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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the UCP Drug Test Mini Cups, a rapid, qualitative, competitive binding immunoassay for detecting various drugs and their metabolites in human urine. It describes the device, its intended use, and performance characteristics compared to a predicate device.

Here's an analysis based on your requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present "acceptance criteria" in a table format with corresponding "reported device performance" in a manner typical for a standalone AI/device study. Instead, it states that the performance was established in a predicate submission and that verification studies were conducted for the modified device (smaller cup size). These verification studies are described as having "demonstrated that UCP Drug Test Mini Cups performs satisfactorily when used according to the package inserts."

However, we can infer the acceptance criteria from the nature of the device (a qualitative drug test) and the fact that its performance was deemed satisfactory by the FDA for substantial equivalence. The key performance characteristics for such a device typically revolve around accuracy (sensitivity and specificity relative to a gold standard like GC/MS at specific cut-off levels), precision, and reproducibility. While specific numerical criteria are not listed, the document states:

"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, Tricyclic Antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level."

Performance Characteristic	Acceptance Criteria (Inferred)	Reported Device Performance
Accuracy	Detect presence/absence of drugs/metabolites at specified cut-off levels (e.g., 50% positive at cut-off, <50% below, >50% above). Preliminary positive results for certain prescription drugs at therapeutic doses.	"UCP Drug Test Mini Cups performs satisfactorily when used according to the package inserts." "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." "The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level."
Precision	Consistent results across replicates and different levels of analyte.	Mentioned as a "precision study" conducted to support the modification, with satisfactory results. Specific quantitative results are not provided.
Reproducibility	Consistent results across different manufacturing lots.	Mentioned as an "inter lots reproducibility study" conducted to support the modification, with satisfactory results. Specific quantitative results are not provided.
Sensitivity	Ability to correctly identify positive samples at or above the cut-off.	Mentioned as a "sensitivity study" conducted to support the modification, with satisfactory results. Specific quantitative results are not provided. The device aims to detect drugs at the specified cut-off concentrations (e.g., Marijuana: 50 ng/mL, Cocaine: 300 ng/mL, etc.).
pH and Specific Gravity	Performance maintained across various pH and specific gravity levels of urine.	Mentioned as a "pH and specific gravity study" conducted to support the modification, with satisfactory results. Specific quantitative results are not provided.
Lay User Performance	Ability for OTC users to correctly perform the test and interpret results according to instructions.	Mentioned as a "lay users study" conducted; "satisfactory" results are implied by the overall conclusion of substantial equivalence for OTC use. The package insert provides information for consumers on the two-step process (initial screening, then confirmatory lab test). The summary emphasizes the preliminary nature of the results and the need for professional judgment.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states, "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."

Test Set Sample Size: Not explicitly stated in this summary. The summary refers to the predicate submission (K130463) for the primary analytical performance data. For the verification studies related to the cup size modification, specific sample sizes are not provided.
Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be laboratory-based analytical studies and a lay user study, which are typically prospective in nature for performance verification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is a drug test kit, not an imaging device typically requiring expert interpretation for ground truth.

Number of Experts & Qualifications: Not applicable in the same way as an imaging study. The "ground truth" for drug detection is typically established through confirmatory laboratory methods, such as Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS)." This implies that GC/MS would be the reference method for determining the true presence or absence of drugs/metabolites at the cut-off levels in the urine samples used for validation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable in the context of this device. Adjudication methods like 2+1 or 3+1 refer to agreement among multiple human readers for an imaging study. For a diagnostic test like this, performance is typically assessed against a definitive laboratory reference method (GC/MS).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a standalone diagnostic test kit (an immunoassay), not an AI system intended to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, this is essentially a standalone device. The UCP Drug Test Mini Cups is a qualitative, competitive binding immunoassay that provides a visual result (line appears or doesn't appear). While a human interprets the visual result, the device itself is a chemical assay, and its performance is evaluated based on its ability to produce correct results given a sample, independent of ongoing human intervention in the assay process. The "lay users study" assesses the human-in-the-loop aspect of over-the-counter use, but the analytical performance (sensitivity, specificity, precision) is intrinsic to the device's chemical reactions.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The type of ground truth used for such drug tests is confirmatory laboratory methods, specifically Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS)." This is the gold standard for drug detection in urine.

8. The sample size for the training set

This device is not an AI/machine learning algorithm, so there is no "training set" in the conventional sense of AI development. The device's design and parameters (e.g., antibodies, cut-off levels) are established through research and development, but not through an iterative learning process on a large training dataset.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for an AI model. The parameters of the immunoassay are determined through biochemical principles and established analytical chemistry.

Summary

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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.

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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

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

1. Date the summary was prepare: July 8, 2015
1. Submitter's Name: UCP Biosciences, Inc
1. Submitter's Address: 1445 Koll Circle, STE 111, San Jose, CA 95112
1. 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

1. Classification
  Product Code: DKZ, DIO, DIS, JXM, DJC, DJR, DJG, LCM, LDJ, LFG, JXN

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:

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

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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.

Regulation Number and Section

§ 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).