(88 days)
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.
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.
Acceptance Criteria and Study for UCP Rapid™ Drug Screening TCA, PPX Tests
This response describes the acceptance criteria and the study conducted to demonstrate the device meets these criteria, based on the provided 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each drug screening test were set against established predicate devices and confirmed by gold standard methods. The reported performance refers to the accuracy demonstrated in the clinical comparison study.
| Test (Drug) | Cut-off Concentration | Acceptance Criteria (Accuracy) | Reported Device Performance (Accuracy) |
|---|---|---|---|
| Tricyclic Antidepressant (TCA) | 1000 ng/mL | ≥ 98% (vs. predicate & GC/MS) | ≥ 98% |
| Propoxyphene (PPX) | 300 ng/mL | ≥ 98% (vs. predicate & GC/MS) | ≥ 98% |
Note: The document explicitly states the "performance of ≥ 98% for all drugs when performance was compared to a legally marketed device and HPLC or GC/MS."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 128 clinical urine specimens per drug.
- This included approximately 10% of specimens with the target drug at concentrations between -50% of the cut-off and the cut-off.
- Another 10% of specimens contained the target drug at concentrations between the cut-off and +50% of the cut-off.
- Total 64 positive clinical urine specimens and 64 negative clinical urine specimens were tested against each drug.
- Data Provenance: The document does not explicitly state the country of origin. It describes them as "clinical urine specimens." The study is described as a "clinical comparison study," implying prospective collection for the study purpose or retrospective use of clinically collected samples. Without more detail, it's hard to definitively state prospective or retrospective, but the phrasing suggests a dedicated collection or selection process for the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The establishment of ground truth for the test set did not involve human experts in the traditional sense (e.g., radiologists interpreting images). Instead, the ground truth was established by laboratory analytical methods.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by objective laboratory analytical methods (HPLC or GC/MS), not by expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic test for qualitative detection of drugs in urine, not an imaging device requiring human reader interpretation or AI assistance for human readers.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done. The "UCP Rapid™ Drug Screening Tricyclic Antidepressant Test" and "UCP Rapid™ Drug Screening Propoxyphene Test" are described as competitive binding, lateral flow immunochromatographic assays that "can be performed without the use of an instrument" and provide "visual, qualitative end results." The accuracy study directly assesses the performance of these devices in isolation against predicate devices and analytical gold standards.
7. Type of Ground Truth Used
The type of ground truth used was objective laboratory analytical methods:
- High-Performance Liquid Chromatography (HPLC)
- Gas Chromatography/Mass Spectrometry (GC/MS)
All test results from the UCP Rapid™ devices and the predicate devices were "confirmed with HPLC or GC/MS analysis."
8. Sample Size for the Training Set
The document does not specify a separate "training set" sample size. This type of device (lateral flow immunoassay) typically does not involve machine learning algorithms that require a distinct training phase with a labeled dataset in the same way modern AI algorithms do. The development and optimization of such assays rely on biochemical principles, antibody-antigen binding characteristics, and extensive experimental validation, rather than algorithmic training on a dataset. The performance data presented is for validation, not for training.
9. How the Ground Truth for the Training Set Was Established
As there is no explicitly defined "training set" in the context of an AI/machine learning algorithm for this device, the concept of establishing ground truth for a training set does not apply directly. The development of the assay would have involved extensive R&D and optimization using various known concentrations of analytes, where the "ground truth" (i.e., the known concentration and presence/absence of the drug) would be intrinsically understood and controlled during the development process.
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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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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
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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
§ 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).