(82 days)
No
The device description and performance studies focus on immunoassay technology and do not mention any AI or ML components.
No
The device is described as an immunoassay for detecting drugs and their metabolites in human urine, providing preliminary positive/negative results, and is explicitly stated as "not intended to be used in monitoring drug levels," which suggests a diagnostic rather than therapeutic purpose.
Yes
The device is described as "rapid, qualitative, competitive binding immunoassays for the detection of the following drugs and their metabolites in human urine". It is intended to provide "information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample", which are all functions of a diagnostic device. While it yields "preliminary positive results" that "should be confirmed by other methods", it still provides diagnostic (detection) information.
No
The device description explicitly 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.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "For In Vitro Diagnostics only."
- Device Description: The device is described as a "competitive binding, lateral flow immunochromatographic assay for qualitatively the detection of... in human urine." This describes a test performed on a sample taken from the body (in vitro) to diagnose or provide information about a condition or substance.
- Sample Type: The test is performed on "human urine," which is a biological sample taken from the body.
- Purpose: The purpose is to detect the presence of drugs and their metabolites in the urine sample, providing information about the individual's drug use.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The UCP Home Drug Screening Test Cards, UCP Home Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of the following drugs and their metabolites in human urine:
Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiates 2000, Oxycodone, Phencyclidine, Propoxyphene, Tricyclic Antidepressant.
The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The tests are intended for over-the-counter (OTC) 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 testing - the second step in the process, along with the materials for shipping the urine specimen to the laboratory, is provided. The test is also intended for prescription use.
The tests will vield 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 tests provide only preliminary data, which should 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 and prescription use For In Vitro Diagnostics only
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 Home Drug Screening Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Benzodiapines, Buprenorphine, Cocaines, Marijuana, Methamphetamine, MDMA, Methadone, Opiates, Opiates 300, 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter (OTC) use and prescription use.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Consumer Studies: The study design and protocol in the consumer study of UCP Home Drug Screening Tests is the same as that described in K091588, K110515, was conducted among 115 lay persons in three geographic regions. Fifty seven females and fifty eight males from ages between 18 and 77 years have participated the study. Fifty seven participants had high school education or less, fifty eight 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 Home Drug Screening 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 Home Drug Screening Tests including the precision study, sensitivity study, specificity and cross reactivity study, interference study and stability study have been also established. The results have demonstrated that UCP Home Drug Screening Tests performs satisfactorily when used according to the package inserts.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Agreement Rate (Lay User vs GC/MS): 97% or above.
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
§ 862.3100 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
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 K130463
UCP Biosciences, Inc Submitter: 1445 Koll Circle, Ste 111 San Jose, CA 95014 Tel: 408-392-0064 Fax: 408-392-0163
Date: May 13, 2013
Contact Person: Dr. Nancy Chen
Trade Name: UCP Home™ Drug Screening Test Cards, UCP Home™ Drug Screening 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 Opiates Test System (Oxycodone) 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 CFR 21 § 862.3620 CFR 21 § 862.3650
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CFR 21 § 862.3870 CFR 21 § 862.3910 CFR 21 § 862.3700 Unclassified, Enzyme immunoassay, Phencyclidine
Panel: Toxicology (91)
Device Classification: II =
Substantially Equivalent Devices:
UCP Home™ Drug Screening Test Cards/UCP Home™ Drug Screening Test Cups (K091588), UCP Drug Screening Test Cups (K110515)
Product Description:
UCP Home Drug Screening Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Benzodiapines, Buprenorphine, Cocaines, Marijuana, Methamphetamine, MDMA, Methadone, Opiates, Opiates 300, 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 Home™ Drug Screening Test Cards, UCP Home™ Drug Screening Test Cups:
The UCP Home Drug Screening Test Cups, UCP Home Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of the following drugs and their metabolites in human urine:
| Test | Calibrator | Cut-off |
|---|---|---|
| Amphetamine | D-Amphetamine | 1000 ng/mL |
| Barbiturates | Secobarbital | 300 ng/mL |
| Benzodiazepines | Oxazepam | 300 ng/mL |
| Buprenorphine | Buprenorphine | 10 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Marijuana | Delta-9-THC-COOH | 50 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| Methamphetamine | D-Methamphetamine | 1000 ng/mL |
| MDMA | MDMA | 500 ng/mL |
| Morphine | Morphine | 300 ng/mL |
| Opiates 2000 | Morphine | 2000 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Phencyclidine | Phencyclidine | 25 ng/mL |
2
| Propoxyphene | Propoxyphene | 300 ng/mL |
|---|---|---|
| Tricyclic Antidepressant | Nortriptyline | 1000 ng/mL |
The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The tests are intended for over-the-counter (OTC) 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 testing - the second step in the process, along with the materials for shipping the urine specimen to the laboratory, is provided. The test is also intended for prescription use. The test also is intended for prescription use.
The tests will vield 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 tests provide only preliminary data, which should 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 and prescription use For In Vitro Diagnostics only
Comparison to Predicate Devices:
When compared to the predicate (K091588), UCP Home Drug Screening Tests can qualitatively detect Amphetamine, Barbiturates, Benzodiazepine, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiates 2000, Oxycodone, Phencyclidine, 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. The UCP Home Drug Screening Tests can detect up to 14 drugs (by also detecting buprenorphine and propoxyphene), whereas the predicates can detect up to 12 drugs.
Safety and Effectiveness Data:
Performance Studies:
3
The method comparison, precificity (interference and cross-reactivity), cut-off study of each drug test in UCP Home Drug Screening Tests can be found in K091612, K091588, and K061457.
Consumer Studies
The study design and protocol in the consumer study of UCP Home Drug Screening Tests is the same as that described in K091588, K110515, was conducted among 115 lay persons in three geographic regions. Fifty seven females and fifty eight males from ages between 18 and 77 years have participated the study. Fifty seven participants had high school education or less, fifty eight 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 Home Drug Screening 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 Home Drug Screening Tests including the precision study, sensitivity study, specificity and cross reactivity study, interference study and stability study have been also established. The results have demonstrated that UCP Home Drug Screening Tests performs satisfactorily when used according to the package inserts.
Conclusion:
The performance data in this submission supports UCP Home™ Drug Screening Test Cards and UCP Home"M Drug Screening Test Cups are substantially equivalent to the predicate device UCP Home™ Drug Screening Test Cards/ UCP Home™ Drug Screening Test Cups (K091588).
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2013
UCP Biosciences, Inc. C/O Ms. Nancy Chen 1445 Koll Circle, Ste. 111 SAN JOSE CA 95112
Re: K130463
Trade/Device Name: UCP Home Drug Screening Test Cards UCP Home Drug Screening 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 13, 2013 Received: March 15, 2013
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 Part 801); 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.
5
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Carol Benson -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
6
Indications for Use
510(k) Number (if known): K130463
Device Name: UCP Home Drug Screening Test Cards UCP Home Drug Screening Test Cups
Indications for Use:
The UCP Home Drug Screening Test Cards, UCP Home Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of the following drugs and their metabolites in human urine:
| Test | Calibrator | Cut-off |
|---|---|---|
| Amphetamine | D-Amphetamine | 1000 ng/mL |
| Barbiturates | Secobarbital | 300 ng/mL |
| Benzodiazepines | Oxazepam | 300 ng/mL |
| Buprenorphine | Buprenorphine | 10 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Marijuana | Delta-9-THC-COOH | 50 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| Methamphetamine | D-Methamphetamine | 1000 ng/mL |
| MDMA | MDMA | 500 ng/mL |
| Morphine | Morphine | 300 ng/mL |
| Opiates 2000 | Morphine | 2000 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Phencyclidine | Phencyclidine | 25 ng/mL |
| Propoxyphene | Propoxyphene | 300 ng/mL |
| Tricyclic Antidepressant | Nortiptyline | 1000 ng/mL |
The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The tests are intended for over-the-counter (OTC) users as the first step in a two step process to provide consumers, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample.
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Denise Johnson-lyless=55333 Division Sign-Off
Office of In Vitro Diagnostics and Radiological Health
510(k) K130463
7
Information regarding confirmatory testing - the second step in the process, along with the materials for shipping the urine specimen to the laboratory, is provided. The test is also intended for prescription use.
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 tests provide only preliminary data, which should 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 results, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.
| Prescription Use x
(21 CFR Part 801 Subpart D) | And/Or | Over the Counter Use x
(21 CFR Part 801 Subpart C) |
| --------------------------------------------------- | -------- | ------------------------------------------------------- |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Denise Johnson=lyless=55
2013.05.14 12:32:35-04-00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K130463 510(k)