(88 days)
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No
The device description and performance studies indicate a standard immunochromatographic assay without any mention of AI or ML components.
No
The device is described as a rapid, qualitative, competitive binding immunoassay for the detection of drugs and their metabolites in human urine. Its intended use is for screening and providing preliminary data, not for monitoring drug levels or for therapeutic purposes.
Yes.
The device is described as a "rapid, qualitative, competitive binding immunoassay for the detection of Tricyclic Antidepressants, Propoxyphene and their metabolites in human urine," which indicates it is used to identify the presence of specific substances in the body, a key function of diagnostic devices.
No
The device description explicitly states it is a lateral flow immunochromatographic assay that can be performed without 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 clearly states that the tests are for the detection of substances (Tricyclic Antidepressants and Propoxyphene) in a human specimen (urine). This is a core characteristic of an IVD.
- Device Description: The description details a "competitive binding, lateral flow immunochromatographic assay" for "qualitatively the detection" of these substances in human urine. This describes a method used to analyze a biological sample in vitro (outside the body).
- Anatomical Site: The specimen is human urine, which is a biological sample collected from the body for analysis.
- Performance Studies: The document describes clinical comparison studies using clinical urine specimens, further indicating that the device is used to test biological samples.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. This device fits that definition.
N/A
Intended Use / Indications for Use
The UCP Rapid TM Drug Screening Tricyclic Antidepressant Test and UCP Rapid™ Drug Screening Propoxyphene Test are rapid, qualitative, competitive binding immunoassays for the detection of Tricyclic Antidepressants, Propoxyphene and their metabolites in human urine at the following cutoff levels:
Test Calibrator Cut-off
Tricyclic Antidepressant Nortriptyline 1000 ng/mL
Propoxyphene Propoxyphene 300 ng/mL
The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). The test configuration comes with either single drug test or in combination with multiple other drug tests. 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 (comma separated list FDA assigned to the subject device)
AFG, JXN, LFG
Device Description
UCP Rapid 100 Drug Screening Tricyclic Antidepressant, Propoxyphene Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Tricyclic Antidepressant, Propoxyphene 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
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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
A clinical comparison study was conducted using 128 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. The study was compared the test results between UCP RapidTM Drug Screening Tricyclic Antidepressant Tests with ACON TCA One Step Tricyclic Antidepressant Tests, UCP Rapid 110 Drug Screening Propoxyphene Test with Instant-View® Propoxyphene Urine test. Total 64 positive clinical urine specimens and 64 negative clinical urine specimens were tested against each drug. All test results were confirmed with HPLC or GC/MS analysis.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A clinical comparison study was conducted using 128 clinical urine specimens per each drug. UCP Rapid11M Drug Screening Tricyclic Antidepressant Test and UCP Rapid™ Drug Screening Propoxyphene Test demonstrated performance of ≥ 98% for all drugs when performance was compared to a legally marketed device and HPLC or GC/MS. The performance characteristics of UCP Rapid™ Drug Screening Tricyclic Antidepressant Test, UCP Rapid™ Drug Screening Propoxyphene Test was evaluated by precision study, sensitivity study, specificity and cross reactivity study, interference study and stability study. The study results indicate that UCP Rapid 100 Drug Screening Tricyclic Antidepressant Test, UCP Rapid 100 Drug Screening Propoxyphene Test performs satisfactorily when used according to the package inserts.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
performance of ≥ 98%
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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§ 862.3910 Tricyclic antidepressant drugs test system.
(a)
Identification. A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.(b)
Classification. Class II (special controls). A tricyclic antidepressant drugs 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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510(K) Submission for UCP Rapid™ Drug Screening TCA, PPX Tests
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 K061457
Submitter:
UCP Biosciences, Inc 1445 Koll Circle, Ste 111 San Jose, CA 95014 Tel: 408-392-0064 Fax: 408-392-0163
Date:
May 22, 2006
Contact Person:
Dr. Nancy Chen
Trade Name:
UCP Rapid TM Drug Screening Tricyclic Antidepressant Test Strips UCP Rapid™ Drug Screening Tricyclic Antidepressant Test Devices UCP Rapid™ Drug Screening Propoxyphene Test Strips UCP Rapid™ Drug Screening Propoxyphene Test Devices
Common Name:
Tricyclic Antidepressant Test System Propoxyphene Test System
Product Code:
AFG (Tricyclic Antidepressant Test System) JXN (Propoxyphene Test System)
Regulation Section:
21 CFR 8628 3910 21 CFR 862§3700
Panel: Toxicology (91)
PROPRIETARY INFORMATION
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510(K) Submission for UCP Rapid™ Drug Screening TCA, PPX Tests
Device Classification: II
Substantially Equivalent Devices:
ACON TCA One Step Tricyclic Antidepressant Test Manufactured by ACON Laboratories
Instant - View® Propoxyphene (PPX) Urine Test Manufactured by Alfa Scientific Designs, Inc
Product Description:
UCP Rapid 100 Drug Screening Tricyclic Antidepressant, Propoxyphene Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Tricyclic Antidepressant, Propoxyphene and their metabolites at the cut-off levels as indicated. The tests can be performed without the use of an instrument.
Intended Use:
UCP Rapid "" Drug Screening Tricyclic Antidepressant, Propoxyphene Test are rapid, qualitative, competitive binding immunoassays and intended for qualitatively the detection Tricyclic Antidepressant, Propoxyphene and their metabolites in human urine at the following cut-off concentrations:
| Tricyclic Antidepressant | 1000 ng/mL |
|---|---|
| Propoxyphene | 300 ng/mL |
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 drugs levels.
Comparison to Predicate Devices:
When compared to the predicates, UCP Rapid™ Drug Screening Tricyclic Antidepressant and Propoxyphene 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
PROPRIETARY INFORMATION PAGE A STATE
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Image /page/2/Picture/0 description: The image shows a logo for UCP Biosciences. The letters "UCP" are stacked on top of each other and enclosed in an oval. Below the oval, the word "Biosciences" is written in a simple, sans-serif font. The logo is black and white.
510(K) Submission for UCP Rapid™ Drug Screening TCA, PPX Tests
A clinical comparison study was conducted using 128 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. The study was compared the test results between UCP RapidTM Drug Screening Tricyclic Antidepressant Tests with ACON TCA One Step Tricyclic Antidepressant Tests, UCP Rapid 110 Drug Screening Propoxyphene Test with Instant-View® Propoxyphene Urine test. Total 64 positive clinical urine specimens and 64 negative clinical urine specimens were tested against each drug. All test results were confirmed with HPLC or GC/MS analysis. UCP Rapid11M Drug Screening Tricyclic Antidepressant Test and UCP Rapid™ Drug Screening Propoxyphene Test demonstrated performance of ≥ 98% for all drugs when performance was compared to a legally marketed device and HPLC or GC/MS.
Other Information about Performance Characteristics:
The performance characteristics of UCP Rapid™ Drug Screening Tricyclic Antidepressant Test, UCP Rapid™ Drug Screening Propoxyphene Test was evaluated by precision study, sensitivity study, specificity and cross reactivity study, interference study and stability study. The study results indicate that UCP Rapid 100 Drug Screening Tricyclic Antidepressant Test, UCP Rapid 100 Drug Screening Propoxyphene Test performs satisfactorily when used according to the package inserts.
Conclusion:
UCP Rapid™ Drug Screening Tricyclic Antidepressant Test is substantially equivalent to ACON TCA One Step Tricyclic Antidepressant Test, UCP Rapid™ Drug Screening Propoxyphene Test is substantially equivalent to Instant-View® Propoxyphene (PPX) Urine Test.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Nancy Chen UCP Biosciences, Inc. 1445 Koll Circle, Suite 111 San Jose, CA 95112
AUG 2 1 2006
Re: K061457
Trade/Device Name: UCP Rapid™ Drug Screening Tricyclic Antidepressant Test UCP Rapid™ Drug Screening Propoxyphene Test Regulation Number: 21 CFR 8862.3910 Regulation Name: Tricyclic antidepressant drugs test system Regulatory Class: Class II Product Code: LFG, JXN Dated: August 10, 2006 Received: August 11, 2006
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Garcia
Alberto Gutierrez, 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): K061457
Device Name: UCP Rapid™ Drug Screening Tricyclic Antidepressant Test UCP Rapid™ Drug Screening Propoxyphene Test
Indications For Use:
The UCP Rapid TM Drug Screening Tricyclic Antidepressant Test and UCP Rapid™ Drug Screening Propoxyphene Test are rapid, qualitative, competitive binding immunoassays for the detection of Tricyclic Antidepressants, Propoxyphene and their metabolites in human urine at the following cutoff levels:
Test
Tricyclic Antidepressant Propoxyphene
Calibrator Nortriptyline Propoxyphene
Cut-off 1000 ng/mL 300 ng/mL
The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). The test configuration comes with either single drug test or in combination with multiple other drug tests. 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 _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D)
(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
Page 40 of 62
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K061457