(396 days)
Not Found
No
The description details a standard immunochromatographic assay for detecting hCG, with no mention of AI or ML components or processes.
No
The device is an early pregnancy test, which is a diagnostic device used to detect pregnancy, not to treat a medical condition.
Yes
An early pregnancy test that detects human Chorionic Gonadotropin (hCG) in urine is a diagnostic device because it identifies the presence of a specific biological marker to determine a physiological state (pregnancy).
No
The device description explicitly states it consists of a plastic housing and test stick containing an immunochromatographic strip, which are physical hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "qualitative detection of human Chorionic Gonadotropin (hCG) in urine." This is a test performed on a sample taken from the human body (urine) to provide information about a physiological state (pregnancy).
- Device Description: The description details the components and how it works using an "immunochromatographic strip" and antibodies to detect hCG. This is a common method used in IVD tests.
- Over-the-counter: While it's an over-the-counter device, it still falls under the definition of an IVD as it's used to diagnose a condition (pregnancy) using a biological sample.
The fact that it's an over-the-counter test for detecting a substance in a bodily fluid for diagnostic purposes firmly places it in the category of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
QuikResponse™ One Step Midstream Early Pregnancy Test is an over-the-counter urine hCG test which is intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine. The test detects pregnancy hormone, in some cases as early as 3 days before the expected period.
Product codes (comma separated list FDA assigned to the subject device)
LCX
Device Description
The device consists of a plastic housing and test stick containing an immunochromatographic strip. The test pad contain colloidal gold conjugate with mouse monoclonal antibodies against beta subunit of hCG and test strip contain mouse monoclonal antibody against alpha subunit of hCG ( test line )and goat antimouse polyclonal antibodies ( Control line ). The device is intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine, in some cases as early as 3 days before the expected period.
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
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
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: K112449
Type of 510(k) Submission: Traditional
Submitter:
Tianjin New Bay Bioresearch Co., Ltd. #1 Jian She Rd, Ba Li Tai Industry Area Jin Nan District, Tianjin, China Telephone: 86-22-28751515 Facsimile: 86-222-875-1516
Contact Person:
Hann Ping Wang Ph.D. Regulatory Consultant 5230 Via Primaria Yorba Linda, CA 92886
Land line: 714-693-0301 Cell: 714-686-2081 Email: hannpingwang@sbcglobal.net
Preparation Date:
January 11, 2011
Device Information:
Trade or Proprietary Name: QuikResponse™ One Step Midstream Early Pregnancy Test
Common/Usual Name:
Lateral flow immunochromatographic assay for detection of human chorionic gonadotropin in human urine
Device Classification Name: Immunoassay of human chorionic gonadotropin
Regulatory Name: Human chorionic gonadotropin (hCG) Test System
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. Regulation Section: 21 CFR § 862. 1155
Regulatory Class: Class II
Product Code: LCX
Panel: Chemistry (75)
Predicate Devices:
QuikResponse™ One Step Midstream Early Pregnancy Test device test is substantially equivalent to the Firstresponse Pregnancy Test cleared by FDA (K030258) for its stated intended use.
Device Description:
The device consists of a plastic housing and test stick containing an immunochromatographic strip. The test pad contain colloidal gold conjugate with mouse monoclonal antibodies against beta subunit of hCG and test strip contain mouse monoclonal antibody against alpha subunit of hCG ( test line )and goat antimouse polyclonal antibodies ( Control line ). The device is intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine, in some cases as early as 3 days before the expected period.
Intended Use:
QuikResponse™ One Step Midstream Early Pregnancy Test is an over-the-counter urine hCG test which is intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine. The test detects pregnancy hormone, in some cases as early as 3 days before the expected period.
Comparison to Predicate Device(s):
Both devices (QuikResponse™ One Step Midstream Early Pregnancy Test device and Firstresponse Pregnancy Test) are for the qualitative determination of the human chorionic gonadotropin. Both test devices are single use devices.
Summary:
The information provided in this pre-market notification demonstrates that QuikResponse™ One Step Midstream Early Pregnancy Test device is substantially equivalent to Firstresponse Pregnancy Test. 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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three swooping lines representing its wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
10903 New Hampshire Avenue Silver Spring, MD 20993
Tianjin New Bay Bioresearch Co., Ltd. c/o Biosource Technology Hann-Ping Wang, Ph. D, Regulatory Consultant 5230 Via Primaria Yorba Linda, CA 92886
SEP
24 2012
Re: K112449
QuikResponse™M One Step Midstream Early Pregnancy Test Trade/Device Name: Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: September 7, 2012 Received: September 11, 2012
Dear Dr. Wang:
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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
Q. M. B. B.
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (K112449):
Device name: QuikResponse™ One Step Midstream Early Pregnancy Test.
Indications for Use:
QuikResponse™ One Step Midstream Early Pregnancy Test is an over-the-counter urine hCG test which is intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine. The test detects pregnancy hormone, in some cases as early as 3 days before the expected period.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
R. Chula
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
K112449 510(k)