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.

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.

AI/ML Overview

Acceptance Criteria and Study for Fastep™ At-Home Pregnancy Tests

Here's an analysis of the acceptance criteria and the study conducted for the Fastep™ At-Home Pregnancy Tests (K122907), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity, specificity, or agreement. However, it implicitly uses the performance of the predicate device (Teco Diagnostics One-Step Midstream Pregnancy Test, K974059) and confirmed hCG quantitative levels as benchmarks for substantial equivalence. The reported performance is as follows:

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Agreement with Predicate Device (Lay Users)	"A minimum of 92.7% agreement"	92.7% agreement with Teco Midstream Pregnancy Test (K974059)
Agreement with Confirmed hCG Quantitative Level (Lay Users - Main Study)	"100% agreement"	100% agreement with confirmed hCG quantitative level of tested specimens
Agreement with Confirmed hCG Quantitative Level (Lay Users - Near-cutoff)	"100% agreement"	100% agreement with confirmed hCG quantitative level of tested specimens (at 20 mIU/ml cutoff)
Sensitivity	Not explicitly stated, but implied to detect elevated hCG levels at 20mIU/mL.	Detects elevated levels of hCG at the sensitivity of 20mIU/mL.
Ease of Use/Interpretation by Lay Users	"Easy to use and interpret result by the lay users."	Demonstrated to be "easy to use and interpret result by the lay users." and "clearly understood and accurately interpreted by laypersons at near-cutoff level concentrations."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size:
- Main Accuracy (Consumer) Study: 148 lay users. The number of specimens isn't explicitly stated but would be at least 148 if each user tested one unique specimen. It is more likely that multiple users tested the same set of specimens.
- Additional Lay User (Near-cutoff) Study: 21 laypersons. Again, the number of specimens isn't explicitly stated, but each layperson tested the "dipstick" mode.
Data Provenance: The document does not specify the country of origin of the data. The studies appear to be prospective as they involved active participation by "lay users" performing tests and interpreting results.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The ground truth for the test set was established through "confirmed hCG quantitative measurements." The document does not specify the number of experts involved in performing or interpreting these quantitative measurements, nor their specific qualifications (e.g., medical technologists, lab directors).

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for conflicting interpretations or results from the lay users. The "agreement" percentages are reported directly against the established ground truth (predicate device results or quantitative hCG levels). It implies a direct comparison rather than an adjudication process between multiple readers.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed as described in the provided text. The studies focused on direct performance and agreement of the device, primarily with lay users, against a predicate device and quantitative lab results. There is no information on the effect size of how much human readers improve with AI vs. without AI assistance, as AI is not a component of this device.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance was done in the sense that the device's ability to detect hCG was assessed independently (against quantitative hCG levels) by lay users following instructions. However, it's crucial to understand that this is a chemical immunoassay device, not an AI algorithm. Therefore, "algorithm only" performance, as typically understood in AI/software domains, does not apply here. The "device performance" is its standalone performance without a human-in-the-loop, though human users perform the physical testing and interpretation.

7. Type of Ground Truth Used

The primary ground truth used was quantitative hCG measurements of the urine specimens. This is a definitive laboratory method for determining the presence and concentration of hCG.
For the main accuracy study, the results of the predicate device (Teco Diagnostics One-Step Midstream Pregnancy Test) were also used as a comparative benchmark, implying that the predicate's results were considered a form of "ground truth" for comparison purposes.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here as this is a chemical immunoassay device, not a machine learning or AI-based system that requires a training set.

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

As there is no training set, this question is not applicable.

Summary

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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:

1. Regulation section: 21 CFR § 862.1155, Human Chorionic Gonadotropin (HCG) test system
1. Classification: Class II
1. Product Codes: LCX Kit, test, pregnancy, hCG, Over-the-Counter
1. 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

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Identification / Product Name:

Fastep™ At-Home Pregnancy Tests

Description:

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.

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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.

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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.

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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

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Indications for Use

510(k) Number (if known): K122907

Device Name: Fastep™ At-Home Pregnancy Tests

Indications for Use:

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

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.