(178 days)
No
The device description and performance studies indicate a lateral flow immunochromatographic assay, which is a chemical-based test, not one that utilizes AI/ML for analysis or interpretation. There is no mention of AI, ML, or related concepts in the document.
No.
This device is designed for the detection of drugs in human urine, providing information about the presence or absence of certain substances. It is intended for diagnostic purposes (in vitro diagnostics) rather than for treating or preventing disease.
Yes
The device is a rapid test for the preliminary detection of drugs in human urine, which provides information concerning the presence or absence of specific substances to assist in a diagnosis. The "Intended Use / Indications for Use" section explicitly states "For In Vitro Diagnostics only."
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:
- Explicitly Stated: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostics only".
- Definition of IVD: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases, conditions, or infections. This device performs tests on human urine to detect the presence of various drugs.
- Purpose: The device is intended to provide information about the presence or absence of drugs in a urine sample, which is a diagnostic purpose.
- Sample Type: The device uses human urine as the sample, which is a common sample type for IVD testing.
- Testing Method: The device uses immunochromatographic assays, which is a common method used in IVD tests.
Therefore, based on the provided information, the UCP Multi-Drug Test Key Cups meet the criteria for an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The UCP Multi-Drug Test Key Cups are rapid tests for preliminary detection of the following drugs in human urine:
| Test | Calibrated to | 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 | Nortriptyline | 1000 ng/mL |
The test configuration comes with a 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 in a urine sample. The second step is to send preliminary positive samples for confirmation testing by GCMS.
The test is not intended to distinguish between prescription use or abuse of the following drugs: Barbiturates, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressants.
There are no uniformly recognized cutoff concentration levels for Barbiturate, Benzodiazepines, Buprenorphine, Oxycodone, Propxyphene, Tricyclic Antidepressant in urine.
Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated.
For Over-The-Counter (OTC) use For In Vitro Diagnostics only
Product codes
DKZ, DIQ, DIS, JXM, DJC, DJR, DJG, LCM, LDJ, LFG, JXN
Device Description
UCP Multi-Drug Test Key Cups 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 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) 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
Accuracy Studies: Total 80 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, at least 10% clinical samples contain drug concentrations between 50% below the cutoff level and the cutoff level, and at least 10 % clinical urine samples contain drug concentrations between the cutoff level and 50% above the cutoff level.
Consumer Studies: The study 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. K122419. K130463, K131811. The performance of the candidate devices was compared to the predicate devices in K130463 by using the clinical samples. Total 80 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, at least 10% clinical samples contain drug concentrations between 50% below the cutoff level and the cutoff level, and at least 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 Multi-Drug Test Key Cups is the same as that described in K091588, K110515, K122419, K130463, K131811 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 Multi-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 Multi-Drug Test Key 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 Multi-Drug Test Key Cups performs satisfactorily when used according to the package inserts.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy Study: 100% agreements between the candidate device and the predicate device, over 97.5% agreement between the candidate devices and the reference method GC/MS.
Consumer Studies: 97% or above agreement rate with GC/MS results.
Predicate Device(s)
UCP Home™ Drug Screening Test Cups (K130463)
Reference Device(s)
K072062, K091588, K110515, K122419, K130463, K131811
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 K132812
UCP Biosciences. Inc Submitter: 1445 Koll Circle, Ste 111 San Jose, CA 95014 Tel: 408-392-0064 Fax: 408-392-0163
Date: February 25, 2014
Contact Person: Dr. Nancy Chen
Trade Name: UCP Multi-Drug Test Key Cups
Amphetamine Test System
Common Name:
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) Unclassified Test System (Enzyme Immunoassay Phencyclidine) Cannabinoid Test System Propoxyphene Test System Tricyclic Antidepressant Test System
Product Code: DKZ, DIQ, 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 |
1
CFR 21 § 862.3650 CFR 21 § 862.3870 CFR 21 § 862.3910 CFR 21 § 862.3700 Unclassified, Enzyme immunoassay, Phencyclidine
Toxicology (91) Panel:
Device Classification: II
Substantially Equivalent Devices:
UCP Home™ Drug Screening Test Cups (K130463)
Product Description:
UCP Multi-Drug Test Key Cups 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 at the cut-off levels as indicated. The tests can be performed without the use of an instrument.
Indications For Use:
UCP Multi-Drug Test Key Cups:
The UCP Multi-Drug Test Key Cups are rapid tests for preliminary detection of the following drugs in human urine:
| Test | Calibrated to | 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 |
2
| Phencyclidine | Phencyclidine | 25 ng/mL |
|---|---|---|
| Propoxyphene | Propoxyphene | 300 ng/mL |
| Tricyclic Antidepressant | Nortriptyline | 1000 ng/mL |
The test configuration comes with a 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 in a urine sample. The second step is to send preliminary positive samples for confirmation testing by GCMS.
The test is not intended to distinguish between prescription use or abuse of the following drugs: Barbiturates, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressants .
There are no uniformly recognized cutoff concentration levels for Barbiturate, Benzodiazepines, Buprenorphine, Oxycodone, Propxyphene, Tricyclic Antidepressant in urine.
Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated.
For Over-The-Counter (OTC) use For In Vitro Diagnostics only
Comparison to Predicate Devices:
When compared to the predicates, UCP Multi-Drug Test Key Cups can qualitatively detect Amphetamine, Barbiturates, Benzodiazepine, Buprenorphine, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opaites 2000, Oxycodone, Phencyclidine. Propoxyphene, Tricyclic Antidepressant 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 prescription use and for OTC consumers use. UCP Multi-Drug Test Key Cups are required a key to activate the tests, whereas the tests in the predicates can be automatically activated while urine specimen is applied into the test cup without requiring a key.
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. K122419. K130463, K131811. The performance of the candidate devices was compared to the
3
predicate devices in K130463 by using the clinical samples. Total 80 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, at least 10% clinical samples contain drug concentrations between 50% below the cutoff level and the cutoff level, and at least 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 Multi-Drug Test Key Cups is the same as that described in K091588, K110515, K122419, K130463, K131811 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 Multi-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 Multi-Drug Test Key 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 Multi-Drug Test Key Cups performs satisfactorily when used according to the package inserts.
4
Conclusion:
.
. "
The performance data in this submission supports UCP Multi-Drug Test Key Cups are
substantially equivalent to the predicate devices UCP Home™ Drug Screening Test Cups (K130463).
.
.
5
Image /page/5/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 representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 6, 2014
UCP BIOSCIENCES. INC. NANCY CHEN 1445 KOLL CIRCLE, STE. 111 SAN JOSE CA 95112
Re: K132812
Trade/Device Name: UCP Multi-Drug Test Key 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: February 18, 2014 Received: February 19, 2014
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Parts 801 and 809): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
6
Page 2-Dr. Chen
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Courtney
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
510{k} Number (if known) K132812
Device Name
UCP Multi-Drug Test Key Cups
Indications for Use (Describe)
The UCP Multi-Drug Test Key Cups are rapid tests for preliminary detection of the following drugs in human urine:
| Test | Calibrated to | 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 | Nortriptyline | 1000 ng/mL |
The test configuration comes with a 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 process to provide consumers with information concerning the presence or absence of the above stated drugs in a urine sample. The second step is to send preliminary positive samples for confirmation testing by GCMS.
The test is not intended to distinguish between prescription use or abuse of the following drugs: Barbiturates, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressants .
There are no uniformly recognized cutoff concentration levels for Barbiturate, Buprenorphine, Oxyodone, Propxyphene, Tricyclic Antidepressant in urine.
Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017 See PRA Statement on last page.
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)
Avis T. Danishefsky -S
FORM FDA 3881 (1/14)
..
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