(107 days)
Not Found
No
The device description indicates a simple lateral flow immunoassay that does not require an instrument for interpretation. There is no mention of AI or ML in the provided text.
No.
This device is an in-vitro diagnostic test used to detect the presence of drugs and their metabolites in human urine. It is not designed to treat, cure, prevent, or mitigate any disease or condition.
Yes
Explanation: The device is designed to detect the presence or absence of various drugs and their metabolites in human urine, which is a rapid, qualitative, competitive binding immunoassay. This is a characteristic of a diagnostic device, even though it provides preliminary results and requires confirmation 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, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for detecting drugs and their metabolites in human urine. This is a biological sample taken from the human body.
- Device Description: The device is described as an "immunochromatographic assay" for the "qualitative detection" of specific substances in urine. This is a common method used in IVD tests.
- Anatomical Site: The specified anatomical site is "human urine," which is a biological specimen.
- Performance Studies: The document mentions "Analytical performance" and "verification studies" conducted to establish the device's performance. This is typical for IVD devices undergoing regulatory review.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K130463) strongly indicates that this device is being compared to a previously cleared IVD device.
The definition of an IVD generally includes devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic purposes. While this device provides "preliminary data" and is the "first step in a two step process," it is still performing an in vitro test on a human specimen to provide information about the presence of substances in the body, which falls under the scope of IVD.
N/A
Intended Use / Indications for Use
The UCP Drug Test Mini Cups are rapid, qualitative, competitive binding immunoassays for 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 | 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 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 - the second step in the process, along with the materials for shipping the urine speciment 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, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Buprenorphine, 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.
Product codes
DKZ, DIO, DIS, JXM, DJC, DJR, DJG, LCM, LDJ, LFG, JXN
Device Description
UCP Drug Test Mini Cups is competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Benzodiapines, Buprenorphine, Cocaines, 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For Over-The-Counter (OTC) use For In Vitro Diagnostics only
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
Analytical performance was established in the predicate submission. In addition, verification studies were conducted in support of the modification - a smaller size test cup, including the precision study, inter lots reproducibility study, sensitivity study, pH and specific gravity study, accuracy study and the lay users study. The results have demonstrated that UCP Drug Test Mini Cups performs satisfactorily when used according to the package inserts.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
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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 three human profiles facing to the right, with flowing lines extending from the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2015
UCP BIOSCIENCES, INC NANCY CHEN 1445 KOLL CIRCLE, STE 111 SAN JOSE CA 95112
Re: K151213
Trade/Device Name: UCP Drug Test Mini 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: July 22, 2015 Received: July 23, 2015
Dear Nancy 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
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Indications for Use
510(k) Number (if known) K151213
Device Name
UCP Drug Test Mini Cups
Indications for Use (Describe)
The UCP Drug Test Mini Cups are rapid, qualitative, competitive binding immunoassays for 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 | 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 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 - the second step in the process, along with the materials for shipping the urine speciment 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, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Buprenorphine, 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.
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)
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)
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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 K151213
Submitter: UCP Biosciences, Inc 1445 Koll Circle, Ste 111 San Jose, CA 95014 Tel: 408-392-0064 Fax: 408-392-0163
-
- Date the summary was prepare: July 8, 2015
-
- Submitter's Name: UCP Biosciences, Inc
-
- Submitter's Address: 1445 Koll Circle, STE 111, San Jose, CA 95112
-
- Name of the Device:
Trade Name: UCP Drug Test Mini 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 |
-
- Classification
Product Code: DKZ, DIO, DIS, JXM, DJC, DJR, DJG, LCM, LDJ, LFG, JXN
- Classification
Regulation Section:
CFR 21 § 862.3100 CFR 21 § 862.3150
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CFR 21 § 862.3170 CFR 21 § 862.3250 CFR 21 § 862.3610 CFR 21 § 862.3620 CFR 21 § 862.3650 CFR 21 § 862.3870 CFR 21 § 862.3910 CFR 21 § 862.3700 Unclassified, Enzyme immunoassay, Phencyclidine
Panel: Toxicology (91)
Device Classification: II
6. Description of the Device:
UCP Drug Test Mini Cups is competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Benzodiapines, Buprenorphine, Cocaines, 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.
7. Test Principle:
UCP Drug Test Mini Cups is competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of drugs and their metabolites at the designed cutoff levels in human urine.
8. Intended Use:
UCP Drug Test Mini 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 |
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| Buprenorphine | Buprenorphine | 10 ng/mL |
|---|---|---|
| Methadone: | Methadone | 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 also is 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 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
9. Comparison to Predicate Devices:
When compared to the predicates, UCP Drug Test Mini Cups can qualitatively detect Amphetamine, Barbiturates, Benzodiazepine, Buprenorphine, Cocaine, Marijuana, Methadone, 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. Only modification was made in the modified device is the test cup has a smaller dimension.
10. Performance Characteristics:
The test strips of the candidate device are the same as those cleared with the predicate device. Drug cutoffs of the candidate devices are also identical to the predicate devices. Analytical performance was established in the predicate submission. In addition, verification studies were conducted in support of the modification - a smaller size test
7
cup, including the precision study, inter lots reproducibility study, sensitivity study, pH and specific gravity study, accuracy study and the lay users study. The results have demonstrated that UCP Drug Test Mini Cups performs satisfactorily when used according to the package inserts.
11. Conclusion:
Based on the test principle and acceptable performance characteristics, it is concluded that the candidate device is substantially equivalent to the predicate in K130463.