EGENS One Step HCG Urine Pregnancy Test Kit (Strip) is a rapid chromatographic immunoassay for the qualitative detection of Human Chorionin (HCG) in urine samples to aid in the early detection of pregnancy by both professional and home users.

EGENS One Step HCG Urine Pregnancy Test Kit (Cassette) is a rapid chromatographic immunoassay for the qualitative detection of Human Chorionic Gonadotrophin (HCG) in urine samples to aid in the early detection of pregnancy by both professional and home users.

EGENS One Step HCG Urine Pregnancy Test Kit (Midstream I) is a rapid chromatographic immunoassay for the qualitative detection of Human Choric Gonadotrophin (HCG) in urine samples to aid in the early detection of pregnancy by home users.

EGENS One Step HCG Urine Pregnancy Test Kit (Midstream II) is a rapid chromatographic immunoassay for the qualitative detection of Human Chorionic Gonadotrophin (HCG) in urine samples to aid in the early detection of pregnancy by home users.

Device Description

One Step HCG Urine Pregnancy Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine for the early detection of pregnancy. HCG is produced by the placenta shortly after the embryo attaches to the uterine lining. This test is capable of detecting pregnancy the first day after a missed period. As pregnancy progresses, higher levels of HCG are present in urine at concentrations of 25mlU/ml (Milli-International Units) or greater. The concentration of HCG in non-pregnant women is normally 5.0mlU/ml. At the time of the last missed menstrual period, urine HCG levels are about 100mlU/ml with peak levels of 100,000 to 200,000mlU/ml. The test devices are in four different formats: Strip, Cassette, Midstream I , and Midstream II .

The HCG assay is a rapid one-step test based on immunochromatographic technology. This device is composed of glass fiber strips of the monoclonal antibody against HCG, anti-mouse IgG, solid cellulose nitrate membrane, and the bonders of absorptive colloidal gold - monoclonal antibody against HCG. It adopts the principles of the double antibody sandwich method and imunochromatography technology to test for the presence of HCG in urine.

AI/ML Overview

This document describes a regulatory submission (K123050) for the EGENS One Step HCG Urine Pregnancy Test Kit. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.

The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies against explicitly defined acceptance criteria as might be found in a clinical trial report or a standalone performance study.

Here's a breakdown of why this information is largely absent from the provided text, and what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in terms of quantitative targets. The "Cut Off Values" are 25 mIU/mL, which is a key performance parameter, but not an "acceptance criterion" for a study.
Reported Device Performance: Not provided in the form of sensitivity, specificity, accuracy, or other metrics from a clinical study. The document states that the EGENS kits "have similar technological characteristics and performances to the predicate," but no specific performance data is presented.

2. Sample Size for Test Set and Data Provenance:

This information is not provided in the document. Substantial equivalence claims often rely on analytical performance comparisons and equivalence in design and intended use, rather than extensive clinical efficacy studies, especially for well-established diagnostic categories like HCG tests.

3. Number of Experts and Qualifications:

This information is not applicable/not provided. The document is a regulatory submission for a medical device cleared via the 510(k) pathway, which typically does not involve human expert adjudication of results in the way, for example, an imaging AI system might.

4. Adjudication Method:

Not applicable/not provided for the reasons stated above.

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

No, this was not done. MRMC studies are typically for complex diagnostic tasks often involving human interpretation (e.g., radiology, pathology) where AI assistance can be quantitatively measured. This device is a simple, qualitative immunoassay.

6. Standalone (Algorithm Only) Performance Study:

The device itself is a standalone test. However, the document does not present a formal "standalone performance study" report with metrics like sensitivity, specificity, etc. It simply describes the device's function and claims substantial equivalence. The analytical performance (e.g., limit of detection, cross-reactivity) would have been assessed by the manufacturer as part of their design validation, but these detailed results are not in this public summary.

7. Type of Ground Truth Used:

Inferred: The ground truth for HCG tests is typically established by using known concentrations of HCG (e.g., from WHO International Standard 3rd Edition as mentioned for traceability) in urine samples, and possibly clinical correlation with documented pregnancies or absence thereof. However, the document does not explicitly state how ground truth was established for any performance evaluation.

8. Sample Size for Training Set:

Not applicable/not provided. This device is a biochemical immunoassay, not an AI/machine learning algorithm that requires a "training set."

9. How Ground Truth for Training Set was Established:

Not applicable/not provided for the same reasons as #8.

Summary Table (Based on what can be extracted or inferred, and explicitly noting what is missing):

Information Category	Details from Document
1. Table of Acceptance Criteria & Reported Device Performance	Acceptance Criteria (Key Performance Parameter):
Parameter	Criterion (Inferred/Stated)
Cut Off Value	25 mIU/mL
Reported Performance:	The document states, "EGENS one step HCG urine pregnancy test kits have similar technological characteristics and performances to the predicate." No specific performance metrics (e.g., sensitivity, specificity, accuracy) from a study are provided in this summary. The substantial equivalence claim is based on matching the predicate's intended use, format, test type, specimen type, cut-off values, and traceability.
2. Sample Size (Test Set) & Data Provenance	Not provided. This document does not detail a specific clinical or analytical study with a defined test set sample size or provenance.
3. Number & Qualifications of Experts for Ground Truth	Not applicable/Not provided. This type of qualitative test does not typically involve human expert adjudication for ground truth and the public summary does not mention any such process.
4. Adjudication Method	Not applicable/None mentioned.
5. MRMC Comparative Effectiveness Study	No. This is a rapid immunoassay, not a system requiring human interpretation with or without AI assistance.
6. Standalone Performance Study (Algorithm Only)	The device itself is a standalone test. However, the regulatory submission summary does not contain the detailed results of a standalone performance study (e.g., full sensitivity, specificity, or accuracy data). It relies on the claim of substantial equivalence to a predicate device.
7. Type of Ground Truth Used	Inferred: Likely involved samples with known HCG concentrations (traceable to WHO International Standard 3rd Edition) and/or clinically confirmed pregnancy status. Not explicitly stated how ground truth was established for any specific performance testing referenced in the submission (if such testing results were included in the full submission, but not in this summary).
8. Sample Size for Training Set	Not applicable. This device is a rapid chromatographic immunoassay, not an AI/machine learning system.
9. How Ground Truth for Training Set was Established	Not applicable.

Summary

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KI23050

SIO(K) SUMMARY

January 28, 2013

FEB 0 5 2013

Date:

1. Submitter:
  NanTong EGENS Biotechnology Co., Ltd. Building 15. Building 12( west) , No. 1692 Xinghu Avenue, Nantong Economy & Technology Development Zone, 226010 Nantong, P.R CHINA Telephone:+85 513-85920700 Fax:0513-85328020

Name of contact person:

Joe Xia LSI International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20878 Telephone: 301-250-0831 Fax: 301-916-6213 Email:jxia@lsi-consulting.org

Device Name:

EGENS One Step HCG Urine Pregnancy Test Kit (Strip) EGENS One Step HCG Urine Pregnancy Test Kit (Cassette) EGENS One Step HCG Urine Pregnancy Test Kit (Midstream I) EGENS One Step HCG Urine Pregnancy Test Kit (Midstream II)

Classification: All are Class II medical devices with the following various product codes with Code of Federal Regulation references:

Product Code	CFR #
LCX	21 CFR, 862.1155
JHI	21 CFR, 862.1155

5. Predicate Devices:

K993317

Acon Laboratories, Inc.

ACON® One Step Pregnancy Test Device,

6. Intended Use:

7. Device Description:

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the first day after a missed period. As pregnancy progresses, higher levels of HCG are present in urine at concentrations of 25mlU/ml (Milli-International Units) or greater. The concentration of HCG in non-pregnant women is normally 5.0mlU/ml. At the time of the last missed menstrual period, urine HCG levels are about 100mlU/ml with peak levels of 100,000 to 200,000mlU/ml. The test devices are in four different formats: Strip, Cassette, Midstream I , and Midstream II .

8. Substantial Equivalence Information

A summary comparison of the features of the One Step HCG Urine Pregnancy Test Kit (Strip), One Step HCG Urine Pregnancy Test Kit (Cassette), One Step HCG Urine Pregnancy Test Kit (Midstream I), One Step HCG Urine Pregnancy Test Kit (Midstream II), and the predicate devices is shown in the following Tables.

Features Comparison of One Step HCG Urine Pregnancy Test Kit (Strip, Cassette, Midstream II) and the Predicate Devices

Item	Device	Predicate - K993317
Indication(s) forUse	For the qualitative determination of hCG in urine.	Same
User	Prescription and over the counter	Prescription
Format	Strip, cassette	cassette
Type of Test	Colloidal Gold Immunoassay	Same
Specimen Type	Human Urine	Same
Cut Off Values	25 mIU/mL	Same
Traceability	WHO International Standard 3rd Edition	Same

Item	Device	Predicate - K993317
Indication(s) forUse	For the qualitative determination of hCG in urine.	Same
User	over the counter	Prescription
Format	midstream	cassette
Type of Test	Colloidal Gold Immunoassay	Same
Specimen Type	Human Urine	Same
Cut Off Values	25 mIU/mL	Same
Traceability	WHO International Standard 3rd Edition	Same

EGENS one step HCG urine pregnancy test kits have similar technological characteristics and performances to the predicate.

9. Standard/Guidance Document Reference

ISO 14971:2007, Medical Devices-Application of Risk Management to Medical Devices .

10. Test Principle

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One Step HCG Urine Pregnancy Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine for the early detection of pregnancy. During pregnancy, HCG is produced by the placenta shortly after the embryo attaches to the uterine lining. This test is capable of detecting pregnancy the first day after a missed period. As pregnancy progresses, higher levels of HCG are present in urine at concentrations of 25mlUml (Milli-International Units) or greater. The concentration of HCG in non-pregnant women is normally 5.0mlU/ml. At the time of the last missed menstrual period, urine HCG levels are about 100mlU/ml with peak levels of 100,000 to 200,000mlU/ml.

11. Summary

The information provided in this pre-market notification demonstrates that EGENS One Step HCG Unine Pregnancy Test Kit (Strip), EGENS One Step HCG Urine Pregnancy Test Kit (Cassette), EGENS One Step HCG Urine Pregnancy Test Kit (Midstream I) and EGENS One Step HCG Urine Pregnancy Test Kit (Midstream II) are substantially equivalent to ACON® One Step Pregnancy Test Device. Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available and analytical predicate devices. The information supports substantial equivalence to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

EGENS Biotechnology c/o Joe Xia Regulatory Affairs 12828 Doe Lane Gaithersburg, Maryland 20878

FEB 0 5 2013

Re: K123050

Trade/Device Name: EGENS One Step HCG Urine Pregnancy Test Kit (Strip) EGENS One Step HCG Urine Pregnancy Test Kit (Cassette) EGENS One Step HCG Urine Pregnancy Test Kit (Midstream I) EGENS One Step HCG Urine Pregnancy Test Kit (Midstream II)

Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX, JHI Dated: January 28, 2013 Received: January 30, 2013

Dear Mr. Xia,

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.

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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Page 2 - Joe Xia

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.

Sincerely yours, C. Benson 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): K123050

Device Name:

..............................................................................................................................................................................

Indications for Use:

EGENS One Step HCG Urine Pregnancy Test Kit (Strip) is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine samples to aid in the early detection of pregnancy by both professional and home users.

EGENS One Step HCG Urine Pregnancy Test Kit (Cassette) is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine samples to aid in the early detection of pregnancy by both professional and home users.

EGENS One Step HCG Urine Pregnancy Test Kit (Midstream I) is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine samples to aid in the early detection of pregnancy by home users.

(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

2013.02.05 12:43:18 -05'00'

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K123050

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Indications for Use

510(k) Number (if known): K123050

Device Name:

Indications for Use:

EGENS One Step HCG Urine Pregnancy Test Kit (Midstream II) is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine samples to aid in the early detection of pregnancy by home users.

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 Diagnostics and Radiological Health (OIR)

Denise Johnson-lyles -5 2013.02.05 12:43:41 -05'00'

Division Sign-Off

Office of In Vitro Diagnostics and Radiological Health

K123050 510(k)_

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.