(190 days)
Not Found
No
The device description and performance studies indicate a simple chromatographic immunoassay without any mention of computational analysis, image processing, or AI/ML terms.
No
The device is described as a diagnostic tool for detecting pregnancy, not for treating or preventing any disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device aids in "the early detection of pregnancy," which is a diagnostic purpose. The device is also referred to as a "rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine," a key biomarker for pregnancy diagnosis.
No
The device description explicitly states it is a "rapid chromatographic immunoassay" and can be performed "without the use of an instrument," indicating it is a physical test strip/cassette, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy." This is a diagnostic purpose performed on a biological sample (urine).
- Device Description: It describes a "rapid chromatographic immunoassay for qualitatively detection of the elevated hCG in urine." This is a laboratory test method performed outside of the body.
- Sample Type: The test uses urine specimens.
- Performance Studies: The document describes performance studies conducted using urine specimens to evaluate the device's accuracy in detecting hCG.
All of these characteristics align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality.
N/A
Intended Use / Indications 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.
Product codes
LCX, JHI
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over the Counter Use Only or Prescription Use Only including at point of care sites.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 25 mIU/mL
Specificity: No interferences when tested with LH, FSH and TSH
Predicate Device(s)
The Quik-Check Home Pregnancy Test Device (K012215)
Reference Device(s)
Not Found
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).
Not Found
§ 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.
0
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
1
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:
2
| t
| S | able | 4 | |
|---|---|---|---|
| Table 1 | ||
|---|---|---|
| Parameter | UCP Home Pregnancy Test, | |
| UCP Pregnancy Test | ||
| (Candidate Device) | The Quik-Check Home | |
| Pregnancy Test Device | ||
| (Predicate Device) | ||
| Intended Use | Qualitative detection of hCG in | |
| human urine to aid in early | ||
| detection of pregnancy | Qualitative detection of | |
| hCG in human urine to aid | ||
| in early detection of | ||
| pregnancy | ||
| Format | Midstream, Dip Card/Strip, | |
| Cassette | Strip, Cassette | |
| Test Principle | Chromatographic immunoassay, | |
| Lateral flow | Chromatographic | |
| immunoassay, Lateral flow | ||
| Test Time | 3 minutes | 3 minutes |
| 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 | ||
| Standardization | WHO Fourth International Standard | WHO Third International |
| Standard |
:
3
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)
4
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
5
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
6
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 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.
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
7
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