(167 days)
No
The device is described as a rapid lateral flow immunoassay, which is a traditional diagnostic technology that does not typically incorporate AI/ML. The summary focuses on the chemical detection method and performance metrics related to accuracy and specificity, with no mention of AI, ML, or related concepts.
No.
This device is an in vitro diagnostic device used to qualitatively detect the presence of various drugs in human urine. It does not provide any form of therapy or treatment.
Yes
The device is described as an "in vitro diagnostic device" and is intended for the "qualitative detection of Amphetamine... drugs in human urine," which clearly falls under the definition of a diagnostic device.
No
The device is described as a "rapid lateral flow immunoassay" and "colloidal gold based lateral flow immunoassays," which are physical test strips/cups, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the tests are for the "qualitative detection of... drugs in human urine." This is a diagnostic purpose, analyzing a biological sample (urine) to determine the presence of specific substances.
- Device Description: The "Device Description" section clearly states, "The tests are single-use, in vitro diagnostic devices..." This directly identifies the device as an IVD.
- Sample Type: The device analyzes human urine, which is a biological specimen. IVDs are designed to test biological samples.
- Purpose: The purpose is to provide a preliminary result for the presence of drugs of abuse, which is a diagnostic assessment.
The information provided strongly indicates that this device falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Chemitrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunossays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, 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 issed 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 must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GCMS) 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 Benzodizepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.
Product codes (comma separated list FDA assigned to the subject device)
DJG, JXN, DKZ, LFG, DIO, LDJ, DNK, LAF, LCM, JXM, DIS, DJC, DJR
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 Dip Card or Cup formats, as indicated by the test name.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Reproducibility (Precision) Studies:
Sample size: 30 replicates per concentration level per device format (Negative, 50% of cutoff, 75% of cutoff, Cutoff, 125% of cutoff, 150% of cutoff).
Data source: GC/MS confirmed drug spiked urine controls.
Annotation protocol: The samples were blind coded according to a random table and randomly distributed to three operators by the research coordinator. Study conducted over ten (10) nonconsecutive days by three (3) Operators with three (3) lots.
Method Comparison (Accuracy) Studies:
Sample size: On average of 85 clinical specimens for each drug test and a total of 685 samples were tested.
Data source: Blind-labeled clinical specimens with GC/MS Reference Method confirmed values.
Annotation protocol: Each blind-labeled sample was randomly distributed to each operator by the Clinical Research Cooperator. Three operators performed the testing.
OTC Lay-user Accuracy Studies:
Sample Size: One hundred (130) intended lay-users participated for each device format (Dip Card and Cup).
Data Source: GC/MS confirmed urine samples. Sample concentrations consisted of negative (0), 50%, 75%, 125%, 150% and 200% of the cutoff by spiking drugs into drug-free urine pool.
Annotation Protocol: 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
1. Reproducibility (Precision) Studies:
Study Type: Precision study.
Sample Size: 30 devices/lot in replicates of 10 for each device format at each concentration level (Negative, 50%, 75%, cut-off, 125%, and 150% of cutoff).
Key Results: For all analytes and cutoffs tested (AMP300/500, BAR200, BZO200, COC150, MET300/500, PPX), the tests consistently showed 0 positives for negative and 50% of cutoff concentrations, 0 negatives for 125% and 150% of cutoff concentrations. At the cutoff concentration, the results showed a mix of positive and negative results (e.g., for AMP Dip Card 300 ng/mL cutoff: 16 positive, 14 negative out of 30). This indicates appropriate performance around the cutoff.
2. Specificity Study:
Study Type: Cross-reactivity study.
Key Results: Various drugs, drug metabolites, and other structurally-similar compounds were tested. Detailed tables showed cross-reactivity percentages for relevant substances (e.g., d-Amphetamine showed 100% cross-reactivity at 500 ng/mL for AMP500).
3. Interference Study:
Study Type: Interference testing.
Key Results: One hundred and three (103) potential interferents were tested. It was found not to cross-react at concentrations of 100 µg/mL at ±25% of the drug cut-off concentrations. Examples of non-interfering endogenous and non-structurally related compounds were provided. Additional interference study confirmed no interference or cross-reactivity among the drug tests.
4. Effect of Urine pH and Specific Gravity Studies:
Study Type: Performance evaluation under varying pH and specific gravity.
Key Results: The testing results demonstrate that urine pH ranges from 2.0 to 9.0 at ±25% of the drug cut-off concentrations do not affect the test performance. Specific gravity (SG) ranges of 1.001, 1.015, 1.020, 1.025 and 1.030 at ±25% of the drug cut-off concentrations do not affect the test results.
5. Stability Study:
Study Type: Shelf life and expiration date establishment.
Key Results: Accelerated temperature (60°C) and real time (2°C to 30°C) stability studies (with three lots of each device format) support a two (2) years shelf-life at (2℃ to 30℃). Real-time stability study is ongoing.
6. Method Comparison (Accuracy) Studies:
Study Type: Accuracy comparison against GC/MS Reference Method.
Sample Size: Average of 85 clinical specimens per drug test, total of 685 samples.
Key Results: The agreements between the Chemtrue® Drug Screen Dip Card Test and GC/MS were generally 100% for drug positive samples and high for drug negative samples (e.g., AMP300 Dip Card: 100% agreement for positive and negative, BAR200 Dip Card: 100% positive, 98.2% negative, COC150 Dip Card: 100% positive and negative). Similar results were seen for Cup Tests, with most analytes showing 100% agreement, and some as low as 97.6-97.8% for negative agreement.
6-2. Discordant Results:
8 discordant results were observed across methods (Dip Card and Cup Tests) for Methamphetamine, Barbiturates, and Amphetamine where the Chemtrue test provided a result that differed from the GC/MS result within specified concentration ranges (e.g., Chemtrue positive at 296 ng/mL for Methamphetamine 300, or Chemtrue negative at 510 ng/mL for Amphetamine 500). All these discordant results were confirmed at the drug cutoff level with the GC/MS concentrations.
7. OTC Lay-user Accuracy Studies:
Study Type: Lay-user accuracy and usability study.
Sample Size: 130 intended lay-users for each device format.
Key Results: The agreement between the Chemtrue® Drug Screen test device and GC/MS values was ≥ 99%. Lay-users' surveys demonstrated that ≥ 96% could easily follow instructions and interpret results. Flesch-Kincaid reading analysis indicated a 7th grade reading level for instructions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The document presents "agreement" percentages with GC/MS values, which represent a form of accuracy.
For Direct Comparison (Accuracy) Studies Tables 6a and 6b:
- Agreement for samples above cutoff confirmed positive by GC/MS (Positive agreement for "GC/MS Positive (>150% of the cutoff)"): Generally 100% for positive results.
- Agreement for samples below cutoff confirmed negative by GC/MS (Negative agreement for "No drug present"): Generally 100% or very high (e.g., 97.6% to 98.2%).
- For samples "Near cutoff positive (Cutoff to 150% of the C/O)", all Chemtrue devices read positive, achieving 100% agreement.
- For samples "Near cutoff negative (50% of the C/O to cutoff)", all Chemtrue devices read negative, achieving 100% agreement.
For OTC Lay-user Accuracy Studies Tables 7a and 7b:
- "Agreement" between the Chemtrue® Drug Screen test device and GC/MS values is ≥ 99% overall. Specific percentages are provided in the tables for different concentration ranges (e.g., 100% for positive and negative categories).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3650 Opiate test system.
(a)
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.(b)
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 18, 2016
CHEMTRON BIOTECH, INC. JANE ZHANG DIRECTOR OF QA/RA 9245 BROWN DEER ROAD SAN DIEGO CA 92121
Re: K153192
Trade/Device Name: Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests. Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG, JXN, DKZ, LFG, DIO, LDJ, DNK, LAF, LCM, JXM, DIS, DJC, DJR Dated: April 1, 2016 Received: April 4, 2016
Dear Ms. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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/ResourcesforYou/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
2
Indications for Use
510(k) Number (if known) K153192
Device Name
Chemtrue® Multi-Panel Drug Screen Cup with OPI 2000 Tests
Indications for Use (Describe)
The Chemitrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunossays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, Morphine, Phencyclidine, Ecstasy, Methadone, 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-Methylenedioxy | |
| methamphetamine | 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 issed 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 must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GCMS) 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 Benzodizepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene 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)
Prescription Use (Part 21 CFR 801 Subpart D)
IX Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K153192
Device Name
Chemtrue® Multi-Panel Drug Screen Dip Card Tests
Indications for Use (Describe)
Indications on Ose (Docking) 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-Methylenedioxy methamphetamine | 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 must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
5
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995,
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
6
Indications for Use
510(k) Number (if known) K153192
Device Name
Chemtrue® Multi-Panel Drug Screen Dip Card with OPI 2000 Tests
Indications for Use (Describe)
The Chemtrue® 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-Methylenedioxy | |
| methamphetamine | 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 must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
7
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
8
Indications for Use
510(k) Number (if known) K153192
Device Name
Chemtrue® Multi-Panel Drug Screen Cup Tests
Indications for Use (Describe)
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-Methylenedioxy | |
| methamphetamine | 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 be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.
Type of Use (Select one or both, as applicable)
IX Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
9
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10
510(k) Summary
AS REQUIRED BY 21 CFR 807.92(c)
SUBMITTER: Chemtron Biotech, Inc. 9245 Brown Deer Road, Suite B, San Diego, CA 92121. A. 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: April 12, 2016
DEVICE B.
Trade or Proprietary Name: Chemtrue® Multi-Panel Drug Screen Cup Tests, Chemtrue® Multi-Panel Drug Screen Cup with OPI2000 Tests, Chemtrue® Drug Screen Dip Card Tests, Chemtrue® Drug Screen Dip Card with OPI2000 Tests Common Name: Single/Multi-Drug Urine Test Panel
Regulatory Class: Class II
Regulatory Information:
| Drug of Abuse | Product Code | Panel | Regulation Section |
|---|---|---|---|
| Amphetamine | DKZ | Toxicology 91 | 21CFR 862.3100, Amphetamine Test System |
| Benzodiazepines | JXM | Toxicology 91 | 21 CFR 862.3170, Benzodiazepines Test System |
| Barbiturates | DIS | Toxicology 91 | 21 CFR 862.3150, Barbiturates 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 |
| Propoxyphene | JXN | Toxicology 91 | 21 CFR 862.3700 Propoxyphene test system |
These devices also incorporate the assays previously cleared under 510(k) numbers K142396 and K143599, which consist of any combinations of the following drug tests:
| Drug of Abuse | Product Code | Panel | Regulation Section |
|---|---|---|---|
| Buprenorphine (BUP) | DJG | Toxicology 91 | 21CFR 862.3650, Opiate Test System |
| Ecstasy (MDMA) | DJC | Toxicology 91 | 21 CFR 862.3610, Methamphetamine Test System |
| Methadone | DJR | Toxicology 91 | 21 CFR 862.3620, Methadone Test System |
| Morphine | DNK | Toxicology 91 | 21 CFR 862.3640, Morphine Test System |
| Opiates | DJG | Toxicology 91 | 21 CFR 862.3650, Opiate Test System |
| Oxycodone | DJG | 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 |
| Tricyclic Antidepressants (TCA) | LFG | Toxicology 91 | 21 CFR 862.3910, Tricyclic antidepressant drugs test system. |
11
C. PREDICATE DEVICES
C-1. K061718: Innovacon Spectrum II Test Card with Integrated Cups, applicant: Innovacon Laboratories, Inc.
C-2. k10329: QuickScreen™ Test. The applicant: Phamatech. Inc.
C-3. K060896: ONSite CupKit™. The applicant: Variance, Inc.
D. INDICATIONS FOR USE:
Chemtrue® Multi-Panel Drug Screen Cup with OPI 2000 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-Methylenedioxy | |
| methamphetamine | 500 | ||
| Methamphetamine | MET | d-Methamphetamine | 300 |
| Methamphetamine | MET | d-Methamphetamine | 500 |
| Methamphetamine | MET | 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 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.
12
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-Methylenedioxy | |
| methamphetamine | 500 | ||
| Methamphetamine | MET | d-Methamphetamine | 300 |
| Methamphetamine | MET | d-Methamphetamine | 500 |
| Methamphetamine | MET | 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 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.
13
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 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-Methylenedioxy | |
| methamphetamine | 500 | ||
| Methamphetamine | MET | d-Methamphetamine | 300 |
| Methamphetamine | MET | d-Methamphetamine | 500 |
| Methamphetamine | MET | 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 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
14
Antidepressants. There are no uniformly recognized cut-off concentration levels for these drugs in urine.
Chemtrue® Multi-Panel Drug Screen Dip Card 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-Methylenedioxy | |
| methamphetamine | 500 | ||
| Methamphetamine | MET | d-Methamphetamine | 300 |
| Methamphetamine | MET | d-Methamphetamine | 500 |
| Methamphetamine | MET | d-Methamphetamine | 1000 |
| Marijuana | THC | 11-nor-A9-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 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.
15
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 Dip Card or Cup formats, as indicated by the test name.
F. SUBSTANTIAL EQUIVALENCE INFORMATION:
Comparison with the predicate devices is outlined below:
| Similarities and Differences | ||
|---|---|---|
| Item | Candidate Devices | Predicate Devices |
| (K061718, K103295 and K060896) | ||
| Indication(s) for use | Same | For qualitative detection of drugs of abuse in |
| human urine | ||
| Specimen Type | Same | Human urine |
| Methodology/Technological | ||
| Characteristics | Same | Lateral flow, competitive binding immunoassay |
| based on the principle of antigen and antibody | ||
| immunochemistry. | ||
| Results | Same | Qualitative |
| Cut Off | Propoxyphene – Same | K061718 |
| Propoxyphene – 300 | ||
| Cocaine – 150 | Cocaine – 150 / 300 | |
| Amphetamine – 500 / 300 | Amphetamine – 300 / 1000 | |
| Methamphetamine – 500 / 300 | Methamphetamine – 500 / 1000 | |
| Methamphetamine – Same | ||
| Barbiturates - Same | ||
| Benzodiazepines – Same | ||
| Methamphetamine 300 – Same | K103295 | |
| Methamphetamine – 500 | ||
| Barbiturates – 200 | ||
| Benzodiazepines – 200 | ||
| K060896 | ||
| Methamphetamine – 300 | ||
| Configurations | Dip Card and Cup | K061718 |
| Dip Card and Cup | ||
| K103295 | ||
| Dipcard and Cassette | ||
| K060896 | ||
| Cup Only | ||
| Intended Use | Same | Prescription / OTC Use |
G. TEST PRINCIPLE
These devices are rapid lateral flow immunoassays in which chemically modified drugs (drugprotein conjugates) compete with drugs that may be present in urine. On each test strip, a drugprotein 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
16
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.
Monoclonal anti-drug antibodies are used on the AMP/ BAR/COC/MET/PPX Test devices which are derived from mouse. The polyclonal and monoclonal anti-drug antibodies which are used on BZO Test devices are derived from sheep/mouse.
H. PERFORMANCE CHARACTERISTICS
Performance data is only provided for AMP300/500, BAR200/BZO200, COC150, MET300/500 and PPX as the new analytes in this submission. AMP1000, BAR3000, BZO300, BUP, COC300, MET1000, MOR, PCP, THC, MDMA, MTD, OPI2000, OXY and TCA analytes were previously cleared under K143599 and K142396.
-
- Reproducibility (Precision) Studies:
The precision study was conducted by three (3) Operators with three (3) lots in replicates of 10 devices/lot of each device format at each concentration level of Negative, 50%, 75%, cut-off, 125% and 150% of the cutoff which are GC/MS confirmed drug spiked urine controls. The study was conducted over a ten (10) nonconsecutive days. The samples were blind coded according to a random table and randomly distributed to three operators by the research coordinator. The data is analyzed and summarized in the tables below:
- Reproducibility (Precision) Studies:
| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 16 | 14 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |
Table 1a. AMP Dip Card Test: Cutoff: 300 ng/mL
Table 1b. AMP Dip Card Test: Cutoff: 500 ng/mL
| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 30 | 0 | 30 |
17
| 50% of cutoff | 30 | 0 | 30 |
|---|---|---|---|
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 14 | 16 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |
Table 1c. BAR Dip Card Test: Cutoff: 200 ng/mL
| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 14 | 16 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |
Table 1d. BZO Dip Card Test: Cutoff: 200 ng/mL
| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 16 | 14 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |
Table 1e. COC Dip Card Test: Cutoff: 150 ng/mL
| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 16 | 14 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |
Table 1f. MET Dip Card Test: Cutoff: 300 ng/mL
| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 14 | 16 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |
Table 1g. MET Dip Card Test: Cutoff: 500 ng/mL
18
| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 14 | 16 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |
Table 1h. Propoxyphene Dip Card Test: Cutoff: 300 ng/mL
| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 15 | 15 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |
Table 1i. AMP Cup Test: Cutoff: 300 ng/mL
| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 13 | 17 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |
Table 1j. AMP Cup Test: Cutoff: 500 ng/mL
| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 14 | 16 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |
Table 1k. BAR Cup Test: Cutoff: 200 ng/mL
| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
19
| Cutoff | 30 | 15 | 15 |
|---|---|---|---|
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |
Table 11. BZO Cup Test: Cutoff: 200 ng/mL
| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 15 | 15 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |
Table 1m. COC Cup Test: Cutoff: 150 ng/mL
| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 17 | 13 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |
Table 1n. MET Cup Test: Cutoff: 300 ng/mL
| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 15 | 15 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |
Table 10. MET Cup Test: Cutoff: 500 ng/mL
| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 17 | 13 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |
20
| + | - | ||
|---|---|---|---|
| Negative | 30 | 0 | 30 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 15 | 15 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |
-
- 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:
- 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.
Amphetamine 500 related compounds:
| Substances | Concentration (ng/mL) | % Cross Reactivity |
|---|---|---|
| d-Amphetamine | 500 | 100 |
| d,l-Amphetamine | 800 | 62.5 |
| l-Amphetamine | >50,000 | 50,000 |
| (50% of the C/O to cutoff) | ||
| AMP300 | ||
| (+) | 0 | 0 |
| (-) | 31 | 11 |
| BAR200 | ||
| (+) | 0 | 1 |
| (-) | 34 | 9 |
| BZO200 | ||
| (+) | 0 | 0 |
| (-) | 31 | 16 |
| COC150 | ||
| (+) | 0 | 0 |
| (-) | 31 | 10 |
| MET300 (+) | 0 | 1 |
| (-) | 31 | 9 |
| PPX | ||
| (+) | 0 | 0 |
| (-) | 31 | 10 |
| AMP500 (+) | 0 | 0 |
| (-) | 31 | 14 |
6-1. Test Result Summary:
Table 6a. Method comparison study summary: Chemtrue® Drug Screen Dip Card Test results vs GC/MS
25
| MET500 | 0 | 1 | 11 | 30 | 100% |
|---|---|---|---|---|---|
| (-) | 31 | 11 | 0 | 0 | 97.8% |
Table 6b. Method comparison study summary - Chemtrue® Drug Screen Cup Test results vs GC/MS
| Concentration By GC/MS (ng/mL) | |||||
|---|---|---|---|---|---|
| Chemtrue® | |||||
| Drug Screen | |||||
| Cup | No drug | ||||
| present | Near cutoff | ||||
| negative | |||||
| (75% of the C/O to cutoff) | Near cutoff positive | ||||
| (Cutoff to 125% of the | |||||
| C/O) | GC/MS Positive | ||||
| (≥150% of the cutoff) | % | ||||
| Agreement | |||||
| AMP300 (+) | 0 | 1 | 14 | 27 | 100% |
| AMP300 (-) | 31 | 10 | 0 | 0 | 97.6% |
| BAR200 (+) | 0 | 1 | 26 | 14 | 100% |
| BAR200 (-) | 34 | 9 | 0 | 0 | 97.7% |
| BZO200 (+) | 0 | 0 | 26 | 14 | 100% |
| BZO200 (-) | 31 | 16 | 0 | 0 | 100% |
| COC150 (+) | 0 | 0 | 15 | 28 | 100% |
| COC150 (-) | 31 | 10 | 0 | 0 | 100% |
| MET300 (+) | 0 | 1 | 14 | 34 | 100% |
| MET300 (-) | 31 | 9 | 0 | 0 | 97.6% |
| PPX (+) | 0 | 0 | 12 | 33 | 100% |
| PPX (-) | 31 | 10 | 0 | 0 | 100% |
| AMP500 (+) | 0 | 1 | 11 | 31 | 97.7% |
| AMP500 (-) | 31 | 13 | 1 | 0 | 97.8% |
| MET500 (+) | 0 | 0 | 11 | 30 | 100% |
| MET500 (-) | 31 | 12 | 0 | 0 | 100% |
6-2. DISCORDANT RESULTS: Table 6c. Dip Card Tests:
| Cutoff Value (ng/mL) | Analyte assay
(POS/NEG) | Drug/Metabolite GC/MS value (ng/mL) | |
|----------------------|----------------------------|-------------------------------------|---------------------|
| | | Drug Analyte | GC/MS Value (ng/mL) |
| Methamphetamine 300 | + | Methamphetamine | 296 |
| Methamphetamine 500 | + | Methamphetamine | 494 |
| Barbiturates 200 | + | Pentobarbital | 185 |
Table 6d. Cup Tests:
| Cutoff Value (ng/mL) | Analyte assay
(POS/NEG) | Drug/Metabolite GC/MS value (ng/mL) | |
|----------------------|----------------------------|-------------------------------------|---------------------|
| | | Drug Analyte | GC/MS Value (ng/mL) |
| Amphetamine 300 | + | Amphetamine | 229 |
| Amphetamine 500 | - | Amphetamine | 510 |
| Amphetamine 500 | + | Amphetamine | 441 |
| Methamphetamine 300 | + | Methamphetamine | 296 |
| Barbiturates 200 | + | Pentobarbital | 185 |
All these eight (8) discordant results were confirmed at the drug cutoff level with the GC/MS concentrations.
-
- OTC Lay-user Accuracy Studies:
One hundred (130) intended lay-users participated in the evaluation for each of the device format (Dip Card and Cup) for OTC accuracy and usability study from three (3) intended user sites with
- OTC Lay-user Accuracy Studies:
26
GC/MS confirmed urine samples. The sample concentrations are consisted of negative (0), 50%, 75%, 125%, 150% and 200% of the cutoff by spiking drugs into drug-free urine pool. Each sample was aliquot 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:
| Concentrations By GC/MS (mL) | ||||||
|---|---|---|---|---|---|---|
| Chemtrue® | ||||||
| Drug Screen Dip | ||||||
| Card Test | (-) | (+) | % | |||
| Agreement | ||||||