UCP Pregnancy Cassette Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Prescription Use Only including at point of care sites.

UCP Pregnancy Dip Card/Strip is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Prescription Use Only including at point of care sites.

UCP Home Pregnancy Cassette Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

UCP Home Pregnancy Midstream Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

UCP Home Pregnancy Dip Card/Strip is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

Device Description

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Parameter	Acceptance Criteria (from Predicate Device)	Reported Device Performance (UCP Home/Pregnancy Test)
Sensitivity	25 mIU/mL	25 mIU/mL
Specificity	No interferences when tested with LH, FSH and TSH	No interferences when tested with LH, FSH and TSH
Agreement (Professional vs. Professional)	Not explicitly stated, but predicate performance is the benchmark.	100% agreement with predicate device results
Agreement (Lay User vs. Professional)	Not explicitly stated, but high agreement is implied for OTC use.	100% agreement between lay users and professionals for UCP Home Pregnancy Tests
Ease of Use/Interpretation (Lay User)	Not explicitly stated, but essential for OTC.	Participant responses support easy understanding of instructions and interpretation of results.

Study Proving Device Meets Acceptance Criteria:

The document describes several studies to demonstrate the safety and effectiveness of the UCP Home Pregnancy Tests/UCP Pregnancy Tests, thereby showing it meets the acceptance criteria (primarily by demonstrating substantial equivalence to the predicate device).

2. Sample Size and Data Provenance:

Test Set Sample Size: 100 urine specimens.
Data Provenance: The document does not explicitly state the country of origin. It indicates that the specimens were collected from "100 women who fit into the following categories: childbearing age, suspected pregnant women, women early in pregnancy, and the first trimester of pregnancy." The study appears to be prospective in the sense that the collection of specimens and testing were part of this specific comparison study.

3. Number and Qualifications of Experts for Ground Truth:

Number of Experts: Not explicitly stated, but "lab professionals" are mentioned as performing testing for both the candidate and predicate devices. It is implied that these professionals are the "experts" in this context.
Qualifications of Experts: "Lab professionals" are mentioned. No further specific qualifications (e.g., years of experience, specific certifications) are provided.

4. Adjudication Method for the Test Set:

The document implies a direct comparison, stating "There was 100% agreement between UCP Home Pregnancy Test results by lay users and by the professionals. The results were also 100% in agreement between UCP Home Pregnancy Tests/UCP Pregnancy Tests and the predicate device results tested by the professionals." This suggests a direct comparison method rather than a formal adjudication process (like 2+1 or 3+1). The predicate device's results, as interpreted by lab professionals, served as the primary benchmark.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done in the sense of evaluating how much human readers improve with AI assistance. This device is a rapid chromatographic immunoassay (a "stick test") for qualitative detection of hCG, not an AI-powered diagnostic imaging or analysis system that would typically be evaluated with MRMC studies.
However, there was a comparison of "readers" – specifically, lay users versus lab professionals – to assess the ease of use and interpretation for the Over-The-Counter (OTC) versions of the device. This is a different type of "reader" evaluation.

6. Standalone (Algorithm Only) Performance Study:

The concept of a "standalone (algorithm only)" study is not applicable here because the device is a physical, chemical immunoassay, not an algorithm. The device itself is the "standalone" component in its intended use. The performance characteristics (sensitivity, specificity, precision, etc.) were established for the device itself.

7. Type of Ground Truth Used:

The primary ground truth appears to be expert consensus / established clinical practice as demonstrated by the predicate device's results when interpreted by "lab professionals."
Implicitly, the presence of hCG in the urine specimens (from "suspected pregnant women, women early in pregnancy, and the first trimester of pregnancy") serves as the underlying clinical truth.

8. Sample Size for the Training Set:

The concepts of "training set" and "test set" are typically used for machine learning algorithms. For this type of immunoassay, there isn't a "training set" in the machine learning sense. The "training" or development of the device would involve biochemical formulation and optimization, not data-driven algorithm training.
The document describes "comparison studies" using 100 urine specimens as the "test set" for performance evaluation against the predicate.

9. How Ground Truth for the Training Set Was Established:

As there is no "training set" in the AI/ML context for this device, this question is not applicable. The development and calibration of the assay would rely on established biochemical principles and standards (e.g., WHO Fourth International Standard for hCG).

Summary

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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 K131236

Submitter: UCP Biosciences, Inc

1445 Koll Circle, Ste 111

San Jose, CA 95014

Tel: 408-392-0064

Fax: 408-392-0163

November 1, 2013 Date:

Contact Person: Dr. Nancy Chen

Trade Name: UCP Home Pregnancy Midstream Test .

UCP Home Pregnancy Dip Card/Strip .

UCP Home Pregnancy Cassette Test

UCP Pregnancy Dip Card/Strip .

UCP Pregnancy Cassette Test .

Common Name: Pregnancy Test

Product Code: LCX, JHI

Regulation Section: 21 CFR §862.1155

Panel: Clinical Chemistry (75)

Device Classification: II

Predicate Device: The Quik-Check Home Pregnancy Test Device (K012215)

Product Description:

UCP Home Pregnancy Test and UCP Pregnancy Test is a rapid chromatographic immunoassay for qualitatively detection of the elevated hCG in urine. The tests can be performed without the use of an instrument.

NOV 0 7 2013

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Intended Use:

See Indications For Use.

Indication For Use

UCP Home Pregnancy Cassette Test is rapid chromatographic immunoassay for . the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Over the Counter Use Only.
. UCP Home Pregnancy Dip Card/Strip is rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Over the Counter Use Only.
. UCP Home Pregnancy Midstream Test is rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Over the Counter Use Only.
. UCP Pregnancy Cassette Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Prescription Use Only including at point of care sites.
. UCP Pregnancy Dip Card/Strip is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The device is intended for Prescription Use Only including at point of care sites.

Comparison to Predicate Devices:

A summary comparison of the features of the UCP Home Pregnancy Test. UCP Pregnancy Test and ACON's The Quik-Check Home Pregnancy Test Device is provided in Table 1 as the following:

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tS		able	4

Table 1
Parameter	UCP Home Pregnancy Test,UCP Pregnancy Test(Candidate Device)	The Quik-Check HomePregnancy Test Device(Predicate Device)
Intended Use	Qualitative detection of hCG inhuman urine to aid in earlydetection of pregnancy	Qualitative detection ofhCG in human urine to aidin early detection ofpregnancy
Format	Midstream, Dip Card/Strip,Cassette	Strip, Cassette
Test Principle	Chromatographic immunoassay,Lateral flow	Chromatographicimmunoassay, Lateral flow
Test Time	3 minutes	3 minutes
Sensitivity	25 mIU/mL	25 mIU/mL
Specificity	No interferences when tested withLH, FSH and TSH	No interferences when testedwith LH, FSH and TSH
Standardization	WHO Fourth International Standard	WHO Third InternationalStandard

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Safety and Effectiveness Data:

Comparison/Consumer Studies:

Comparison studies between UCP Home Pregnancy Tests/UCP Pregnancy Tests and a predicate device were conducted by the lab professionals, using 100 urine specimens collected from 100 women who fit into the following categories: childbearing age, suspected pregnant women, women early in pregnancy, and the first trimester of pregnancy. Each urine specimen was tested by the lab professionals, who performed testing by using UCP Home Pregnancy Tests/UCP Pregnancy Tests and a predicate device. In addition, 100 lay users also tested the urine specimens by using UCP Home Pregnancy Tests. There was 100% agreement between UCP Home Pregnancy Test results by lay users and by the professionals. The results were also 100% in agreement between UCP Home Pregnancy Tests/UCP Pregnancy Tests and the predicate device results tested by the professionals. The lay users were asked the questions including whether the test was easy to run, the results were easy to read, the test results were easy to read. Participant responses support that the lay users can understand how to run the test, interpret the test results by properly following the test instruction.

Other Information about Performance Characteristics:

The performance characteristics of UCP Home Pregnancy Tests/UCP Pregnancy Tests including the precision study, sensitivity study, specificity and cross reactivity study, interference study and stability study have been also established. The results have demonstrated that UCP Home Pregnancy Tests/UCP Pregnancy Tests performs satisfactorily when used according to the package inserts.

Conclusion:

The performance data in this submission supports UCP Home Pregnancy Midstream Test, UCP Home Pregnancy Dip Card/Strip, UCP Home Pregnancy Cassette Test, UCP Pregnancy Dip Card/Strip, and UCP Pregnancy Cassette Test is substantially equivalent to the predicate device The Quik-Check Home Pregnancy Test (K012215)

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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 eagle with three wavy lines extending from its body, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol.

Public Health Service

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

November 7, 2013

UCP Biosciences, Inc. C/O Nancy Chen 1445 Koll Circle, Suite 111 SAN JOSE CA 951-12

Re: K131236

Trade/Device Name: UCP Pregnancy Cassette Test UCP Pregnancy Dip/Card Strip UCP Home Pregnancy Cassette Test UCP Home Pregnancy Midstream Test UCP Home Pregnancy Dip/Card Strip Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (hCG) test system Regulatory Class: II Product Code: LCX. JHI Dated: August 12, 2013 Received: August 15, 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 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 (OS) regulation (21 CFR Part 820); and if applicable, the

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Page 2—Ms. Chen

electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1 050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its bitement address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm Also, plaaress 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Carol C. Benson -S for

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): K131236

Device Name: UCP Pregnancy Cassette Test UCP Pregnancy Dip Card/Strip UCP Home Pregnancy Cassette Test UCP Home Pregnancy Midstream Test

UCP Home Pregnancy Dip Card/Strip

Indications for Use:

Prescription Use _ X _

And/Or Over the Counter Use _________________________________________________________________________________________________________________________________________________________

(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 Diagnostics and Radiological Health (OIR)

Denise Johnson-lyles -S

Division Sign-Off

Office of In Vitro Diagnostics and Radiological Health

510(k) ki31236

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Indications for Use

510(k) Number (if known): K131236

Device Name: UCP Pregnancy Cassette Test UCP Pregnancy Dip Card/Strip UCP Home Pregnancy Cassette Test UCP Home Pregnancy Midstream Test UCP Home Pregnancy Dip Card/Strip

Indications for Use:

UCP Home Pregnancy Cassette Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

UCP Home Pregnancy Midstream Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

UCP Home Pregnancy Dip Card/Strip is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

Prescription Use __

And/Or

Over the Counter Use 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 Diagnostics and Radiological Health (OIR)

Denise Johnson-lyles -S

Division Sign-Off

Office of In Vitro Diagnostics and Radiological Health

510(k)_k131236

Regulation Number and Section

§ 862.1155 Human chorionic gonadotropin (HCG) test system.

(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.