(58 days)
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No
The device description and performance studies indicate a simple lateral flow immunoassay, which does not involve AI or ML. The analysis relies on chemical reactions and visual interpretation, not algorithmic processing of data.
No.
This device is a diagnostic tool used for screening drugs in human urine, not for providing therapy or treatment.
Yes
Explanation: The device is described as a "rapid, qualitative, competitive binding immunoassay for the detection of... metabolites in human urine." It provides preliminary data for the detection of substances in the human body, which is a diagnostic function.
No
The device description explicitly states it is a "lateral flow immunochromatographic assay" and can be performed "without the use of an instrument," indicating it is a physical test strip/device, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "detection of Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Methamphetamine, MDMA, Opiates, Methadone, Oxycodone, Phencyclidine, Marijuana and their metabolites in human urine." This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide information about a person's health status (presence of drugs).
- Device Description: The device is described as a "competitive binding, lateral flow immunochromatographic assay." These types of assays are commonly used in IVD tests to detect specific substances in biological samples.
- Performance Studies: The document describes clinical comparison studies using "clinical specimens" (human urine) to evaluate the device's performance. This is a standard practice for validating IVD devices.
- Predicate Device: The mention of a "Predicate Device(s)" (ACON One Step Drugs of Abuse Tests) is a strong indicator that this device is being compared to another legally marketed IVD device for regulatory purposes.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The UCP Rapid TM Drug Screening Tests are rapid, qualitative, competitive binding immunoassays and intended for qualitatively the detection of Amphetamine, Barbiturate, Cocaine, Methamphetamine, MDMA, Opiates, Methadone, Oxycodone, Phencyclidine, Marijuana (THC) and their metabolites in human urine at the following cut-off concentrations: Amphetamine 1000 ng/mL Barbiturates 300 ng/mL Benzodiazepine 300 ng/mL 300 ng/mL Cocaine 1000 ng/mL Methamphetamine 300 ng/mL Methadone 500 ng/mL MDMA 300 ng/mL Opiates300 2000 ng/mL Opiates 2000 100 ng/mL Oxycodone 25 ng/mL Phencvclidine 50 ng/mL Cannabinoids The tests provide only preliminary test results, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical other methous 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.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DIS, JXM, DIO, DJC, DJC, DMB, DJG, DJG, LCM, LDJ
Device Description
UCP Rapid TM Drug Screening Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of drugs 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 specimens per each drug type 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 Rapid™ Drug Screening Tests with ACON One Step Drugs of Abuse Tests. Total 64 positive clinical urine specimens and 64 negative clinical urine specimens were tested against each drug. All test results were confirmed with GC/MS analysis.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy: A clinical comparison study was conducted using 128 clinical specimens per each drug type. UCP Rapid™ Drug Screening Tests demonstrated performance of > 96% for all drugs when performance was compared to a legally marketed device and GC/MS.
Other Performance Characteristics: The performance characteristics of UCP Rapid™ Drug Screening Tests was evaluated by precision study, sensitivity study, specificity and cross reactivity study, interference study and stability study. The study results indicate that UCP Rapid™ Drug Screening Tests perform satisfactorily when used according to the package inserts.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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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§ 862.3100 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/0 description: The image shows the logo for UCP Biosciences. The logo consists of the letters "UCP" in a bold, sans-serif font, enclosed within an oval shape. Below the oval, the word "Biosciences" is written in a smaller, sans-serif font.
APR 2 9 2005
510(K) Submission for
UCP Rapid ™ Drug Screening Tests (K050540)
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 _k050540
Submitter:
UCP Biosciences, Inc 1445 Koll Circle, Ste 111 San Jose, CA 95014 Tel: 408-392-0064 Fax: 408-392-0163
Date:
February 28, 2005
Contact Person:
Dr. Nancy Chen
Trade Name:
UCP Rapid™ Drug Screening Test Strips UCP Rapid™ Drug Screening Test Devices
Common Name:
Amphetamine Test System Barbiturate Test System Benzodiazepine Test System Cocaine and Cocaine Metabolite Test System Methamphetamine Test System (Methamphetamine) Methamphetamine Test System (MDMA) Opiate Test System (Opiates) Methadone Test System Opiate Test System (Oxycodone) Phencyclidine Test System Cannabinoid Test System
Product Code:
DKZ (Amphetamine Test System) DIS (Barbiturate Test System) JXM (Benzodiazepine Test System) DIO (Cocaine Test System) DJC (Methamphetamine Test System) DJC (Methamphetamine Test System -- MDMA)
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Image /page/1/Picture/0 description: The image shows the logo for UCP Biosciences. The logo consists of the letters "UCP" inside of an oval shape. Below the oval, the word "Biosciences" is written in a smaller font.
510(K) Submission for
UCP Rapid ™ Drug Screening Tests (K050540)
DMB (Methadone Test System) DJG (Opiates Test System) DJG (Opiates Test System -- Oxycodone) LCM (Amphetamine Test System-Phencyclidine) LDJ (Cannabinoid Test System)
Regulation Section:
- 21 CFR 862§ 3100 21 CFR 862 § 3150 21 CFR 862 § 3170 21 CFR 862 § 3250 21 CFR 862 § 3610 21 CFR 862 § 3610 (MDMA) 21 CFR 862 § 3620 21 CFR 862 § 3250 21 CFR 862 § 3250 (Oxycodone) 21CFR 862 § 3100 (Phencyclidine) 21 CFR 862 § 3870
Toxicology (91) Panel:
Device Classification: II
Substantially Equivalent Devices:
Product: ACON One Step Drugs of Abuse Tests Manufactured by ACON Laboratories
Product Description:
UCP Rapid TM Drug Screening Tests are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of drugs 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 TM Drug Screening Tests are rapid, qualitative, competitive binding immunoassays and intended for qualitatively the detection of Amphetamine, Barbiturate, Cocaine, Methamphetamine, MDMA, Opiates, Methadone, Oxycodone, Phencyclidine, Marijuana (THC) and their metabolites in human urine at the following cut-off concentrations:
| Amphetamine | 1000 ng/mL |
|---|---|
| Barbiturates | 300 ng/mL |
| Benzodiazepine | 300 ng/mL |
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Image /page/2/Picture/0 description: The image shows a logo for UCP Biosciences. The logo consists of the letters "UCP" stacked on top of each other inside of an oval shape. Below the oval shape, the word "Biosciences" is written in a simple, sans-serif font.
510(K) Submission for UCP Rapid ™ Drug Screening Tests (K050540)
300 ng/mL Cocaine 1000 ng/mL Methamphetamine 300 ng/mL Methadone 500 ng/mL MDMA 300 ng/mL Opiates300 2000 ng/mL Opiates 2000 100 ng/mL Oxycodone 25 ng/mL Phencvclidine 50 ng/mL Cannabinoids
The tests provide only preliminary test results, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical other methous 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 Tests provide the qualitative determination of the same twelve 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 128 clinical specimens per each drug type 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 Rapid™ Drug Screening Tests with ACON One Step Drugs of Abuse Tests. Total 64 positive clinical urine specimens and 64 negative clinical urine specimens were tested against each drug. All test results were confirmed with GC/MS analysis. UCP Rapid™ Drug Screening Tests demonstrated performance of > 96% for all drugs when performance was compared to a legally marketed device and GC/MS.
Other Information about Performance Characteristics:
The performance characteristics of UCP Rapid™ Drug Screening Tests was evaluated by precision study, sensitivity study, specificity and cross reactivity study, interference study and stability study. The study results indicate that UCP
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Image /page/3/Picture/0 description: The image shows the logo for UCP Biosciences. The logo consists of the letters "UCP" inside of an oval shape. Below the oval is the word "Biosciences".
510(K) Submission for UCP Rapid ™ Drug Screening Tests (K050540)
Rapid™ Drug Screening Tests perform satisfactorily when used according to the package inserts.
Conclusion:
Collelusion.
UCP Rapid™ Drug Screening Tests is substantially equivalent to ACON Laboratories One Step Drug of Abuse Tests.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a bird or eagle with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
APR 2 9 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Nancy Chen UCP Biosciences, Inc. 1445 Koll Circle, Suite 111 San Jose, CA 95112
K050540 Re: K0505 10
Trade/Device Name: UCP Rapid™ Drug Screening Test Strips UCP Rapid™ Drug Screening Test Devices Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Regulatory Class: Class: Classis, JXM, LDJ, DIO, DJC, DJR, DJG, LCM Dated: February 28, 2005 Received: March 2, 2005
Dear Ms. Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovened your been mined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered pror to Tria) 2011-07-11 accordance with the provisions of the Federal Food, Drug, de necs mat have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelors, mains of the Act include requirements for annual registration, listing of general controls profice, 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 it may be subject to bach adde 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 r lease oc advised that I Dr ovision that your device complies with other requirements of the Act that I DA has made a acternalations administered by other Federal agencies. You must of any I ederal station and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice of it and 807), accesses of 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) I mis letter will and in your of substantial equivalence of your device to a legally premaired 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 Tou may overnment 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,
Jean M. Cooper, MS, DUM
Jean M. Cooper, MS, D.V.M. 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): K050540 9 ro(K) Nambor (CP Rapid™ Drug Screening Test Strips UCP Rapid™ Drug Screening Test Devices
Indications For Use:
ions For Use.
The UCP Rapid™ Drug Screening Test Strips and UCP Rapid™ Drug Screening T The OOT Trapid - Drug Soroshing rompetitive binding immunoassays for the Test Devious are rapierine, Barbiturate, Benzodiazepine, Cocaine, detection of Amphotamine, Datastes, Methadone, Oxycodone, Phencyclidine, Marijuana and their metabolites in human urine at the following cutoff levels:
| Test | Calibrator | Cut-off |
|---|---|---|
| Amphetamine | D-Amphetamine | 1000 ng/mL |
| Barbiturates | Secobarbital | 300 ng/mL |
| Benzodiazepine | Oxazepam | 300 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Methamphetamine | D-Methamphetamine | 1000 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| MDMA | D, L-MDMA | 500 ng/mL |
| Opiates 300 | Morphine | 300 ng/mL |
| Opiates 2000 | Morphine | 2000 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Phencyclidine | Phencyclidine | 25 ng/mL |
| Cannabinoids | 11-nor-Δ9-THC-9 COOH | 50 ng/mL |
The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical methous buon as gas efessional judgment should be applied to any drug of considerations and proiection when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.
AND/OR Prescription U X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use -(21 CFR 801 Subpart C)
(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-0
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) kos0540
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