(266 days)
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No
The device description and performance studies indicate a simple lateral flow immunoassay that provides a qualitative result without the need for an instrument or complex data analysis. There is no mention of AI, ML, or any form of computational learning or decision-making process.
No
This device is for in vitro diagnostic use, specifically for drug screening in human urine, and is not described as providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The test is intended for in vitro diagnostics use."
No
The device description explicitly states it comes in three formats: Test Card/Strip, Test Device, and Test Cup, which are physical hardware components for performing the immunoassay. It also mentions it can be performed without an instrument, further indicating it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The test is intended for in vitro diagnostics use."
- Nature of the Test: The device performs a qualitative immunoassay on human urine, which is a biological specimen. This is a hallmark of in vitro diagnostic testing.
- Purpose: The purpose is to detect the presence of specific drugs in the urine, providing a preliminary analytical result for diagnostic purposes (screening for drug use).
- Comparison to Confirmatory Methods: The document mentions that a more specific alternate chemical method (GC/MS or LC/MS) must be used for confirmation, which is standard practice for IVD screening tests.
- Intended User: The test is for "professional use only," indicating it's intended for use in a healthcare or laboratory setting, typical for IVDs.
N/A
Intended Use / Indications for Use
UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests are rapid, qualitative, competitive binding immunoassays and intended for qualitatively the detection of Buprenorphine, Amphetamine, Methamphetamine, Cocaine and their metabolites in human urine at the following cut-off concentrations:
| Buprenorphine | 10 ng/mL |
|---|---|
| Amphetamine | 300 ng/mL |
| Methamphetamine | 500 ng/mL |
| Cocaine | 150 ng/mL |
The tests provide only preliminary test results, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS) or liquid chromatography/mass spectrometry (LC/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 drugs levels.
For professional use only For In Vitro Diagnostics only
Product codes (comma separated list FDA assigned to the subject device)
DJG, DKZ, LAF, DIO
Device Description
UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Buprenorphine, Amphetamine, Methamphetamine, Cocaine and their metabolites at the cut-off levels as indicated. The tests can be performed without the use of an instrument.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
For professional use only
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A clinical comparison study was conducted using 80 clinical urine specimens per each drug including approximately 10% of the specimens containing one type drug at concentrations between -50% cutoff to cutoff ranges, another 10% of the specimens containing one type drug at concentrations between cutoffs to +50% cutoff ranges at the point of care sites. The study was compared the test results between UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Test with GC/MS or LC/MS analysis and the predicate devices. UCP Drug Screening Buprenorphine, AMP 300, mAMP 500 and COC 150 Test demonstrated performance of >= 97% for all drugs when performance was compared to a legally marketed device and GC/MS or LC/MS.
The performance characteristics of UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests were evaluated by precision study, sensitivity study, specificity and cross reactivity study, interference study and stability study. The study results indicate that UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests performs satisfactorily when used according to the package inserts.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Performance >= 97% for all drugs.
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.
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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.
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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).
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§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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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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 K091612
FEB 2 4 2010
Submitter:
UCP Biosciences, Inc 1445 Koll Circle, Ste 111 San Jose, CA 95014 Tel: 408-392-0064 Fax: 408-392-0163
Date:
May 28, 2009
Contact Person:
Dr. Nancy Chen
Trade Name:
UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests
Common Name:
Buprenorphine Test System Amphetamine Test System Methamphetamine Test System Cocaine Test System
Product Code:
DJG, DKZ, LAF, DIO
Regulation Section:
| CFR 21 § 862.3650 |
|---|
| CFR 21 § 862.3100 |
| CFR 21 § 862.3610 |
| CFR 21 § 862.3250 |
Toxicology (91) Panel:
Device Classification: II
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Substantially Equivalent Devices:
ACON BUP One Step Buprenorphine Test Strip ACON BUP One Step Buprenorphine Test Device
ACON AMP-300 One Step Amphetamine Test Strip ACON AMP-300 One Step Amphetamine Test Device
ACON mAMP-500 One Step Methamphetamine Test Strip ACON mAMP-500 One Step Methamphetamine Test Device
ACON COC-150 One Step Cocaine Test Strip ACON COC-150 One Step Cocaine Test Device
Product Description:
UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Buprenorphine, Amphetamine, Methamphetamine, Cocaine and their metabolites at the cut-off levels as indicated. The tests can be performed without the use of an instrument.
Intended Use:
UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests are rapid, qualitative, competitive binding immunoassays and intended for qualitatively the detection of Buprenorphine, Amphetamine, Methamphetamine, Cocaine and their metabolites in human urine at the following cut-off concentrations:
| Buprenorphine | 10 ng/mL |
|---|---|
| Amphetamine | 300 ng/mL |
| Methamphetamine | 500 ng/mL |
| Cocaine | 150 ng/mL |
The tests provide only preliminary test results, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS) or liquid chromatography/mass spectrometry (LC/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 drugs levels.
For professional use only For In Vitro Diagnostics only
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Comparison to Predicate Devices:
When compared to the predicates. UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests provide the qualitative determination of the same drugs in the same matrix, and utilizes the same cutoff concentrations. Both tests 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.
Safety and Effectiveness Data:
Accuracy
A clinical comparison study was conducted using 80 clinical urine specimens per each drug including approximately 10% of the specimens containing one type drug at concentrations between -50% cutoff to cutoff ranges, another 10% of the specimens containing one type drug at concentrations between cutoffs to +50% cutoff ranges at the point of care sites. The study was compared the test results between UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Test with GC/MS or LC/MS analysis and the predicate devices. UCP Drug Screening Buprenorphine, AMP 300, mAMP 500 and COC 150 Test demonstrated performance of ≥ 97% for all drugs when performance was compared to a legally marketed device and GC/MS or LC/MS.
Other Information about Performance Characteristics:
The performance characteristics of UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests were evaluated by precision study, sensitivity study, specificity and cross reactivity study, interference study and stability study. The study results indicate that UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests performs satisfactorily when used according to the package inserts.
Conclusion:
UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests are substantially equivalent to ACON BUP One Step Buprenorphine Test, ACON AMP-300 One Step Amphtamine Test, ACON mAMP-500 One Step Methamphtamine Test, ACON COC-150 One Step Cocaine Test.
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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
UCP Biosciences Inc. c/o Nancy Chen 1445 Koll Circle Suite 111 San Jose, CA 95112
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
FEB 2 4 2010
Re: K091612
Trade Name: UCP Rapid Drug Screening BUP, AMP 300, mAMP 500 and Cocaine 150 Tests Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Codes: DKZ, DJG, LAF, DIO Dated: January 25, 2010 Received: January 27, 2010
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket. surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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/Reportalroblem/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 tollofme number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Signature
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K091612
Device Name: UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests,
Indications For Use:
The UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests are rapid, qualitative, competitive binding immunoassays for the detection the following drug in human urine:
| Test | Calibrator | Cut-off |
|---|---|---|
| Buprenorphine | Buprenorphine | 10 ng/mL |
| Amphetamine | D-Amphetamine | 300 ng/mL |
| Methamphetamine | D-Methamphetamine | 500 ng/mL |
| Cocaine | Benzoylecgonine | 150 ng/mL |
The tests contain three formats: 1) Test Card/Strip; 2) Test Device, 3) Test Cup. The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use.
The tests only provide a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or Liguid chromatography/mass spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration 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 drug levels.
Prescription Ues × AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
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Office of In Vito Diagnostic Device Evaluation and Safety
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