(130 days)
Not Found
No
The device description details a rapid chromatographic immunoassay based on immunochromatographic technology and the double antibody sandwich method, which are standard biochemical detection methods and do not involve AI or ML. There is no mention of AI, ML, or related concepts in the provided text.
No.
This device is for the detection of HCG to aid in the early detection of pregnancy, not for therapeutic purposes.
Yes
The device is described as a "rapid chromatographic immunoassay for the qualitative detection of Human Chorionic Gonadotrophin (HCG) in urine samples to aid in the early detection of pregnancy," which directly indicates its use for diagnosing pregnancy.
No
The device description clearly outlines physical components like glass fiber strips, membranes, and colloidal gold, indicating it is a hardware-based immunoassay test, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "qualitative detection of Human Chorionin (HCG) in urine samples to aid in the early detection of pregnancy". This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide diagnostic information (detection of pregnancy).
- Device Description: The description details the mechanism of action, which is a "rapid chromatographic immunoassay". This is a common method used in IVD tests to detect specific substances in biological samples.
- Sample Type: The device uses "urine samples", which are biological specimens.
- Purpose: The purpose is to "aid in the early detection of pregnancy", which is a diagnostic purpose.
- User: The device is intended for both "professional and home users", which is typical for many IVD tests, especially those for common conditions like pregnancy.
The definition of an In Vitro Diagnostic (IVD) device generally includes devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device fits that definition perfectly.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
LCX, JHI
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.
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
Professional and home users (for Strip and Cassette formats); Home users (for Midstream I and Midstream II formats)
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
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
KI23050
SIO(K) SUMMARY
January 28, 2013
FEB 0 5 2013
- Date:
-
- 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
- Submitter:
- 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:
Acon Laboratories, Inc.
ACON® One Step Pregnancy Test Device,
6. Intended Use:
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.
7. 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
1
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) for | ||
| Use | 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) for | ||
| Use | 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
2
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.
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.
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.
3
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.
4
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
5
Indications for Use
510(k) Number (if known): K123050
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)
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
6
Indications for Use
510(k) Number (if known): K123050
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)
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)_