(113 days)
No
The device description and performance studies indicate a standard immunoassay test with visual interpretation, not involving AI/ML for analysis or interpretation.
No.
The device is a diagnostic tool designed for drug screening through urine analysis. It does not provide any form of therapy or treatment for medical conditions.
Yes
Explanation: The device is intended to detect the presence or absence of specific drugs and their metabolites in human urine, which is a form of diagnostic testing. It provides preliminary data that should be confirmed by other methods, indicating its role in identifying potential conditions (drug presence).
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.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the detection of drugs and their metabolites in human urine. This is a biological specimen taken from the human body.
- Diagnostic Purpose: The purpose of the test is to provide information concerning the presence or absence of specific drugs or their metabolites. While it's a preliminary screening test, it's used to aid in a diagnostic process (identifying potential drug use).
- In Vitro: The test is performed outside of the human body, using a sample (urine) collected from the individual.
The definition of an IVD generally includes devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic purposes. This device clearly fits that description.
N/A
Intended Use / Indications for Use
UCP Home Drug Screening Test 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
Opiate 300: Morphine 300 ng/mL
Phencyclidine: Phencyclidine 25 ng/mL
Barbiturares: Secobarbital 300 ng/mL
Benzodiazepines: Oxazepam 300 ng/mL
Methadone: Methadone 300 ng/mL
Oxycodone: Oxycodone 100 ng/mL
MDMA: MDMA 500 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 tests will yield preliminary positive results when the prescription drugs Barbiturates. Benzodiazepines, Oxycodone, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, 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 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 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
Device Description
UCP Home Drug Screening Test Cups are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Benzodiapines, Cocaines, Marijuana, Methamphetamine, MDMA, Methadone, Opiates, Opiates 300, Oxycodone, Phencyclidine, 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, health care professional users
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
Total·120 clinical urine samples per one drug test were included in the comparison study. The clinical samples were obtained from the reference laboratories, all clinical urine samples including drug negative urine samples and drug positive urine samples were tested by the reference method GC/MS, except TCA. The TCA positive urine samples were tested by HPLC method. For each drug test. 10% clinical samples contain drug concentrations between 50% below the cutoff level and the cutoff level, other 10 % clinical urine samples contain drug concentrations between the cutoff level and 50% above the cutoff level.
For consumer studies, 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy Studies: The testing results have demonstrated that 100% agreements between the candidate device and the predicate device, over 97.5% agreement between the candidate devices and the reference method GC/MS in the comparison study by using clinical urine specimens.
Consumer Studies: The study was conducted among 115 lay persons in three geographic regions. Fifty eight females and fifty seven males from ages between 18 and 77 years have participated the study. Fifty eight participants had high school education or less, fifty seven participants had finished college courses. None of the participants had experiences using drug testing products before. 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 Test Cups 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
NOV 3 0 2012
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 K122419
Submitter: UCP Biosciences, Inc 1445 Koll Circle, Ste 111 San Jose, CA 95014 Tel: 408-392-0064 Fax: 408-392-0163
Date: August 7, 2012
Contact Person: Dr. Nancy Chen
Trade Name: UCP Home™ Drug Screening Test Cups
Common Name:
Amphetamine Test System Methamphetamine Test System Cocaine Test System Barbiturate Test System Benzodiazepine 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 Tricyclic Antidepressant Test System
Product Code: DKZ, DIO, DIS, JXM, DJC, DJR, DJG, LCM, LDJ, LFG
1
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 |
1
CFR 21 § 862.3870
CFR 21 § 862.3910 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)
Product Description:
UCP Home Drug Screening Test Cups are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Benzodiapines, Cocaines, Marijuana, Methamphetamine, MDMA, Methadone, Opiates, Opiates 300, Oxycodone, Phencyclidine, 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 Cups:
UCP Home™ Drug Screening Test 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 |
| Opiate 300: | Morphine | 300 ng/mL |
| Phencyclidine: | Phencyclidine | 25 ng/mL |
| Barbiturares: | Secobarbital | 300 ng/mL |
| Benzodiazepines: | Oxazepam | 300 ng/mL |
| Methadone: | Methadone | 300 ng/mL |
| Oxycodone: | Oxycodone | 100 ng/mL |
| MDMA: | MDMA | 500 ng/mL |
| Tricyclic Antidepressants: | Nortriptyline | 1000 ng/mL |
2
2
- 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 tests will yield preliminary positive results when the prescription drugs Barbiturates. Benzodiazepines, Oxycodone, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, 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 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 For In Vitro Diagnostics only
Comparison to Predicate Devices:
When compared to the predicates, UCP Home Drug Screening Test Cups can qualitatively detect Amphetamine, Barbiturates, Benzodiazepine, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opaites 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. UCP Home Drug Screening Test Cups can hold up to three drug tests per strip, whereas the predicates contain one drug test pre strip.
Safety and Effectiveness Data:
Accuracy Studies:
The study design and protocol in the comparison study of using a series of patient specimens is the same as that described in K072062, K091588, K110515. The performance of the candidate devices was compared to the predicate devices in K072062, K091588 and k 110515 by using the clinical samples. Total·120 clinical urine samples per one drug test were included in the comparison study. The clinical samples were obtained from the reference laboratories, all clinical urine samples including drug negative urine samples
3
3
and drug positive urine samples were tested by the reference method GC/MS, except TCA. The TCA positive urine samples were tested by HPLC method. For each drug test. 10% clinical samples contain drug concentrations between 50% below the cutoff level and the cutoff level, other 10 % clinical urine samples contain drug concentrations between the cutoff level and 50% above the cutoff level. The testing results have demonstrated that 100% agreements between the candidate device and the predicate device, over 97.5% agreement between the candidate devices and the reference method GC/MS in the comparison study by using clinical urine specimens
Consumer Studies
The study design and protocol in the consumer study of UCP Home Drug Screening Test Cup is the same as that described in K091588, K110515, was conducted among 115 lay persons in three geographic regions. Fifty eight females and fifty seven males from ages between 18 and 77 years have participated the study. Fifty eight participants had high school education or less, fifty seven 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 Test Cups 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 Test Cups 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 Cup performs satisfactorily when used according to the package inserts.
Conclusion:
4
The performance data in this submission supports UCP Home™ Drug Screening Trest
Cups are substantially equivalent to the predicate devices UCP Home™ Drug Screening
Test Cards
.
5
5
DEPARTMENT OF HEALTH & HUM AN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an eagle or bird in flight, with three curved lines representing its wings and tail. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 30, 2012
UCP Biosciences, Inc. c/o Dr. Nancy Chen 1445 Koll Circle, Ste 111 San Jose, CA 95014
Re: K122419 Trade/Device Name: UCP Home Drug Screening Test Cups
Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Code: DKZ, DIS, JXM, DIO, DJC, DJR, DJG, LCM, LDJ, LFG Dated: November 2, 2012 Received: November 6, 2012
Dear Dr. 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.
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
6
Page 2 - Dr. Nancy Chen
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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 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/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benson 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
7
Indications for Use
510(k) Number (if known): K122419
Device Name: UCP Home Drug Screening Test Cups
Indications for Use:
The UCP Home Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays for the detection 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 |
| 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 |
| Tricyclic Antidepressant | Nortiptyline | 1000 ng/mL |
The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is 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. 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 health care professional users.
(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 Brumley
Division Sign-Office of In Vitro Diagnostics and Radiological Health
510(k)
8
The tests will yield preliminary positive results when the prescription drugs Barbiturates, Benzodiazepines, Oxycodone, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Oxycodone, 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 _ Y (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use Y (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 Ohnantyles
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) | 122419