(120 days)
K142396/CR140334
No
The device description and performance studies indicate a traditional lateral flow immunoassay, with no mention of AI/ML for interpretation or analysis.
No
This device is an in vitro diagnostic test designed to detect the presence of various drugs in urine, not to treat or alleviate a disease or condition.
Yes
The "Device Description" explicitly states, "The Chemtrue® Drug Screen Cup Tests are... in vitro diagnostic devices." Furthermore, the "Intended Use / Indications for Use" section describes its purpose as the "qualitative detection of [various] drugs in human urine," which is a diagnostic function.
No
The device is described as a "colloidal gold based lateral flow immunoassay" and a "single-use, in vitro diagnostic device, which come in the Cup format". This indicates a physical test device that interacts with a urine sample, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the tests are "rapid lateral flow immunoassays for the qualitative detection of... drugs in human urine." This describes a test performed in vitro (outside the body) on a biological sample (human urine) to provide diagnostic information (detection of drugs).
- Device Description: The device description clearly states, "The tests are single-use, in vitro diagnostic devices..." This directly identifies the device as an IVD.
- Anatomical Site: The test is performed on "human urine," which is a biological specimen.
- Performance Studies: The document describes various performance studies, including "Method Comparison Studies" comparing the device to a "GC/MS Reference Method," "OTC Lay-user Accuracy and Usability Studies," "Reproducibility (Precision) Studies," "Specificity Study," and "Interference" studies. These types of studies are characteristic of the validation required for IVD devices to demonstrate their performance characteristics.
- Predicate Device(s): The mention of predicate devices (K061718 INNOVACON® Integrated E-Z Cup; K060896 OnSite CupKit™) and a reference device (K142396 Chemtrue® BUP/TCA Drug Screen Cup Tests) with K numbers indicates that this device is being compared to other devices that have gone through regulatory clearance as IVDs.
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Chemtrue® Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine, Amphetamine, Cocaine, Morphine 300, Methamphetamine, Phencyclidine, Benzodiazepines, Barbiturates, Ecstasy, Methadone, Oxycodone and Tricyclic Antidepressants drugs in human urine.
The Chemtrue® Drug Screen Cup Tests with OPI 2000 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 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 and Tricyclic Antidepressants. There are no uniformly recognized cutoff concentration levels for these drugs in urine.
Product codes
DJG, LFG, DKZ, DIO, LDJ, DNK, LAF, LCM, JXM, DIS, DJC, DJR
Device Description
The Chemtrue® Drug Screen Cup 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 Cup format, 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
human urine
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:
The precision study was conducted by three (3) Operators with three (3) lots in replicates of 10 devices/lot 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 project Manager.
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.
Interference:
Over one hundred of potential interferers were tested and found not to cross-react when tested at concentrations of 100 µg/mL at ±25% of the drug cut-off concentrations.
Additional interference study: In addition to the cross-reactivity and interference studies presented in this submission, all the drug tests were tested with each of the 14 drugs at 150% and 50% of the drug cut-off urine samples.
Effect of Urine pH and Specific Gravity Studies:
The testing results demonstrate that the urine pH ranges from 2.0 to 9.0 at ±50% of the drug cut-off concentrations do not affect the test performance. The specific gravity (SG) ranges of 1.001, 1.010, 1.015, 1.020, 1.025 and 1.030 at ±50% of the drug cut-off concentrations do not affect the test results.
Method Comparison Studies:
Chemtrue® Drug Screen Cup 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 blindlabeled clinical specimen correlation study (On average of 85 clinical specimens for each drug test and a total of 586 samples were tested). Three operators performed the testing. Each blind labeled sample was randomly distributed to each operator by the Clinical Research Cooperator.
OTC Lay-user Accuracy and Usability Studies:
This study demonstrates OTC accuracy and usability with AMP/BAR/BZO/COC/MDMA/MET/ MTD/MOR/OPI2000/OXY/PCP/THC and previously cleared BUP/TCA Tests (K142396). One hundred (100) intended lay-users participated in this OTC accuracy and usability study from three (3) intended user sites with GC/MS confirmed urine samples at the following concentrations: negative, 50%, 75%, 125% and 150% 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, one blind labeled sample and one test device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Reproducibility (Precision) Studies:
Study type: Reproducibility (Precision) Studies
Sample size: replicates of 10 devices/lot at each concentration level (Negative, 50%, 75%, cut-off, 125%, 150%) across 3 lots and 3 operators over 10 nonconsecutive days. Total n for negative in all tables is 210, for other concentration levels total n is 30.
Key results: For AMP, BAR, BZO, COC, MDMA, MET, MTD, MOR300, OPI2000, OXY, PCP, THC, all negative samples (210) were negative. For 50% & 75% of cutoff, all samples (30 each) were negative. For 125% & 150% of cutoff, all samples (30 each) were positive. At cutoff, results varied:
AMP: 16 positive, 14 negative
BAR: 16 positive, 14 negative
BZO: 15 positive, 15 negative
COC: 18 positive, 12 negative
MDMA: 17 positive, 13 negative
MET: 16 positive, 14 negative
MTD: 13 positive, 17 negative
MOR300: 16 positive, 14 negative
OPI2000: 18 positive, 12 negative
OXY: 16 positive, 14 negative
PCP: 18 positive, 12 negative
THC: 15 positive, 15 negative
Specificity Study:
Study type: Specificity Study
Key results: Various drugs, drug metabolites, and other structurally-similar compounds were tested for cross-reactivity and found to be positive if the levels were greater than the listed concentrations (tables provided in the document).
Interference:
Study type: Interference study
Key results: Over one hundred potential interferents (listed in the document) were tested at concentrations of 100 µg/mL at ±25% of the drug cut-off concentrations and found not to cross-react. No interference or cross-reactivity among the 14 drug tests was observed when tested with each of the 14 drugs at 150% and 50% of the drug cut-off urine samples.
Effect of Urine pH and Specific Gravity Studies:
Study type: Urine pH and Specific Gravity Studies
Key results: Urine pH ranges from 2.0 to 9.0 at ±50% of the drug cut-off concentrations do not affect the test performance. Specific gravity (SG) ranges of 1.001, 1.010, 1.015, 1.020, 1.025 and 1.030 at ±50% of the drug cut-off concentrations do not affect the test results.
Method Comparison Studies:
Study type: Method Comparison Studies (Accuracy)
Sample size: On average of 85 clinical specimens for each drug test and a total of 586 samples were tested.
Key results:
AMP: 97.6% agreement
BAR: 100% agreement
BZO: 98% agreement
COC: 98% agreement
MDMA: 98.3% agreement
MET: 100% agreement
MTD: 100% agreement
MOR300: 100% agreement
OPI2000: 98% agreement
OXY: 100% agreement
PCP: 98% agreement
THC: 100% agreement
There were six (6) discordant results in total across all 12-drug tests, which were confirmed at the drug cutoff level with GC/MS concentrations.
OTC Lay-user Accuracy and Usability Studies:
Study type: OTC Lay-user Accuracy and Usability Studies
Sample size: One hundred (100) intended lay-users.
Key results: All tested analytes (AMP, BAR, BZO, BUP, COC, MDMA, MET, MTD, MOR, OPI, OXY, PCP, TCA) showed 100% agreement with GC/MS values for "No Drug present", "50% of the cutoff", "125% of the cutoff", and "150% of the cutoff" concentrations. For "75% of the cutoff", all analytes showed 100% agreement except THC which showed 90% agreement. ≥ 98% of the lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis of the package insert revealed a reading grade level of less than 7.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Agreement values from Method Comparison Studies:
AMP: 97.6% agreement
BAR: 100% agreement
BZO: 98% agreement
COC: 98% agreement
MDMA: 98.3% agreement
MET: 100% agreement
MTD: 100% agreement
MOR300: 100% agreement
OPI2000: 98% agreement
OXY: 100% agreement
PCP: 98% agreement
THC: 100% agreement
Agreement values from OTC Lay-user Accuracy and Usability Studies:
AMP: 100% agreement across all tested concentrations.
BAR: 100% agreement across all tested concentrations.
BZO: 100% agreement across all tested concentrations.
BUP: 100% agreement across all tested concentrations.
COC: 100% agreement across all tested concentrations.
MDMA: 100% agreement across all tested concentrations.
MET: 100% agreement across all tested concentrations.
MTD: 100% agreement across all tested concentrations.
MOR: 100% agreement across all tested concentrations.
OPI: 100% agreement across all tested concentrations.
OXY: 100% agreement across all tested concentrations.
PCP: 100% agreement across all tested concentrations.
TCA: 100% agreement across all tested concentrations.
THC: 100% agreement for "No Drug present", "50% of the cutoff", "125% of the cutoff", and "150% of the cutoff", and 90% agreement for "75% of the cutoff".
Predicate Device(s)
Reference Device(s)
K142396/CR140334
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three heads, which are represented by curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 17, 2015
CHEMTRON BIOTECH, INC. JANE ZHANG DIRECTOR OF QA/RA 9245 BROWN DEER ROAD SAN DIEGO CA 92121
Re: K143599
Trade/Device Name: Chemtrue® Drug Screen Cup Tests Chemtrue® Drug Screen Cup Tests With OPI 2000 Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG, LFG, DKZ, DIO, LDJ, DNK, LAF, LCM, JXM, DIS, DJC, DJR Dated: April 9, 2015 Received: April 13, 2015
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 (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 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,
Stayce Beck -S
For : 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) K143599
Device Name
Chemtrue Drug Screen Cup Tests
Indications for Use (Describe)
The Chemtrue® Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine, Amphetamine, Cocaine, Morphine 300, 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 | 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® Drug Screen Cup 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, Buprenorphine, Oxycodone and Tricyclic Antidepressants. There are no uniformly recognized cutoff 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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) K143599
Device Name
Chemtrue Drug Screen Cup Tests with OPI 2000
Indications for Use (Describe)
The Chemtrue Drug Screen Cup Tests with OPI 2000 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 | d-Methamphetamine | 1000 |
| Opiates 2000 | MOR | Morphine | 2000 |
| 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 Drug Screen Cup Tests with OPI 2000 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 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 Benzodizzepines, Buprenorphine, Oxycodone and Tricyclic Antidepressants. There are no uniformly recognized cutoff 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
5
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
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 OA/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 15, 2015
B. DEVICE
Trade or Proprietary Name: Chemtrue® Drug Screen Cup Tests Chemtrue® Drug Screen Cup Tests with OPI 2000
Common Name: 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 |
| Cocaine | DIO | Toxicology 91 | 21 CFR 862.3250, Cocaine and metabolites Test System |
| Methamphetamine | LAF | Toxicology 91 | 21 CFR 862.3610, Methamphetamine Test System |
| Morphine | DNK | Toxicology 91 | 21 CFR 862.3640, Morphine Test System |
| Opiates | DJG | Toxicology 91 | 21 CFR 862.3650 Opiates Test System |
| Phencyclidine | LCM | Toxicology 91 | Unclassified, Enzyme immunoassay Phencyclidine |
| Marijuana (THC) | LDJ | Toxicology 91 | 21 CFR 862.3870, Cannabinoids Test System |
| Benzodiazepines | JXM | Toxicology 91 | 21 CFR 862.3170, Benzodiazepines Test System |
| Barbiturates | DIS | Toxicology 91 | 21 CFR 862.3150, Barbiturates 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 |
| Oxycodone | DJG | Toxicology 91 | 21 CFR 862.3650, Opiate Test System |
In addition, previously FDA cleared Chemtrue® BUP/TCA Drug Screen Cup Tests (K142396/CR140334):
| Drug of Abuse | Product Code | Panel | Regulation Section |
|---|---|---|---|
| Buprenorphine (BUP) | DIG | Toxicology 91 | 21CFR 862.3650 |
| Tricyclic Antidepressants (TCA) | LFG | Toxicology 91 | 21 CFR 862.3910 |
C. PREDICATE DEVICE
7
C-1.K061718
INNOVACON® Integrated E-Z Cup, submitter: INNOVACON Laboratories, Inc.
- C-2. K060896
OnSite CupKit™, submitter: Varian, Inc.
D. INDICATIONS FOR USE:
Device Name: Chemtrue® Drug Screen Cup Tests
Chemtrue® Drug Screen Cup Tests with OPI 2000
Indications for Use:
Chemtrue® Drug Screen Cup Tests:
The Chemtrue® Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Buprenorphine, Amphetamine, Cocaine, Marijuana, Morphine 300, 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-THC-9-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® Drug Screen Cup 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.
8
Chemtrue® Drug Screen Cup Tests with OPI 2000:
The Chemtrue® Drug Screen Cup Tests with OPI 2000 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 2000 | OPI | Morphine | 2000 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Marijuana | THC | 11-nor-Δ9-THC-9-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® Drug Screen Cup Tests with OPI 2000 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.
E. DEVICE DESCRIPTION
The Chemtrue® Drug Screen Cup 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 Cup format, as indicated by the test name.
F. SUBSTANTIAL EQUIVALENCE INFORMATION:
Comparison with the predicate devices is outlined below:
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| Similarities and Differences | ||
|---|---|---|
| Item | Candidate Devices | Predicate (K061718 and K060896) |
| Intended Use | Same | For qualitative detection of drugs of abuse in |
| human urine | ||
| Results | Same | Qualitative |
| Methodology | Same | Lateral flow, competitive binding |
| immunoassay based on the principle of antigen | ||
| and antibody immunochemistry. | ||
| Storage | 2 - 30°C until the expiration date | K061718: 2 - 30°C until the expiration date; |
| K060896: 15 – 30°C. | ||
| Intended Users | Prescription and Over-the-Counter | |
| (OTC) users | K061718:Prescription users, including point-of- | |
| care; | ||
| K060896:Prescription users | ||
| Analytes and Cut | ||
| Offs (ng/mL) | Buprenorphine – same | |
| Barbiturates – same | ||
| Tricyclic Antidepressants – same | ||
| Opiates 2000 – same | ||
| MDMA – same | ||
| Methadone – same | ||
| Oxycodone - same | ||
| Propoxyphene – not included in the | ||
| device | ||
| Amphetamine – 1000 | ||
| Benzodiazepines – 300 | ||
| Cocaine - 300 | ||
| Methamphetamine – 1000 | ||
| Morphine - 300 | ||
| Phencyclidine – same | ||
| Marijuana – same | K061718 | |
| Buprenorphine – 10 | ||
| Barbiturates - 300 | ||
| Tricyclic Antidepressants – 1000 | ||
| Opiates 2000 – 2000 | ||
| MDMA - 500 | ||
| Methadone - 300 | ||
| Oxycodone - 100 | ||
| Propoxyphene - 300 | ||
| K061718 and K060896 | ||
| Amphetamine – 1000 / 300 | ||
| Benzodiazepines – 300 / 200 | ||
| Cocaine - 300 / 150 | ||
| Methamphetamine – 1000 / 500 / 300 | ||
| Morphine - 300 / 2000 | ||
| Phencyclidine – 25 | ||
| Marijuana – 50 | ||
| Format | Cup only | K061718-Cup and Dipcard; K060896-Cup |
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
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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 BUP/AMP/COC/MET/MOR/OPI2000/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.
H. PERFORMANCE CHARACTERISTICS
Performance data is only provided for AMP, COC, MAMP, OPI2000, MOR300, PCP, THC, BZO, BAR, MDMA, MTD, and OXY, as the new analytes. BUP/TCA analytes of the candidate devices were previously cleared under K142396/CR140334.
1. Reproducibility (Precision) Studies:
The precision study was conducted by three (3) Operators with three (3) lots in replicates of 10 devices/lot 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 project Manager. The data is analyzed and summarized in the tables below:
| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 210 | 0 | 210 |
| 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 Cup Test: Cutoff: 1000 ng/mL | |||
|---|---|---|---|
| -------------------------------------------- | -- | -- | -- |
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| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 210 | 0 | 210 |
| 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 1b. BAR Cup Test: Cutoff: 300 ng/mL
Table 1c. BZO Cup Test: Cutoff: 300 ng/mL
| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 210 | 0 | 210 |
| 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 1d. COC Cup Test: Cutoff: 300 ng/mL
| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 210 | 0 | 210 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 18 | 12 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |
Table 1e. MDMA Cup Test: Cutoff: 500 ng/mL
| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 210 | 0 | 210 |
| 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 |
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| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 210 | 0 | 210 |
| 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 Cup Test: Cutoff: 1000 ng/mL
Table 1g. MTD Cup Test: Cutoff: 300 ng/mL
| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 210 | 0 | 210 |
| 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 1h. MOR 300 Cup Test: Cutoff: 300 ng/mL
| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 210 | 0 | 210 |
| 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 11. OPI 2000 Cup Test: Cutoff: 2000 ng/mL
| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 210 | 0 | 210 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 18 | 12 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |
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| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 210 | 0 | 210 |
| 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 1j. OXY Cup Test: Cutoff: 100 ng/mL
Table 1k. PCP Cup Test: Cutoff: 25 ng/mL
| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 210 | 0 | 210 |
| 50% of cutoff | 30 | 0 | 30 |
| 75% of cutoff | 30 | 0 | 30 |
| Cutoff | 30 | 18 | 12 |
| 125% of cutoff | 30 | 30 | 0 |
| 150% of cutoff | 30 | 30 | 0 |
Table 1L. THC Cup Test: Cutoff: 50 ng/mL
| Concentration Level | n | TOTAL | |
|---|---|---|---|
| + | - | ||
| Negative | 210 | 0 | 210 |
| 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:
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Amphetamine related compounds:
| Substances | Conc. (ng/mL) | % Cross Reactivity |
|---|---|---|
| d-Amphetamine | 1,000 | 100 |
| d,l-Amphetamine | 2,500 | 40 |
| l-Amphetamine | >100,000 | 100,000 |
THC related compounds:
| Substances | Concentration (ng/mL) | % Cross Reactivity |
|---|---|---|
| 11-nor-Δ9-THC-9-COOH | 50 | 100 |
| 11-nor-Δ8-THC-9-COOH | 30 | 167 |
| Δ9-Tetrahydrocannabinol | 12,000 | 0.4 |
| Cannabidol | >100,000 | 0.05 |
| Cannabinol | >100,000 | 0.05 |
3. Interference:
- 3-1. 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 cut-off concentrations.
Table 3. The following compounds do not interfere with the tests:
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Endogenous Compounds:
| Albumin | Creatinine | Riboflavin |
|---|---|---|
| Bilirubin | Glucose | Sodium Chloride |
| Cholesterol | Hemoglobin | Uric Acid |
Un-structurally related compound:
| Un-structurally related compound: | ||
|---|---|---|
| Acetaminophen | 5, 5-Diphenylhydantoin | Octopamine |
| Acetone | Dopamine | Oxalic Acid |
| Acetylsalicylic Acid | 1-Erythromycin, | Papaverine |
| Amoxicillin | Estradiol | Penicillin-G |
| Ampicillin | Estrone | Perphenazine |
| R-(-)-Apomorphine | Ethanol | Phenelzine |
| L-Ascorbic Acid | Fenofibrate | Phenylethylamine |
| Aspirin | Fentanyl | Prednisone |
| Aspartame | Fotemustine | Promazine |
| Atropine | Furosemide | Promethazine |
| Baclofen | Gemfibrozil | d-Propoxyphene |
| Benzocaine | Guaiacolglyceryl ether | d,l-Propranolol |
| Benzoic Acid | Gentisic acid | Pyridoxine |
| Carisoprodol | Hydralazine | Pyrilamine |
| Chloramphenicol | Hydrocortisone | Pyrogallol |
| Chlordiazepoxide | 3-Hydroxytyramine | Quinidine |
| (+)-Chlorpheniramine | (+/-)-Isoproterenol | Quinine |
| Chlorpromazine | Ketamine | Quinolinic Acid |
| Clofibrate | Meprobamate | Ranitidine |
| Clonidine | Methapyrilene | Salicylic Acid |
| Cortisone | Methylphenidate | Sulfamethazine |
| (-)-Cotinine | Nalidixic Acid | Sulindac |
| Creatine Hydrate | Naloxone | Tetracycline |
| Cyclobenzaprine | Naltrexone | Tetrahydrozoline |
| Cyclodextrin-r | (+)-Naproxen | Thiamine |
| Cyproheptadine | Niacinamide | Thioridazine |
| Deoxycorticosterone | Nicotinic Acid | Tramadol |
| Dextromethorphan | Nifedipine | Trifluoperazine |
| Diclofenac | 19-Norethindrone | Tryptamine |
| Diflunisal | Norpropoxyphene | Tyramine |
| 4-Dimethyl-aminoantipyrine | Noscapine | Zomepirac sodium salt |
| Diphenhydramine |
Additional interference study: In addition to the cross-reactivity and interference studies presented in this submission, all the drug tests were tested with each of the 14 drugs at 150% and 50% of the drug cut-off urine samples. The results confirmed that there is no interference or cross-reactivity among these drug tests.
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Effect of Urine pH and Specific Gravity Studies: The testing results demonstrate that the urine pH ranges from 2.0 to 9.0 at ±50% of the drug cut-off concentrations do not affect the test performance. The specific gravity (SG) ranges of 1.001, 1.010, 1.015, 1.020, 1.025 and 1.030 at ±50% of the drug cut-off concentrations do not affect the test results.
- Stability Study: To establish and support the shelf life and expiration date, stability studies were 4. conducted under accelerated temperature (at 60°C and 40°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℃). The real time stability study is still on-going.
-
- Method Comparison Studies:
Chemtrue® Drug Screen Cup 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 blindlabeled clinical specimen correlation study (On average of 85 clinical specimens for each drug test and a total of 586 samples were tested). Three operators performed the testing. Each blind labeled sample was randomly distributed to each operator by the Clinical Research Cooperator. The results are summarized in the tables below:
| Concentrations by GC/MS (ng/mL) | |||||
|---|---|---|---|---|---|
| Chemtrue® | |||||
| Drug Screen Cup | (-) | (+) | |||
| Negative | |||||
| ( |