/13 |
| | 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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| BAR 200 | 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 | 5/4 | 5/7 | 5/4 | 15/15 |
| | 125% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| | 150% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| BZO 200 | 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 | 6/7 | 3/3 | 6/5 | 15/15 |
| | 125% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| | 150% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| COC 150 | 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 | 5/2 | 4/5 | 4/10 | 13/17 |
| | 125% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| | 150% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| MAMP 300 | 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 | 1/4 | 8/5 | 6/6 | 15/15 |
| | 125% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| | 150% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| AMP 500 | 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 | 3/5 | 6/2 | 7/7 | 16/14 |
| | 125% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| | 150% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| MAMP 500 | 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 | 4/7 | 5/4 | 4/6 | 13/17 |
| | 125% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| | 150% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| PPX 300 | 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 | 5/4 | 2/5 | 8/6 | 15/15 |
| | 125% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
| | 150% of cutoff | 0/10 | 0/10 | 0/10 | 0/30 |
Precision performance for the remaining fourteen drugs (AMP 1000, BAR 300, BZO
{12}
300, BUP 10, COC 300, MDMA 500, MAMP 1000, THC 50, MTD 300, MOR 300, OP 2000, OXY 100, PCP 25, and TCA 1000) was established in k142396.
# b. Linearity/assay reportable range:
Not applicable. These devices are intended for qualitative use only.
# c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Stability: Device stability has been evaluated through accelerated and real-time studies. The real-time studies are ongoing. Protocols and acceptance criteria were described and found to be acceptable. The manufacturer claims that the devices are stable for two years (24 months) when stored at $2 - 30^{\circ}\mathrm{C}$ .
Quality control: Control materials are not supplied with the devices; however the labeling provides information on how to obtain quality control materials.
# d. Detection limit:
See Precision/Reproducibility section in M.1.a above.
# e. Analytical specificity:
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:
| Target Drug and Cutoff | Compound | Concentration Equivalent to the Cutoff (ng/mL) | Cross-Reactivity (%) |
| --- | --- | --- | --- |
| AMP 300 | D,L-AMP | 600 | 50.0 |
| | L-AMP | >30000 | <1 |
| | D-Methamphetamine | >30000 | <1 |
| | L-Methamphetamine | >30000 | <1 |
| | D,L-Methamphetamine | >30000 | <1 |
| | +/- MDMA | >30000 | <1 |
| | Ephedrine | >30000 | <1 |
| | D,L-MDA | 300 | 100.0 |
| | D,L-MDEA | >30000 | <1 |
| | Pseudoephedrine | >30000 | <1 |
| | Phentermine | 4000 | 7.5 |
| | Phenylephrine | >30000 | <1 |
| | Tyramine | >30000 | <1 |
{13}
| AMP 500 | D,L-AMP | 700 | 62.5 |
| --- | --- | --- | --- |
| L-AMP | 50000 | <1 |
| D-Methamphetamine | 50000 | <1 |
| L-Methamphetamine | 50000 | <1 |
| D,L-Methamphetamine | 50000 | <1 |
| D,L MDMA | 50000 | <1 |
| D,L-MDA | 700 | 100.0 |
| D,L-MDEA | 50000 | <1 |
| Ephedrine | 50000 | <1 |
| Pseudoephedrine | 50000 | <1 |
| Phentermine | 4000 | 10.0 |
| Phenylephrine | 50000 | <1 |
| Tyramine | 50000 | <1 |
| AMP 1000 | D,L-AMP | 1500 | 62.5 |
| L-AMP | 100000 | <1 |
| 0-Methamphetamine | 100000 | <1 |
| L-Methamphetamine | 100000 | <1 |
| D,L-Methamphetamine | 100000 | <1 |
| D,LMDMA | 100000 | <1 |
| D,L-MDA | 900 | 100.0 |
| D,L-MDEA | 100000 | <1 |
| Ephedrine | 100000 | <1 |
| Pseudoephedrine | 100000 | <1 |
| Phentermine | 6000 | 14.3 |
| Phenylephrine | 100000 | <1 |
| Tyramine | 100000 | <1 |
| BAR 200 | Alphenal | 300 | 66.7 |
| Amobarbital | 400 | 50.0 |
| Aprobarbital | 400 | 50.0 |
| Barbital | 6000 | 3.3 |
| Butabarbital | 300 | 66.7 |
| Butalbital | 1000 | 20.0 |
| Cyclopentobarbital | 240 | 83.3 |
| Phenobarbital | 1400 | 14.3 |
| BAR 300 | Alphenal | 500 | 60.0 |
| Amobarbital | 600 | 50.0 |
| Aprobarbital | 500 | 60.0 |
| Barbital | 10000 | 3.0 |
| Butabarbital | 500 | 60.0 |
| Butalbital | 2000 | 15.0 |
| Cyclopentobarbital | 500 | 60.0 |
| Phenobarbital | 2000 | 15.0 |
14
{14}
| BENZ 200 | Alprazolam | 200 | 100.0 |
| --- | --- | --- | --- |
| | Alphahydroxyalprazolam | 200 | 100.0 |
| | Bromazepam | 200 | 100.0 |
| | Chlordiazepoxide | 400 | 50.0 |
| | Clobazam | 600 | 33.3 |
| | Clonazepam | 20000 | 1.0 |
| | Clorazepate | 1800 | 11.1 |
| | Desalkyflurazepam | 800 | 25.0 |
| | Diazepam | 300 | 66.7 |
| | Estazolam | 200 | 100.0 |
| | Flunitrazepam | 4600 | 4.3 |
| | Flurazepam | 200 | 100.0 |
| | Lorazepam | 600 | 33.3 |
| | Lormetazepam | 2800 | 7.1 |
| | Midazolam | 8000 | 2.5 |
| | Nitrazepam | 800 | 25.0 |
| | Nordiazepam | 5200 | 3.8 |
| | Temazepam | 400 | 50.0 |
| | Trialozam | 1200 | 16.7 |
| BENZ 300 | Alprazolam | 300 | 100.0 |
| | Alphahydroxyalprazolam | 300 | 100.0 |
| | Bromazepam | 300 | 100.0 |
| | Chlordiazepoxide | 600 | 50.0 |
| | Clobazam | 800 | 37.5 |
| | Clonazepam | 30000 | 1.0 |
| | Clorazepate | 2000 | 15.0 |
| | Desalkyflurazepam | 1000 | 30.0 |
| | Diazepam | 500 | 60.0 |
| | Estazolam | 300 | 100.0 |
| | Flunitrazepam | 4800 | 6.3 |
| | Flurazepam | 300 | 100.0 |
| | Lorazepam | 800 | 37.5 |
| | Lormetazepam | 3600 | 8.3 |
| | Midazolam | 10000 | 3.0 |
| | Nitrazepam | 1000 | 30.0 |
| | Nordiazepam | 8000 | 3.8 |
| | Temazepam | 600 | 50.0 |
| | Triazolam | 1800 | 16.7 |
| BUP 10 | Buprenorphine | 10 | 100 |
| | Norbuprenorphine | 10 | 100 |
| | Morphine | 1000 | <1 |
| | Codeine | 1000 | <1 |
{15}
| COC 150 | Cocaethylene | 150 | 100.0 |
| --- | --- | --- | --- |
| | Cocaine | 180 | 83.3 |
| COC 300 | Ecgonine | 15000 | <1 |
| | Ecgonine HCl | 15000 | <1 |
| COC 300 | Cocaethylene | 300 | 100.0 |
| | Cocaine | 300 | 100.0 |
| COC 300 | Ecgonine | 30000 | <1 |
| | Ecgonine HCl | 30000 | <1 |
| MDMA 500 | MDA | 15000 | 3.3 |
| | MDEA | 1000 | 50 |
| MDMA 500 | d-Methamphetamine | 50000 | <1 |
| | d-Amphetamine | 50000 | <1 |
| MAMP 300 | L-Methamphetamine | 2000 | 15.0 |
| | D,L-Methamphetamine | 1600 | 18.8 |
| | D-Amphetamine | 30000 | <1 |
| | L-Amphetamine | 30000 | <1 |
| | D,L-Amphetamine | 30000 | <1 |
| | MDA | 30000 | <1 |
| | MDEA | 20000 | 1.5 |
| | MDMA | 2000 | 15.0 |
| | Ephedrine | 30000 | <1 |
| | Pseudoephedrine | 30000 | <1 |
| | Phenylephrine | 30000 | <1 |
| | Phentermine | 30000 | <1 |
| MAMP 500 | L-Methamphetamine | 2500 | 20.0 |
| | D,L-Methamphetamine | 2000 | 25.0 |
| | D-Amphetamine | 50000 | <1 |
| | L-Amphetamine | 50000 | <1 |
| | D,L-Amphetamine | 50000 | <1 |
| | MDA | 50000 | <1 |
| | MDEA | 25000 | 2.0 |
| | MDMA | 2600 | 19.2 |
| | Ephedrine | 50000 | <1 |
| | Pseudoephedrine | 50000 | <1 |
| | Phenylephrine | 50000 | <1 |
| | Phentermine | 50000 | <1 |
{16}
The sponsor also evaluated the potential for positive and negative interference from non-structurally related compounds, endogenous compounds, pH, and specific gravity. The structurally unrelated compounds and endogenous substances study was performed by spiking structurally unrelated compounds and endogenous substances at a concentration of $100\mu \mathrm{g / mL}$ into urine samples containing drug at $\pm 25\%$ of the respective drug cutoff concentrations.
The following substances showed no positive or negative interference in this study:
| Albumin | Creatinine | Riboflavin |
| --- | --- | --- |
| Bilirubin | Glucose | Sodium Chloride |
| Cholesterol | Hemoglobin | Uric Acid |
| Acetaminophen | Diphenylhydantoin | Octopamine |
| Acetone | Dopamine | Oxalic Acid |
| Acetylsalicylic Acid | Erythromycin | Papaverine |
| Amoxicillin | Estradiol | Penicillin-G |
| Ampicillin | Estrone | Perphenazine |
| Apomorphine | Ethanol | Phenelzine |
| Ascorbic Acid | Fenofibrate | Phenylethylamine |
| Aspirin | Fentanyl | Prednisone |
| Aspartame | Fotemustine | Promazine |
| Atropine | Furosemide | Promethazine |
| Baclofen | Gemfibrozil | Propoxyphene |
| Benzocaine | Guaiacolglyceryl ether | Propranolol |
| Benzoic Acid | Gentisic Acid | Pyridoxine |
| Carisoprodol | Hydralazine | Pyrilamine |
{17}
| Chloramphenicol | Hydrocortisone | Pyrogallol |
| --- | --- | --- |
| Chlordiazepoxide | Hydroxytyramine | Quinidine |
| Chlorpheniramine | Isoproterenol | Quinine |
| Chlorpromazine | Ketamine | Quinolinic Acid |
| Clofibrate | Meprobamate | Ranitidine |
| Clonidine | Methapyrilene | Salicylic Acid |
| Cortisone | Methylphenidate | Sulfamethazine |
| Cotinine | Nalidixic Acid | Sulindac |
| Creatine Hydrate | Naloxone | Tetracycline |
| Cyclobenzaprine | Naltrexone | Tetrahydrozoline |
| Cyclodextrin-r | Naproxen | Thiamine |
| Cyproheptadine | Niacinamide | Thioridazine |
| Deoxycorticosterone | Nicotinic Acid | Tramadol |
| Dextromethorphan | Nifedipine | Trifluoperazine |
| Diclofenac | Norethindrone | Tryptamine |
| Diflunisal | Norpropoxyphene | Tyramine |
| Dimethyl-aminoantipyrine | Noscapine | Zomepirac sodium salt |
| Diphenhydramine | | |
To evaluate the effect of pH value on the test results, urine controls at $\pm 25\%$ 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 $\pm 25\%$ 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.
f. Assay cut-off:
Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section, M.1.a., above.
2. Comparison studies:
The sponsor performed a method comparison study comparing performance of the test strips of the cup devices to the GC/MS reference method. Results are summarized below:
a. Method comparison with predicate device:
{18}
# Dipcard Format
AMP 300
| Candidate Device Result | Concentration by reference method (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤ cutoff –50% | cutoff –50% to the cutoff | cutoff to cutoff +50% | ≥ cutoff +50% |
| POS | 0 | 0 | 14 | 27 |
| NEG | 31 | 11 | 0 | 0 |
Agreement among positives = 41/41 = 100%
Agreement among negatives = 42/42 = 100%
AMP 500
| Candidate Device Result | Concentration by reference method (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤ cutoff –50% | cutoff –50% to the cutoff | cutoff to cutoff +50% | ≥ cutoff +50% |
| POS | 0 | 0 | 12 | 31 |
| NEG | 31 | 14 | 0 | 0 |
Agreement among positives = 43/43 = 100%
Agreement among negatives = 45/45 = 100%
BAR 200
| Candidate Device Result | Concentration by reference method (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤ cutoff –50% | cutoff –50% to the cutoff | cutoff to cutoff +50% | ≥ cutoff +50% |
| POS | 0 | 1* | 26 | 14 |
| NEG | 34 | 9 | 0 | 0 |
Agreement among positives = 40/40 = 100%
Agreement among negatives = 43/44 = 98%
*Sample contained pentobarbital at 185 ng/mL
BENZ 200
| Candidate Device Result | Concentration by reference method (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤ cutoff –50% | cutoff –50% to the cutoff | cutoff to cutoff +50% | ≥ cutoff +50% |
| POS | 0 | 0 | 26 | 14 |
| NEG | 31 | 16 | 0 | 0 |
Agreement among positives = 40/40 = 100%
Agreement among negatives = 47/47 = 100%
COC 150
| Candidate Device Result | Concentration by reference method (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤ cutoff –50% | cutoff –50% to the cutoff | cutoff to cutoff +50% | ≥ cutoff +50% |
| POS | 0 | 0 | 15 | 28 |
| NEG | 31 | 10 | 0 | 0 |
Agreement among positives = 43/43 = 100%
Agreement among negatives = 41/41 = 100%
19
{19}
MAMP 300
| Candidate Device Result | Concentration by reference method (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤ cutoff -50% | cutoff -50% to the cutoff | cutoff to cutoff +50% | ≥ cutoff +50% |
| POS | 0 | 1* | 14 | 34 |
| NEG | 31 | 9 | 0 | 0 |
Agreement among positives = 48/48 = 100%
Agreement among negatives = 40/41 = 98%
* Sample contained methamphetamine at 296 ng/mL
MAMP 500
| Candidate Device Result | Concentration by reference method (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤ cutoff -50% | cutoff -50% to the cutoff | cutoff to cutoff +50% | ≥ cutoff +50% |
| POS | 0 | 1* | 11 | 30 |
| NEG | 31 | 11 | 0 | 0 |
Agreement among positives = 41/41 = 100%
Agreement among negatives = 42/43 = 98%
*Sample contained methamphetamine at 494 ng/mL
PPX 300
| Candidate Device Result | Concentration by reference method (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤ cutoff -50% | cutoff -50% to the cutoff | cutoff to cutoff +50% | ≥ cutoff +50% |
| POS | 0 | 0 | 12 | 33 |
| NEG | 31 | 10 | 0 | 0 |
Agreement among positives = 45/45 = 100%
Agreement among negatives = 41/41 = 100%
Cup Format
AMP 300
| Candidate Device Result | Concentration by reference method (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤ cutoff -50% | cutoff -50% to the cutoff | cutoff to cutoff +50% | ≥ cutoff +50% |
| POS | 0 | 1* | 14 | 27 |
| NEG | 31 | 10 | 0 | 0 |
Agreement among positives = 41/41 = 100%
Agreement among negatives = 41/42 = 98%
*Sample contained amphetamine at 229 ng/mL
{20}
AMP 500
| Candidate Device Result | Concentration by reference method (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤ cutoff -50% | cutoff -50% to the cutoff | cutoff to cutoff +50% | ≥ cutoff +50% |
| POS | 0 | 1* | 11 | 31 |
| NEG | 31 | 13 | 1† | 0 |
Agreement among positives = 42/43 = 98%
Agreement among negatives = 44/45 = 98%
*Sample contained amphetamine at 441 ng/mL
†Sample contained amphetamine at 510 ng/mL
BAR 200
| Candidate Device Result | Concentration by reference method (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤ cutoff -50% | cutoff -50% to the cutoff | cutoff to cutoff +50% | ≥ cutoff +50% |
| POS | 0 | 1* | 26 | 14 |
| NEG | 34 | 9 | 0 | 0 |
Agreement among positives = 40/40 = 100%
Agreement among negatives = 43/44 = 98%
*Sample contained pentobarbital at 185 ng/mL
BENZ 200
| Candidate Device Result | Concentration by reference method (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤ cutoff -50% | cutoff -50% to the cutoff | cutoff to cutoff +50% | ≥ cutoff +50% |
| POS | 0 | 0 | 26 | 14 |
| NEG | 31 | 16 | 0 | 0 |
Agreement among positives = 40/40 = 100%
Agreement among negatives = 47/47 = 100%
COC 150
| Candidate Device Result | Concentration by reference method (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤ cutoff -50% | cutoff -50% to the cutoff | cutoff to cutoff +50% | ≥ cutoff +50% |
| POS | 0 | 0 | 15 | 28 |
| NEG | 31 | 10 | 0 | 0 |
Agreement among positives = 43/43 = 100%
Agreement among negatives = 41/41 = 100%
MAMP 300
| Candidate Device Result | Concentration by reference method (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤ cutoff -50% | cutoff -50% to the cutoff | cutoff to cutoff +50% | ≥ cutoff +50% |
| POS | 0 | 1* | 14 | 34 |
| NEG | 31 | 9 | 0 | 0 |
Agreement among positives = 48/48 = 100%
Agreement among negatives = 40/41 = 98%
*Sample contained methamphetamine at 296 ng/mL
{21}
MAMP 500
| Candidate Device Result | Concentration by reference method (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤ cutoff -50% | cutoff -50% to the cutoff | cutoff to cutoff +50% | ≥ cutoff +50% |
| POS | 0 | 0 | 11 | 30 |
| NEG | 31 | 12 | 0 | 0 |
Agreement among positives $= 41 / 41 = 100\%$
Agreement among negatives $= 43 / 43 = 100\%$
PPX 300
| Candidate Device Result | Concentration by reference method (ng/mL) | | | |
| --- | --- | --- | --- | --- |
| | ≤ cutoff -50% | cutoff -50% to the cutoff | cutoff to cutoff +50% | ≥ cutoff +50% |
| POS | 0 | 0 | 12 | 33 |
| NEG | 31 | 10 | 0 | 0 |
Agreement among positives $= 45 / 45 = 100\%$
Agreement among negatives $= 41 / 41 = 100\%$
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 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. One hundred and thirty (130) lay-users participated in this study from three (3) intended user sites with GC/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 and up to two (2) random blind labeled samples with the tests of each device format. The results are summarized below:
{22}
| Chemtrue® Cup Test | Candidate Device Result | (-) | | | (+) | | % Agreement with reference method |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | <50% of the C/O | Negative (50% of the C/O) | Near cutoff Negative (50% of the cutoff to the cutoff) | Near cutoff positive (cutoff to 125% of the cutoff) | Positive (≥125% of the C/O) | |
| AMP1000 | + | 0 | 0 | 0 | 10 | 10 | 100% |
| | - | 60 | 10 | 10 | 0 | 0 | 100% |
| AMP500 | + | 0 | 0 | 0 | 26 | 21 | 100% |
| | - | 60 | 23 | 39 | 0 | 0 | 100% |
| AMP300 | + | 0 | 0 | 0 | 23 | 48 | 100% |
| | - | 51 | 21 | 25 | 0 | 0 | 100% |
| BAR300 | + | 0 | 0 | 0 | 10 | 10 | 100% |
| | - | 60 | 10 | 10 | 0 | 0 | 100% |
| BAR200 | + | 0 | 0 | 0 | 43 | 22 | 100% |
| | - | 194 | 26 | 22 | 0 | 0 | 100% |
| BUP | + | 0 | 0 | 0 | 39 | 23 | 100% |
| | - | 189 | 35 | 21 | 0 | 0 | 100% |
| BZO300 | + | 0 | 0 | 0 | 10 | 10 | 100% |
| | - | 60 | 10 | 10 | 0 | 0 | 100% |
| BZO200 | + | 0 | 0 | 0 | 22 | 24 | 100% |
| | - | 184 | 37 | 40 | 0 | 0 | 100% |
| COC300 | + | 0 | 0 | 0 | 10 | 10 | 100% |
| | - | 60 | 10 | 10 | 0 | 0 | 100% |
| COC150 | + | 0 | 0 | 0 | 37 | 41 | 100% |
| | - | 182 | 25 | 22 | 0 | 0 | 100% |
| MDMA | + | 0 | 0 | 1 | 37 | 39 | 100% |
| | - | 189 | 21 | 20 | 0 | 0 | 99.50% |
{23}
| Chemtrue® Dipcard Test | Candidate Device Result | (-) | | | (+) | | % Agreement with reference method |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | <50% of the C/O | Negative (50% of the C/O) | Near cutoff Negative (50% of the cutoff to the cutoff) | Near cutoff positive (cutoff to 125% of the cutoff) | Positive (≥125% of the C/O) | |
| MET 1000 | + | 0 | 0 | 0 | 10 | 10 | 100% |
| | - | 60 | 10 | 10 | 0 | 0 | 100% |
| MET 500 | + | 0 | 0 | 0 | 26 | 22 | 100% |
| | - | 55 | 41 | 25 | 0 | 0 | 100% |
| MET 300 | + | 0 | 0 | 0 | 23 | 42 | 100% |
| | - | 56 | 22 | 25 | 0 | 0 | 100% |
| MTD | + | 0 | 0 | 0 | 21 | 20 | 100% |
| | - | 208 | 21 | 37 | 0 | 0 | 100% |
| MOR300 | + | 0 | 0 | 0 | 19 | 58 | 100% |
| | - | 56 | 19 | 18 | 0 | 0 | 100% |
| OPI2000 | + | 0 | 0 | 0 | 20 | 20 | 100% |
| | - | 58 | 20 | 20 | 0 | 0 | 100% |
| OXY | + | 0 | 0 | 0 | 39 | 21 | 100% |
| | - | 176 | 21 | 20 | 0 | 0 | 100% |
| PCP | + | 0 | 0 | 0 | 21 | 20 | 100% |
| | - | 192 | 39 | 35 | 0 | 0 | 100% |
| PPX | + | 0 | 0 | 1 | 38 | 40 | 100% |
| | - | 185 | 22 | 21 | 0 | 0 | 99.60% |
| TCA | + | 0 | 0 | 1 | 20 | 36 | 100% |
| | - | 177 | 21 | 22 | 0 | 0 | 99.60% |
| THC | + | 0 | 0 | 0 | 21 | 37 | 100% |
| | - | 190 | 39 | 20 | 0 | 0 | 100% |
{24}
| Chemtrue® Dipcard Test | Candidate Device Result | (-) | | | (+) | | % Agreement with reference method |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | <50% of the C/O | Negative (50% of the C/O) | Near cutoff Negative (50% of the cutoff to the cutoff) | Near cutoff positive (cutoff to 125% of the cutoff) | Positive (≥125% of the C/O) | |
| AMP1000 | + | 0 | 0 | 0 | 10 | 10 | 100% |
| | - | 60 | 10 | 10 | 0 | 0 | 100% |
| AMP500 | + | 0 | 0 | 0 | 28 | 21 | 100% |
| | - | 54 | 39 | 41 | 0 | 0 | 100% |
| AMP300 | + | 0 | 0 | 1 | 24 | 46 | 100% |
| | - | 53 | 21 | 23 | 0 | 0 | 99% |
| BAR300 | + | 0 | 0 | 0 | 10 | 10 | 100% |
| | - | 60 | 10 | 10 | 0 | 0 | 100% |
| BAR200 | + | 0 | 0 | 0 | 43 | 22 | 100% |
| | - | 194 | 26 | 22 | 0 | 0 | 100% |
| BUP 10 | + | 0 | 0 | 0 | 35 | 26 | 100% |
| | - | 202 | 35 | 23 | 0 | 0 | 100% |
| BZO300 | + | 0 | 0 | 0 | 10 | 10 | 100% |
| | - | 60 | 10 | 10 | 0 | 0 | 100% |
| BZO200 | + | 0 | 0 | 0 | 21 | 25 | 100% |
| | - | 184 | 37 | 40 | 0 | 0 | 100% |
| COC300 | + | 0 | 0 | 0 | 10 | 10 | 100% |
| | - | 60 | 10 | 10 | 0 | 0 | 100% |
| COC150 | + | 0 | 0 | 0 | 37 | 40 | 100% |
| | - | 183 | 25 | 22 | 0 | 0 | 100% |
| MDMA | + | 0 | 0 | 0 | 38 | 39 | 100% |
| | - | 204 | 20 | 20 | 0 | 0 | 100% |
| MET1000 | + | 0 | 0 | 0 | 10 | 10 | 100% |
| | - | 60 | 10 | 10 | 0 | 0 | 100% |
{25}
| Chemtrue® Dipcard Test | Candidate Device Result | (-) | | | (+) | | % Agreement with reference method |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | <50% of the C/O | Negative (50% of the C/O) | Near cutoff Negative (50% of the cutoff to the cutoff) | Near cutoff positive (cutoff to 125% of the cutoff) | Positive (≥125% of the C/O) | |
| MET500 | + | 0 | 0 | 0 | 22 | 36 | 100% |
| | - | 55 | 44 | 26 | 0 | 0 | 100% |
| MET300 | + | 0 | 0 | 1 | 24 | 43 | 100% |
| | - | 57 | 20 | 23 | 0 | 0 | 99% |
| MTD 300 | + | 0 | 0 | 0 | 20 | 20 | 100% |
| | - | 222 | 21 | 38 | 0 | 0 | 100% |
| MOR 300 | + | 0 | 0 | 0 | 19 | 59 | 100% |
| | - | 51 | 34 | 19 | 0 | 0 | 100% |
| OP2000 | + | 0 | 0 | 0 | 19 | 19 | 100% |
| | - | 59 | 21 | 20 | 0 | 0 | 100% |
| OXY | + | 0 | 0 | 0 | 39 | 21 | 100% |
| | - | 191 | 20 | 20 | 0 | 0 | 100% |
| PCP | + | 0 | 0 | 0 | 35 | 22 | 100% |
| | - | 194 | 35 | 35 | 0 | 0 | 100% |
| PPX | + | 0 | 0 | 0 | 38 | 40 | 100% |
| | - | 185 | 22 | 22 | 0 | 0 | 100% |
| TCA | + | 0 | 0 | 0 | 21 | 36 | 100% |
| | - | 174 | 35 | 25 | 0 | 0 | 100% |
| THC | + | 0 | 0 | 0 | 21 | 38 | 100% |
| | - | 203 | 39 | 20 | 0 | 0 | 100% |
4. Clinical cut-off:
Not applicable.
5. Expected values/Reference range:
Not applicable.
{26}
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.
27
