(234 days)
Looking at the provided text, there are no K/DEN numbers listed under "Predicate Device(s)". The section states "Not Found".
Not Found
No
The summary describes a standard immunochromatographic assay for pregnancy detection, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
This device is an in vitro diagnostic (IVD) test used to detect pregnancy, not a device intended for treating a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the devices are "in vitro diagnostic" assays designed to "aid in the early detection of pregnancy," which is a diagnostic purpose.
No
The device descriptions clearly indicate physical test strips, cassettes, and midstream tests, which are hardware components used for in vitro diagnostic testing. There is no mention of software as the primary or sole component.
Yes, all three devices described are explicitly stated to be IVDs (In Vitro Diagnostics) in their "Intended Use / Indications for Use" sections.
Here's why:
- Pregnancy One Step Rapid Test Strip: The text states "The Pregnancy One Step Rapid Test Strip is an in vitro diagnostic visual qualitative immunochromatographic assay..."
- Pregnancy One Step Rapid Test Cassette: The text states "The Pregnancy One Step Rapid Test Cassette is an in vitro diagnostic visual qualitative immunochromatographic assay..."
- Pregnancy One Step Rapid Midstream Test: The text states "The Pregnancy One Step Rapid Midstream Test is an in vitro diagnostic visual qualitative immunochromatographic assay..."
The definition of an IVD is a medical device that is used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. These devices fit that description as they analyze urine to detect hCG for pregnancy.
N/A
Intended Use / Indications for Use
The Pregnancy One Step Rapid Test Strip is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. For professional use only.
The Pregnancy One Step Rapid Test Cassette is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. For professional use only.
The Pregnancy One Step Rapid Midstream Test is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. For OTC self-testing use.
Product codes
LCX
Device Description
Not Found
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
For professional use only; For OTC self-testing use.
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Zhejiang Orient Gene Biotech Co., Ltd. c/o Gary Lehnus 150 Cherry Lane Rd. East Stroudsburg, PA 18301
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
JUL 2 8 2011
Re: K103574
Trade/Device Name: Pregnancy One Step Rapid Test (Strip), (Cassette), (Midstream) Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (I-ICG) Test System Regulatory Class: Class II Product Code: LCX Dated: 21 July 2011 Received: 26 July 2011
Dear Mr. Lehnus:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
1
Page 2 --
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 Diagnostic Device Evaluation and Safety 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-fre ne (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.
Sincerely yours,
C.C.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
ﺗﺮﮐﺰ ﭘﺎ
Enclosure
2
Indications for Use
510(k) Number (if known):
Pregnancy One Step Rapid Test (Strip) Device Name:
Indications For Use:
The Pregnancy One Step Rapid Test Strip is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. For professional use only.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OIVD)
Rute Charles
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103574
Page 1 of 3
3
Indications for Use
510(k) Number (if known):
Device Name: ___ Pregnancy One Step Rapid Test (Cassette)
Indications For Use:
The Pregnancy One Step Rapid Test Cassette is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. For professional use only.
Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OIVD)
Rute Club
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 103574
4
Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
The Pregnancy One Step Rapid Midstream Test is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. For OTC self-testing use.
AND/OR Over-The-Counter Use X Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OIVD)
Rute Choster
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103574