(215 days)
Not Found
No
The device description and performance studies indicate a simple lateral flow immunoassay without any mention of computational analysis or algorithms.
No.
This device is a diagnostic tool used to detect the presence of drugs and their metabolites in urine, providing preliminary test results. It does not provide any form of therapy or treatment.
Yes
The document explicitly states that the devices are "rapid, qualitative, competitive binding immunoassays for qualitatively the detection of the following drugs and their metabolites in human urine". The goal of detecting substances in the body to identify a condition (in this case, the presence of drugs) aligns with the definition of a diagnostic device, even though it provides "preliminary test results" that "must be confirmed by other methods".
No
The device description clearly states it is a "competitive binding, lateral flow immunochromatographic assay" and can be performed "without the use of an instrument," indicating it is a physical test kit, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for the qualitative detection of drugs and their metabolites in human urine. This is a biological specimen taken from the human body.
- Purpose: The purpose is to provide information concerning the presence of these substances in the urine sample. This is a diagnostic purpose, even though it's a preliminary screening test.
- Device Description: It's a competitive binding, lateral flow immunochromatographic assay. These are common technologies used in IVD tests.
- Performance Studies: The document describes accuracy studies comparing the device's results to a reference method (GC/MS) using clinical urine specimens. This is typical for validating the performance of an IVD.
- Intended User/Care Setting: While it's intended for OTC consumer use, it's still performing a diagnostic test on a human sample. The mention of healthcare professional use also aligns with IVD use.
The fact that it's a preliminary test and requires confirmation by other methods doesn't negate its classification as an IVD. It's performing a diagnostic function on a biological sample.
N/A
Intended Use / Indications for Use
UCP Compact Drug Tests Cards and UCP Compact Drug Tests Cups are rapid, qualitative, competitive binding immunoassays for qualitatively the detection of the following drugs and their metabolites in human urine at the following cut-off concentrations:
| Test | Calibrator | Cut-off |
|---|---|---|
| Marijuana: | Delta-9-THC-COOH | 50 ng/mL |
| Cocaine: | Benzoylecgonine | 300 ng/mL |
| Amphetamine: | D-Amphetamine | 1000 ng/mL |
| Methamphetamine: | D-Methamphetamine | 1000 ng/mL |
| Opiates: | Morphine | 2000 ng/mL |
| Morphine: | Morphine | 300 ng/mL |
| Phencyclidine: | Phencyclidine | 25 ng/mL |
| Barbiturates: | Secobarbital | 300 ng/mL |
| Benzodiazepines: | Oxazepam | 300 ng/mL |
| Buprenorphine | Buprenorphine | 10 ng/mL |
| Methadone: | Methadone | 300 ng/mL |
| EDDP: | EDDP | 300 ng/mL |
| Oxycodone: | Oxycodone | 100 ng/mL |
| MDMA: | MDMA | 500 ng/mL |
| Propoxyphene | Propoxyphene | 300 ng/mL |
| Tricyclic Antidepressants: | Nortriptyline | 1000 ng/mL |
The tests are intended for over-the-counter (OTC) consumer use as the first step process to provide the consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory test in the second step of the two-step process, is provided in the package labeling.
The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The tests will yield preliminary positive results when the prescription drugs Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidentessants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Buprenorphine, Oxycodone, Tricyclic Antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level. The tests provide only preliminary test results, which must be confirmed by other methods such as gas chromatography/mass spectrometry (GCMS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring the drug levels.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DIO, DIS, JXM, DJC, DJR, DJG, LCM, LDJ, LFG, JXN
Device Description
UCP Compact Drug Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Benzodiapines, Buprenorphine, Cocaines, EDDP (Methadone metabolite), Marijuana, Methamphetamine, MDMA, Methadone, Opiates, Morphine, Oxycodone, Phencyclidine, Propoxyphene. Tricyclic Antidepressants and their metabolites at the cut-off levels as indicated. The tests can be performed without the use of an instrument.
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
over-the-counter (OTC) consumer / Not Found
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
The accuracy study for UCP EDDP tests was conducted using 80 clinical urine specimens per each drug including approximately 10% of the specimens containing one type drug at concentrations between -50% cutoff ranges, another 10% of the specimens containing one type drug at concentrations between cutoffs to +50% cutoff ranges. The study was compared the test results between UCP EDDP tests with the reference method GC/MS. UCP EDDP tests demonstrated performance of ≥ 98% accuracy when compared to the reference method GC/MS.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy Studies: The accuracy study for Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, Morphine, Phencyclidine, Barbiturates, Buprenorphine, Benzodiazepines, Methadone, Oxycodone, MDMA, Propoxyphene, Tricyclic Antidepressants drug tests in UCP Compact Drug Tests can be found in 510(k) submissions: K061457, K091588, K091612, K110515, K122419, K123863, K130463, K131811, K132812. The accuracy study for UCP EDDP tests was conducted using 80 clinical urine specimens per each drug. UCP EDDP tests demonstrated performance of ≥ 98% accuracy when compared to the reference method GC/MS.
Consumer Studies: The study design and protocol in the consumer study of UCP Compact Drug Tests is the same as that described in K091588, K091612, K110515, K122419, K123863, K130463, K131811, K132812 and was conducted among 230 lay persons in three geographic regions. One hundred fifteen females and one hundred fifteen males from ages between 18 and 75 years have participated the study. One hundred fourteen participants had high school education or less, one hundred sixteen participants had finished college courses. None of the participants had experiences using drug testing products before. The urine samples were prepared to contain strong negative (0% of cutoff), a very weak negative (50% of cutoff), a weak negative (75% of cutoff), a very weak positive (125% of cutoff), a weak positive (150% of cutoff) and high positive (300% of Cutoff). The urine samples with various drug concentrations were prepared by spiking pure drugs or drug metabolites into drug free human urine, the final drug concentrations in each urine sample were confirmed by GC/MS but TCA, TCA concentrations in the urine samples was confirmed by HPLC. The test results performed by the lay users showed 97% or above agreement rate with GC/MS results and indicate the lay users can perform UCP Compact Drug Tests satisfactorily by following the test instruction. The post-study survey was conducted to determine if the lay users can understand the test instruction, the meaning of the test results and how to interpret the test results. Consumers were asked 9 questions including whether the test was easy to run, the results was easy to read, how to interpret the test results, importance of confirmatory test and some medicines and foods may affect the test results. Participant responses support that the lay users can understand how to run the test, interpret the test results, the importance of confirmatory test, and some issues concerning certain prescription medicines and foods may affect the test results.
Other Performance Characteristics: The performance characteristics of UCP Compact Drug Tests including the precision/reproducibility study, sensitivity study, specificity and cross reactivity study, interference study and stability study have been also established. The results have demonstrated that UCP Compact Drug Tests performs satisfactorily when used according to the package inserts.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
UCP EDDP tests demonstrated performance of ≥ 98% accuracy when compared to the reference method GC/MS.
The test results performed by the lay users showed 97% or above agreement rate with GC/MS results.
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.
Not Found
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
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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 design featuring a symbol that resembles three human profiles connected by flowing lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2016
UCP BIOSCIENCES, INC NANCY CHEN OFFICIAL CORRESPONDENT 1445 KOLL CIRCLE, SUITE 111 SAN JOSE CA 95112
Re: K152908
Trade/Device Name: UCP Compact Drug Test Cards, UCP Compact Drug Test Cups Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: II Product Code: DKZ, DIO, DIS, JXM, DJC, DJR, DJG, LCM, LDJ, LFG, JXN Dated: March 21, 2016 Received: March 23, 2016
Dear Ms. Chen:
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152908
Device Name
UCP Compact Drug Test Cards, UCP Compact Drug Test Cups
Indications for Use (Describe)
UCP Compact Drug Tests Cards and UCP Compact Drug Tests Cups are rapid, qualitative, competitive binding immunoassays for qualitatively the detection of the following drugs and their metabolites in human urine at the following cut-off concentrations:
| Test | Calibrator | Cut-off |
|---|---|---|
| Marijuana: | Delta-9-THC-COOH | 50 ng/mL |
| Cocaine: | Benzoylecgonine | 300 ng/mL |
| Amphetamine: | D-Amphetamine | 1000 ng/mL |
| Methamphetamine: | D-Methamphetamine | 1000 ng/mL |
| Opiates: | Morphine | 2000 ng/mL |
| Morphine: | Morphine | 300 ng/mL |
| Phencyclidine: | Phencyclidine | 25 ng/mL |
| Barbiturates: | Secobarbital | 300 ng/mL |
| Benzodiazepines: | Oxazepam | 300 ng/mL |
| Buprenorphine | Buprenorphine | 10 ng/mL |
| Methadone: | Methadone | 300 ng/mL |
| EDDP: | EDDP | 300 ng/mL |
| Oxycodone: | Oxycodone | 100 ng/mL |
| MDMA: | MDMA | 500 ng/mL |
| Propoxyphene | Propoxyphene | 300 ng/mL |
| Tricyclic Antidepressants: | Nortriptyline | 1000 ng/mL |
The tests are intended for over-the-counter (OTC) consumer use as the first step process to provide the consumers with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory test in the second step of the two-step process, is provided in the package labeling.
The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The tests will yield preliminary positive results when the prescription drugs Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidentessants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Buprenorphine, Oxycodone, Tricyclic Antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level. The tests provide only preliminary test results, which must be confirmed by other methods such as gas chromatography/mass spectrometry (GCMS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring the drug levels.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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."
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10. 510(K) SUMMARY
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92.
The Assigned 510(k) number is K152908
- Submitter: UCP Biosciences, Inc 1445 Koll Circle. Ste 111 San Jose, CA 95014 Tel: 408-392-0064 Fax: 408-392-0163
Date: February 15, 2016
Contact Person: Dr. Nancy Chen
- Trade Name: UCP Compact™ DrugTest Cards, UCP Compact™ Drug Test Cups
- Common Name: Amphetamine Test System Methamphetamine Test System Cocaine Test System Barbiturate Test System Benzodiazepine Test System Buprenorphine Test System Methamphetamine Test System (MDMA) Opiates Test System Methadone Test System Methadone Test System (EDDP) Amphetamine Test System (Enzyme Immunoassay Phencyclidine) Cannabinoid Test System Propoxyphene Test System Tricyclic Antidepressant Test System
Product Code: DKZ, DIO, DIS, JXM, DJC, DJR, DJG, LCM, LDJ, LFG, JXN
Regulation Section:
| CFR 21 § 862.3100 |
|---|
| CFR 21 § 862.3150 |
| CFR 21 § 862.3170 |
| CFR 21 § 862.3250 |
| CFR 21 § 862.3610 |
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CFR 21 § 862.3620 CFR 21 § 862.3650 CFR 21 § 862.3870 CFR 21 § 862.3910 CFR 21 § 862.3700
Panel: Toxicology (91)
Device Classification: II
Predicates:
UCP Compact™ Drug Test Cards/UCP Compact™ Drug Test Cups (K131811) Advin Multi-Drug Screen Test Dip Card and Advin Multi-Drug Test Cup (K122809)
Product Description:
UCP Compact Drug Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Benzodiapines, Buprenorphine, Cocaines, EDDP (Methadone metabolite), Marijuana, Methamphetamine, MDMA, Methadone, Opiates, Morphine, Oxycodone, Phencyclidine, Propoxyphene. Tricyclic Antidepressants and their metabolites at the cut-off levels as indicated. The tests can be performed without the use of an instrument.
Intended Use:
UCP Compact™ Drug Test Cards, UCP Compact™ Drug Test Cups:
UCP Compact™ Drug Tests Cards and UCP Compact™ Drug Tests Cups are rapid, qualitative, competitive binding immunoassays for qualitatively the detection of the following drugs and their metabolites in human urine at the following cut-off concentrations:
| Test | Calibrator | Cut-off |
|---|---|---|
| Marijuana: | Delta-9-THC-COOH | 50 ng/mL |
| Cocaine: | Benzoylecgonine | 300 ng/mL |
| Amphetamine: | D-Amphetamine | 1000 ng/mL |
| Methamphetamine: | D-Methamphetamine | 1000 ng/mL |
| Opiates: | Morphine | 2000 ng/mL |
| Morphine: | Morphine | 300 ng/mL |
| Phencyclidine: | Phencyclidine | 25 ng/mL |
| Barbiturates: | Secobarbital | 300 ng/mL |
| Benzodiazepines: | Oxazepam | 300 ng/mL |
| Buprenorphine: | Buprenorphine | 10 ng/mL |
| Methadone: | Methadone | 300 ng/mL |
6
| EDDP: | EDDP | 300 ng/mL |
|---|---|---|
| Oxycodone: | Oxycodone | 100 ng/mL |
| MDMA: | MDMA | 500 ng/mL |
| Propoxyphene | Propoxyphene | 300 ng/mL |
| Tricyclic Antidepressants: | Nortriptyline | 1000 ng/mL |
The tests are intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide the consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory test in the second step of the two-step process, is provided in the package labeling.
The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The tests will yield preliminary positive results when the prescription drugs Barbiturates, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressant in urine. The multidrug of abuse urine test device shows the drug was or was not present at the cutoff level. The tests provide only preliminary test results, which must be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring the drug levels.
For Over-The-Counter (OTC) use For In Vitro Diagnostics only
Comparison to Predicate Devices:
When compared to the predicates. UCP Compact Drug Tests can qualitatively detect Amphetamine, Barbiturates, Benzodiazepine, Buprenorphine, Cocaine, Marijuana, Methadone, EDDP (Methadone metabolite), Methamphetamine, MDMA, Morphine, Opaites 2000, Oxycodone, Phencyclidine, Propoxyphene, Tricyclic Antidepressant and their metabolites in human urine. Both devices utilize the same cutoff concentrations. Both devices are immunochromatographic, lateral flow assays for the qualitative detection of drugs with visual, qualitative end results. Both tests are intended to provide preliminary analytical test results. Both devices are intended for health care professionals use and for OTC consumers use. UCP Compact Drug Tests can detect up to 16 drugs including new drug EDDP, whereas the predicates can detect up to 15 drugs.
Safety and Effectiveness Data:
Accuracy Studies:
7
The accuracy study for Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, Morphine, Phencyclidine, Barbiturates, Buprenorphine, Benzodiazepines, Methadone, Oxycodone, MDMA, Propoxyphene, Tricyclic Antidepressants drug tests in UCP Compact Drug Tests can be found in the following 510(k) submissions: K061457, K091588, K091612, K110515, K122419, K123863, K130463, K131811, K132812.
The accuracy study for UCP EDDP tests was conducted using 80 clinical urine specimens per each drug including approximately 10% of the specimens containing one type drug at concentrations between -50% cutoff ranges, another 10% of the specimens containing one type drug at concentrations between cutoffs to +50% cutoff ranges. The study was compared the test results between UCP EDDP tests with the reference method GC/MS. UCP EDDP tests demonstrated performance of ≥ 98% accuracy when compared to the reference method GC/MS.
Consumer Studies
The study design and protocol in the consumer study of UCP Compact Drug Tests is the same as that described in K091588, K091612, K110515, K122419, K123863, K130463, K131811, K132812 and was conducted among 230 lay persons in three geographic regions. One hundred fifteen females and one hundred fifteen males from ages between 18 and 75 years have participated the study. One hundred fourteen participants had high school education or less, one hundred sixteen participants had finished college courses. None of the participants had experiences using drug testing products before. The urine samples were prepared to contain strong negative (0% of cutoff), a very weak negative (50% of cutoff), a weak negative (75% of cutoff), a very weak positive (125% of cutoff), a weak positive (150% of cutoff) and high positive (300% of Cutoff). The urine samples with various drug concentrations were prepared by spiking pure drugs or drug metabolites into drug free human urine, the final drug concentrations in each urine sample were confirmed by GC/MS but TCA, TCA concentrations in the urine samples was confirmed by HPLC. The test results performed by the lay users showed 97% or above agreement rate with GC/MS results and indicate the lay users can perform UCP Compact Drug Tests satisfactorily by following the test instruction. The post-study survey was conducted to determine if the lay users can understand the test instruction, the meaning of the test results and how to interpret the test results. Consumers were asked 9 questions including whether the test was easy to run, the results was easy to read, how to interpret the test results, importance of confirmatory test and some medicines and foods may affect the test results. Participant responses support that the lay users can understand how to run the test, interpret the test results, the importance of confirmatory test, and some issues concerning certain prescription medicines and foods may affect the test results.
Other Information about Performance Characteristics:
The performance characteristics of UCP Compact Drug Tests including the precision/reproducibility study, sensitivity study, specificity and cross reactivity study, interference study and stability study have been also established. The results have
8
demonstrated that UCP Compact Drug Tests performs satisfactorily when used according to the package inserts.
Conclusion:
The performance data in this submission supports UCP Compact™ Drug Test Cards and UCP Compact™ Drug Test Cups are substantially equivalent to the predicate devices UCP Compact™ Drug Test Cards and UCP Compact™ Drug Test Cups in K131811, and Advin Multi-Drug Screen Test Dip Card and Advin Multi-Drug Test Cup in K122809.