Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests
Device Facts
| Record ID | K142396 |
|---|---|
| Device Name | Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests |
| Applicant | Chemtron Biotech, Inc. |
| Product Code | DJG · Clinical Toxicology |
| Decision Date | Oct 9, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3650 |
| Device Class | Class 2 |
Intended Use
The Chemtrue® BUP/TCA Single/Multi-Panel Drug Screen Dip Cassette Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine (BUP) and/or Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: Analyte: Buprenorphine, Abbreviation: BUP, Calibrator: Buprenorphine, Cutoff Concentration (ng/mL): 10; Analyte: Tricyclic Antidepressants, Abbreviation: TCA, Calibrator: Nortriptyline, Cutoff Concentration (ng/mL): 1000. The single and multi-panel tests are available in Dip Card, Cup and Cassette formats. 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 distinguish between prescription use or abuse of Buprenorphine and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for Buprenorphine and Tricyclic Antidepressants in urine.
Device Story
Rapid lateral flow immunoassays for qualitative detection of drugs of abuse in human urine; formats include dip card, cup, or cassette. Principle: competitive binding immunoassay using drug-protein conjugates and anti-drug antibody-colloidal gold conjugates. Input: human urine sample; capillary action moves sample across membrane. Output: visual color bands; presence of line in test region indicates negative result; absence indicates preliminary positive. Used in clinical or home settings; operated by healthcare professionals or lay-users. Results are preliminary; require confirmation via GC/MS or LC/MS. Clinical decision-making requires professional judgment. Benefits: rapid, preliminary screening for drugs of abuse.
Clinical Evidence
Performance evaluated via bench testing and lay-user studies. Method comparison study (n=174 clinical specimens) against GC/MS showed high agreement (96.3%-100%). Reproducibility study (n=30 per concentration level) conducted across 6 days with 3 operators. OTC lay-user study (n=300) confirmed ease of use and performance across various drug concentrations. Interference and cross-reactivity studies performed for >100 compounds.
Technological Characteristics
Lateral flow, competitive binding immunoassay. Materials: colloidal gold-labeled monoclonal/polyclonal anti-drug antibodies, drug-protein conjugates. Formats: dip card, cup, cassette. Standalone, single-use, in vitro diagnostic device. No electronic components or software.
Indications for Use
Indicated for qualitative detection of Buprenorphine and/or Tricyclic Antidepressants in human urine. Intended for prescription and OTC use. Not intended to distinguish between prescription use or abuse of Buprenorphine or Tricyclic Antidepressants.
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 and Innovacon Spectrum II Test Card with Integrated Cups (k061718)
Related Devices
- 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
- K142580 — Chemtrue Multi-Panel DOA DIP Card Tests · Chemtron Biotech, Inc. · Dec 1, 2014
- K152590 — ACCU NEWS Drug Screening Test Card/Urine Cup · Coretests, Inc. · Apr 15, 2016
- K111322 — CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD · Chemtron Biotech, Inc. · Sep 14, 2011
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 9, 2014
CHEMTRON BIOTECH, INC. JANE ZHANG QA/RA DIRECTOR 9245 BROWN DEER ROAD, SUITE B SAN DIEGO CA 92121
Re: K142396
Trade/Device Name: Chemtrue® BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests: Chemtrue® Multi-Panel Drug Screen Dip Card Tests; Chemtrue® Multi-Panel Drug Screen Dip Card with OPI 2000 Tests Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG, LFG Dated: August 27, 2014
Received: August 28, 2014
Dear Ms. Jane Zhang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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### Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) k142396
#### Device Name
Chemtrue® BUP / TCA Single/Multi-Panel Drug Screen Dip Card / Cup / Cassette Tests Chemtrue® Multi-Panel Drug Screen Dip Card Tests Chemtrue® Multi-Panel Drug Screen Dip Card with OPI 2000 Tests
#### Indications for Use (Describe)
| Chemtrue® BUP / TCA Single/Multi-Panel Drug Screen Dip Card / Cup / Cassette Tests: | | | |
|-------------------------------------------------------------------------------------|--------------|---------------|-------------------------------------------------------------------------------------------------------------------|
| | | | The Chemtrue® BUP/TCA Single/Multi-Panel Drug Screen Dip Cassette Tests are rapid lateral flow |
| | | | immunoassays for the qualitative detection of Buprenorphine (BUP) and/or 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) |
| Buprenorphine | BUP | Buprenorphine | 10 |
| Tricyclic Antidepressants | TCA | Nortriptyline | 1000 |
The single and multi-panel tests are available in Dip Card, Cup and Cassette formats. 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 distinguish between prescription use or abuse of Buprenorphine and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for Buprenorphine and Tricyclic Antidepressants in urine.
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 Buprenorphine, Amphetamine, Cocaine, Marijuana, Morphine, Methamphetamine, Phencyclidine, Benzodiazepines, Barbiturates, Ecstasy, Methadone, Oxycodone and Tricyclic Antidepressants 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) |
|---------------------------|--------------|-----------------------------------|------------------------------|
| Buprenorphine | BUP | Buprenorphine | 10 |
| Tricyclic Antidepressants | TCA | Nortriptyline | 1000 |
| Amphetamine | AMP | d-Amphetamine | 1000 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Methamphetamine | MAMP/MET | d-Methamphetamine | 1000 |
| Morphine | MOR | Morphine | 300 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Marijuana | THC | 11-nor-Δ9-THC9-COOH | 50 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxymethamphetamine | 500 |
| Methadone | MTD | Methadone | 300 |
| Oxycodone | OXY | Oxycodone | 100 |
The Chemtrue® Multi-Panel Drug Screen Dip Card Tests panel can consist of any combination of the above listed drug analytes. 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
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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 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 OPI 2000 Tests:
The Chemtrue® Multi-Panel Drug Screen Dip Card with OPI 2000 Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine, Amphetamine, Cocaine, Marijuana, Opiates 2000, Methamphetamine, Phencyclidine, Benzodiazepines, Barbiturates, Ecstasy, Methadone, Oxycodone and Tricyclic Antidepressants 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) |
|---------------------------|--------------|-----------------------------------|------------------------------|
| Buprenorphine | BUP | Buprenorphine | 10 |
| Tricyclic Antidepressants | TCA | Nortriptyline | 1000 |
| Amphetamine | AMP | d-Amphetamine | 1000 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Methamphetamine | MAMP/MET | d-Methamphetamine | 1000 |
| Opiates | OPI | Morphine | 2000 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Marijuana | THC | 11-nor-A9-THC9-COOH | 50 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxymethamphetamine | 500 |
| Methadone | MTD | Methadone | 300 |
| Oxycodone | OXY | Oxycodone | 100 |
The Chemtrue® Multi-Panel Drug Screen Dip Card with OP1 2000 Tests can consist of any combination of the above listed drug analytes. The tests are intended for prescription and Over-The-Counter (OTC) use.
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, Barbiturates, Buprenorphine, Oxycodone and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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# 510(k) Summary
### AS REQUIRED BY 21 CFR 807.92(c)
### A. SUBMITTER: Chemtron Biotech, Inc. 9245 Brown Deer Road, Suite B, San Diego, CA
92121.
TEL: 858-450-0044
FAX: 858-450-0046
Contact Person: Jane Zhang, Director of QA/RA
Official FDA Correspondent 9245 Brown Deer Road, Suite B San Diego, CA 92121 Office: (858) 450-0044; FAX: (858) 450-0046 Email: jane@uschemtronbio.com
Date Prepared: October 08, 2014
### B. DEVICE
Device Name: Chemtrue® BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests Chemtrue® Multi-Panel Drug Screen Dip Card Tests Chemtrue® Multi-Panel Drug Screen Dip Card with OPI 2000 Tests
Common Name: Multi-Drug Urine Test Panel
Regulatory Class: Class II
Regulatory Information:
| Drug of Abuse | Product Code | Device Panel | Regulation Number |
|---------------------------------|--------------|---------------|-------------------|
| Buprenorphine (BUP) | DJG | Toxicology 91 | 21CFR 862.3650 |
| Tricyclic Antidepressants (TCA) | LFG | Toxicology 91 | 21 CFR 862.3910 |
This 510(k) has been submitted for clearance of new BUP/TCA drugs of abuse cup devices and to incorporate BUP/TCA analytes to previously FDA cleared Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests (k102203, k111322, k121339, and k123080). These tests have been previously cleared for prescription use (k102203 and k111322) and over-the-counter use (k121339 and k123080) and already contain the following drugs of abuse analytes:
| Drug of Abuse | Product Code | Panel | Regulation Section |
|-----------------|--------------|---------------|------------------------------------------------------|
| Amphetamine | DKZ | Toxicology 91 | 21CFR 862.3100, Amphetamine Test System |
| Cocaine | DIO | Toxicology 91 | 21 CFR 862.3250, Cocaine and metabolites Test System |
| Methamphetamine | LAF | Toxicology 91 | 21 CFR 862.3610, Methamphetamine Test System |
| Opiates | DIG | Toxicology 91 | 21 CFR 862.3650, Opiate Test System |
| Phencyclidine | LCM | Toxicology 91 | Unclassified, Enzyme immunoassay Phencyclidine |
| Marijuana | LDJ | Toxicology 91 | 21 CFR 862.3870, Cannabinoids Test System |
| Benzodiazepines | JXM | Toxicology 91 | 21 CFR 862.3170, Benzodiazepines Test System |
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| Barbiturates | DIS | Toxicology 91 | 21 CFR 862.3150, Barbiturates Test System |
|----------------|-----|---------------|----------------------------------------------|
| Ecstasy (MDMA) | DIC | Toxicology 91 | 21 CFR 862.3610, Methamphetamine Test System |
| Methadone | DJR | Toxicology 91 | 21 CFR 862.3620, Methadone Test System |
| Oxycodone | DJG | Toxicology 91 | 21 CFR 862.3650, Opiate Test System |
| Morphine | DNK | Toxicology 91 | 21 CFR 862.3640, Morphine Test System |
#### C. PREDICATE DEVICE:
510(k): k061718. Innovacon Spectrum II Test Card and Innovacon Spectrum II Test Card with Integrated Cups
#### D. INDICATONS FOR USE:
Device Name: Chemtrue® BUP / TCA Single/Multi-Panel Drug Screen Dip Card / Cup / Cassette Tests
Chemtrue® Multi-Panel Drug Screen Dip Card Tests
Chemtrue® Multi-Panel Drug Screen Dip Card with OPI 2000 Tests
Indications for Use:
Chemtrue® BUP / TCA Single/Multi-Panel Drug Screen Dip Card / Cup / Cassette Tests:
The Chemtrue® BUP/TCA Single/Multi-Panel Drug Screen Dip Card /Cup/Cassette Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine (BUP) and/or 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 |
|---------------------------|--------------|---------------|----------------------|
| Buprenorphine | BUP | Buprenorphine | 10 ng/mL |
| Tricyclic Antidepressants | TCA | Nortriptyline | 1000 ng/mL |
The single and multi-panel tests are available in Dip Card, Cup and Cassette formats. The tests are intended for prescription and Over-The-Counter (OTC) use. 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 distinguish between prescription use or abuse of Buprenorphine and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for Buprenorphine and Tricvclic Antidepressants in urine.
Chemtrue® Multi-Panel Drug Screen Dip Card Tests:
The Chemtrue® Multi-Panel Drug Screen Div Card Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine, Amphetamine, Cocaine, Marijuana, Morphine, Methamphetamine, Phencyclidine, Benzodiazepines, Barbiturates,
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| Analyte | Abbreviation | Calibrator | Cutoff Concentration<br>(ng/mL) |
|---------------------------|--------------|-----------------------------------|---------------------------------|
| Buprenorphine | BUP | Buprenorphine | 10 |
| Tricyclic Antidepressants | TCA | Nortriptyline | 1000 |
| Amphetamine | AMP | d-Amphetamine | 1000 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Methamphetamine | MAMP /MET | d-Methamphetamine | 1000 |
| Morphine | MOR | Morphine | 300 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Marijuana | THC | 11-nor-Δ'-THC9-COOH | રેણ |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Ecstasy | MDMA | d.l-Methylenedioxymethamphetamine | 500 |
| Methadone | MTD | Methadone | 300 |
| Oxycodone | OXY | Oxycodone | 100 |
Ecstasy, Methadone, Oxycodone and Tricyclic Antidepressants drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
The Chemtrue® Multi-Panel Drug Screen Dip Card Tests panel can consist of any combination of the above listed drug analytes. 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 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 OPI 2000 Tests:
The Chemtrue® Multi-Panel Drug Screen Dip Card with OPI 2000 Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine, Amphetamine, Cocaine, Marijuana. Opiates 2000. Methamphetamine. Phencyclidine. Benzodiazepines. Barbiturates. Ecstasy, Methadone, Oxycodone and Tricyclic Antidepressants 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<br>(ng/mL) |
|---------------------------|--------------|-----------------|---------------------------------|
| Buprenorphine | BUP | Buprenorphine | 10 |
| Tricyclic Antidepressants | TCA | Nortriptyline | 1000 |
| Amphetamine | AMP | d-Amphetamine | 1000 |
| Cocaine | COC | Benzoylecgonine | 300 |
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| Methamphetamine | MAMP /MET | d-Methamphetamine | 1000 |
|-----------------|-----------|-----------------------------------|------|
| Opiates | OPI | Morphine | 2000 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Marijuana | THC | 11-nor- $\Delta^9$ -THC9-COOH | 50 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Barbiturates | BAR | Secobarbital/Pentobarbital | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxymethamphetamine | 500 |
| Methadone | MTD | Methadone | 300 |
| Oxycodone | OXY | Oxycodone | 100 |
The Chemtrue® Multi-Panel Drug Screen Dip Card with OPI 2000 Tests can consist of any combination of the above listed drug analytes. 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 and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.
### E. DEVICE DESCRIPTION
The Chemtrue® Drug Screen Tests 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 the formats of dip card, cup, or cassette, as indicated by the test name.
### F. SUBSTANTIAL EQUIVALENCE INFORMATION
Comparison with the predicate devices is outlined below:
| Item | Candidate Devices | Predicate |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Indication(s) for use | For qualitative detection of drugs of abuse in human urine | Same |
| Specimen Type | Human urine | Same |
| Methodology/<br>Technological<br>Characteristics | Lateral flow, competitive binding immunoassay based on<br>the principle of antigen and antibody immunochemistry. | Same |
| Results | Qualitative | Same |
| Cut Off | Buprenorphine 10 ng/mL<br>Tricyclic Antidepressants 1000 ng/mL<br>Amphetamine 1000 ng/mL<br>Cocaine 300 ng/mL | Same, except the<br>predicate also has a<br>300 ng/mL cut off |
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| | Methamphetamine 1000 ng/mL<br>Morphine 300 ng/mL<br>Opiates 2000 ng/mL<br>PCP 25 ng/mL<br>THC 50 ng/mL<br>Benzodiazepines 300 ng/mL<br>Barbiturates 300 ng/mL<br>Ecstasy (MDMA) 500 ng/mL<br>Methadone 300 ng/mL<br>Oxycodone 100 ng/mL | and a 500 ng/mL<br>cut off, for<br>Amphetamine and<br>Methamphetamine,<br>respectively. |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Configurations | Dip Card, Cup (for BUP/TCA tests only) and Cassette | Test Card and test<br>card with integrated<br>cup |
| Intended Use | Prescription and OTC Use | Prescription Use<br>only |
## G. TEST PRINCIPLE
The Chemtrue® Drug Screen Tests 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 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 drugprotein 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.
Monoclonal anti-drug antibodies are used on the BUP/AMP/COC/MET/MOR/OPV PCP/THC/BAR/MDMA/MTD/OXY Test devices which are derived from mouse. The polyclonal anti-drug antibodies are used on TCA/BZO Test devices which are derived from sheep/mouse.
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#### H. PERFORMANCE CHARACTERISTICS
Performance data is only provided for BUP and TCA, as the new analytes. All other drugs of abuse analytes of the candidate devices (AMP, COC, MAMP, OPI, MOR, PCP, THC, BZO, BAR, MDMA, MTD, and OXY) were previously cleared under k102203, k111322, k121339, and k123080. Test strips, sample matrix, test format, and cut-off concentrations for the other drugs of abuse analytes are identical to those cleared under k102203, k111322, k121339, and k123080. See k102203, k111322, k121339, and k123080 for additional precision, specificity, interference, method comparison, and lay-user study information.
#### 1. Reproducibility (Precision) Studies:
The precision study was conducted by three (3) Operators with three (3) lots of each device format in replicates of 10 devices/lot at each concentration level of Negative, 50%, 75%, cutoff, 125% and 150% of the cutoff. The study was conducted over a six (6) day period using GC/MS confirmed drug spiked samples. The samples were blind coded according to a random table and randomly distributed to three operators by the project Manager. The data is analyzed and summarized in the tables below:
| Concentration<br>Level | n | TOTAL | |
|------------------------|----|-------|----|
| | | + | - |
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 10 | 20 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |
Table 1a. BUP Dip Card Test: Cutoff: 10 ng/mL
#### Table 1b. TCA Dip Card Test: Cutoff: 1000 ng/mL
| Concentration<br>Level | n | TOTAL | |
|------------------------|----|-------|----|
| | | + | - |
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 1 | 29 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |
#### Table 1c. BUP Cup Test: Cutoff: 10 ng/mL
| Concentration<br>Level | n | TOTAL | |
|------------------------|----|-------|----|
| | | + | - |
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
{10}------------------------------------------------
| 75% of cutoff | 30 | 1 | 29 |
|----------------|----|----|----|
| Cutoff | 30 | 5 | 25 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |
Table 1d. TCA Cup Test: Cutoff: 1000 ng/mL
| Concentration | n | TOTAL | |
|----------------|----|-------|----|
| Level | | + | - |
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 1 | 29 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |
Table 1e. BUP Cassette Test: Cutoff: 10 ng/mL
| Concentration<br>Level | n | TOTAL | |
|------------------------|----|-------|----|
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 9 | 21 |
| 125% of cutoff | 30 | 29 | 1 |
| 150% of cutoff | 30 | 30 | 0 |
Table 1f. TCA Cassette Test: Cutoff: 1000 ng/mL
| Concentration<br>Level | n | TOTAL | |
|------------------------|----|-------|----|
| | | + | - |
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 2 | 28 |
| Cutoff | 30 | 18 | 12 |
| 125% of cutoff | 30 | 29 | 1 |
| 150% of cutoff | 30 | 30 | 0 |
- 2. Specificity Study: These studies were conducted by adding various drugs, drug metabolites, and other structurally-similar compounds likely to be present in the actual urine specimen. The following structurally-related compounds were tested for cross-reactivity and found to be positive if the levels were greater than the following listed concentrations:
#### Table 2a. Buprenorphine (BUP):
{11}------------------------------------------------
| Substances | Concentration (ng/mL) | % Cross Reactivity |
|------------------|-----------------------|--------------------|
| Buprenorphine | 10 | 100 |
| Norbuprenorphine | 10 | 100 |
### Table 2b. Tricyclic Antidepressants (TCA):
| Substances | Concentration (ng/mL) | % Cross Reactivity |
|---------------|-----------------------|--------------------|
| Nortriptyline | 1000 | 100 |
| Amitriptyline | 1000 | 100 |
| Desipramine | 300 | 333 |
| Doxepin HCl | 2,000 | 50 |
| Imipramine | 50 | 2000 |
| Protriptyline | 4750 | 21.1 |
| Trimipramine | 2,000 | 50 |
### 3. Interference:
Over one hundred of potential interferents were tested and found not to cross-react when tested at concentrations of 100 µg/mL at ±25% of the drug (BUP and TCA) cut-off concentrations.
| Acetaminophen | Estrone | Oxolinic Acid |
|--------------------------|--------------------------------|---------------------|
| Acetanilide | Ethanol | Oxymetazoline HCl |
| 6-Acetylmorphine | ß-Estradiol | Oxymorphone |
| N-Acetylprocainamide | Fenoprofen | Papaverine HCl |
| 4-Aminoantipyrine | Glucose | Penicillin G |
| Ampicillin | L-Glutamine | Pentazocine |
| (±) Amphetamine | Hydrochlorothiazide | Phenacetin |
| R(-)Amphetamine | Hemoglobin Human | Phenalzine Sulfate |
| S(+)Amphetamine | Hydralazine | Pheniramine Maleate |
| R (-) Apomorphine HCl | Hydrocodone | R- Phenylephrine |
| Aspirin | Hydrocortisone | Prednisolone |
| L-Ascorbic Acid | Hydromorphone | Prednisone |
| Atropine | 3-Hydroxytyramine hydrobromide | Protryptiline |
| Benzocaine | Imipramine | (+) Quinidine |
| Benzoic Acid | Isoprenaline HCl | (-) Quinine |
| Benzoylecgonine | Ketamine | Ranitidine |
| Bilirubin | Labetolol HCl | Riboflavin |
| Bromopheniramine Maleate | Loperamide HCl | Salicylic Acid |
| Buprenorphine | (+/-) Methadone | Serotonin HCl |
| Cannabidiol | Methoxyphenamine | Sodium Chloride |
Table 3. The following compounds do not interfere with the tests:
{12}------------------------------------------------
| Chloramphenicol | Morphine | Sulfamethazine |
|------------------------------------|------------------|-------------------------|
| Chlorothiazide | Naloxone | Temazepam |
| Cholesterol | Nalidixic Acid | Tetracycline |
| Cholic Acid | Naproxen | Tetrahydrozoline HCl |
| Cortisone | Niacinamide | Δ°-Tetrahydrocannabinol |
| (-)-Cotinine | Nicotinamide | Thiamine HCl |
| 11-Deoxycorticosterone | Nifedipine | Trifluoperazine HCl |
| Desalkyl Flurazepam | Norcodeine | Trimethoprim |
| Diazepam | Nordiazepam | Tryptamine |
| Diclofenac Sodium Salt | 19-Norethindrone | Tyramine |
| Diflunisal | Normorphine | DL-Tyrosine |
| 2,5 Dihydroxybenzoic(Gentisic)Acid | Norsertraline | L-Tryptophan |
| Dopamine | Noscapine HCl | Uric Acid |
| Doxepin HCl | Nortriptyline | Verapamil HCl |
| Duloxetine HCl | (+/-) Octapamine | Zomepirac sodium salt |
| EDDP Percholate | Oxazepam | |
- 4. Effect of Urine pH and Specific Gravity Studies: The testing results demonstrate that the urine pH ranges from 3.0 to 8.5 at ±25% and ±50% drug (BUP and TCA) cut-off concentrations do not affect the test performance. The specific gravity (SG) ranges of 1.002, 1.010, 1.015, 1.020, 1.025 and 1.030 at ±25% and ±50% drug (BUP and TCA) cut-off concentrations do not affect the test results.
- 5. Stability Study: To establish and support the shelf life and expiration date, stability studies were conducted under accelerated temperature (at 60°C and real time (25°C±2°C) with three (3) lots of each device format. The stability study results support two (2) years shelf-life of the products at (2 to 30°C). The real time stability study is still on-going.
- 6. Method Comparison Studies:
Chemtrue® BUP/TCA Single /Multi-Panel Tests were compared to the GC/MS Reference Method. The accuracy of the Chemtrue® Test devices were evaluated against the confirmed GC/MS values in this blind-labeled clinical specimen correlation study (a total of 174 clinical specimens). Three operators performed the testing. Each operator tested one device format with one unique set of blind coded samples. Each blind labeled sample was randomly distributed to each operator by the Clinical Research Cooperator. The results are summarized in the tables below:
Table 6a. Summary from method comparison (Accuracy) study of Chemtrue® Drug Screen Dip Card Test results versus GC/MS
| Chemtrue® | (-) | (+) | % Agreement |
|-----------|-----|-----|-------------|
|-----------|-----|-----|-------------|
{13}------------------------------------------------
| Drug Screen<br>Dip Card | No drug<br>present | GC/MS<br>Negative<br>(≤ 50% of the<br>cutoff) | Near cutoff<br>negative<br>(75% of the<br>C/O to cutoff) | Near cutoff<br>positive<br>(Cutoff to 125%<br>of the C/O) | GC/MS<br>Positive<br>(≥150% of the<br>cutoff) | with GC/MS<br>values |
|-------------------------|--------------------|-----------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------|----------------------|
| BUP (+) | 0 | 0 | 2 | 6 | 25 | 100% |
| (-) | 40 | 7 | 5 | 0 | 0 | 96.3% |
| TCA (+) | 0 | 0 | 0 | 8 | 26 | 100% |
| (-) | 40 | 6 | 9 | 0 | 0 | 100% |
Table 6b. Summary of a method comparison (Accuracy) study of Chemtrue® Drug Screen Cup Test results versus the GC/MS
| Chemtrue®<br>Drug<br>Screen Cup | No drug<br>present | (-) | | (+) | | % Agreement<br>with GC/MS<br>values |
|---------------------------------|--------------------|-----------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------|-------------------------------------|
| | | GC/MS<br>Negative<br>(≤ 50% of the<br>cutoff) | Near cutoff<br>negative<br>(75% of the C/O to<br>cutoff) | Near cutoff<br>positive<br>(Cutoff to 125% of<br>the C/O) | GC/MS<br>Positive<br>(≥150% of the<br>cutoff) | |
| BUP (+) | 0 | 0 | 2 | 6 | 25 | 100% |
| BUP (-) | 40 | 7 | 5 | 0 | 0 | 96.3% |
| TCA (+) | 0 | 0 | 0 | 8 | 26 | 100% |
| TCA (-) | 40 | 6 | 9 | 0 | 0 | 100% |
Table 6c. Summary of a method comparison (Accuracy) study of Chemtrue® Drug Screen Cassette Test results versus the GC/MS
| Chemtrue®<br>Drug<br>Screen<br>Cassette | | No<br>drug<br>present | (-)<br>GC/MS<br>Negative<br>(≤50% of the<br>cutoff) | (-)<br>Near cutoff<br>negative<br>(75% of the C/O<br>to cutoff) | (+)<br>Near cutoff<br>positive<br>(Cutoff to 125%<br>of the C/O) | (+)<br>GC/MS<br>Positive<br>(≥150% of the cutoff) | % Agreement<br>with<br>GC/MS<br>values |
|-----------------------------------------|-----|-----------------------|-----------------------------------------------------|-----------------------------------------------------------------|------------------------------------------------------------------|---------------------------------------------------|----------------------------------------|
| BUP | (+) | 0 | 0 | 2 | 6 | 25 | 100% |
| | (-) | 40 | 7 | 5 | 0 | 0 | 96.3% |
| TCA | (+) | 0 | 0 | 0 | 8 | 26 | 100% |
| | (-) | 40 | 6 | 9 | 0 | 0 | 100% |
Table 6d. DISCORDANT RESULTS: There are two (2) discordant results for each format:
| Cutoff Value (ng/mL) | Analyte assay (POS/NEG) | Drug/Metabolite GC/MS value (ng/mL) | |
|----------------------|-------------------------|-------------------------------------|---------------------|
| | | Drug Analyte | GC/MS Value (ng/mL) |
| Buprenorphine 10 | + | Buprenorphine | 9.5 |
| Buprenorphine 10 | + | Buprenorphine | 9.8 |
7. OTC Lay-user Studies:
A total of 300 people participated in an OTC lay-user study at three (3) intended user sites with LC/MS confirmed urine samples at the following concentrations: negative, 50%, 75%, 150% and 200% of the cutoff by spiking drugs into drug-free urine pool. Each sample was aliquotted into an individual blind-labeled container. Each lay-user was provided with a package insert, up to two blind labeled samples and test device(s). The results are summarized below:
{14}------------------------------------------------
| Drug | Cut Off<br>(ng/mL) | Results | Drug Concentrations (Per LC/MS Values) | | | | | |
|---------|--------------------|---------------|----------------------------------------|----------------------|----------------------|-----------------------|-----------------------|-----------------------|
| Analyte | | | No Drug<br>present | 50% of the<br>cutoff | 75% of<br>the cutoff | 125% of<br>the cutoff | 150% of<br>the cutoff | 200% of<br>the cutoff |
| | | | | | | | | |
| BUP | 10 | # of positive | 0 | 0 | 0 | 30 | 30 | 30 |
| | | # of Negative | 30 | 30 | 30 | 0 | 0 | 0 |
| | | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| | | Agreement | 100% | 100% | 100% | 100% | 100% | 100% |
Table 7a. Chemtrue® BUP/TCA Drug Screen Dip Card Test vs LC/MS Value Analysis
### Table 7b. Chemtrue® BUP/TCA Drug Screen Dip Card Test vs LC/MS Value Analysis
| Drug<br>Analyte | Cut Off<br>(ng/mL) | | Drug Concentrations (Per LC/MS Values) | | | | | |
|-----------------|--------------------|---------------|----------------------------------------|----------------------|----------------------|-----------------------|-----------------------|-----------------------|
| | | Results | No Drug<br>present | 50% of the<br>cutoff | 75% of<br>the cutoff | 125% of<br>the cutoff | 150% of<br>the cutoff | 200% of<br>the cutoff |
| TCA | 1000 | # of positive | 0 | 0 | 1 | 30 | 30 | 30 |
| | | # of Negative | 30 | 30 | 29 | 0 | 0 | 0 |
| | | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| | | Agreement | 100% | 100% | 96.7% | 100% | 100% | 100% |
## Table 7c. Chemtrue® BUP/TCA Drug Screen Cup Test vs LC/MS Value Analysis
| Drug | Cut Off | | Drug Concentrations (Per LC/MS Values) | | | | | |
|---------|---------|---------------|----------------------------------------|-------------------|-------------------|--------------------|--------------------|--------------------|
| Analyte | (ng/mL) | Results | No Drug present | 50% of the cutoff | 75% of the cutoff | 125% of the cutoff | 150% of the cutoff | 200% of the cutoff |
| BUP | 10 | # of positive | 0 | 0 | 0 | 30 | 30 | 30 |
| | | # of Negative | 30 | 30 | 30 | 0 | 0 | 0 |
| | | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| | | Agreement | 100% | 100% | 100% | 100% | 100% | 100% |
### Table 7d. Chemtrue® BUP/TCA Drug Screen Cup Test vs LC/MS Value Analysis
| Drug<br>Analyte | Cut Off<br>(ng/mL) | Results | Drug Concentrations (Per LC/MS Values) | | | | | |
|-----------------|--------------------|---------------|----------------------------------------|----------------------|----------------------|-----------------------|-----------------------|-----------------------|
| | | | No Drug<br>present | 50% of the<br>cutoff | 75% of<br>the cutoff | 125% of<br>the cutoff | 150% of<br>the cutoff | 200% of<br>the cutoff |
| TCA | 1000 | # of positive | 0 | 0 | 0 | 30 | 30 | 30 |
| | | # of Negative | 30 | 30 | 30 | 0 | 0 | 0 |
| | | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| | | Agreement | 100% | 100% | 100% | 100% | 100% | 100% |
Table 7e. Chemtrue® BUP/TCA Drug Screen Cassette Test vs LC/MS Value Analysis
| Drug<br>Analyte | Cut Off<br>(ng/mL) | Results | Drug Concentrations (Per LC/MS Values) | | | | | |
|-----------------|--------------------|---------------|----------------------------------------|----------------------|----------------------|-----------------------|-----------------------|-----------------------|
| | | | No Drug<br>present | 50% of the<br>cutoff | 75% of<br>the cutoff | 125% of<br>the cutoff | 150% of<br>the cutoff | 200% of<br>the cutoff |
| BUP | 10 | # of positive | 0 | 0 | 0 | 30 | 30 | 30 |
| | | # of Negative | 30 | 30 | 30 | 0 | 0 | 0 |
| | | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| | | Agreement | 100% | 100% | 100% | 100% | 100% | 100% |
Table 7f. Chemtrue® BUP/TCA Drug Screen Cassette Test vs LC/MS Value Analysis
| Drug<br>Analyte | Cut<br>Off<br>(ng/mL) | Results | Drug Concentrations (Per LC/MS Values) | | | | | |
|-----------------|-----------------------|---------|----------------------------------------|----------------------|----------------------|-----------------------|-----------------------|-----------------------|
| | | | No Drug<br>present | 50% of the<br>cutoff | 75% of the<br>cutoff | 125% of the<br>cutoff | 150% of the<br>cutoff | 200% of the<br>cutoff |
{15}------------------------------------------------
| TCA | 1000 | # of positive | 0 | 0 | 0 | 30 | 30 | 30 |
|-----|------|---------------|------|------|------|------|------|------|
| | | # of Negative | 30 | 30 | 30 | 0 | 0 | 0 |
| | | Total | 30 | 30 | 30 | 30 | 30 | 30 |
| | | Agreement | 100% | 100% | 100% | 100% | 100% | 100% |
Lay-users were also given surveys on the ease of understanding the package insert instructions. 99% of the lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on the package insert and the score revealed a reading grade level of less than 7.
### I. CONCLUSION:
Based on the test principle and performance characteristics of the proposed device, it is concluded that the candidate devices are substantially equivalent to the predicate device.
