(174 days)
Not Found
No
The device description and performance studies focus on a traditional immunoassay method for detecting hCG, with no mention of AI or ML for result interpretation or any other function.
No
The device is an at-home pregnancy test, which is a diagnostic tool, not a therapeutic one. It detects hCG to aid in pregnancy detection but does not treat or alleviate any condition.
Yes
Explanation: The device is designed for the "visual, qualitative detection of human chorionic gonadotropin (hCG) in urine specimen to aid in the early detection of pregnancy," which directly fits the definition of a diagnostic device as it determines the presence of a medical condition (pregnancy).
No
The device description clearly outlines a physical test strip with chemical reagents and plastic housing, indicating it is a hardware-based medical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "visual, qualitative detection of human chorionic gonadotropin (hCG) in urine specimen to aid in the early detection of pregnancy." This involves testing a biological sample (urine) outside of the body to gain information about a physiological state (pregnancy).
- Device Description: The description details the use of "monoclonal antibody reagents" and a "rapid chromatographic immunoassay" to detect a specific analyte (hCG) in a biological specimen (urine). This is a hallmark of in vitro diagnostic tests.
- Testing of Biological Sample: The device is designed to be used with a "urine specimen."
- Purpose: The purpose is to "aid in the early detection of pregnancy," which is a diagnostic purpose.
Therefore, based on the provided information, the Polymed Therapeutics' Fastep™ At-home Pregnancy Test clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Polymed Therapeutics' Fastep™ At-Home Pregnancy Test is a rapid chromatographic immunoassay for the visual, qualitative detection of human chorionic gonadotropin (hCG) in urine specimen to help in the early determination of pregnancy, intended to be distributed for over-the-counter (OTC) setting.
The Polymed Therapeutics' Fastep™ At-home Pregnancy Test is a rapid chromatographic immunoassay for the visual, qualitative detection of human chorionic gonadotropin (hCG) in urine specimen to aid in the early detection of pregnancy. Polymed Therapeutics' Fastep™ At-Home Pregnancy Test is intended to be distributed for Over-the-Counter (OTC) use.
Product codes (comma separated list FDA assigned to the subject device)
LCX Kit, test, pregnancy, hCG, Over-the-Counter
LCX
Device Description
Polymed Therapeutics' Fastep™ At-Home Pregnancy Test utilizes monoclonal antibody reagents to selectively detected elevated levels of hCG in urine specimen at the sensitivity of 20mIU/mL. It is designed to be tested in midstream and dipstick mode. The Fastep™ At-Home Pregnancy Test consists of a single test strip encased in plastic device housing, with an absorbent tip. The result is generated by immersing the tip in the urine stream or urine cup for a sufficient amount of time to absorb an adequate sample volume. Each test reagent strip consists of a mouse monoclonal anti-a-hCG antibody coated membrane and a dried chemical pad containing mouse monoclonal anti-ß-hCG anybody colloidal gold conjugate. The control antibodies are goat anti-mouse IgG.
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 (OTC) setting / lay users
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
Accuracy (consumer) study: 148 lay users, urine specimens were confirmed indirectly through quantitative hCG measurements.
Lay user study: 21 laypersons, tested the "dipstick" mode, confirmed hCG quantitative level of tested specimens.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Internal and external performance studies and evaluation.
Accuracy (consumer) study: 148 lay users, indicating a minimum of 92.7% agreement compared with Teco Midstream Pregnancy Test (K974059) and 100% agreement compared with confirmed hCG quantitative level of tested specimens.
Additional lay user study: 21 laypersons, 100% agreement compared with confirmed hCG quantitative level of tested specimens (at 20 mIU/ml cutoff).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Teco Diagnostics One-Step Midstream Pregnancy Test (K974059)
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.
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 AS REQUIRED BY SECTION 807.92(C)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92(C)
The Assigned 510(k) number is: K122907
Date of Summary: March 12th, 2013
Common Name: hCG (Human Chorionic Gonadotropin) Pregnancy Midstream Test
Regulatory Information:
-
- Regulation section: 21 CFR § 862.1155, Human Chorionic Gonadotropin (HCG) test system
-
- Classification: Class II
-
- Product Codes: LCX Kit, test, pregnancy, hCG, Over-the-Counter
-
- Panel: Clinical Chemistry (75)
Applicant and Initial Importer:
Polymed Therapeutics, Inc. 3040 Post Oak Blvd., Ste 1110 Houston, TX 77056 Tel.: (713) 777-7088, Fax: (713) 777-7091
Contact Persons:
Primary Contact: Mrs. Feng-Yu Lee Correspondent for this Application Polymed Therapeutics, Inc. c/o IVDD Regulatory Consultant 27001 La Paz Road Suite 266B Mission Viejo, CA 92691 Tel: (949) 951-3046; Fax: (949) 951-2042 fengvulee@ivddreg.com
Alternate Only:
Terri Wallace Polymed Therapeutics, Inc 3040 Post Oak Blvd., Ste 1110 Houston, TX 77056 Tel .: (713) 777-7088, Fax: (713) 777-7091 terri@polymedt.com
1
Identification / Product Name:
Fastep™ At-Home Pregnancy Tests
Description:
Polymed Therapeutics' Fastep™ At-Home Pregnancy Test utilizes monoclonal antibody reagents to selectively detected elevated levels of hCG in urine specimen at the sensitivity of 20mIU/mL. It is designed to be tested in midstream and dipstick mode. The Fastep™ At-Home Pregnancy Test consists of a single test strip encased in plastic device housing, with an absorbent tip. The result is generated by immersing the tip in the urine stream or urine cup for a sufficient amount of time to absorb an adequate sample volume. Each test reagent strip consists of a mouse monoclonal anti-a-hCG antibody coated membrane and a dried chemical pad containing mouse monoclonal anti-ß-hCG anybody colloidal gold conjugate. The control antibodies are goat anti-mouse IgG.
Intended Use:
The Polymed Therapeutics' Fastep™ At-Home Pregnancy Test is a rapid chromatographic immunoassay for the visual, qualitative detection of human chorionic gonadotropin (hCG) in urine specimen to help in the early determination of pregnancy, intended to be distributed for over-the-counter (OTC) setting.
Substantial Equivalence (Predicate Kit):
Teco Diagnostics One-Step Midstream Pregnancy Test is used as predicate device for Polymed Therapeutics' At-Home Pregnancy Test to compare their performance of required studies. The clinical urine specimens used for midstream and dipstick accuracy study were confirmed indirectly through quantitative hCG measurements.
510(k) numbers for predicate device is: Teco Diagnostics One-Step Midstream Pregnancy Test (K974059)
Performance:
The product performance characteristics of Polymed Therapeutics' Fastep™ At-Home Pregnancy Test were assessed through internal and external performance studies and evaluation. An accuracy (consumer) study was performed using 148 lay users, indicating a minimum of 92.7% agreement compared with Teco Midstream Pregnancy Test (K974059) and 100% agreement compared with confirmed hCG quantitative level of tested specimens.
An additional lay user study was performed to demonstrate that intended users can correctly interpret test results with hCG concentrations around the cutoff level of the device (20 mIU/ml). 21 laypersons performed the study, each testing the "dipstick" mode by following the testing and reading result instructions of our package insert, and indicated 100% agreement compared with confirmed hCG quantitative level of tested specimens.
2
Conclusion:
.. The results of evaluated studies demonstrate the substantial equivalency- between Polymed Therapeutics' Fastep"M At-Home Pregnancy Test and the Predicate kit. It is demonstrated that Polymed Therapeutics' Fastep" At-Home Pregnancy Test is safe and effective in detecting human chorionic gonadotropin (hCG) in urine sample to aid in the early determination of pregnancy, it is easy to use and interpret result by the lay users. Additionally, it is demonstrated that the Fastep ™ At-Home Pregnancy Test are able to be clearly understood and accurately interpreted by laypersons at near-cutoff level concentrations.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The logo is black and white and appears to be a scanned image.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14, 2013
Polymed Therapeutics, Inc. c/o Feng-Yu Lee IVDD Regulatory Consultant 27001 La Paz Rd, Suite 266B Mission Viejo, CA 92691
Re: K122907
Trade/Device Name: Fastep™ At-Home Pregnancy Tests Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: II Product Code: LCX Dated: January 31, 2013 Received: February 07, 2013
Dear Feng-Yu Lee:
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.
4
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/CDRH/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
CarolG.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
5
Indications for Use
510(k) Number (if known): K122907
Device Name: Fastep™ At-Home Pregnancy Tests
Indications for Use:
The Polymed Therapeutics' Fastep™ At-home Pregnancy Test is a rapid chromatographic immunoassay for the visual, qualitative detection of human chorionic gonadotropin (hCG) in urine specimen to aid in the early detection of pregnancy.
Polymed Therapeutics' FastepTM At-Home Pregnancy Test is intended to be distributed for Over-the-Counter (OTC) use.
Prescription Use (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 Diagnostics and Radiological Health (OIR)
Denise Johnson-lyles -S 2013.03.14 10:51:18 -04'00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K122907