The UCP Compact Drug Test Cards and UCP Compact Drug Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of the following drugs and their metabolites in human urine: Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiates 2000, Oxycodone, Phencyclidine, Propoxyphene, Tricyclic Antidepressants. 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 confirmatory testing - the second step in the process, along with the materials for shipping the urine specimen to the laboratory, is provided. The test is also intended for health care professional users. 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 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

Not Found

AI/ML Overview

The provided text describes the UCP Compact Drug Test Cards and Cups, rapid, qualitative, competitive binding immunoassays for detecting various drugs and their metabolites in human urine. The information relevant to acceptance criteria and supporting studies is extracted below.

Acceptance Criteria and Device Performance

The acceptance criteria for each drug are defined by their respective cut-off concentrations. The device's performance is demonstrated by its qualitative detection of these drugs at or above these cut-off levels. The document indicates that the tests will yield preliminary positive results when the prescription drugs [listed] are ingested, even at or above therapeutic doses. This implies the device is performing as intended when it detects the presence of the drug at or above the specified cut-off.

A table summarizing the acceptance criteria (Cut-off) for each drug is provided below. The "Reported Device Performance" column indicates the qualitative detection capabilities as implied by the "Indications for Use" statement.

Test	Calibrator	Acceptance Criteria (Cut-off)	Reported Device Performance
Amphetamine	D-Amphetamine	1000 ng/mL	Detects at or above cut-off
Barbiturates	Secobarbital	300 ng/mL	Detects at or above cut-off
Benzodiazepines	Oxazepam	300 ng/mL	Detects at or above cut-off
Buprenorphine	Buprenorphine	10 ng/mL	Detects at or above cut-off
Cocaine	Benzoylecgonine	300 ng/mL	Detects at or above cut-off
Marijuana	Delta-9-THC-COOH	50 ng/mL	Detects at or above cut-off
Methadone	Methadone	300 ng/mL	Detects at or above cut-off
Methamphetamine	D-Methamphetamine	1000 ng/mL	Detects at or above cut-off
MDMA	MDMA	500 ng/mL	Detects at or above cut-off
Morphine	Morphine	300 ng/mL	Detects at or above cut-off
Opiates 2000	Morphine	2000 ng/mL	Detects at or above cut-off
Oxycodone	Oxycodone	100 ng/mL	Detects at or above cut-off
Phencyclidine	Phencyclidine	25 ng/mL	Detects at or above cut-off
Propoxyphene	Propoxyphene	300 ng/mL	Detects at or above cut-off
Tricyclic Antidepressants	Nortiptyline	1000 ng/mL	Detects at or above cut-off

Study Information

The provided document is an FDA 510(k) clearance letter and an "Indications for Use" form. While it states that the device is "substantially equivalent" to legally marketed predicate devices, it does not include details of specific studies, test sets, or validation methodologies that demonstrate the device meets these acceptance criteria. The information below is not explicitly available in the provided text.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the provided text.
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): Not specified. However, the document mentions that results "should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS)," implying that GC/MS would serve as a confirmatory ground truth method.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.
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 device is a rapid diagnostic test (immunoassay), not an AI-assisted diagnostic tool requiring human reader interpretation in an MRMC study context.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is designed for standalone performance, providing preliminary positive/negative results. However, the document states it's the "first step in a two step process" where confirmatory testing (e.g., GC/MS) is the second step. The performance statistics for this standalone step are not detailed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "Indications for Use" form states that "preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS)." This implies that GC/MS is the intended "gold standard" or ground truth for confirmation.
The sample size for the training set: Not applicable, as this is an immunoassay device, not a machine learning algorithm that requires a "training set."
How the ground truth for the training set was established: Not applicable for the same reason as above.

Summary

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 19, 2013

UCP Biosciences, Inc C/O Nancy Chen 1445 Koll Circle, Ste. 111 SAN JOSE CA 95112

Re: KI31811 Trade/Device Name: UCP Compact Drug Test Cards UPC Compact Drug Test 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: June 21, 2013 Received: June 24, 2013

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. 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 Part 801); 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.

{1}------------------------------------------------

Page 2-Ms. Chen

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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, Ph.D.

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

{2}------------------------------------------------

Indications for Use Form

510(k) Number (if known): K131811

Device Name: UCP Compact Drug Test Cards, UCP Compact Drug Test Cups

Indications for Use:

The UCP Compact Drug Test Cards and UCP Compact Drug Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of 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	Morphine	2000 ng/mL
Oxycodone	Oxycodone	100 ng/mL
Phencyclidine	Phencyclidine	25 ng/mL
Propoxyphene	Propoxyphene	300 ng/mL
Tricyclic Antidepressants	Nortiptyline	1000 ng/mL

Prescription Use	x
(21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use	x
(21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)

Katherine Serrano -S

Division Sign-Off Office of In Vitro Devices and Radiologic Health

510(k)_k131811

{3}------------------------------------------------

Indications for Use Form

510(k) Number (if known): K131811

Device Name: UCP Compact Drug Test Cards, UCP Compact Drug Test Cups

Indications for Use:

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 confirmatory testing - the second step in the process, along with the materials for shipping the urine specimen to the laboratory, is provided. The test is also intended for health care professional users.

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 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.

Prescription Use

And/Or

Over the Counter Use _x _ x

(21 CFR Part 801 Subpart D)

(21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)

Katherine Serrano -S

Division Sign-Off Office of In Vitro Devices and Radiologic Health

510(k) K131811

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).